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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)

Physiotens 0.2 mg contains an active substance called moxonidine. This medicine belongs to a group of medicines called “anti-hypertensives”.

 

Physiotens 0.2 mg is used to treat high blood pressure (hypertension). It works by relaxing and widening your blood vessels, an effect that will help to lower your blood pressure.


Do not take Physiotens 0.2 mg:

-      if you are allergic (hypersensitive) to moxonidine or any of the other ingredients of this medicinal product mentioned in section 6;

-      if your heart rate is slow due to a heart problem called “sick sinus syndrome” or “second or third degree AV block”;

-      if you have heart failure.

 

Do not take Physiotens 0.2 mg if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Physiotens 0.2 mg.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking your medicine:

-      if you have a heart problem called “first degree AV block”;

-      if you have severe coronary artery disease or unstable chest pain (angina);

-   if you have kidney problems. Your doctor may need to adjust your dose.

 

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Physiotens 0.2 mg.

 

Taking Physiotens 0.2mg together with Other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is necessary because Physiotens 0.2 mg can affect the way other medicines work. Also, other medicines can affect the way Physiotens 0.2 mg works.

 

It is particularly important to tell your doctor or pharmacist if you are taking any of the following medicines:

-      Other medicines to lower your blood pressure. Physiotens 0.2 mg may increase the effect of these medicines.

-      Medicines for depression, such as imipramine or amitriptyline.

-      Tranquillisers, sedatives or sleeping tablets such as benzodiazepines.

-      Beta-blockers (see “If you stop taking Physiotens 0.2 mg” in section 3).

-      Physiotens 0.2 mg is removed from your body by your kidneys through a process called “tubular excretion”. Other medicines removed from the kidneys in the same way could affect how Physiotens 0.2 mg works.

 

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Physiotens 0.2 mg.

 

Physiotens 0.2 mg with food and drink

The tablets can be taken with or without food.

 

Pregnancy, breast-feeding and Fertility

Tell your doctor if you are pregnant or might become pregnant. Your doctor will normally advise you to stop taking Physiotens 0.2 mg. Your doctor will advise you to take another medicine instead of Physiotens 0.2 mg.

 

Tell your doctor if you are breast-feeding or about to start breast-feeding. Physiotens 0.2 mg is not recommended for mothers who are breast-feeding. Your doctor may advise you to take another medicine if you want to breast-feed, or may ask you to stop breast-feeding.

 

If you are pregnant or breastfeeding, or if you suspect you are pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

 

Driving and using machines

You may feel sleepy or dizzy while taking Physiotens 0.2 mg. If this happens, talk to your doctor before driving or using any tools or machines.

 

Physiotens 0.2 mg contains lactose. If you have been told by your doctor that you cannot tolerate certain types of sugar, talk to your doctor before taking this medicine.


Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.

 

Taking this medicine

Swallow the tablets whole with a full glass of water.

Try to take your tablets at about the same time each day. This will help you remember to take them.

 

How much to take

The usual starting dose is 0.2 mg a day.

Your doctor may increase this dose to up to 0.6 mg a day. If your doctor has told you to take 0.6 mg a day, this should be divided into two doses (0.3 mg in the morning and 0.3 mg in the evening).

The maximum single dose is 0.4 mg.

Your doctor may tell you to take a lower dose if you have kidney problems.

 

Use in children and adolescents

Physiotens 0.2 mg should not be given to children and adolescents under 18 years of age.

 

If you take more Physiotens 0.2 mg than you should

If you take more Physiotens 0.2 mg than you should, talk to a doctor or go to a hospital straight away. Take the medicine with you. The following may develop: headache, feeling sleepy (somnolence, sedation), fall in blood pressure (hypotension), slow heart rate (bradycardia), feeling dizzy (vertigo), dry mouth, nausea (vomiting), feeling tired (fatigue), weakness and stomach ache (abdominal pain).

 

If you forget to take Physiotens 0.2 mg

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.

 

Do not take a double dose to make up for a forgotten dose.

 

If you stop taking Physiotens 0.2 mg

Keep taking your tablets until your doctor decides that you should stop.

 

If you need to stop, your doctor will slowly lower your dose over a period of a few weeks. If you are taking more than one medicine for high blood pressure (such as beta-blockers), your doctor will tell you which medicine to stop first so that your body can slowly adjust to the change.

