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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)

Olmetec belongs to a group of medicines called angiotensin-II receptor
antagonists. They lower blood pressure by relaxing the blood vessels.
Olmetec is used for the treatment of high blood pressure )also known
as ‘hypertension'(. High blood pressure can damage blood vessels in
organs such as the heart, kidneys, brain and eyes. In some cases, this
may lead to a heart attack, heart or kidney failure, stroke or blindness.
Usually, high blood pressure has no symptoms.
It is important to have your blood pressure checked to prevent damage
occurring. High blood pressure can be controlled with medicines such
as Olmetec tablets. Your doctor has probably also recommended that
you make some changes in your lifestyle to help lower your blood
pressure )for example losing weight, giving up smoking, reducing the
amount of alcohol you drink and reducing the amount of salt in your
diet(. Your doctor may also have urged you to take regular exercise,
such as walking or swimming. It is important to follow this advice from
your doctor.
 


Do not take Olmetec
• If you are allergic )hypersensitive( to Olmesartan medoxomil or to any
other of the ingredients of Olmetec
• If you are pregnant or may be pregnant )see pregnancy section.(
• Olmetec should not be co-administered with aliskiren fumarate in
patients with diabetes )except for patients with poor blood pressure
control with other antihypertensive treatment( or renal impairment
• If you suffer from yellowing of the skin and eyes )jaundice( or problems
with drainage of the bile from the gallbladder )biliary obstruction e.g.,
gallstones(.
Take special care with Olmetec
Before you take the tablets, tell your doctor if you have any of the
following health problems:
• Dual Blockade of the Renin-Angiotensin-aldosterone System )RAAS(:
Combination of Olmetec with ACE inhibitors, or aliskiren may cause
increased risks of hyperkalemia, worsening of kidney function and
hypotension. Therefore, this combination should not be used, especially
in patients with kidney problems.
• Kidney problems
• Liver disease
• Heart failure or problems with your heart valves or heart muscle.
• Severe vomiting, diarrhoea, treatment with high doses of water
tablets )diuretics( or if you are on a low salt diet.
• Increased levels of potassium in your blood.
• Problems with your adrenal glands.
As with any medicine which reduces blood pressure, an excessive drop
in blood pressure in patients with blood flow disturbances of the heart
or brain could lead to a heart attack or stroke. Your doctor will therefore
check your blood pressure carefully.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any of the following medicines:
• Aliskiren fumarate )In patients with diabetes, except for patients
with very poor blood pressure control with other antihypertensive
treatment( or renal impairment• Dual blockade )e.g by adding ACE
inhibitor to Olmetec( should not be used, especially in patients with
Kidney problems.
• Potassium supplements, a salt substitute which contains potassium,
water tablets )diuretics( or heparin )for thinning the blood(. Using
these medicines at the same time as Olmetec may raise the levels of
potassium in your blood.
• Lithium )a medicine used to treat mood swings and some types of
depression( used at the same time, as Olmetec may increase the
toxicity of lithium. If you have to take lithium, your doctor will measure
your lithium blood levels.
• Non-Steroidal Anti-Inflammatory )NSAIDs( medicines )medicines used
to relieve pain, swelling and other symptoms of inflammation, including
arthritis( used at the same time as Olmetec may increase the risk of
kidney failure and the effect of Olmetec can be decreased by NSAIDs.
• Other blood pressure lowering medicines, as the effect of Olmetec
can be increased.
• Certain antacids )indigestion remedies(, as the effect of Olmetec can
be slightly decreased.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Taking Olmetec with food and drink
Olmetec can be taken with or without food. Swallow the tablets with a
little water. If possible, take your daily dose at the same time each day,
for example at breakfast time.
Children and adolescents )under 18(
Olmetec is not recommended for children and adolescents under the
age of 18.
Elderly patients
If you are over 65 years of age and your doctor decides to increase your
dose of olmesartan medoxomil to 40 mg daily, then you need to have
your blood pressure regularly checked by your doctor to make sure that
your blood pressure does not become too low.
Black patients
As with other similar drugs the blood pressure lowering effect of
Olmetec is somewhat less in black patients.
Pregnancy and breastfeeding
Pregnancy

OLMETEC should be avoided in pregnant or potentially pregnant
women. Administration should be discontinued immediately if the
patient is found to be pregnant during treatment
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Olmetec is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you
wish to breast-feed, especially if your baby is newborn, or was born
prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Olmetec will affect your ability to drive or operate
machinery. However, dizziness or fatigue can occasionally occur during
the treatment of high blood pressure. If you notice such effects, do not
drive or use machines until the symptoms wear off. Ask your doctor
for advice.
Important information about some of the ingredients in Olmetec
This medicine contains lactose )a type of sugar(. If you have been told
by your doctor that you have intolerance to some sugars, you should
contact your doctor before taking this medicinal product.


Always take Olmetec exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets can be taken with or without food. Swallow the tablets with a little water. If possible, take your daily dose at the same time each day, for example at breakfast time.

The usual starting dose is one 10 mg tablet once a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose up to 20 or 40 mg once a day, or prescribe additional medicines.

In patients with mild to moderate kidney disease, your dose will not be higher than 20 mg once a day.

If you take more Olmetec than you should

If you take more tablets than you should or if a child accidentally swallows some, go to your doctor or nearest emergency department immediately and take your medicine pack with you.

If you forget to take Olmetec

If you forget a dose, take your normal dose on the following day as usual. Do not take any extra tablets to make up for the missed dose.

If you stop taking Olmetec

It is important to continue to take Olmetec unless your doctor tells you to stop.

If you have any further questions on the use of this product, ask your doctor or pharmacist.


Like all medicines, Olmetec can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

Although not many people may get them, the following two side effects can be serious:

On very rare occasions the following allergic reactions have been reported:

Swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during

treatment with Olmetec.

 If this happens stop taking Olmetec and contact your doctor immediately. Rarely (but slightly more often in elderly patients) Olmetec can cause the blood pressure to fall too low in

susceptible individuals. This could cause severe light-headedness or fainting. If this occurs stop taking Olmetec, contact your doctor immediately and lie down flat.

To give you an idea of how many patients might get side effects, they have been listed as common, uncommon, rare and very rare. These mean the following: Common (less than 1 in 10 people.) Uncommon (less than 1 in 100 people.)

Rare (less than 1 in 1,000 people.)

Very rare (less than 1 in 10,000 people.)

•    Common side effects:

Dizziness, nausea, indigestion, diarrhoea, stomach ache, gastroenteritis, tiredness, sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain in the chest, back, bones or joints, infection of the urinary tract, swelling of ankles, feet, legs, hands, or arms, blood in the urine.

Some changes in blood test results have also been seen and include the following:

Increased fat levels (hypertriglyceridaemia), increased uric acid levels (hyperuricaemia), increases in tests of liver and muscle function

•    Uncommon side effects:

Vertigo, skin rash, angina (pain or uncomfortable feeling in the chest)

•    Rare side effects:

Rarely, blood test results have shown increased potassium levels (hyperkalaemia).

•    Very rare side effects:

Headache, muscle cramps and muscular pain, impaired kidney function, kidney failure, weakness, lack of energy, feeling unwell, vomiting, itching, exanthema (skin eruption).

