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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Aciloc™ contains the active substance omeprazole. It belongs to a group of medicines called ‘proton 
pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
Aciloc™ is used to treat the following conditions:
In adults:
• Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the 
gullet (the tube which connects your throat to your stomach) causing pain, inflammation and 
heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, 
your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Aciloc™ can also 
be used to stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
In children:
Children over 1 year of age and ≥ 10 kg
• ‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the 
gullet (the tube which connects your throat to your stomach) causing pain, inflammation and 
heartburn.
In children, the symptoms of the condition can include the return of stomach contents into the 
mouth (regurgitation), being sick (vomiting) and poor weight gain.
Children and adolescents over 4 years of age
• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, you                                                                
infection and allow the ulcer to heal.


• If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of
Aciloc™.
• If you are allergic to medicines containing other proton pump inhibitors (eg pantoprazole,
lansoprazole, rabeprazole, esomeprazole.
• If you are taking a medicine containing nelfinavir (used for HIV infection)
If you are not sure, talk to your doctor or pharmacist before taking Aciloc™.
Take special care with Aciloc™
Aciloc™ may hide the symptoms of other diseases. Therefore, if any of the following
happen to you before you start taking Aciloc™ or while you are taking it, talk to your
doctor straight away:
• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
• You experience severe or persistent diarrhoea, as omeprazole has been associated with a
small increase in infectious diarrhoea.
• You have severe liver problems.
If you take Aciloc™ on a long-term basis (longer than 1 year) your doctor will probably
keep you under regular surveillance. You should report any new and exceptional symptoms
and circumstances whenever you see your doctor.
Taking a proton pump inhibitor like Aciloc™, especially over a period of more than one
year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if
you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).


Recent reports revealed an increased number of cases diagnosed with clostridium difficileassociated
diarrhea (CDAD). In certain number of studies, both conditions were found to be
significantly associated with the use of PPIs in hospitalized or non-hospitalized patients.
However, some studies did not find link between the CDAD with PPIs administration
although the influencing factors are controlled.

Observational studies found association between use of PPIs and development of CDAD.
All studies discussed the rate and risk of CDAD among PPIs users. It was clearly stated in
some studies that CDAD is more likely to be associated with PPIs consumption, however,
some studies indicated that the risk measurements do not yield a significant association
between CDAD and PPIs. The duration of therapy with PPIs found to be unrelated to
CDAD episodes.


Seek immediate care if you use PPIs and develop diarrhea that does not improve. This may
be a sign of Clostridium difficile-associated diarrhea (CDAD).
Do not stop taking your prescription PPI drug without talking to your healthcare
professional.

Subacute cutaneous lupus etythematosus (SCLE):
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur,
especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient
should seek medical help promptly and the health care professional should consider
stopping this medication. SCLE after previous treatment with a proton pump inhibitor may
increase the risk of SCLE with other proton pump inhibitors.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. This is because Aciloc™
can affect the way some medicines work and some medicines can have an effect on
Aciloc™.
Do not take Aciloc™ if you are taking a medicine containing nelfinavir (used to treat HIV
infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to
monitor you when you start or stop taking Aciloc™.
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers.
Your doctor may need to monitor you when you start or stop taking Aciloc™.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (in cases of organ transplantation).
• St John’s wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi).
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as
Aciloc™ to treat ulcers caused by Helicobacter pylori infection, it is very important that
you tell your doctor about any other medicines you are taking.
Taking Aciloc™ with food and drink
You can take your capsules with food or on an empty stomach.

Pregnancy and breast-feeding
Before taking Aciloc™, tell your doctor if you are pregnant or trying to get pregnant. Your
doctor will decide whether you can take Aciloc™ during this time.

Your doctor will decide whether you can take Aciloc™ if you are breast-feeding.

Driving and using machines
Aciloc™ is not likely to affect your ability to drive or use any tools or machines.
Side effects such as dizziness and visual disturbances may occur (see section 4). If affected,
you should not drive or operate machinery.

Important information about some of the ingredients of Aciloc™
Aciloc™ capsules contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.


Always take Aciloc™ exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Your doctor will tell you how many capsules to take and how long to take them for. This
will depend on your condition and how old you are.
The usual doses are given below.
Adults:
To treat symptoms of GORD such as heartburn and acid regurgitation:
• If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual
dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg
for a further 8 weeks if your gullet has not yet healed.
To treat ulcers in the upper part of the intestine (duodenal ulcer):
• The usual dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the
same dose for a further 2 weeks if your ulcer has not yet healed.
• If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcer):
• The usual dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the
same dose for a further 4 weeks if your ulcer has not yet healed.
• If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.
To prevent the duodenal and stomach ulcers from coming back:
• The usual dose is 20 mg once a day. Your doctor may increase the dose to 40 mg once a
day.
To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs):
• The usual dose is 20 mg once a day for 4–8 weeks.
To prevent duodenal and stomach ulcers if you are taking NSAIDs
• The usual dose is 20 mg once a day.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
• The usual dose is 20 mg Aciloc™ twice a day for one week.
• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin
and metronidazole.
To treat too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison syndrome):

• The usual dose is 60 mg daily.
• Your doctor will adjust the dose depending on your needs and will also decide how long
you need to take the medicine for.
Children:
To treat symptoms of GORD such as heartburn and acid regurgitation:
• Children over 1 year of age and with a body weight of more than 10 kg may take
Aciloc™. The dose for children is based on the child’s weight and the doctor will decide the
correct dose.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
• Children aged over 4 years may take Aciloc™. The dose for children is based on the
child’s weight and the doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for
your child.
Taking this medicine
• It is recommended that you take your capsules in the morning.
• You can take your capsules with food or on an empty stomach.
• Swallow your capsules whole with half a glass of water. Do not chew or crush the
capsules. This is because the capsules contain coated pellets which stop the medicine from
being broken down by the acid in your stomach. It is important not to damage the pellets.
What to do if you or your child have trouble swallowing the capsules
• If you or your child have trouble swallowing the capsules:
- Open the capsules and swallow the contents directly with half a glass of water or put the
contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or
pineapple) or apple sauce.
- Always stir the mixture just before drinking it (the mixture will not be clear). Then drink
the mixture straight away or within 30 minutes.
- To make sure that you have drunk all of the medicine, rinse the glass very well with half a
glass of water and drink it. The solid pieces contain the medicine do not chew or crush
them.
If you take more Aciloc™ than you should
If you take more Aciloc™ than prescribed by your doctor, talk to your doctor or pharmacist
straight away.
If you forget to take Aciloc™
If you forget to take a dose, take it as soon as you remember it. However, if it is almost time
for your next dose, skip the missed dose. Do not take a double dose to make up for a
forgotten dose.


Like all medicines, Aciloc™ can cause side effects, although not everybody gets them.

If you notice any of the following rare but serious side effects, stop taking Aciloc™ and contact a 
doctor immediately:

• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties 
in swallowing (severe allergic reaction).

• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in 
the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic 
epidermal necrolysis’.

• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

Other side effects include:

Common side effects (affects 1 to 10 users in 100)

• Headache.              

• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, 
   wind (flatulence).    

• Feeling sick (nausea) or being sick (vomiting).

  Uncommon side effects (affects 1 to 10 users in 1,000)

• Swelling of the feet and ankles.          

• Disturbed sleep (insomnia).

• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.

• Spinning feeling (vertigo).

• Changes in blood tests that check how the liver is working.

• Skin rash, lumpy rash (hives) and itchy skin.