 

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


Like all medicines, this medicine also can cause side effects, although not everybody gets them. This medicine may cause the following side effects:

 

Stop taking Physiotens 0.2 mg and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

-      swelling of the face, lips or mouth (angioedema). This is uncommon, affecting less than 1 in 100 people.

 

Other side effects include:

 

Very common (may affect more than 1 in 10 people)

-      Dry mouth

 

Common (may affect up to 1 in 10 people)

-      Back pain

-      Headache

-      Weakness (asthenia)

-      Giddiness, dizziness (vertigo)

-      Rash or itching (pruritus)

-      Sleep disorders (insomnia), sleepiness

-      Nausea, diarrhoea, vomiting, indigestion

 

Uncommon (may affect up to 1 in 100 people)

-      Neck pain

-      Nervousness

-      Fainting (syncope)

-      Swelling (oedema)

-      Ringing or noises in the ears (tinnitus)

-      Unusually slow heartbeat (bradycardia)

-      Low blood pressure, including low blood pressure when standing up

 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

 

To report any side effect(s):

-National Pharmacovigilance Center (NPC)

o Fax: +966-11-205-7662

o SFDA Call Center: 19999

o E-mail: npc.drug@sfda.gov.sa

o Website: https://ade.sfda.gov.sa

 


Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Store in the original package.

Shelf life: 2 years

Do not use this medicine after the expiry date which is stated on the carton and blister strips. The expiry date refers to the last day of that month.

Do not dispose any medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine if you stop using it. These measures will help protect the environment.


The active substance is moxonidine. Each tablet contains 0.2 mg of moxonidine.

 

The other ingredients are crospovidone type A (Ph. Eur.), lactose monohydrate, magnesium stearate (Ph. Eur.) [vegetable], povidone (K25), iron(III) oxide, ethylcellulose, hypromellose, macrogol 6000, talc, and titanium dioxide.


The film-coated tablets are round, convex, light pink, and marked “0.2” on one side. Physiotens 0.2 mg is available in packs of 28 or 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Abbott Laboratories GmbH, Hannover, Germany 

 

Manufacturer:

Rottendorf Pharma GmbH, Germany

 

Packaged and Released by:

AJA Pharmaceutical Industries Company Ltd. (AJA Pharma)

Hail 55414 , Hail Industry City MODON

Kingdom of Saudi Arabia


04/2019
  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 فيزيوتنس 0.2 ملغم على مادة فعالة تسمى موكسونيدين. واللذي ينتمي إلى مجموعة من الأدوية تسمى "مضادات لضغط الدم المرتفع".  

فيزيوتنس 0.2 ملغم يستخدم لعلاج ارتفاع ضغط الدم. وهو يعمل عن طريق استرخاء وتوسيع الأوعية الدموية، والذي من شأنه أن يساعد على خفض ضغط الدم.

لا تقم باستعمال فيزيوتنس  0.2ملغم:

•            إذا كنت تعاني من فرط الحساسية )حساسية لموكسونيدين أو أي من السواغات الأخرى لدواء فيزيوتنس  0.2ملغم المدرجة في القسم (6.

•            إذا كان معدل ضربات القلب بطيئا بسبب مشكلة في القلب تسمى "العقدة الجيبية المريضة " أو الدرجة الثانية أو الثالثة من احصار انسداد القلب الأذيني البطيني.

•            إذا كان لديك قصور في القلب.

يجب عدم تناول هذا الدواء إذا كان أي مما سبق ينطبق عليك. إذا لم تكن متأكدا، تحدث مع طبيبك أو الصيدلي قبل تناول فيزيوتنس  0.2ملغم.

التحذيرات والاحتياطات:

تحدث إلى طبيبك أو إلى الصيدلي قبل تناول فيزيوتنس  0.2ملغم .

•            إذا كان لديك مشكلة في القلب تسمى احصار انسداد القلب الأذيني البطيني من الدرجة الأولى.

•            إذا كان لديك مرض شديد بالشريان التاجي أو ألم غير مستقر في الصدر (الذبحة الصدرية).

•            إذا كان لديك مشاكل في الكلى. قد يحتاج طبيبك إلى ضبط جرعتك.

إذا كان أي من ما سبق ينطبق عليك أو إذا لم تكن متأكدا، تحدث مع طبيبك أو الصيدلي قبل تناول فيزيوتنس  0.2ملغم . 