Some changes in blood test results have also been seen. These include increased levels of compounds related to kidney function and reduced numbers of a type of blood cell, known as platelets (thrombocytopenia).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

•    Not known:

- Sprue-like enteropathy, you should contact your healthcare
professional right away if you experience severe diarrhea, diarrhea
that does not go away, or significant weight loss."
- If you experience yellowing of the whites of the eyes, dark urine,
itching of the skin, even if you started therapy with Olmetec long ago,
contact your doctor immediately who will evaluate your symptoms and
decide on how to continue your blood pressure medication.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell doctor or pharmacist.


Keep out of the reach and sight of children.

Store below 30°C

Do not use Olmetec after the expiry date (“EXP”) which is stated on the box and on the blister strip. The expiry date refers to the last day of that month.

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 olmesartan medoxomil

Each film-coated tablet contains 20 mg olmesartan medoxomil.

•    Other ingredients are

Hydroxypropylcellulose, Lactose, Low-substituted Hydroxypropyl
cellulose, Opadry، magnesium stearate and microcrystalline cellulose


Olmetec 20 mg is white to off white, circular, film coated tablet and Coded by SJ 171 on one side and plain on the other side Packs of 28 film-coated tablets.

SAJA Pharmaceuticals

Saudi Arabian Japanese pharmaceutical company limited

Jeddah - Saudi Arabia

Under license from Daiichi Sankyo Co. Ltd.

Tokyo-Japan

To report any side effect(s)
• Saudi Arabia
- The National Pharmacovigilance Centre )NPC(:
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa

• Other GCC states /other countries
-Please contact the relevant competent authority.


May/2023
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يَنْتَمِي أولِميتك إلى مجموعة من الأدوية تُسَمّى مُنَاهضات مستقبلات هرمون الأنجيوتنسين 2. وَهِي تُقَلّل ضَغْطَ الدّم عَن طَرِيق إِرخَاء الأوعية الدموية.

يُستخدم أولميتك لعلاج ارتفاع ضَغْط الدّم. من الممكن أَنْ يَضُرّ ضَغْطِ الدّم المُرْتَفع الأوعيةَ الدمويّةَ في الأعضاءِ مِثْل القَلْب والكليتينِ والمخ والعَينَينِ، وَقَد يُؤدّي ذَلك في بعض الأحيان إلى حُدُوث نَوْبَة قَلبيّة أو هُبُوط (فشلِ) القَلْبِ أو فَشَل كُلَويَ أو سَكْتَة دِمَاغيّة أو عَمَى. وَلا تُوجَد في العادة أَعْرَاض لارتفاع ضَغْط الدّم. منَ المهم فَحْصُ ضَغْطِ الدّم لَدَيك لِمَنْع وُقُوعٍ أيِّ ضَرَرٍ عَلَيْك.

يُمْكِنَ التّحَكُم في ضَغْطِ الدّم المُرتَفع باستخدام أدوِية مثل أقرَاص أولميتك. قد يَكُون طبيبُك قد أوْصَاك أيضًا بإجراء بَعْض التَغييرات في أسْلوب حَيَاتك للمساعدةِ في خَفْض ضَغْط الدّم لديك (على سبيلِ المثالِ إنقَاص الوَزن والإقلاعِ عن التدخين وتَقْلِيل كِمّيَة الكُحُوليّات التي تشربها وتَقْليل كمّيّة الملح في طَعَامِك). وَقَد يَكُون طبِيبُك قَدَ حَثّك أيضًا على مُمَارَسة التّمَارين بِشَكْلِ مُنْتَظم، مِثل المشي أو السِّبَاحة. منَ المهم أن تَتّبِع هَذه النَّصِيحَة من طبيبكَ.

لا تَتَناول أولميتك في الحالات الآتية:

∙ إذَا كُنْتِ تُعَانِي من حساسية (فرط الحساسية) تجَاه أولميسارتان ميدوكسوميل أو لأيّ من مكونات أولميتِك.

•إذا كنت حام ًلا أو قد تكونين حام ًلا. (انظري قسم "الحمل.)"
• يجـب تجنـب تنـاول أولميتيـك مـع فومـارات اليسـكيرين فـي المرضـى الذيـن يعانـون مـن
مـرض السكري(باسـتثناء المرضـى الذيـن يعانـون مـن صعوبـة التحكـم فـي ضغـط الـدم مـع
العلاجـات الخافضـة للضغـط الأخـرى) أو القصـور الكلـوي

∙ إذَا كُنْتِ تُعَاني من اصفرار البشرة والعينين (اليرقان) أو مشاكل مُرْتَبطة بِتَصْريف العُصَارَة الصّفراوية مِن المرارة (انسداد مراري؛ مِثل حصى المرارة).

تَوَخِّ حَذرًا خاصًّا مع أوِلميتك

قَبْل أن تَتَنَاول الأقراص، أَخْبر طَبيبك إِذَا كُنْت تُعَاني من أيّ من المشاكل الصِّحّية التالية:

∙ نظام حاصرات الرينين أنجيوتنسين ألدوستيرون (RAAS):

استعمال أولميتك مع مثبطات الإنزيم المحول للأنجيوتنسين، أو اليسكارين قد يسبب مخاطر ارتفاع نسبه البوتاسيوم بالدم، وتدهو وظائف الكلى وانخفاض ضغط الدم. ولذلك، يجب ألا تستعمل هذه الأدوية معًا، خصوصًا في المرضى الذين يعانون من مشاكل في الكلى.

∙ مَشاكل في الكُلَى.

∙ مَرَضَ بالكَبِد.

∙ هُبُوطِ القَلْبِ أو مَشَاكِل في صمامات القَلْب أو عَضَلة القلب.

∙ قيء شَديد أو إسْهَالَ أو كُنْت تَتَنَاول عِلاجًا بِجُرعات مُرْتَفعة مِن أقراص الماء (مدرات البول) أو إذَا كُنْتَ تَتّبِع نِظَامًا غذائيًّا مَحدود الملح.

∙ ارتِفَاع مُستَويَاتِ البوتاسيوم في الدّم.

∙ مَشَاكِل في الغُدَد الكَظَريةِ.

كَمَا هوَ الحَالِ مَع أيِّ دَوَاء خَافِض لضَغط الدّم، قَد يُؤدي الانخفاض المتزايد في ضَغْط الدّمِ لدى المرضى الذين يُعانون من اضطرابات تَدَفّق الدَّم بالقلب أو الدّمَاغ إلى نوبَة قلبية أو سكتة دماغية؛ ولِذا يَجِب أن يَقُوم طَبِيبك بِفَحْص ضَغْط الدَّم لديك بِعِنَايَة.

يَجِب إِبْلاغ طبيبك إِذَا كنتِ تعتقدين أنكِ حامل (أو قد تُصْبحين حاملاً). لا يُوصي بِتَناوُل أولميتك في مَرَاحل الحمل المُبَكّرة، وَيَجب عَدَم تَنَاوُلَه إِذَا تَجَاوَزَ حَمْلِك الشهرَ الثالث، حَيْث قَد يَلحق بِطِفلكِ ضررٌ خطيرٌ إِذَا تمّ استخدامه في هذه المرحلة (انظري قِسم "الحمل").