• Generally feeling unwell and lacking energy.

   Rare side effects (affects 1 to 10 users in 10,000)

• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, 
   bruising or make infections more likely.

• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, 
   fever, wheezing.

• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.  • 
   Feeling agitated, confused or depressed.  

• Taste changes.

• Eyesight problems such as blurred vision.

• Suddenly feeling wheezy or short of breath (bronchospasm).

• Dry mouth.   • An inflammation of the inside of the mouth.

• An infection called “thrush” which can affect the gut and is caused by a fungus.

• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.

• Hair loss (alopecia).   • Skin rash on exposure to sunshine.

• Joint pains (arthralgia) or muscle pains (myalgia).

• Severe kidney problems (interstitial nephritis).  

• Increased sweating.

  Very rare side effects (affects less than 1 user in 10,000)

• Changes in blood count including agranulocytosis (lack of white blood cells).

• Aggression.    

• Seeing, feeling or hearing things that are not there (hallucinations).

• Severe liver problems leading to liver failure and inflammation of the brain.

• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high 
  fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). 
• Muscle weakness. • Enlarged breasts in men.

  Not known (frequency cannot be estimated from the available data)

• If you are on Aciloc™ for more than three months it is possible that the levels of magnesium in 
your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle 
contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of 
these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a 
reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular 
blood tests to monitor your levels of magnesium.

Aciloc™ may in very rare cases affect the white blood cells leading to immune deficiency. If you 
have an infection with symptoms such as fever with a severely reduced general condition or fever 
with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in 
urinating, you must consult your doctor as soon as possible so that a lack of white blood cells 
(agranulocytosis) can be ruled out by a blood test. It is important for you to give information 
about your medicine at this time.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious,

or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


• Keep out of the reach and sight of children.
• Do not store above 30 °C.
• Do not use Aciloc™ after the expiry date which is stated on the pack after EXP.
• Store this blister in the original package.
• Medicines should not be disposed of via wastewater or household waste. Ask your
   pharmacist how to dispose of medicines no longer required. These measures will help to
   protect the environment.


The active substance is omeprazole. Aciloc™ hard gastro-resistant capsules
(gastro-resistant capsules) contain 20 mg or 40 mg of omeprazole.
- The other ingredients are mannitol, sucrose, disodium hydrogen phosphate, sodium lauryl
sulphate, lactose, calcium carbonate, hydroxy propyl methyl cellulose, methacrylic acid
L30D, propylene glycol, diethyl pthalate, cetyl alcohol, sodium hydroxide, tween 80,
PVPK-30, talc, titanium dioxide, erythrosine (FD&C red no.3), quinoline yellow (D&C
yellow no.10), brilliant blue FCF (FD&C Blue no.1 ), allura red (FD&C red no.40), sunset
yellow (FD&C yellow no.6) and gelatin.


• Aciloc™ 20 mg capsules: A brown opaque cap and light brown opaque body, hard gelatin capsules printed with 'Jamjoom' on cap and 'Aci 20' on body in black, filled with white to pale yellow colored spherical pellets. • Aciloc™ 40 mg capsules: A brown opaque cap and light brown opaque body, hard gelatin capsules printed with 'Jamjoom' on cap and 'Aci 40' on body in black, filled with white to pale yellow colored spherical pellets. Aciloc™ 20 mg comes in packs of 7 & 14 & 28 capsules. Aciloc™ 40 mg comes in packs of 7 & 14 & 28 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Jamjoom Pharmaceuticals Co., Jeddah, Saudi Arabia.
Tel: +966-12-6081111, Fax: +966-12-6081222.
Website: www.jamjoompharma.com
To report any side effect(s):
• Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc


05/2013
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يحتوي أسيلوك على أوميبرازول كمادة فعالة وهي تنتمي إلى فئة من الأدوية تسمى "مثبطات مضخة البروتون"
وهي تعمل على تقليل كمية الحمض الذي تنتجه المعدة.
لعلاج الحالات الآتية: ™ يستخدم أسيلوك
للبالغين:
- الارتجاع المعدي المريئي حيث يهرب الحمض من داخل المعدة إلى المرئ (قناة تصل بين المعدة والحلق) مما
يسبب الألم والالتهاب وحرقة المعدة.
- قرحة في الجزء العلوي من الأمعاء (الإثنا عشر) أو المعدة.
- القرح التي تسببها عدوى بكتيريا تسمى (هيليكوباكتر بايلوري). إذا كنت مصابا بهذه الحالة فمن الممكن أن يصف
الطبيب لك مضادا حيويا لعلاج العدوى ومن ثم يمكن للقرحة ان تلتئم.
يمكن لأسيلوكأن يوقف - القرح التي تسببها فئة من الأدوية تسمى الأدوية غير الستيرودية والمضادة للالتهاب .
تكون القرح إذا كنت تستخدم الأدوية غير الستيرودية والمضادة للالتهاب.
- زيادة إفراز الحمض في المعدة الذي يسببه ورم في البنكرياس (متلازمة زولينجر إليسون).
للأطفال:
الأطفال الأكبر من عام و يزنون ۱۰ كجم أو أكثر
- الارتجاع المعدي المريئي حيث يهرب الحمض من داخل المعدة إلى المرئ (قناة تصل بين المعدة والحلق) مما
يسبب الألم والالتهاب وحرقة المعدة.
قد تشتمل الأعراض عند الأطفال على ارتجاع محتوى المعدة داخل الفم (الاجترار)، الشعور بالغثيان (القئ)،
انخفاض معدل زيادة الوزن.
الأطفال الأكبر والمراهقين الأكبر من ٤ أعوام
- القرح التي تسببها عدوى بكتيريا تسمى (هيليكوباكتر بايلوري). إذا كان طفلك مصابا بهذه الحالة فمن الممكن أن
يصف الطبيب له مضادا حيويا لعلاج العدوى ومن ثم يمكن للقرحة ان تلتئم.

 