تناول أدوية أخرى مع فيزيوتنس 0.2 ملغم: 

أخبر طبيبك أو الصيدلي أو الممرضة إذا كنت تناولت، أو قد تتناول مؤخرا أي أدوية أخرى، بما في ذلك الأدوية والأعشاب الطبية التي تم تناولها دون وصفة طبية، هذا ضروري لأن فيزيوتنس  0.2ملغم يمكن أن تؤثر على طريقة عمل الأدوية الأخرى. أيضا، الأدوية الأخرى يمكن أن تؤثر على طريقة عمل فيزيوتنس 0.2 ملغم.  

من المهم وبشكل خاص إخبار الطبيب أو الصيدلي إذا كنت تتناول أي من الأدوية التالية:

•            أدوية أخرى لخفض ضغط الدم. تناول فيزيوتنس  0.2ملغم قد يزيد من تأثير هذه الأدوية.

•            أدوية للاكتئاب، مثل إيميبرامين أو أميتريبتيلين.

•            المهدئات أو الأقراص المنومة مثل البنزوديازيبينات.

•            حاصرات بيتا انظر التوقف عن تناول فيزيوتنس 0.2 ملغم في القسم 3.

•            فيزيوتنس  0.2ملغم يتم إزالتها (الإخراج) من جسمك عن طريق الكلى عن طريق عملية تسمى "إفراز أنبوبي". الأدوية الأخرى التي يتم إزالتها من الكلى بنفس الطريقة يمكن أن تؤثر على كيفية عمل فيزيوتنس  0.2ملغم .

إذا كانت أي من الحالات السابقة تنطبق عليك أو إذا لم تكن متأكدا، تحدث مع طبيبك أو الصيدلي قبل تناول فيزيوتنس 0.2 ملغم.

 

تناول فيزيوتنس 0.2 ملغم مع الطعام والشراب: 

يمكن تناول فيزيوتنس 0.2 ملغم مع أو بدون طعام.

الحمل والرضاعة الطبيعية والخصوبة:

أخبر طبيبك إذا كنت حاملا أو قد تصبحين حاملا. سوف ينصحك الطبيب عادة بالتوقف عن تناول فيزيوتنس 0.2 ملغم. وسوف ينصحك طبيبك بتناول دواء آخر بدلا من فيزيوتنس 0.2 ملغم.

أخبر طبيبك إذا كنت في مرحلة الرضاعة الطبيعية أو على وشك البدء في الرضاعة الطبيعية. لا ينصح بتناول فيزيوتنس  0.2ملغم للأمهات اللاتي في مرحلة الرضاعة الطبيعية . قد ينصحك الطبيب بتناول دواء آخر إذا كنت ترغبين في الرضاعة الطبيعية، أو قد يطلب منك التوقف عن الرضاعة الطبيعية.

إذا كنت حاملا أو مرضعة، أو إذا كنت في شك من أنك حامل أو تنوي الحمل، اطلب من الطبيب أو الصيدلي الحصول على المشورة قبل تناول هذا الدواء.

 

القيادة واستخدام الآلات: 

قد تشعر بالنعاس أو بالدوار أثناء تناول فيزيوتنس  0.2ملغم . إذا حدث ذلك، تحدث مع طبيبك قبل القيادة أو استخدام أي أدوات أو آلات.

 

فيزيوتنس 0.2 ملغم يحتوي على اللاكتوز. إذا أخبرك طبيبك إنك لا تستطيع تحمل أنواع معينة من السكر، تحدث مع طبيبك قبل تناول هذا الدواء.

https://localhost:44358/Dashboard

تناول دائمًا هذا الدواء كما وصف الطبيب لك، استشر طبيبك أو الصيدلي إن لم تكن متأكدا.

طريقة تناول هذا الدواء

يتم ابتلاع الأقراص كاملة مع كوب كامل من الماء.

حاول أن تأخذ أقراصك في نفس الوقت تقريبا من كل يوم. هذا سوف يساعدك على تذكر أن تتناول الجرعة كل يوم.

الكمية التي يجب تناولها

جرعة البداية المعتادة هي  0.2ملغم يوميا .

قد يزيد طبيبك هذه الجرعة لتصل إلى  0.6مجم يوميا . إذا أخبرك طبيبك أن تناول  0.6ملغ يوميا ، يجب تقسيمها إلى جرعتين 0.3 ملغم في الصباح و  0.3ملغم في المساء .

 الحد الأقصى للجرعة الواحدة هو 0.4 ملغم.

قد يخبرك طبيبك أن تتناول جرعة أقل إذا كان لديك مشاكل في الكلى.