تَنَاوُل أَدْوِيَة أُخرى

يُرجى إبلاغ الطّبيب أو الصيدليّ الخَاصّ بك إذَا كُنْتَ تَتَنَاول أو تَنَاوَلت مُؤَخّرًا أيًّا من الأدوية التالية:

• فومـارات اليسـكيرين فـي المرضـى الذيـن يعانـون مـن مـرض السكري(باسـتثناء المرضـى
الذيــن يعانــون مــن صعوبــة التحكــم فــي ضغــط الــدم مــع العلاجــات الخافضــة للضغــط
الأخـرى) أو القصـور الكلـوي

∙ مُكّمّلات غِذَائِيَة تَحتَوي عَلَى البوتاسيوم أو بَدَائل مَلْح تحتَوي عَلَى البوتاسيوم أو أقْرَاص مَاء (مُدرّات بول) أو هيبارين (لزيَادة سيولة الدّم). إنّ استخْدَام هذه الأدوية في نَفْس الوقت مع أولميتك قَدْ يَرْفع من مستويات البوتَاسيوم لدَيك في الدّم.

∙ اللِيثيوم (دَوَاء يُستَخْدَم لعلاج التّقلبات المزاجية وبَعض أنْواع الاكتئاب)، حَيثُ إنّ استخدامه في نفْس الوقت مع أولميتك قَد يَزِيْد من سُمّية الليثيوَمَ. إذا كانَ يَجب عَليك تَنَاوُل الليثيوم، فَسَيَقُوم طَبيبُك بِقيَاس مُستَويَات الليثيوم لديك في الدّم.

∙ مُضَادّات الالتهاب غير الستيرويدية "NSAIDS" (أدْوية تُستخدم لتَخْفِيفَ الألَمَ والتورم وأَعْرَاض أخرى للالتهابِ، من بينها التهابِ المفاصل)، حَيْث إنّ استخدامها في نفس الوَقت مع أولميتَك قَدْ يَزيد من خُطُورة الفَشَل الكُلَوي. وَقَد يَقلّ تَأثِير أولميتك عنْد تَنَاوُله مع مُضَادّاتَ الالتهابِ غير الستيرويدية.

∙ أدْوية أُخْرَى خَافضَة لضَغط الدّم؛ لأن ذَلِك قَد يَزيد من تَأثِير أولميتك.

∙ مُضَّادّات حُمُوضَة معينَة (علاجاتِ لعسرَ الهضم) حَيْث قَدَ يَقِلّ تأثير أولميتك إلى حَدّ ما.

يُرجى إبلاغِ الطبيب أو الصيدلي الخَاصّ بك إذَا كُنْت تَتَنَاول أو تَنَاوَلت مُؤخَّرًا أيّة أدْويةً أُخْرى، بما فيها الأدوية الّتي يَتِمّ الحصولَ عَلَيها دُوْن وَصْفة طِبيّة.

تَنَاوَل أولميتك مع الطعام والشراب

يُمْكن تَنَاوُل أولميتك مَعَ الطّعَام أو بدونه. ابْتَلع الأقْرَاص مَعَ كَمِّيّة قَلِيلَة من الماء. إِنْ أَمْكَن، تَنَاول جُرْعَتَك اليومية في نَفْسِ الوَقْت مِنَ كُلّ يَوم، عَلَى سَبيل المِثالِ؛ في وقت الإفطَار.

الأطفال والمراهقون (أقل من 18 سنة)

لا يُوصى باستخدام أولميتك للأطفال والمراهقين أَقَلّ من 18 سنة.

المرضى وكبار السن

إِذَا كَانَ عُمْرُك يَتَعدى 65 عامًا وقَرّر طَبيبُك زِيَادَة جُرْعَتك من أولميسارتان ميدوكسوميل إلى 40 ملج، فَيَجِب أَن يَقُوم طَبِيبُك حينئذٍ بِفَحْص ضَغْط الدّم لديك بانتظَام؛ لِلتّأكُّد من أن ضَغْط الدّم لديم لم يَنْخَفِض بِشِدَّة.

 

الحَمْل والرِّضَاعة الطّبِيعيّة

الحَمْل

يجـب تجنـب اسـتخدام أولميتيـك فـي النسـاء الحوامـل أو اللواتـي قـد يكـن حوامـل. يجـب
وقـف العـلاج علـى الفـور إذا تبيـن أن المريضـة حامـل خـلال فتـرة العـلاج
 

الرّضَاعَة الطّبيعية

أخبري طبيبك إِذَا كُنتِ ترضعينِ طفلك طبيعيًّا أو كُنتِ عَلَى وَشْك البدء في إرضاعه طبِيعيًا. لا يُوصَى باستخدامِ أولميتك للأمهات المرضعات، وَقَد يخْتَار طبيبَك عَلاجًا آخرَ لك إذَا كنتِ تريدين الإرضاع طبيعيًا، خَاصّة إذا كانَ طفلك حَديث الولادة أو مُبْتسرا.

استشيري الطبيب أو الصيدلي الخَاصَ بكِ قَبْل تَنَاوُل أي دَوَاء.

القيادة واستخدام الآلات

من غَير المُرَجّح أنْ يُؤثر أولميتك في قُدْرَتِك عَلَى القِيَادَة أو استخدام الآلات. ومع ذلك، قَدْ تَحْدُث دَوْخَة أَو إرْهَاق في بَعْض الأحْيَان أثْنَاء علاج ضَغْطِ الدّم المُرْتَفع. إذا لاحَظتَ هذه الأعراض، فلا تَقُم بالقيادة ولا تَسْتَخْدم الآلات حتى تَزول الأعراض. استشر طبيبكَ.

معلومات هامة عن بعض مكونات أولميتك

يَحْتَوي هَذَا الدّواء عَلَى سُكّر الـ"لاكتوز". إذَا كَانَ طَبِيبك قَد أَبْلَغَك بِأَنّك لا تَتَحَمّل بَعْض أَنْواع السّكّريات، فَيَجِب استشَارَتَه قَبْل تَنَاوُل هذا الدواء.

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تَنَاوَل دَائِمًا أولميتك بالضّبط كَمَا أَخْبَرَك طَبِيبكَ. إِذَا لَم تَكُن مُتَأكّدًا، يَجِب عَلَيك مُرَاجَعَةِ الطّبيب أو الصيدلي الخاص بك.

يُمكن تَنَاوُل الأقراص مع الطّعَام أو بدونه. ابْتَلِع الأقْرَاص مع كِمِّيَة قَليلَة من الماء. إِنْ أمْكَن، تَنَاول جُرْعَتَك اليومية في نفس الوقت كُلّ يَوم، عَلَى سَبيلِ المثال؛ في وقت الإفطار.

جُرْعَة البِدء المعتادة هي قُرْص واحد 10 ملج مَرّةً وَاحِدَة في اليوم. ومع ذَلك، إِذَا لَم يَتِمّ التَّحَكُّمِ في ضَغْط الدَّم لَدَيك، فَقَد يُقَرّر طبيبك تَغْيير جُرْعَتك لِتَصل إلى 20 أو 40 ملج مَرّةَ وَاحدَة في اليومِ، أو يَقُوم بِوَصفَ أدْوية إضَافيّة.

بالنّسبة للمرضى المُصابين بِمَرَضِ خَفيفٍ إلى مُتَوَسّط بُالكُلى، لَن تَكُون الجُرعَة أعْلَى من 20 ملج مَرّة واحدة في اليوم.