لا تستخدم أسيلوك إذا:
 - إذا كنت تعاني من فرط الحساسية ضد أوميبرازول أو أي مكون آخر من مكونات أسيلوك
- إذا كان لديك حساسية تجاه أي دواء آخر يحتوي علي مثبطات مضخة البروتون مثل بانتوبرازول، لانسوبرازول،
رابيبرازول، ايسوميبرازول.
- إذا كنت تستخدم دواء يحتوي علي مادة نيلفينافير [تستخدم في حالات فيروس نقص المناعة المكتسب (الإيدز)].
™ إذا كنت غير متأكد استشر طبيبك أو الصيدلي قبل استخدامك أسيلوك
استخدم أسيلوك بحذر إذا:
من الممكن أن يخفي أسيلوك أعراض الأمراض الأخرى ولذلك إذا حدث لك أي شئ من الأشياء التالية بمجرد بدء 
استخدام الدواء أو أثناء استخدامه استشر طبيبك علي الفور:
- لاحظت فقدان الوزن بدون سبب ومشاكل في البلع.
- ألم في المعدة او عسر الهضم.
- إذا بدأت في تقيؤ الطعام او الدم.
- كان لون البراز أسود (براز مخضب بالدم).
- إذا أصبت بإسهال شديد أو مستمر حيث أن أوميبرازول يكون مصحوب بزيادة في حدوث الإسهال المعدي.
- كان لديك مشاكل حادة في الكبد.
على المدى الطويل ، خصوصا لو كان ذلك لفترة أطول من عام، فمن المحتمل ان يضعك ™ إذا قمت باستخدام أسيلوك
الدكتور تحت الملاحظة المنتظمة باستمرار. يجب عليك إبلاغ الطبيب عند زيارته عن أي أعراض أو ظروف جديدة
أو استثنائية.
أظهرت التقارير الأخيرة زيادة في عدد الحالات التي تم تشخيصها مع المطثية العسيرة المصحوبة بالإسهال
في عدد معين من الدراسات، تم العثور على كل من الشروط التي يجب أن يرتبط بشكل كبير مع استخدام .(CDAD)
مثبطات مضخة البروتون في المرضى في المستشفى أو في غير المستشفيات. ومع ذلك، فإن بعض الدراسات لم تجد
مع إستخدام مثبطات مضخة البروتون على الرغم من تثبيت العوامل المؤثرة. CDAD صلة بين
ناقشت جميع الدراسات .CDAD وجدت الدراسات الرصدية ارتباط بين استخدام مثبطات مضخة البروتون وتطور
CDAD بين مستخدمي مثبطات مضخة البروتون. وذكر بوضوح في بعض الدراسات أن CDAD معدل وخطر
من المرجح أن تترافق مع استهلاك مثبطات مضخة البروتون، ومع ذلك، أشارت بعض الدراسات إلى أن قياسات
و مثبطات مضخة البروتون. ووجد أن لا علاقة بين مدة العلاج مع CDAD الخطر لم تسفر وجود صلة واضحة بين
.CDAD مثبطات مضخة البروتون و نوبات
التماس الرعاية الفورية إذا كنت تستخدم مثبطات مضخة البروتون وتطور الإسهال الذي لا يتحسن. فقد يكون هذا
.(CDAD) علامة على المطثية العسيرة المصحوبة بالإسهال
الموصوفة لك دون التحدث الى مقدم الرعاية الصحية (PPI) لا تتوقف عن استخدام مثبطات مضخة البروتون
الخاص بك.
تناول الأدوية الأخرى
يرجى إخبار الطبيب حول أي أدوية أخرى تتناولها حاليا أو تناولتها منذ فترة وجيزة بما في ذلك الأدوية التي قمت
من الممكن أن يؤثر في طريقة عمل بعض الأدوية الأخرى ™ باستخدامها دون وصفة طبيبة وهذا بسبب أن أسيلوك
™ كما يمكن لبعض الأدوية الأخرى أن تؤثر في طريقة عمل أسيلوك
إذا كنت تستخدم دواء يحتوي على مادة نيلفينافير [تستخدم في حالات فيروس نقص المناعة ™ لا تتناول أسيلوك
المكتسب (الإيدز)].
أخبر طبيبك أو الصيدلي إذا كنت تتناول أي من الأدوية التالية:
- كيتوكونازول، ايتراكونازول، فوريكونازول (تستخدم لعلاج عدوى الفطريات).
- ديجوكسين (يستخدم لعلاج مشاكل القلب).
- ديازيبام (يستخدم في علاج القلق، باسط للعضلات، الصرع).
- فينيتوين (يستخدم في علاج الصرع). إذا كنت تستخدم فينيتوين سيحتاج الطبيب لوضعك تحت الملاحظة بعد توقفك
™ عن تناول أسيلوك
- الأدوية التي تستخدم لتمييع الدم ومنع تخثره مثل الوارفارين أو حاصرات فيتامين ك الأخرى. سيحتاج الطبيب
™ لوضعك تحت الملاحظة بعد توقفك عن تناول أسيلوك
- ريفامبيسين (يستخدم لعلاج السل).
- أتازانافير [يستخدم في حالات فيروس نقص المناعة المكتسب (الإيدز)].
- تاكروليماس (في حالات زرع الأعضاء).
- نبتة سنات جونز او حشيشة القلب (هايبريكام بيرفوراتام) (تستخدم في علاج الاكتئاب البسيط).
- سيلوستازول (يستخدم في علاج العرج المتقطع).
- ساكوينافير[يستخدم في حالات فيروس نقص المناعة المكتسب (الإيدز)].
- كلوبيدوجريل (يمنع تكون جلطات الدم).
لعلاج القرحة الناتج ™ إذا وصف لك الطبيب مضاد حيوي مثل الأموكسيسيللين أو الكلاريثرومايسين بجانب أسيلوك
عن بكتيريا الهيليكوباتر بايلوري، من المهم جدا أن تخبر طبيبك حول الأدوية الأخرى التي تتناولها.
مع الطعام والشراب ™ تناول أسيلوك
يمكنك أن تتناول كبسولات الدواء مع الطعام أو على معدة خالية.
الحمل والإرضاع
قبل استخدام أسيلوك يرجى إخبار الطبيب إذا كنتِ حاملاً أو تخططين للحمل. سيقرر الطبيب إمكانية تناول أسيلوك ™ من عدمه في هذا الوقت.
سيقرر الطبيب إمكانية تناول أسيلوك من عدمه إذا كنتِ مرضعة.  
قيادة المركبات وتشغيل الآلات
على قدرتك على قيادة المركبات أو تشغيل المعدات. ™ من غير المحتمل أن يؤثر أسيلوك
قد تحدث بعض الآثار الجانبية مثل الدوخة أو اضطراب في الرؤية وفي هذه الحالات يجب الامتناع عن قيادة
السيارات أو تشغيل الآلات.
معلومات هامة حول بعض مكونات أسيلوك
تحتوي كبسولات أسيلوك علي اللاكتوز. إذا كان قد تم إخبارك بواسطة طبيبك عن أنك لديك حساسية ضد بعض 
السكريات فيجب عليك استشارة الطبيب قبل استخدام هذا الدواء

https://localhost:44358/Dashboard

يجب أن يكون تناول أسيلوك وفقا لما يخبرك به الطبيب. يجب عليك مراجعة الطبيب أو الصيدلي إذا لم تكن متأكدا.  
سيخبرك الطبيب عن عدد الكبسولات التي ستتناولها والمدة التي ستتناول فيها الدواء. سيتوقف ذلك على حالتك وعلى
عمرك.
الجرعات الاعتيادية موضحة بالأسفل.
البالغين:
لعلاج أعراض الارتجاع المعدي المريئي مثل حرقة المعدة واجترار الحمض:
- إذا وجد طبيبك أن قناة الطعام (المرئ) قد أصابها بعض التلف تكون الجرعة الاعتيادية هي ۲۰ ملجم مرة واحدة في
۸ أسابيع. من الممكن أن يصف لك الطبيب جرعة ٤۰ ملجم لمدة ۸ أسابيع أخرى في حالة عدم التئام - اليوم ولمدة ٤
المرئ.
لعلاج قرح الجزء العلوي من الأمعاء (قرحة الاثنا عشر):
- الجرعة الاعتيادية هي ۲۰ ملجم مرة واحدة في اليوم ولمدة أسبوعين. من الممكن أن يصف لك الطبيب نفس
الجرعة لمدة أسبوعين آخرين في حالة عدم التئام القرحة.
- إذا لم تلتئم القرحة بشكل كامل يمكن زيادة الجرعة إلى ٤۰ ملجم مرة واحدة في اليوم ولمدة ٤ أسابيع.
لعلاج قرحة المعدة:
- الجرعة الاعتيادية هي ۲۰ ملجم مرة واحدة في اليوم ولمدة ٤ أسابيع. من الممكن أن يصف لك الطبيب نفس
الجرعة لمدة ٤ أسابيع أخرى في حالة عدم التئام القرحة.
- إذا لم تلتئم القرحة بشكل كامل يمكن زيادة الجرعة إلى ٤۰ ملجم مرة واحدة في اليوم ولمدة ۸ أسابيع.
لمنع عودة حدوث قرحة المعدة والاثني عشر:
- الجرعة الاعتيادية هي ۲۰ ملجم مرة واحدة يوميا. قد يزيد الطبيب الجرعة لتصبح ٤۰ ملجم مرة واحدة يوميا.
لعلاج قرحة المعدة والاثنى عشر التي تتسبب فيها الأدوية غير الستيرودية والمضادة للالتهاب:
۸ أسابيع. - - الجرعة الاعتيادية هي ۲۰ ملجم مرة واحدة يوميا لمدة ٤
لمنع عودة حدوث قرحة المعدة والاثني عشر التي تتسبب فيها الأدوية غير الستيرودية والمضادة
للالتهاب:
- الجرعة الاعتيادية هي ۲۰ ملجم مرة واحدة يوميا
لعلاج القرح التي تتسبب فيها بكتيريا هيليكوباكتر بايلوري ولمنع عودة حدوثها مرة أخرى:
- الجرعة الاعتيادية هي ۲۰ ملجم مرتين يوميا ولمدة أسبوع.
- سيصف لك الطبيب أيضا استخدام اثنين من المضادات الحيوية: أموكسيسيللين، كلاريثرومايسن، ميترونيدازول.
لعلاج فرط إفراز الحمض داخل المعدة بسبب ورم في البنكرياس (متلازمة زولينجر إيليسون):
- الجرعة الاعتيادية هي ٦۰ ملجم يوميا
- سيقوم الطبيب بتعديل الجرعة وفقا لحالتك واحتياجك وسيحدد أيضا الفترة التي ستستمر في تناول الدواء خلالها.