الاستخدام للأطفال والمراهقين

لا ينبغي أن تعطى فيزيوتنس 0.2 ملغم للأطفال والمراهقين تحت سن 18 سنة من العمر.

إذا تناولت جرعة زائدة من فيزيوتنس 0.2 ملغم:

إذا تناولت فيزيوتنس 0.2 ملغم أكثر مما ينبغي، تحدث مع الطبيب أو اذهب إلى المستشفى على الفور. ويجب أخذ الدواء معك. قد تعاني من ما يلي: الصداع، الشعور بالنعاس، التخدير، انخفاض ضغط الدم، بطء معدل ضربات القلب (بطء القلب)، الشعور بالدوار، جفاف الفم، الغثيان، القيء، الشعور بالتعب ضعف وآلام في المعدة آلام في البطن.

إذا نسيت تناول فيزيوتنس 0.2 ملغم:

إذا نسيت أن تتناول جرعة من الأقراص، تخطى تلك الجرعة الفائتة ثم تناول الجرعة التالية في موعدها.

لا تتناول جرعة مضاعفة لتعويض الجرعة المنسية.

التوقف عن تناول فيزيوتنس 0.2 ملغم:

استمر في تناول أقراصك حتى يقرر طبيبك أن تتوقف.

إذا كنت بحاجة إلى التوقف عن تناول الدواء، سوف يقوم طبيبك بخفض جرعتك ببطء وعلى مدى فترة من بضعة أسابيع. إذا كنت تتناول أكثر من دواء لضغط الدم المرتفع (مثل حاصرات بيتا)، فإن طبيبك سيخبرك بالدواء الذي سيتوقف أولا حتى يتمكن الجسم من التكيف ببطء مع التغيير.

إذا كان لديك أية أسئلة أخرى حول هذا المنتج واستخدامه اسأل طبيبك أو الصيدلي.

مثل جميع الأدوية، يمكن أن يتسبب هذا الدواء في آثار جانبية، على الرغم من أنها لا تؤثر في الجميع. الآثار الجانبية التالية قد تحدث مع تناول هذا الدواء:

يجب التوقف عن تناول فيزيوتنس 0.2 ملغم واستشر الطبيب أو اذهب إلى المستشفى على الفور إذا عانيت من الأعراض التالية، فقد تحتاج إلى علاج طبي عاجل:

- تورم في الوجه والشفتين أو الفم (وذمة وعائية). هذا أمر غير شائع، حيث يؤثر على أقل من شخص من أصل 100 شخص.

أعراض جانبية أخرى وتشمل:

شائعة جدا (قد تصيب أكثر من شخص من أصل 10 أشخاص)

•            جفاف بالفم

شائعة (قد تصيب ما يصل إلى شخص من أصل 10 أشخاص).

•            ألم في الظهر

•            صداع الراس

•            الضعف (الوهن)

•            الدوخة، (الدوار)

•            طفح جلدي أو حكة 

•            اضطرابات النوم (الأرق)، والنعاس

•            الغثيان والإسهال والقيء وعسر الهضم

غير شائعة (قد تصيب ما يصل إلى شخص من أصل 100 شخص)

•            ألم الرقبة

•            العصبية

•            إغماء 

•            تورم (وذمة)

•            رنين أو ضوضاء في الأذنين (طنين)

•            بطء غير عادي وبشكل غير طبيعي في نبض القلب (بطء القلب)

•            انخفاض ضغط الدم، بما في ذلك انخفاض ضغط الدم عند الوقوف

إذا زادت حدة أي من هذه الأعراض الجانبية، أو لاحظت ظهور أعراض جانبية غير ما تم ذكره في هذه النشرة، يرجى إبلاغ الطبيب المعالج أو الصيدلي. وهذا يشمل أي آثار جانبية محتملة غير مدرجة في هذه النشرة. بالإبلاغ عن الآثار الجانبية يمكنك المساعدة في توفير مزيد من المعلومات حول أمان هذا الدواء. 

للإبلاغ عن الأعراض الجانبية

-          المركز الوطني للتيقظ والسلامة الدوائية (NPC)

o         فاكس 7662-205-11-966+

o         مركز الاتصال: 19999

o         البريد الإلكتروني: npc.drug@sfda.gov.sa

o         الموقع الإلكتروني: https://ade.sfda.gov.sa

•            يحفظ بعيدا عن متناول أيدي الأطفال أو على مرأى منهم. 