إذا تَنَاوَلت كِمّيّة من أولميتك أكثر مِمّا يَجب

إذَا تَنَاوَلتِ أَقْراصًا أَكْثَر مِمّا يَجِب، أو إِذَا قَامَ طِفْل بابتلاع بعضٍ منها بِطَريق الخطأ، فَتَوجّه إِلى طَبِيبك أَو إِلى أَقْرَب قِسْمٍ للطوارئ عَلَى الفور واصطَحب مَعَك عبوة الدّواء.

إذَا نَسيت تَنَاوُل أولميتك

إذَا نَسيت تَنَاوُل جُرْعَة، فَتَنَاوَل جُرْعَتِك العادية في اليوم التّالي كالمعتاد. لا تَتَنَاوَل أَيّة أَقْرَاص إِضَافِيّة لِتَعْوِيض الجرعة التي نسيتَها.

إذَا تَوَقّفْت عَنِ تَنَاوُل أولميتك

من المهم أن تستمرّ في تناوُل أولميتك مَا لَم يُخْبِرك طَبِيبك بالتّوقف.

إذّا كَانَ لديك أيّة أسئلة أخرى حَولَ استخدام هذا المنتج الدوائي، فاستشر الطبيب أو الصيدلي الخاصّ بِك.

مثْل جَميع الأدوية، يُمْكِن أن يُسبب أولميتك أعراضًا جانبية، لَكِنّها لا تَحْدُث للجميع. وإذَا حَدَثَت، تَكُون غالبًا خَفِيفة ولا تَحتَاج إلى إيقَاف العلاج.

بِالرَغم من عَدَم مُعَاناة أَشْخَاص كَثيرين منها، غَير أَنَّ العرضين الجانبيين التّاليين قَد يكونان خطيرين:

تَمّ الإبلاغ في حَالات نَادِرَة جدًا عن تفاعلات الحساسية التالية:

تَوَرُّم في الوجه، الفم و / أو الحنجرة (صندوق الصوت) مع حَكّة وَطَفْح جِلْدِي أَثْنَاء العلاج باستخدام أولميتك. إذَا حَدَثَ ذلك فَتَوَقّفِ عَن تَنَاوُل أولميتك، واتصل بطبيبك على الفور.

يُمْكن أن يُسَبّب أوَلميتك انخفاضًا كبيرًا جدًا في ضَغْط الدّم في الأفراد الأكثر عُرْضَة لذلك، إلا أن ذلك يَحْدُث بِشَكلِ نَادر (ولكن في كثير من الأحيان يَكُون أكْثر قَليلاً في المرضى كِبار السن). وَقَد يُسَبب ذلك دوخَة أو إغْماء. إذَا حَدَثَ ذلكَ فَتَوقّفَ عَن تَنَاوُلِ أولميتك، واتصل بطبيبِكَ على الفور وتمدّد في وضع الاستلقاء.

لِنُعطيكَ فِكْرَة عَن عَدَد المرضَى الذين قَدْ يُعانون مِن الأعراض الجانبية، تَمّ إِدْراج الأعراض الجانبية على هيئة أعراضٍ جَانِبِيّة شائِعَة وغَيرِ شائِعَة وَنَادِرَة ونادِرَة جدًا. وهي تعني ما يلي:

شَائِعَة (أقل مِن شَخْصَ وَاحد بَين كُلِّ 10 أشْخَاص)

غَير شائِعة (أَقَلِ مِن شَخْصَ وَاحد بَين كُلّ 100 شخص)

نَادِرَة (أَقَلّ مِن شَخْصِ وَاحد بينَ كُلّ 1000 شخص)

نَادِرَة جدًا (أَقَلّ مِن شَخصَ وَاحِد بين كُلّ 10.000 شخص)

∙ الأعراض الجانبية الشائعة:

دوخة، غثيان، عُسْر هَضْم، إِسْهَال، أَلَم بالمعدَة، التهاب المِعدَة والأمعاء، تَعَب، التهاب الحَلْق، رَشْح الأَنْف أو انسِدادها، التهاب القصبات الهوائية، أَعْراض شَبِيهَة بالأَنْفلوَنزا، سُعَال، أَلَمَ في الصّدْر والظهر وَالعظام أو المفاصل، عَدْوى في المَسَالِك البَولية، تَوَرّم الكاحلين، القدمين، السّاقَين، اليدين أو الذراعين، ظُهُور دَم في البول.

كَمَا تَمّت مُلاحَظَة بَعض التّغَييرات في فُحُوصَات الدَّم وَتَتَضَمّن ما يلي:

ارتفاع مستويات الدَّهون (فَرْط الدُهون الثّلاَثِية بالدّم) وَزِيادَة مستويات حمض اليوريك وارتفاعًا في قيم اختبارات وظائف الكبد والعَضَلاَت.

∙ الأعراض الجانبية غِير الشائعة:

دُوَار، طَفْح جِلْدي، ذَبْحة (أَلَم أو شُعور بِعَدَم الرّاحَة في الصّدْر).

∙ الأعراض الجانبية النادرة:

نادِرًا ما أظْهَرت نَتَائج اختِبَار الدّم ارتفاعًا بمستويات البوتاسيوم في الدّم.

∙ الأعراض الجانبية النّادرة جدًا:

صُدَاع، تَقَلّصات عَضَلِية وَأَلم عَضَلِي، قُصُور بِوَظَائِف الكُلَى، فَشَل كُلَوي، ضَعْف، فُقْدَان الطّاقَة، الشّعُور بالمرض، قَيء، حَكّة، طفْحِ جلدي.

كَمَا تَمّت أيضًا مُلاحظَة بَعْضِ التّغَييراتِ في نَتَائج اختبَار الدّم، وتَتَضَمّن ارتفاع مستويات المُركبات المتعلقة بوَظَائف الكُلَى وانخفاض أعْدَاد نَوْع مِن خَلايا الدّم، يُعْرَفَ بِالصَّفائحَ الدّمَوية (قِلّة الصّفَائِح الدّمَوية).

∙ غير معروف:

ذرب الأمعـاء: إسـهال شـديد بسـبب مـرض فـي الأمعـاء ويسـبب فقـدان للـوزن وينبغـي
الاتصـال بالطبيـب علـى الفـور عنـد الشـعور بهـذه الأعـراض.
- إذا كنـت تعانـي مـن اصفـرار بيـاض العيـن، والبـول الداكـن، وحكـة فـي الجلـد، حتـى لـو
كنـت بـدأت العـلاج بأولميتـك منـذ فتـرة طويلـة، فاتصـل بطبيبـك علـى الفـور الـذي سـيقيم
أعراضـك ويقـرر كيفيـة متابعـة عـلاج ضغـط الـدم
إذا أصبـح أي ً مـن الأعـراض الجانبيـة خطيـرا، أو إذا لاحظت أ ّية أعـراض جانبيـة غيـر
ّ المدرجــة فــي هــذه النشـرة، فيرجــى إبــلاغ الطبيــب أو الصيدلــي الخــاص بــك

 

يُحفظ بعيدًا عن مُتَنَاوَل ورُؤْية الأطفال.

يُخَزّن في دَرَجة حَرَارة أقل من 30 دَرَجةِ مئوية.

لا تَسْتَخْدم أولَميتك بَعْدَ تَارِيخ انتِهَاء الصَّلاحية ("EXP") المدون على العبوة والشريط. ويُشِيرُ تَارِيخ انتهاء الصّلاحِيّة إلى اليوم الأخير في ذلك الشهر.