الأطفال:
لعلاج أعراض الارتجاع المعدي المريئي مثل حرقة المعدة واجترار الحمض:
تعتمد الجرعة في هذه الحالة علي .™ - الأطفال الاكبر من عام ويزنون اكثر من ۱۰ كجم من الممكن أن يتعاطوا أسيلوك
وزن الطفل ويقوم الطبيب بتحديد الجرعة الصحيحة.
لعلاج القرح التي تتسبب فيها بكتيريا هيليكوباكتر بايلوري ولمنع عودة حدوثها مرة أخرى:
الأطفال الأكبر من ٤ أعوام من الممكن أن يتعاطوا أسيلوك تعتمد الجرعة في هذه الحالة علي وزن الطفل ويقوم 
الطبيب بتحديد الجرعة الصحيحة.
- سيصف الطبيب لطفلك استخدام اثنين من المضادات الحيوية هما أموكسيسيللين، كلاريثرومايسن.
تناول هذا الدواء
- ينصح بتناول هذه الكبسولات عند الصباح.
- يمكنك تناول الكبسولات مع الطعام أو على معدة خالية.
- ابلع كامل الكبسولة مع نصف كوب من الماء. لا تمضغ أو تطحن الكبسولة وهذا بسبب أن هذه الكبسولة تحتوي على
كريات مغلفة تحمي الدواء من أن يتم تكسيره بواسطة الحمض في المعدة. من المهم أن لا تقوم بإتلاف هذه الكريات.
ماذا تفعل إذا كان لديك أو لدى طفل مشاكل في بلع الكبسولات؟
إذا كان لديك أو لدى طفلك مشاكل في بلع الكبسولات.
- افتح الكبسولة وابتلع محتوياتها مباشرة مع نصف كوب من الماء، أو ضع محتوياتها في كوب من الماء (غير الغازي)
أو أي عصير حامضي مثل البرتقال أو التفاح أو الأناناس أو صوص التفاح.
- دائما قم بتقليب الخليط (الخليط لن يكون نقيا) ثم قم بشرب الخليط مباشرة أو خلال ۳۰ دقيقة.
- للتأكد من أنك قمت ببلع كامل كمية الدواء قم بشطف الكوب بنصف كوب من الماء بشكل جيد ثم اشربه. الأجزاء
الصلبة تكون محتوية علي دواء.لا تقم بتحطيمها أو مضغها.
إذا تناولت أسيلوك بكمية أكثر مما ينبغي  
إذا تناولت أسيلوك بكمية أكثر مما وصفه لك الطبيب، اتصل بطبيبك أو الصيدلي فوراً.  
 إذا نسيت أن تتناول أسيلوك
إذا نسيت موعد الجرعة فقم بتناولها فور أن تتذكر، فإذا كان موعد الجرعة التالية قد حان فقم بالغاء الجرعة التي نسيتها.
لا تتناول ضعف الجرعة لكي تعوض الجرعة الفائتة