•            لا تخزنه في درجة حرارة أعلى من 25 درجة مئوية.

•            خزن الدواء في علبته الأصلية.

•            فترة الصلاحية: سنتين

•            لا تستخدم فيزيوتنس 0.2 ملغم بعد انتهاء تاريخ الصلاحية المذكور على العبوة الخارجية. تاريخ انتهاء الصلاحية يشير إلى اليوم الأخير من ذلك الشهر. 

•            لا ينبغي أن يتم التخلص من الأدوية في مياه الصرف الصحي أو عن طريق النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد مطلوبة. هذه التدابير تساعد في الحفاظ على البيئة.

المادة الفعالة هي موكسونيدين. حيث يحتوي كل قرص على 2.0 ملغم من موكسونيدين.

الصواغات الأخرى هي لاكتوز وحيد التمية، بوفيدون K25، كروسبوفيدون، استيارات المغنيسيوم، هيبروميلوز، سليلوز الإتيل، ماكروغول 6000، طلق، أكسيد حديد أحمر (E172) ، ثاني أكسيد التيتانيوم (E171) .

فيزيوتنس 0.2 ملغم عبارة عن أقراص مغلفة بطبقة رقيقة مستديرة، و محدبة ذات اللون الوردي الفاتح، محفور عليها علامة "0.2" على جانب واحد.

يتم توفير فيزيوتنس  0.2ملغم  في عبوة تحتوي على 28 أو 98  أقراص مغلفة بطبقة رقيقة.

قد لا تتوافر كافة العبوات في السوق

صاحب حق التسويق:

أبوت لابوراتوريز جي إم بي إتش، هانوفر، ألمانيا

 

 المصنع: 

روتيندورف للأدوية – ألمانيا

 

مغلفة و مطلقة من قبل:

شركة اجا للصناعات الدوائية المحدودة (اجا فارما(

حائل ٥٥٤١٤، المدينة الصناعية – حائل

المملكة العربية السعودية

04/2019
 Read this leaflet carefully before you start using this product as it contains important information for you

Physiotens® 0.2 mg, film-coated tablets Active substance: Moxonidine

Physiotens 0.2 mg: Each film-coated tablet contains 0.2 mg moxonidine. Other ingredients with known effects: Lactose monohydrate For full list of excipients, see section 6.1.

Film-coated tablets Physiotens 0.2 mg: Round, convex, light pink, film-coated tablets with “0.2” embossed on one side.

For the treatment of primary forms of arterial hypertension or arterial hypertension with no recognisable cause (essential hypertension).

 


Psology

Moxonidine should be dosed on an individual basis. The therapeutic daily dose is usually between 0.2 mg moxonidine and 0.4 mg moxonidine.

 

Treatment should be started at the lowest dose of moxonidine, i.e. 0.2 mg moxonidine per day, corresponding to1 film-coated tablet of Physiotens 0.2 mg in the morning.

 

If the effect is inadequate, the dose should be increased after 3 weeks at the earliest to 0.4 mg moxonidine per day, corresponding to 2 film-coated tablets of Physiotens 0.2 mg in the morning or 1 film-coated tablet of Physiotens 0.2 mg twice daily (1 film-coated tablet in the morning, 1 film-coated tablet in the evening).

 

If a higher daily dose is indicated, Physiotens 0.3 mg and Physiotens 0.4 mg are available to simplify usage.

 

A single dose of 0.4 mg moxonidine and a daily dose of 0.6 mg moxonidine should not be exceeded.

 

Impaired kidney function:

In patients with moderately impaired kidney function (GFR higher than 30 ml/min but less than 60 ml/min), a single dose of 0.2 mg moxonidine and a daily dose of 0.4 mg moxonidine should not be exceeded.

 

In haemodialysis patients, the initial dose is 0.2 mg daily. If necessary and it is well tolerated, in patients with moderately impaired kidney function the dose can be increased to 0.4 mg daily and in patients with severe kidney impairment to 0.3 mg daily (see section 4.4).

 

Impaired liver function:

So far there are no studies on patients with impaired liver function. As moxonidine is not liable to extensive liver metabolism, no substantial effect on pharmacokinetics is expected. Therefore the recommended dose for patients with mild to moderate liver damage corresponds to the normal dose recommendation for adults.

 

Children and Adolescents:

Because of the lack of data on safety and efficacy, the use of moxonidine in children and adolescents under 18 years of age is not recommended.