يَجِب عَدَم التّخَلّص من الأدْويَة عَن طَرِيق إلْقَائها في ميَاه الصّرف أو مَعَ المُخَلّفَات المنزلية. استفسر من الصيدلي الخاصّ بِك عَن كيفية التّخلص منَ الأدوَية الّتي لَمَ تَعُد بِحَاجَة إليهَا. ستساعَد هَذِه الإجراءات عَلَى حِمَايَة البيئة.

∙ المادّة الفَعّالَة هي أولميسارتان ميدوكسوميل

يَحْتَوِي كُلّ قُرْص مُغَلَّف عَلَى 20 ملج أولميسارتان ميدوكسوميل.

∙ المكونات الأخرى هي:

هيدروكسـي بروبيـل السـليلوز، لاكتـوز، هيدروكسـي بروبيـل السـليلوز منخفض الاسـتعاضة،
أوبـادري, سـتيرات المغنيسـيوم و سـليلوز دقيـق التبلـور
 

أولميتـك 20 ملـج: أقـراص مغلفـة، ذات ْ اللـون الأبيض و ّ دائريـة الشكل منقـوش علـى أحـد
جانبيهـا SJ 171
تحتوي العبوة على ً 28 قرصا مغلفا

مصنع سَاجَا للصناعات الدوائية

الشركة العربية السعودية اليابانية للمنتجات الصيدلانية المحدودة

جَدّة – المملكة العربية السعودية

بِتَرْخِيصِ من

شِركَة دَاييَشي سانكيو المَحْدُودة

طوكيو - اليابان

للإبلاغ عن أية آثار جانبية
المملكة العربية السعودية
المركز الوطني للتيقظ والسلامة الدوائية
- مركز اتصالات الهيئة العامة للغذاء والدواء السعودية : 19999
npc.drug@sfda.gov.sa :- البريد الإلكتروني
https://ade.sfda.gov.sa :-

دول الخليج الأخرى/ الدول الأخرى
- الرجاء الاتصال بالمؤسسات و الهيئات الوطنية في كل دولة

مايو/2023
 Read this leaflet carefully before you start using this product as it contains important information for you

Olmetec 20 mg film-coated tablet Olmetec 40 mg film-coated tablet

Each 20 mg tablet contains 20 mg of Olmesartan medoxomil Each 40 mg tablet contains 40 mg of Olmesartan medoxomil Excipients: lactose monohydrate (see section 4.4) For a full list of excipients, see section 6.1

OLMETEC 20 mg White to off white, circular, film-coated tablet, coded by 171 on one side and plain on the other side OLMETEC 40 mg White to off white, Oval, film-coated tablet, coded by 172 on one side and plain on the other side Olmesartan medoxomil is a pro-drug which is hydrolysed to the active metabolite olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as (5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl4-(1- hydroxy-1-methylethyl)-2-propyl-1[[2'-(1H-tetrazol- 5-yl)-1,1'-biphenyl-4-yl]methyl] 1H-imidazol-5- carboxylate. Alternatively, it can be described as “2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3- carbonate”. Its empirical formula is C29H30N6O6 and its structural formula is

Treatment of essential hypertension
 


Adults
The recommended starting dose of Olmesartan medoxomil is 10 mg once daily. In
patients whose blood pressure is not adequately controlled at this dose, the dose of
Olmesartan medoxomil may be increased to 20 mg once daily as the optimal dose. If
additional blood pressure reduction is required, Olmesartan medoxomil dose may be
increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be
added.
The antihypertensive effect of Olmesartan medoxomil is substantially present within
2 weeks of initiating therapy and is maximal by about 8 weeks after initiating
therapy. This should be borne in mind when considering changing the dose regimen
for any patient.
In order to assist compliance, it is recommended that Olmetec tablets be taken at
about the same time each day, with or without food, for example at breakfast time.
Elderly
No adjustment of dosage is generally required in elderly patients (see below for dose
recommendations in patients with renal impairment). If up-titration to the maximum
dose of 40 mg daily is required, blood pressure should be closely monitored.
Renal impairment
The maximum dose in patients with mild to moderate renal impairment (creatinine
clearance of 20 – 60 mL/min) is 20 mg Olmesartan medoxomil once daily, owing to
limited experience of higher dosages in this patient group. The use of Olmesartan
medoxomil in patients with severe renal impairment (creatinine clearance < 20
mL/min) is not recommended, since there is only limited experience in this patient
group (see sections 4.4, 5.2).
Hepatic impairment
No adjustment of dosage recommendations is required for patients with mild
hepatic impairment. In patients with moderate hepatic impairment, an initial dose of
10 mg Olmesartan medoxomil once daily is recommended and the maximum dose
should not exceed 20 mg once daily. Close monitoring of blood pressure and renal
function is advised in hepatically-impaired patients who are already receiving
diuretics and/or other antihypertensive agents. There is no experience of
Olmesartan medoxomil in patients with severe hepatic impairment, therefore use is
not recommended in this patient group (see sections 4.4 and 5.2). Olmesartan
medoxomil should not be used in patients with biliary obstruction (see 4.3).
Children and adolescents
Olmetec is not recommended for use in children below 18 years due to a lack of data
on safety and efficacy.
 


Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Pregnant women and women who may be pregnant (see sections 4.4 and 4.6). Biliary obstruction (see section 5.2). Patients with diabetes on aliskiren fumarate (except for patients with poor blood pressure control with other antihypertensive treatment) or renal impairment