يمكن لأسيلوك أن يتسبب في تأثيرات جانبية ولكنها لا تصيب كل الأشخاص. ™ كما هو الحال مع كل الأدوية.
 إذا لا حظت ظهور أي من الأعراض الجانبية التالية النادرة والخطيرة توقف عن استخدام أسيلوكواتصل بالطبيب
على الفور:
- صفير مفاجئ، تورم (الشفاة، اللسان، الحلق، الجسم)، طفح جلدي، إغماء، صعوبة في البلع (تفاعل تحسسي حاد).
- احمرار الجلد مع وجود بثور أو تقشر. من الممكن أيضا ان يكون هناك بثور حادة ونزيف في الشفاة، العيون، الفم،
الأنف، الأعضاء التناسلية. من الممكن أن يكون ذلك هو متلازمة ستيفين جونسون أو انحلال البشرة السمي.
- الجلد الأصفر، البول الداكن، الإجهاد من الممكن أن يكونوا أعراض لمشاكل في الكبد.
الآثار الجانبية الأخرى
۱۰ أشخاص من أصل ۱۰۰ يستخدمون الدواء) - شائعة ( يصاب بها من ۱
- الصداع. - تأثيرات علي المعدة أو الجهاز الهضمي: إسهال، ألم في المعدة، إمساك، ريح (انتفاخ).
- الشعور بالغثيان أو القئ.
۱۰ أشخاص من أصل ۱۰۰۰ يستخدمون الدواء) - غير شائعة (يصاب بها من ۱
- تورم القدم و الكاحل. - اضطراب النوم (الأرق).
- الدوخة، الشعور بالوخز (مثل وخز الإبر والدبابيس)، الشعور بالنعاس.
- الشعور بالدوار. - تغيرات في نتائج اختبارات الدم التي تدل على سلامة وظائف الكبد.
- طفح جلدي، طفح عُقدي (أرتيكاريا)، حكة في الجلد. - الشعور بالتعب وفقدان الطاقة.
۱۰ أشخاص من أصل ۱۰۰۰۰ يستخدمون الدواء) - نادرة (يصاب من ۱
- مشاكل في الدم مثل انخفاض عدد خلايا الدم البيضاء أو الصفائح الدموية. من الممكن أن يتسبب ذلك في الشعور
بالضعف، الكدمات، سهولة الإصابة بالعدوى.
- تفاعل تحسسي، يكون حادا في بعض الاحيان ويشمل تورم في (الشفاة، اللسان، الحلق)، حمى، صفير.
- انخفاض معدل الصوديوم في الدم وهو ما يمكن أن يتسبب في الضعف أو القئ أو تقلصات في العضلات.
- الشعور بالهياج أو التوتر أو الاكتئاب.
- تغيرات في حاسة التذوق. - مشاكل في الرؤية مثل عدم وضوح الرؤية.
- ضيق النفس مع الشعور بالصفير (انقباض في الشعب الهوائية).
- جفاف في الفم. - التهاب داخل الفم.
- الإصابة بعدوى تسمى "القلاع" والتي تصيب القناة الهضمية ويتسبب فيها أحد الفطريات.
- مشاكل في الكبد بما في ذلك الصفراء والتي تشمل اصفرار في الجلد وبول داكن والشعور بالتعب.
- سقوط الشعر (الصلع). - طفح جلدي عن التعرض لأشعة الشمس.
- آلام في المفاصل والعضلات. - مشاكل حادة في الكلى. - زيادة إفراز العرق.
نادرة جدا (يصاب بها أقل من ۱ من أصل ۱۰۰۰۰ شخص يستخدمون الدواء)
- تغيرات في عدد خلايا الدم بما في ذلك ما يسمى بندرة المحببات (نقص عدد خلايا الدم البيضاء).
- العدوانية. - رؤية أو سماع أو الشعور بأشياء غير موجودة (الهلوسة).
- مشاكل حادة في الكبد تؤدي إلى فشل في وظائف الكبد والتهاب في المخ.
- ظهور مفاجئ لطفح جلدي أو بثور أو تقشر في الجلد.من الممكن ان يكون ذلك مصحوبا بحمى شديدة وآلام في
المفاصل (حُمامى عديدة الأشكال، متلازمة ستيفن جونز، انحلال البشرة النخري)
- ضعف في العضلات. - تضخم في الثدي عند الرجال.
غير معروفة (لا يمكن توقع معدل تكرارها من البيانات المتاحة).
إذا كنت تتناول أسيلوك منذ أكثر من ۳ أشهر فمن الممكن ان يهبط مستوى الماغنسيوم في الدم. انخفاض مستوى  -
الماغنسيوم يظهر علي شكل إجهاد ، انقباضات لا إرادية في العضلات، التوهان، تشنجات، دوخة، ازدياد معدل
ضربات القلب.
إذا كان لديك أحد هذه الأعراض أخبر طبيبك على وجه السرعة.
انخفاض مستوى الماغنسيوم في الدم قد يؤدي أيضا إلي انخفاض في مستويات الكالسيوم والبوتاسيوم. قد ينصحك
الطبيب بعمل فحوصات دورية للدم لمراقبة مستوى الماغنسيوم.
على خلايا الدم البيضاء بما يؤدي إلي نقص في المناعة. إذا كان لديك ™ في بعض الحالات النادرة جدا قد يؤثر أسيلوك
عدوي مع اعراض مثل الحمى مع انخفاض حاد في الحالة العامة أو حمى مع أعراض عدوى موضعية مثل آلام في
الرقبة أو الحلق أو الفم أو صعوبة في التبول، يجب عليك استشارة الطبيب بأقصى سرعة ممكنة ولهذا فإن نقص خلايا
الدم البيضاء (ندرة المحببات) يمكن استبعاده عن طريق عمل اختبار أو تحليل للدم. من المهم أن تعطي معلومات حول
دوائك في هذا التوقيت.
لا تقلق من هذه القائمة الخاصة بالأعراض الجانبية فقد لا يصيبك أيا منها. إذا وصلت أيا من هذه الأعراض لدرجة
الخطورة أو لاحظت ظهور أعراض أخرى غير مذكورة في هذه النشرة، يرجى اخبار الطبيب أو الصيدلي.

• يحفظ بعيداً عن متناول و مرأى الأطفال .
• يحفظ في درجة حرارة لا تزيد عن ۳۰ درجة مئوية.
• لا تستخدم أسيلوك بعد تاريخ انتهاء الصلاحية المدون على العبوة بعد.EXP
• قم بتخزين الشريط داخل العلبة الأصلية.
• لا ينبغي التخلص من الأدوية عبر بالوعات الصرف أو ضمن مخلفات المنزل.
اسأل الصيدلي الخاص بك عن طريقة التخلص من الأدوية التي لم تعد بحاجة إليها. ستساعد هذه التدابير في حماية البيئة

تحتوي كبسولات أسيلوك المقاومة للعصارة الهضمية علي المادة فعالة هي أوميبرازول.
۲۰ ملجم أو ٤۰ ملجم من الأوميبرازول.
- المكونات الأخرى هي: مانيتول، سكروز، ثنائي الصوديوم هيدروجين فوسفات، سلفات لوريل الصوديوم، لاكتوز،
بروبيلين جليكول، ثنائي اثيل ،L30D كربونات الكالسيوم، هيدروكسي بروبيل ميثيل السليلوز، حمض ميثاكريليك
التلك، ثاني أكسيد التيتانيوم ، ،PVPK-30 ، بثالات، كحول سيتيل، هيدروكسيد الصوديوم، توين ۸۰
،( أحمر رقم. ۱ FD&C) أصفررقم. ۱۰ )، أزرق C & D) أحمر رقم. ۳)، وأصفر الكينولين FD&C) إيريثروثينِ
أحمر رقم. ٦) و جيلاتين. FD&C) أحمر رقم. ٤۰ )، أصفر FD&C) الأحمر اليورا

كبسولات أسيلوك20 ملجم ذات جزء علوي بني اللون غير شفاف والجزء الآخر السفلي بني فاتح اللون غير شفاف مطبوع عليها كلمة "Jamjoom" على الجزء العلوي وكلمة "Aci20"على الجزء السفلي باللون الأسود.
كبسولات جيلاتينية صلبة مملوءة بحبيبات كروية لونها أبيض إلى أصفر فاتح.

كبسولات أسيلوك 40 ملجم ذات جزء علوي بني اللون غير شفاف والجزء الآخر السفلي بني فاتح اللون غير شفاف مطبوع عليها كلمة "Jamjoom" على الجزء العلوي وكلمة "Aci40"على الجزء السفلي باللون الأسود.
كبسولات جيلاتينية صلبة مملوءة بحبيبات كروية لونها أبيض إلى أصفر فاتح.


أسيلوك 20ملجم, عبوة تحتوي على7,14,28 كبسولة. 
أسيلوك 40ملجم, عبوة تحتوي على7,14,28 كبسولة. 
قد لا تكون كل أحجام العبوات مطروحة بالسوق

شركة مصنع جمجوم للأدوية المحدودة، جدة، المملكة العربية السعودية
- الهاتف: 608111-12-966+ فاكس : 608222-12-966+
الموقع الإلكتروني: www.jamjoompharma.com 
للإبلاغ عن أي أثار جانبيه:
• المملكة العربية السعودية:
المركز الوطني للتيقظ و السلامة الدوائية
- فاكس: 7662-205-11-966+ 
للإتصال بالإدارة التنفيذية للتيقظ وإدارة الأزمات.
هاتف: 22228302-11-966+ تحويلة: 2317-2356-2353-2354-2334-2340
الهاتف المجاني: 8002490000
بريد إلكتروني: npc.drug@sfda.gov.sa
الموقع الالكتروني: www.sfda.gov.sa/npc
• دول الخليج الأخرى:
الرجاء الاتصال بالمؤسسات و الهيئات الوطنية في كل دولة

05/2013
 Read this leaflet carefully before you start using this product as it contains important information for you

Aciloc 20 mg Capsules

Each capsule contains gastro-resistant pallets equivalent to Omeprazole 20 mg For Excipients: Please see 6.1

Capsules

Aciloc 20 mg capsules are indicated in:
Adults
• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer
disease

• Treatment of NSAID-associated gastric and duodenal ulcers
• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
• Treatment of reflux oesophagitis
• Long-term management of patients with healed reflux oesophagitis
• Treatment of symptomatic gastro-oesophageal reflux disease
• Treatment of Zollinger-Ellison syndrome
Paediatric use
Children over 1 year of age and ≥ 10 kg
• Treatment of reflux oesophagitis

• Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease
Children and adolescents over 4 years of age
• In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori


Posology
Adults
Treatment of duodenal ulcers
The recommended dose in patients with an active duodenal ulcer is Aciloc 20 mg once daily. In most
patients healing occurs within two weeks. For those patients who may not be fully healed after the initial
course, healing usually occurs during a further two weeks treatment period. In patients with poorly
responsive duodenal ulcer Aciloc 40 mg once daily is recommended and healing is usually achieved
within four weeks.