Dual Blockade of the Renin-Angiotensin-aldosterone System (RAAS):
Combination of Olmesartan with ACE inhibitors, or aliskiren may cause increased
risks of hyperkalemia, worsening of kidney function and hypotension. Therefore, this
combination should not be used, especially in patients with kidney problems.
Intravascular volume depletion:
Symptomatic hypotension, especially after the first dose, may occur in patients who
are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt
restriction, diarrhoea or vomiting. Such conditions should be corrected before the
administration of Olmesartan medoxomil.
Other conditions with stimulation of the renin-angiotensin-aldosterone system:
In patients whose vascular tone and renal function depend predominantly on the
activity of the renin-angiotensin-aldosterone system (e.g. patients with severe
congestive heart failure or underlying renal disease, including renal artery stenosis),
treatment with other drugs that affect this system has been associated with acute
hypotension, azotaemia, oliguria or, rarely, acute renal failure. The possibility of
similar effects cannot be excluded with angiotensin II receptor antagonists.
Renovascular hypertension:
There is an increased risk of severe hypotension and renal insufficiency when
patients with bilateral renal artery stenosis or stenosis of the artery to a single
functioning kidney are treated with medicinal products that affect the reninangiotensin-aldosterone system.
Renal impairment and kidney transplantation:
When Olmesartan medoxomil is used in patients with impaired renal function,
periodic monitoring of serum potassium and creatinine levels is recommended. Use
of Olmesartan medoxomil is not recommended in patients with severe renal
impairment (creatinine clearance < 20 mL/min) (see sections 4.2, 5.2). There is no
experience of the administration of Olmesartan medoxomil in patients with a recent
kidney transplant or in patients with end-stage renal impairment (i.e. creatinine
clearance <12 mL/min).
Hepatic impairment:
There is no experience in patients with severe hepatic impairment and therefore use
of Olmesartan medoxomil in this patient group is not recommended (see section 4.2
for dosage recommendations in patients with mild or moderate hepatic
impairment).
Hyperkalaemia:
The use of medicinal products that affect the renin-angiotensin-aldosterone system
may cause hyperkalaemia.
The risk, that may be fatal, is increased in elderly, in patients with renal insufficiency
and in diabetic patients, in patients concomitantly treated with other medicinal
products that may increase potassium levels, and/or in patients with intercurrent
events.
Before considering the concomitant use of medicinal products that affect the reninangiotensin-aldosterone system, the benefit risk ratio should be evaluated and other
alternatives considered.
The main risk factors for hyperkalaemia to be considered are:
- Diabetes, renal impairment, age (> 70 years)
- Combination with one or more other medicinal products that affect the reninangiotensin-aldosterone system and/or potassium supplements. Some medicinal
products or therapeutic class of medicinal products may provoke a hyperkalaemia:
salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors,
angiotensin II receptors antagonists, non steroidal anti-inflammatory drugs
(including selective COX-2 inhibitors), heparin, immunosuppressor as ciclosporin or
tacrolimus, trimethoprim
- Intercurrent events, in particular dehydration, acute cardiac decompensation,
metabolic acidosis, worsening of renal function, sudden worsening of the renal
condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia,
rhabdomyolysis, extended trauma).
Close-monitoring of serum potassium in at risk patients is recommended (see section
4.5).
Lithium:
As with other angiotensin-II receptor antagonists, the combination of lithium and
Olmesartan medoxomil is not recommended (see section 4.5).
Aortic or mitral valve stenosis; obstructive hypertrophic cardiomyopathy:
As with other vasodilators, special caution is indicated in patients suffering from
aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism:
Patients with primary aldosteronism generally will not respond to antihypertensive
drugs acting through inhibition of the renin-angiotensin system. Therefore, the use
of Olmesartan medoxomil is not recommended in such patients.
Ethnic differences:
As with all other angiotensin II antagonists, the blood pressure lowering effect of
Olmesartan medoxomil is somewhat less in black patients than in non-black patients,
possibly because of a higher prevalence of low-renin status in the black hypertensive
population.
Sprue-like Enteropathy
Severe, chronic diarrhea with substantial weight loss has been reported in patients
taking olmesartan months to years after drug initiation. Intestinal biopsies of
patients often demonstrated villous atrophy. If a patient develops these symptoms
during treatment with olmesartan, exclude other etiologies. Consider
discontinuation of Olmetec in cases where no other etiology is identified.
Pregnancy:
Angiotensin II antagonists should not be initiated during pregnancy. Unless
continued angiotensin II antagonists therapy is considered essential, patients
planning pregnancy should be changed to alternative anti-hypertensive treatments
which have an established safety profile for use in pregnancy. When pregnancy is
diagnosed, treatment with angiotensin II antagonists should be stopped immediately
and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Other:
As with any antihypertensive agent, excessive blood pressure decrease in patients
with ischaemic heart disease or ischaemic cerebrovascular disease could result in a
myocardial infarction or stroke.
This medicinal product contains lactose. Patients with rare hereditary problems of
galactose intolerance, the Lapp-lactase deficiency or glucose-galactose
malabsorption should not take this medicinal product.
 


Interaction studies have only been performed in adults.
Dual RAAS Blockade:
The combination of Olmesartan with Aliskiren, ACEIs or other ARBs is
contraindicated in patients with diabetes mellitus or renal impairment.

Aliskiren fumarate (In patients with diabetes, except for patients with very poor blood pressure control with other antihypertensive treatment)

Dual blockade (e.g by adding ACE inhibitor to Olmesartan ) should not be used,
especially in patients with Kidney problems.
Effects of other medicinal products on Olmesartan medoxomil:
Potassium supplements and potassium sparing diuretics:
Based on experience with the use of other drugs that affect the renin-angiotensin
system, concomitant use of potassium-sparing diuretics, potassium supplements,
salt substitutes containing potassium or other drugs that may increase serum
potassium levels (e.g. heparin) may lead to increases in serum potassium (see
section 4.4). Such concomitant use is therefore not recommended.
Other antihypertensive medications:
The blood pressure lowering effect of Olmesartan medoxomil can be increased by
concomitant use of other antihypertensive medications.
Non-steroidal anti-inflammatory drugs (NSAIDs):
NSAIDs (including acetylsalicylic acid at doses> 3 g/day and also COX-2 inhibitors)
and angiotensin-II receptor antagonists may act synergistically by decreasing
glomerular filtration. The risk of the concomitant use of NSAIDs and angiotensin II
antagonists is the occurrence of acute renal failure. Monitoring of renal function at
the beginning of treatment should be recommended as well as regular hydration of
the patient.
Additionally, concomitant treatment can reduce the antihypertensive effect of
angiotensin II receptor antagonists, leading to their partial loss of efficacy.
Other compounds:
After treatment with antacid (aluminium magnesium hydroxide), a modest reduction
in bioavailability of Olmesartan was observed. Coadministration of warfarin and
digoxin had no effect on the pharmacokinetics of Olmesartan.
Effects of Olmesartan medoxomil on other medicinal products:
Lithium:
Reversible increases in serum lithium concentrations and toxicity have been
reported during concomitant administration of lithium with angiotensin converting
enzyme inhibitors and angiotensin II antagonists. Therefore use of Olmesartan
medoxomil and lithium in combination is not recommended (see section 4.4). If use
of the combination proves necessary, careful monitoring of serum lithium levels is
recommended.
Other compounds:
Compounds which have been investigated in specific clinical studies in healthy
volunteers include warfarin, digoxin, an antacid (magnesium aluminium hydroxide),
hydrochlorothiazide and pravastatin. No clinically relevant interactions were
observed and in particular Olmesartan medoxomil had no significant effect on the
pharmacokinetics or pharmacodynamics of warfarin or the pharmacokinetics of
digoxin.
Olmesartan had no clinically relevant inhibitory effects on in vitro human
cytochrome P450 enzymes 1A1/2, 2A6, 2C8/9, 2C19, 2D6, 2E1 and 3A4, and had no
or minimal inducing effects on rat cytochrome P450 activities. Therefore in vivo
interaction studies with known cytochrome P450 enzyme inhibitors and inducers
were not conducted, and no clinically relevant interactions between Olmesartan and
drugs metabolised by the above cytochrome P450 enzymes are expected.


1.1.   Pregnancy:

Text Box: OLMETEC should be avoided in pregnant or potentially pregnant women. Administration should be discontinued immediately if the patient is found to be pregnant during treatment. 
Oligoamnios, fetal or neonatal death, and neonatal hypotension, renal failure, hyperkalemia, cranial hypoplasia, acrocontracture possibly due to oligoamnios, craniofacial deformity, and lung hypoplasia have been reported in patients receiving angiotensin II receptor antagonists or ACE inhibitors during mid- or late

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II antagonists, similar risks may exist

 

for this class of drugs. Unless continued angiotensin receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.

Angiotensin II antagonists therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See also 5.3 “Preclinical Safety Data”.)

Should exposure to angiotensin II antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II antagonists should be closely observed for hypotension (see also sections 4.3 and 4.4).

Lactation:

Olmesartan is excreted in the milk of lactating rats but it is not known whether Olmesartan is excreted in human milk. Because no information is available regarding the use of Olmetec during breast-feeding, Olmetec is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.


No studies on the effect on the ability to drive and use machines have been
performed. With respect to driving vehicles or operating machines, it should be
taken into account that occasionally dizziness or fatigue may occur in patients taking
antihypertensive therapy.
 


a. Tabulated list of Adverse reaction:
Market experience
The following adverse reactions have been reported in post-marketing experience.
They are listed by System Organ Class and ranked under headings of frequency using
the following convention: very common (≥1/10); common (≥1/100, <1/10);
uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000)
including isolated reports.

System Organ Class

Very rare

Blood and lymphatic system disorders

Thrombocytopenia

Metabolism and nutrition disorders

Hyperkalaemia

Nervous system disorders

Dizziness, headache

Respiratory, thoracic and mediastinal disorders

Cough

Gastrointestinal disorders

Abdominal pain, nausea, vomiting

 

Skin and subcutaneous tissue disorders

Pruritus, exanthem, rash

 

Allergic conditions such as angioneurotic oedema, dermatitis allergic, face oedema and urticaria

 

 

Musculoskeletal and connective tissue disorders

Muscle cramp, myalgia

Renal and urinary disorders

Acute renal failure and renal insufficiency (See also under Investigations)

General disorders and administration site conditions

Asthenic conditions such as asthenia, fatigue, lethargy, malaise

Investigations

Abnormal renal function tests such as blood creatinine increased and blood urea increased

 

Increased hepatic enzymes

 

Clinical trials

In double-blind, placebo-controlled monotherapy studies, the overall incidence of treatment-emergent adverse events was 42.4% on olmesartan medoxomil and 40.9% on placebo.

In placebo-controlled monotherapy studies, the only adverse drug reaction that was unequivocally related to treatment was dizziness (2.5% incidence on olmesartan medoxomil and 0.9% on placebo).

In long-term (2-year) treatment, the incidence of withdrawals due to adverse events on olmesartan medoxomil 10 – 20 mg once daily was 3.7%. The following adverse events have been reported across all clinical trials with olmesartan medoxomil (including trials with active as well as placebo control), irrespective of causality or incidence relative to placebo. They are listed by body system and ranked under headings of frequency using the conventions described :

 

MedDRA System Organ Class

Adverse reactions / Frequency

Common

Rare

Uncommo n

Not Known

Central nervous system disorders

Dizziness

 

Vertigo

 

 

Cardiovascular disorders

 

Hypotension

Angina pectoris

 

Respiratory system disorders

Bronchitis, cough, pharyngitis, rhinitis

 

 

 

Gastro-

intestinal disorder

Abdominal pain, diarrhoea, dyspepsia,

gastroenteritis,

 

 

Sprue-like

enteropath y

 

Skin and appendages disorders

 

 

Rash

 

Musculoskeleta l disorders

Arthritis, back pain, skeletal pain

 

 

 

Urinary system

disorders

Haematuria, urinary tract infection

 

 

 

General disorders

Chest pain, fatigue,

influenza-like symptoms, peripheral

oedema, pain

 

 

 

Metabolic and nutritional disorders

Increased creatine phosphokinase, hypertriglyceridaemia

, hyperuricaemia

Hyperkalaemia

 

 

Liver and biliary

disorders

Liver enzyme elevations

 

 

Autoimmune hepatitis

 

Additional information on special populations

In elderly patients the frequency of hypotension is slightly increased from rare to uncommon.

b. Description of selected adverse reaction:
Single cases of rhabdomyolysis have been reported in temporal association with the
intake of angiotensin II receptor blockers. A causal relationship, however, has not
been established.

Cases of autoimmune hepatitis with a latency of few months to years have been reported post-marketing, that were reversible after the withdrawal of Olmesartan.

Post Marketing Experience
Data from one controlled trial and an epidemiologic study have suggested that highdose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the
overall data are not conclusive. The randomized, placebo-controlled, double-blind
ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria
Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in
patients with type 2 diabetes mellitus, normoalbuminuria, and at least one
additional risk factor for CV disease. The trial met its primary endpoint, decrease in
time-to-onset of microalbuminuria, but olmesartan had no beneficial effect on
decline in glomerular filtration rate (GFR). There was a finding of increased CV
mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke,
revascularization death) in the olmesartan group compared to the placebo group (15
olmesartan vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk
of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35,
1.18).
The epidemiologic study included patients 65 years and older with overall exposure
of >300,000 patient-years. In the sub-group of diabetic patients receiving high-dose
olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of
death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin
receptor blockers. In contrast, high-dose olmesartan use in non-diabetic patients
appeared to be associated with a decreased risk of death (HR 0.46, 95% CI 0.24,
0.86) compared to similar patients taking other angiotensin receptor blockers. No
differences were observed between the groups receiving lower doses of olmesartan
compared to other angiotensin blockers or those receiving therapy for < 6 months.
Overall, these data raise a concern of a possible increased CV risk associated with the
use of high-dose olmesartan in diabetic patients. There are, however, concerns with
the credibility of the finding of increased CV risk, notably the observation in the large
epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to
the adverse finding in diabetics.
c. Other special population:
Renal impairment and kidney transplantation:
When Olmesartan medoxomil is used in patients with impaired renal function,
periodic monitoring of serum potassium and creatinine levels is recommended. Use
of Olmesartan medoxomil is not recommended in patients with severe renal
impairment (creatinine clearance < 20 mL/min) (see sections 4.2, 5.2). There is no
experience of the administration of Olmesartan medoxomil in patients with a recent
kidney transplant or in patients with end-stage renal impairment (i.e. creatinine
clearance <12 mL/min).
Hepatic impairment:
There is no experience in patients with severe hepatic impairment and therefore use
of Olmesartan medoxomil in this patient group is not recommended (see section 4.2
for dosage recommendations in patients with mild or moderate hepatic
impairment).
Pregnancy:
The use of angiotensin II antagonists is not recommended during the first trimester
of pregnancy (see section 4.4). The use of angiotensin II antagonists is
contraindicated during the second and third trimester of pregnancy
Elderly
No adjustment of dosage is generally required in elderly patients (see below for dose
recommendations in patients with renal impairment). If up-titration to the maximum
dose of 40 mg daily is required, blood pressure should be closely monitored.
Children and adolescents
Olmetec is not recommended for use in children below 18 years due to a lack of data
on safety and efficacy.
 

-To report any side effect (s)

·         Saudi Arabia :

 
 Text Box: − National Pharmacovigilance Center (NPC)
-	SFDA Call Center:19999
-	E-mail: npc.drug@sfda.gov.sa
-	Website:https://ade.sfda.gov.sa



Other GCC states /other countries

-Please contact the relevant competent authority.


Only limited information is available regarding over dosage in humans. The most
likely effect of over dosage is hypotension. In the event of over dosage, the patient
should be carefully monitored and treatment should be symptomatic and
supportive.
No information is available regarding the dialysability of Olmesartan.
 