Prevention of relapse of duodenal ulcers
For the prevention of relapse of duodenal ulcer in H. pylori negative patients or when H.
pylori eradication is not possible the recommended dose is Aciloc 20 mg once daily. In some patients a
daily dose of 10 mg may be sufficient. In case of therapy failure, the dose can be increased to 40 mg.

Treatment of gastric ulcers
The recommended dose is Aciloc 20 mg once daily. In most patients healing occurs within four weeks.
For those patients who may not be fully healed after the initial course, healing usually occurs during a
further four weeks treatment period. In patients with poorly responsive gastric ulcer Aciloc 40 mg once
daily is recommended and healing is usually achieved within eight weeks.

Prevention of relapse of gastric ulcers

For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is
Aciloc 20 mg once daily. If needed the dose can be increased to Aciloc 40 mg once daily.

H. pylori eradication in peptic ulcer disease

For the eradication of H. pylori the selection of antibiotics should consider the individual patient's drug
tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and
treatment guidelines.

• Aciloc 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg, each twice daily for one week, or
• Aciloc 20 mg + clarithromycin 250 mg (alternatively 500 mg) + metronidazole 400 mg (or 500 mg or
tinidazole 500 mg), each twice daily for one week or
• Aciloc 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg or tinidazole
500 mg), both three times a day for one week.

In each regimen, if the patient is still H. pylori positive, therapy may be repeated.

Treatment of NSAID-associated gastric and duodenal ulcers

For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is Aciloc 20
mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully
healed after the initial course, healing usually occurs during a further four weeks treatment period.

Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

For the prevention of NSAID-associated gastric ulcers or duodenal ulcers in patients at risk (age> 60,
previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended
dose is Aciloc 20 mg once daily.

Treatment of reflux oesophagitis
The recommended dose is Aciloc 20 mg once daily. In most patients healing occurs within four weeks.
For those patients who may not be fully healed after the initial course, healing usually occurs during a
further four weeks treatment period.

In patients with severe oesophagitis Aciloc 40 mg once daily is recommended and healing is usually
achieved within eight weeks.

Long-term management of patients with healed reflux oesophagitis

For the long-term management of patients with healed reflux oesophagitis the recommended dose is
Aciloc 10 mg once daily. If needed, the dose can be increased to Aciloc 20-40 mg once daily.

Treatment of symptomatic gastro-oesophageal reflux disease

The recommended dose is Aciloc 20 mg daily. Patients may respond adequately to 10 mg daily, and
therefore individual dose adjustment should be considered.

If symptom control has not been achieved after four weeks treatment with Aciloc 20 mg daily, further
investigation is recommended.

Treatment of Zollinger-Ellison syndrome

In patients with Zollinger-Ellison syndrome the dose should be individually adjusted and treatment
continued as long as clinically indicated. The recommended initial dose is Aciloc 60 mg daily. All
patients with severe disease and inadequate response to other therapies have been effectively controlled
and more than 90% of the patients maintained on doses of Aciloc 20-120 mg daily. When dose exceed
Aciloc 80 mg daily, the dose should be divided and given twice daily.

Paediatric population

Children over 1 year of age and ≥ 10 kg

Treatment of reflux oesophagitis

Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease

The posology recommendations are as follows:

Age Weight Posology

AgeWeightPosology
≥ 1 year of age10-20 kg10 mg once daily. The dose can be increased to 20 mg once daily if needed
≥ 2 years of age> 20 kg20 mg once daily. The dose can be increased to 40 mg once daily if needed

Reflux oesophagitis: The treatment time is 4-8 weeks.

Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease: The
treatment time is 2–4 weeks. If symptom control has not been achieved after 2–4 weeks the patient should
be investigated further.

Children and adolescents over 4 years of age

Treatment of duodenal ulcer caused by H. pylori

When selecting appropriate combination therapy, consideration should be given to official national,
regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days
but sometimes up to 14 days), and appropriate use of antibacterial agents.

The treatment should be supervised by a specialist.

The posology recommendations are as follows:

          WeightPosology
15–30 kgCombination with two antibiotics: Aciloc 10 mg, amoxicillin 25 mg/kg body weight and clarithromycin 7.5 mg/kg body weight are all administered together two times daily for one week.
          31–40 kgCombination with two antibiotics: Aciloc 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administered two times daily for one week.
          > 40 kgCombination with two antibiotics: Aciloc 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administered two times daily for one week.

Special populations
Renal impairment
Dose adjustment is not needed in patients with impaired renal function (see section 5.2).
Hepatic impairment
In patients with impaired hepatic function a daily dose of 10–20 mg may be sufficient (see section 5.2).
Elderly
Dose adjustment is not needed in the elderly (see section 5.2).


Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed in section 6.1. Omeprazole like other proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir (see section 4.5).

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting,
dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy
should be excluded, as treatment may alleviate symptoms and delay diagnosis.

Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5). If
the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical
monitoring (e.g virus load) is recommended in combination with an increase in the dose of atazanavir
to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.

Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin
B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with
reduced body stores or risk factors for reduced vitamin B12absorption on long-term therapy.

Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential
for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is
observed between clopidogrel and omeprazole (see section 4.5). The clinical relevance of this
interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be
discouraged.

Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like
omeprazole for at least three months, and in most cases for a year. Serious manifestations of
hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia
can occur but they may begin insidiously and be overlooked. In most affected patients,
hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may
cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring
magnesium levels before starting PPI treatment and periodically during treatment.

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may
modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence
of other recognised risk factors. Observational studies suggest that proton pump inhibitors may
increase the overall risk of fracture by 10-40%. Some of this increase may be due to other risk factors.
Patients at risk of osteoporosis should receive care according to current clinical guidelines and they
should have an adequate intake of vitamin D and calcium.

Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially
in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical
help promptly and the health care professional should consider stopping Aciloc . SCLE after previous
treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump
inhibitors.

Interference with laboratory tests

Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.
To avoid this interference, omeprazole treatment should be stopped for at least 5 days before CgA
measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after
initial measurement, measurements should be repeated 14 days after cessation of proton pump
inhibitor treatment.

Some children with chronic illnesses may require long-term treatment although it is not recommended.

Aciloc contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections
such as Salmonellaand Campylobacter and, in hospitalised patients, possibly also Clostridium
difficile (see section 5.1).

As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should
be kept under regular surveillance.


Effects of omeprazole on the pharmacokinetics of other active substances
Active substances with pH dependent absorption

The decreased intragastric acidity during treatment with omeprazole might increase or decrease the
absorption of active substances with a gastric pH dependent absorption.

Nelfinavir, atazanavir
The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with
omeprazole.