Pharmaco-therapeutic group:
Angiotensin II antagonists, ATC code: C09C A 08.
Olmesartan medoxomil is a potent, orally active, selective angiotensin II receptor
(type AT1) antagonist. It is expected to block all actions of angiotensin II mediated by
the AT1 receptor, regardless of the source or route of synthesis of angiotensin II. The
selective antagonism of the angiotensin II (AT1) receptors results in increases in
plasma renin levels and angiotensin I and II concentrations, and some decrease in
plasma aldosterone concentrations.
Angiotensin II is the primary vasoactive hormone of the renin-angiotensinaldosterone system and plays a significant role in the pathophysiology of
hypertension via the type 1 (AT1) receptor.
In hypertension, Olmesartan medoxomil causes a dose-dependent, long-lasting
reduction in arterial blood pressure. There has been no evidence of first-dose
hypotension, of tachyphylaxis during long-term treatment, or of rebound
hypertension after cessation of therapy.
Once daily dosing with Olmesartan medoxomil provides an effective and smooth
reduction in blood pressure over the 24 hour dose interval. Once daily dosing
produced similar decreases in blood pressure as twice daily dosing at the same total
daily dose.
With continuous treatment, maximum reductions in blood pressure are achieved by
8 weeks after the initiation of therapy, although a substantial proportion of the
blood pressure lowering effect is already observed after 2 weeks of treatment. When
used together with hydrochlorothiazide, the reduction in blood pressure is additive
and coadministration is well tolerated.
The effect of Olmesartan on mortality and morbidity is not yet known.
 


Absorption and distribution
Olmesartan medoxomil is a prodrug. It is rapidly converted to the pharmacologically
active metabolite, Olmesartan, by esterases in the gut mucosa and in portal blood
during absorption from the gastrointestinal tract.
No intact Olmesartan medoxomil or intact side chain medoxomil moiety have been
detected in plasma or excreta. The mean absolute bioavailability of Olmesartan from
a tablet formulation was 25.6%.
The mean peak plasma concentration (Cmax) of Olmesartan is reached within about 2
hours after oral dosing with Olmesartan medoxomil, and Olmesartan plasma
concentrations increase approximately linearly with increasing single oral doses up
to about 80 mg.
Food had minimal effect on the bioavailability of Olmesartan and therefore
Olmesartan medoxomil may be administered with or without food.
No clinically relevant gender-related differences in the pharmacokinetics of
Olmesartan have been observed.
Olmesartan is highly bound to plasma protein (99.7%), but the potential for clinically
significant protein binding displacement interactions between Olmesartan and other
highly bound coadministered drugs is low (as confirmed by the lack of a clinically
significant interaction between Olmesartan medoxomil and warfarin). The binding of
Olmesartan to blood cells is negligible. The mean volume of distribution after
intravenous dosing is low (16 – 29 L).
Metabolism and elimination
Total plasma clearance was typically 1.3 L/h (CV, 19%) and was relatively slow
compared to hepatic blood flow (ca 90 L/h). Following a single oral dose of 14C
labelled Olmesartan medoxomil, 10 - 16% of the administered radioactivity was
excreted in the urine (the vast majority within 24 hours of dose administration) and
the remainder of the recovered radioactivity was excreted in the faeces. Based on
the systemic availability of 25.6%, it can be calculated that absorbed Olmesartan is
cleared by both renal excretion (ca 40%) and hepato-biliary excretion (ca 60%). All
recovered radioactivity was identified as Olmesartan. No other significant metabolite
was detected. Enterohepatic recycling of Olmesartan is minimal. Since a large
proportion of Olmesartan is excreted via the biliary route, use in patients with biliary
obstruction is contraindicated (see section 4.3).
The terminal elimination half life of Olmesartan varied between 10 and 15 hours
after multiple oral dosing. Steady state was reached after the first few doses and no
further accumulation was evident after 14 days of repeated dosing. Renal clearance
was approximately 0.5 – 0.7 L/h and was independent of dose.
Pharmacokinetics in special populations
Elderly:
In hypertensive patients, the AUC at steady state was increased by ca 35% in elderly
patients (65 – 75 years old) and by ca 44% in very elderly patients ( 75 years old)
compared with the younger age group. This may be at least in part related to a mean
decrease in renal function in this group of patients.
Renal impairment:
In renally impaired patients, the AUC at steady state increased by 62%, 82% and
179% in patients with mild, moderate and severe renal impairment, respectively,
compared to healthy controls (see sections 4.2, 4.4).
Hepatic impairment:
After single oral administration, Olmesartan AUC values were 6% and 65% higher in
mildly and moderately hepatically impaired patients, respectively, than in their
corresponding matched healthy controls. The unbound fraction of Olmesartan at 2
hours post-dose in healthy subjects, in patients with mild hepatic impairment and in
patients with moderate hepatic impairment was 0.26%, 0.34% and 0.41%,
respectively. Following repeated dosing in patients with moderate hepatic
impairment, Olmesartan mean AUC was again about 65% higher than in matched
healthy controls. Olmesartan mean Cmax values were similar in hepatically-impaired
and healthy subjects. Olmesartan medoxomil has not been evaluated in patients
with severe hepatic impairment (see sections 4.2, 4.4).
 


In chronic toxicity studies in rats and dogs, Olmesartan medoxomil showed similar
effects to other AT1 receptor antagonists and ACE inhibitors: raised blood urea (BUN)
and creatinine (through functional changes to the kidneys caused by blocking AT1
receptors); reduction in heart weight; a reduction of red cell parameters
(erythrocytes, haemoglobin, haematocrit); histological indications of renal damage
(regenerative lesions of the renal epithelium, thickening of the basal membrane,
dilatation of the tubules). These adverse effects caused by the pharmacological
action of Olmesartan medoxomil have also occurred in preclinical trials on other AT1
receptor antagonists and ACE inhibitors and can be reduced by simultaneous oral
administration of sodium chloride.
In both species, increased plasma renin activity and hypertrophy/hyperplasia of the
juxtaglomerular cells of the kidney were observed. These changes, which are a
typical effect of the class of ACE inhibitors and other AT1 receptor antagonists, would
appear to have no clinical relevance.
Like other AT1 receptor antagonists Olmesartan medoxomil was found to increase
the incidence of chromosome breaks in cell cultures in vitro. No relevant effects
were observed in several in vivo studies using Olmesartan medoxomil at very high
oral doses of up to 2000 mg/kg. The overall data of a comprehensive genotoxicity
testing suggest that Olmesartan is very unlikely to exert genotoxic effects under
conditions of clinical use.
Olmesartan medoxomil was not carcinogenic, neither in rats in a 2 year study nor in
mice when tested in two 6 month carcinogenicity studies using transgenic models.
In reproductive studies in rats, Olmesartan medoxomil did not affect fertility and
there was no evidence of a teratogenic effect. In common with other angiotensin II
antagonists, survival of offspring was reduced following exposure to Olmesartan
medoxomil and pelvic dilatation of the kidney was seen after exposure of the dams
in late pregnancy and lactation. In common with other antihypertensive agents,
Olmesartan medoxomil was shown to be more toxic to pregnant rabbits than to
pregnant rats, however, there was no indication of a fetotoxic effect.
 


Microcrystalline cellulose, Lactose monohydrate, Low substitute Hydroxy propylcellulose, Hydroxy propylcellulose, magnesium stearate, and Opadry

white


Not applicable.
 


4 years.

Store below 30°C.
 


Forming Aluminium / aluminium blister pack.
Packs of 28 film-coated tablets.
 


No special requirements.
 


SAJA Pharmaceuticals Saudi Arabian Japanese pharmaceutical company limited Jeddah – Saudi Arabia Under license from Daiichi Sankyo Co. Ltd. Tokyo-Japan

May 2023
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