Concomitant administration of omeprazole with nelfinavir is contraindicated (see section 4.3). Coadministration
of omeprazole (40 mg once daily) reduced mean nelfinavir exposure by ca. 40% and the
mean exposure of the pharmacologically active metabolite M8 was reduced by ca. 75 –90%. The
interaction may also involve CYP2C19 inhibition.

Concomitant administration of omeprazole with atazanavir is not recommended (see section 4.4).
Concomitant administration of omeprazole (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg to
healthy volunteers resulted in a 75% decrease of the atazanavir exposure. Increasing the atazanavir dose to
400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration
of omeprazole (20 mg once daily) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted
in a decrease of approximately 30% in the atazanavir exposure as compared to atazanavir 300
mg/ritonavir 100 mg once daily.

Digoxin
Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the
bioavailability of digoxin by 10%. Digoxin toxicity has been rarely reported. However caution should be
exercised when omeprazole is given at high doses in elderly patients. Therapeutic drug monitoring of
digoxin should be then be reinforced.


Clopidogrel
Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD)
interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and omeprazole (80
mg p.o. daily) resulting in a decreased exposure to the active metabolite of clopidogrel by an average of
46% and a decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 16%.
Inconsistent data on the clinical implications of a PK/PD interaction of omeprazole in terms of major
cardiovascular events have been reported from both observational and clinical studies. As a precaution,
concomitant use of omeprazole and clopidogrel should be discouraged (see section 4.4).

Other active substances
The absorption of posaconazole, erlotinib, ketoconazole and itraconazole is significantly reduced and thus
clinical efficacy may be impaired. For posaconazole and erlotinib concomitant use should be avoided.
Active substances metabolised by CYP2C19

Omeprazole is a moderate inhibitor of CYP2C19, the major omeprazole metabolising enzyme. Thus, the
metabolism of concomitant active substances also metabolised by CYP2C19, may be decreased and the
systemic exposure to these substances increased. Examples of such drugs are R-warfarin and other
vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol
Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC
for cilostazol by 18% and 26% respectively, and one of its active metabolites by 29% and 69%
respectively.

Phenytoin
Monitoring phenytoin plasma concentration is recommended during the first two weeks after initiating
omeprazole treatment and, if a phenytoin dose adjustment is made, monitoring and a further dose
adjustment should occur upon ending omeprazole treatment.

Unknown mechanism

Saquinavir
Concomitant administration of omeprazole with saquinavir/ritonavir resulted in increased plasma levels
up to approximately 70% for saquinavir associated with good tolerability in HIV-infected patients.

Tacrolimus
Concomitant administration of omeprazole has been reported to increase the serum levels of tacrolimus. A
reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should
be performed, and dosage of tacrolimus adjusted if needed.

Methotrexate
When given together with proton-pump inhibitors, methotrexate levels have been reported to increase in
some patients. In high-dose methotrexate administration a temporary withdrawal of omeprazole may need
to be considered.

Effects of other active substances on the pharmacokinetics of omeprazole
Inhibitors of CYP2C19 and/or CYP3A4

Since omeprazole is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit
CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased omeprazole
serum levels by decreasing omeprazole's rate of metabolism. Concomitant voriconazole treatment resulted
in more than doubling of the omeprazole exposure. As high doses of omeprazole have been well-tolerated
adjustment of the omeprazole dose is not generally required. However, dose adjustment should be
considered in patients with severe hepatic impairment and if long-term treatment is indicated.

Inducers of CYP2C19 and/or CYP3A4
Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St John's wort)
may lead to decreased omeprazole serum levels by increasing omeprazole's rate of metabolism.


Pregnancy
Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no
adverse effects of omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole can
be used during pregnancy.

Breast-feeding
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Fertility
Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects
with respect to fertility.


Aciloc is not likely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness
and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate
machinery.


Summary of the safety profile
The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea,
flatulence and nausea/vomiting.
Tabulated list of adverse reactions
The following adverse drug reactions have been identified or suspected in the clinical trials programme
for omeprazole and post-marketing. None was found to be dose-related. Adverse reactions listed below
are classified according to frequency and System Organ Class (SOC). Frequency categories are defined
according to the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon
(≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be
estimated from the available data).

SOC/frequencyAdverse reaction
Blood and lymphatic system disorders
Rare:Leukopenia, thrombocytopenia
Very rare:Agranulocytosis, pancytopenia
Immune system disorders
Rare:Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock
Metabolism and nutrition disorders 
Rare:Hyponatraemia
Not known:Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia.
Hypomagnesaemia may also be associated with hypokalaemia.
Psychiatric disorders 
Uncommon:Insomnia
Rare:Agitation, confusion, depression
Very rare:Aggression, hallucinations
Nervous system disorders
Common:Headache
Uncommon:Dizziness, paraesthesia, somnolence
Rare:Taste disturbance
Eye disorders 
Rare:Blurred vision
Ear and labyrinth disorders 
Uncommon:Vertigo
Respiratory, thoracic and mediastinal disorders 
Rare:Bronchospasm
Gastrointestinal disorders
Common:Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland
polyps (benign)
Rare:Dry mouth, stomatitis, gastrointestinal candidiasis
Not known:Microscopic colitis
Hepatobiliary disorders 
Uncommon:Increased liver enzymes
Rare:Hepatitis with or without jaundice
Very rare:Hepatic failure, encephalopathy in patients with pre-existing liver disease
Skin and subcutaneous tissue disorders
Uncommon:Dermatitis, pruritus, rash, urticaria
Rare:Alopecia, photosensitivity
Very rare:Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
(TEN)
Not known:Subacute cutaneous lupus erythematosus (see section 4.4)
Musculoskeletal and connective tissue disorders 
Uncommon:Fracture of the hip, wrist or spine
Rare:Arthralgia, myalgia
Very rare:Muscular weakness
Renal and urinary disorders 
Rare:Interstitial nephritis
Reproductive system and breast disorders 
Very rare:Gynaecomastia
General disorders and administration site conditions 
Uncommon:Malaise, peripheral oedema
Rare:Increased sweating

Paediatric population
The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related
disease. There are limited long-term safety data from 46 children who received maintenance therapy of
omeprazole during a clinical study for severe erosive oesophagitis for up to 749 days. The adverse event

profile was generally the same as for adults in short- as well as in long-term treatment. There are no longterm
data regarding the effects of omeprazole treatment on puberty and growth.


There is limited information available on the effects of overdoses of omeprazole in humans. In the
literature, doses of up to 560 mg have been described, and occasional reports have been received when
single oral doses have reached up to 2,400 mg omeprazole (120 times the usual recommended clinical
dose). Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported. Also
apathy, depression and confusion have been described in single cases.

The symptoms described have been transient, and no serious outcome has been reported. The rate of
elimination was unchanged (first order kinetics) with increased doses. Treatment, if needed, is
symptomatic.


Pharmacotherapeutic group: Drugs for acid-related disorders, proton pump inhibitors, ATC code:
A02BC01

Mechanism of action
Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly
targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly
acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.

Omeprazole is a weak base and is concentrated and converted to the active form in the highly acidic
environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H+ K+-
ATPase - the acid pump. This effect on the final step of the gastric acid formation process is dosedependent
and provides for highly effective inhibition of both basal acid secretion and stimulated acid
secretion, irrespective of stimulus.

Pharmacodynamic effects
All pharmacodynamic effects observed can be explained by the effect of omeprazole on acid secretion.
Effect on gastric acid secretion

Oral dosing with omeprazole once daily provides for rapid and effective inhibition of daytime and nighttime
gastric acid secretion with maximum effect being achieved within 4 days of treatment. With
omeprazole 20 mg, a mean decrease of at least 80% in 24-hour intragastric acidity is then maintained in
duodenal ulcer patients, with the mean decrease in peak acid output after pentagastrin stimulation being
about 70% 24 hours after dosing.

Oral dosing with omeprazole 20 mg maintains an intragastric pH of ≥ 3 for a mean time of 17 hours of the
24-hour period in duodenal ulcer patients.

As a consequence of reduced acid secretion and intragastric acidity, omeprazole dose-dependently
reduces/normalizes acid exposure of the oesophagus in patients with gastro-oesophageal reflux disease.

The inhibition of acid secretion is related to the area under the plasma concentration-time curve (AUC) of
omeprazole and not to the actual plasma concentration at a given time.

No tachyphylaxis has been observed during treatment with omeprazole.

Effect on H. pylori
H. pylori is associated with peptic ulcer disease, including duodenal and gastric ulcer disease. H. pylori is
a major factor in the development of gastritis. H. pylori together with gastric acid are major factors in the
development of peptic ulcer disease. H. pylori is a major factor in the development of atrophic gastritis
which is associated with an increased risk of developing gastric cancer.

Eradication of H. pylori with omeprazole and antimicrobials is associated with, high rates of healing and
long-term remission of peptic ulcers.

Dual therapies have been tested and found to be less effective than triple therapies. They could, however,
be considered in cases where known hypersensitivity precludes use of any triple combination.

Other effects related to acid inhibition

During long-term treatment gastric glandular cysts have been reported in a somewhat increased frequency.
These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and
appear to be reversible.

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of
bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to
slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in
hospitalised patients, possibly also Clostridium difficile.

During treatment with antisecretory medicinal products, serum gastrin increases in response to the
decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level
may interfere with investigations for neuroendocrine tumours. Available published evidence suggests that
proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements.
This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to
reference range.

An increased number of ECL cells possibly related to the increased serum gastrin levels, have been
observed in some patients (both children and adults) during long term treatment with omeprazole. The
findings are considered to be of no clinical significance.

Paediatric population
In a non-controlled study in children (1 to 16 years of age) with severe reflux oesophagitis, omeprazole at
doses of 0.7 to 1.4 mg/kg improved oesophagitis level in 90% of the cases and significantly reduced reflux
symptoms. In a single-blind study, children aged 0–24 months with clinically diagnosed gastrooesophageal
reflux disease were treated with 0.5, 1.0 or 1.5 mg omeprazole/kg. The frequency of
vomiting/regurgitation episodes decreased by 50% after 8 weeks of treatment irrespective of the dose.

Eradication of H. pylori in children
A randomised, double blind clinical study (Héliot study) concluded that omeprazole in combination with
two antibiotics (amoxicillin and clarithromycin), was safe and effective in the treatment of H.
pylori infection in children age 4 years old and above with gastritis: H. pylori eradication rate: 74.2%
(23/31 patients) with omeprazole + amoxicillin + clarithromycin versus 9.4% (3/32 patients) with
amoxicillin + clarithromycin. However, there was no evidence of any clinical benefit with respect to
dyspeptic symptoms. This study does not support any information for children aged less than 4


Absorption
Omeprazole and omeprazole magnesium are acid labile and are therefore administered orally as
enteric-coated granules in capsules or tablets. Absorption of omeprazole is rapid, with peak plasma
levels occurring approximately 1-2 hours after dose. Absorption of omeprazole takes place in the
small intestine and is usually completed within 3-6 hours. Concomitant intake of food has no influence
on the bioavailability. The systemic availability (bioavailability) from a single oral dose of omeprazole
is approximately 40%. After repeated once-daily administration, the bioavailability increases to about 60%.

Distribution
The apparent volume of distribution in healthy subjects is approximately 0.3 l/kg body weight.
Omeprazole is 97% plasma protein bound.

Biotransformation
Omeprazole is completely metabolised by the cytochrome P450 system (CYP). The major part of its
metabolism is dependent on the polymorphically expressed CYP2C19, responsible for the formation
of hydroxyomeprazole, the major metabolite in plasma. The remaining part is dependent on another
specific isoform, CYP3A4, responsible for the formation of omeprazole sulfone. As a consequence of
high affinity of omeprazole to CYP2C19, there is a potential for competitive inhibition and metabolic
drug-drug interactions with other substrates for CYP2C19. However, due to low affinity to CYP3A4,
omeprazole has no potential to inhibit the metabolism of other CYP3A4 substrates. In addition,
omeprazole lacks an inhibitory effect on the main CYP enzymes.

Approximately 3% of the Caucasian population and 15-20% of Asian populations lack a functional
CYP2C19 enzyme and are called poor metabolisers. In such individuals the metabolism of omeprazole
is probably mainly catalysed by CYP3A4. After repeated once-daily administration of 20 mg
omeprazole, the mean AUC was 5 to 10 times higher in poor metabolisers than in subjects having a
functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations were also
higher, by 3 to 5 times. These findings have no implications for the posology of omeprazole.

Elimination
The plasma elimination half-life of omeprazole is usually shorter than one hour both after single and
repeated oral once-daily dosing. Omeprazole is completely eliminated from plasma between doses
with no tendency for accumulation during once-daily administration. Almost 80% of an oral dose of
omeprazole is excreted as metabolites in the urine, the remainder in the faeces, primarily originating
from bile secretion.

Linearity/non-linearity
The AUC of omeprazole increases with repeated administration. This increase is dose-dependent and
results in a non-linear dose-AUC relationship after repeated administration. This time- and dosedependency
is due to a decrease of first pass metabolism and systemic clearance probably caused by
an inhibition of the CYP2C19 enzyme by omeprazole and/or its metabolites (e.g. the sulfone).

No metabolite has been found to have any effect on gastric acid secretion.
Special populations

Hepatic impairment
The metabolism of omeprazole in patients with liver dysfunction is impaired, resulting in an increased
AUC. Omeprazole has not shown any tendency to accumulate with once daily dosing.

Renal impairment
The pharmacokinetics of omeprazole, including systemic bioavailability and elimination rate, are
unchanged in patients with reduced renal function.

Elderly
The metabolism rate of omeprazole is somewhat reduced in elderly subjects (75-79 years of age).

Paediatric population
During treatment with the recommended doses to children from the age of 1 year, similar plasma
concentrations were obtained as compared to adults. In children younger than 6 months, clearance
of omeprazole is low due to low capacity to metabolize omeprazole.


Gastric ECL-cell hyperplasia and carcinoids, have been observed in life-long studies in rats treated with
omeprazole. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition.
Similar findings have been made after treatment with H2-receptor antagonists, proton pump inhibitors and
after partial fundectomy. Thus, these changes are not from a direct effect of any individual active
substance.


Mannitol

Disodium Hydrogen orthosphosphate

Sodium Lauryl Sulphate

HPMC phthalate HP55

HPMC E5

Cetyl Alcohol

Sucrose

Calcium Carbonate

TiO2


Not applicable.


24 months

Do not store above 30°C
Protect from light. Keep out of reach of children


Primary :
Immediate container: Alu-Alu printed blister strip.
Secondary:
Outer individual carton
PIL


No special requirements


JAMJOOM PHARMACEUTICALS COMPANY P.O Box 6267 Jeddah 21442 Tel : +966-12-6081111 Fax: +966-12-6081222 Kingdom of Saudi Arabia

Dec-2017
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