 

Method of Administration

 

The film-coated tablets should preferably be taken with sufficient fluid. They may be taken with or without food.

 

No time limit on duration of use is envisaged.

 

Although in a limited number of studies, following sudden discontinuation of moxonidine, no counter-regulation of blood pressure (rebound effect) was noted, it is not recommended - as is usual with all antihypertensives - that the treatment with moxonidine is ended abruptly in case this is necessary. Moxonidine should be discontinued by reducing it over a period of 2 weeks.


Moxonidine should not be used in the case of: • sick sinus syndrome • 2nd and 3rd degree atrioventricularblock • resting bradycardia below 50 beats a minute • cardiac insufficiency • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

After market launch, cases of AV block of varying degree have been reported in patients treated with moxonidine. Because of these case reports, a contributory role of moxonidine in delayed atrioventricular conduction cannot be ruled out. Caution is therefore advisable in the treatment of patients in whom a tendency to develop an AV block is possible.

 

If moxonidine is used in patients with 1st degree atrioventricularblock, care must be taken in particular to avoid bradycardia. Moxonidine should not be used in cases of AV block of a higher degree (see section 4.3).

 

When using moxonidine in patients with severe coronary artery disease or unstable angina pectoris, special care is required, as there is only limited experience with this patient population.

 

When using moxonidine in patients with kidney damage, caution is advisable since moxonidine is eliminated primarily through the kidneys. In these patients, especially at the start of therapy, care should be exercised when increasing the dose. The dose should be started at 0.2 mg daily and in patients with moderately impaired kidney function (GFR > 30 ml/min but < 60 ml/min) can be increased to a maximum of 0.4 mg daily and in patients with severely impaired kidney function (GFR < 30 ml/min) to 0.3 mg daily, if this is indicated clinically and is well tolerated.

 

If moxonidine is used with a beta-blocker and both therapies have to be terminated, the beta-blocker should be stopped first and then the moxonidine a few days later.

 

So far no rebound effect on blood pressure has been noted after stopping moxonidine therapy. However, abrupt termination of treatment with moxonidine is not advisable; it is better to reduce the dose gradually over a period of two weeks.

 

Patients with the rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Physiotens.

 

Older people may be more sensitive to the effect of antihypertensives. Therefore the therapy should be started at the lowest dose and the dose should be carefully increased in order to avoid serious secondary reactions.


Co-administration of other antihypertensives increases the hypotensive effect of moxonidine.

As tricyclic antidepressantscan reduce the effect of centrally acting antihypertensives, concomitant administration of tricyclic antidepressantswith moxonidine is not recommended.

Moxonidine can potentiate the sedative effect of tricyclic antidepressants (co-prescribing should be avoided), tranquillisers, alcohol, sedatives and hypnotics.

Moxonidine moderately increases loss of cognitive performance in test subjects who received lorazepam. Moxonidine can increase the sedative effect of benzodiazepines when administered at the same time.

Moxonidine is eliminated by tubular secretion. Interaction with other substanceseliminated by tubular secretion cannot be ruled out. However, studies with digoxin and hydrochlorothiazide did not reveal any evidence of interactions. Oral bioavailability of glibenclamide was reduced by 11%.


Pregnancy:

There are no adequate data on the use of moxonidine in pregnant women. Studies on animals have revealed embryotoxic effects (see section 5.3). The potential risk for humans is unknown. Moxonidine should be used in pregnancy only if clearly necessary.

Breast-feeding:

Moxonidine is excreted in breast milk and should therefore not be used when breastfeeding. If therapy with moxonidine is considered essential, weaning is necessary


No studies on the effects on the ability to drive and use machines have been carried out.

 

The treatment of arterial hypertension with this medicinal product requires regular medical supervision. Because of various reactions that occur in individual cases (e.g. dizziness, drowsiness), responsiveness can be changed to such an extent that the ability to drive, use machines or work without secure support is affected. This applies even more so at the start of treatment, if the dose is increased or the medication changed, and during interaction with alcohol.


The undesirable effects most commonly reported when taking moxonidine include dry mouth, dizziness, asthenia and somnolence. These effects normally diminish after the first few weeks of treatment.

 

Undesirable effects according to system organ class: Class (The following undesirable effects were noted in placebo-controlled clinical trials with n=866 patients who received moxonidine and at the following frequencies):

 

 

 

 

System organ class according to MedRA

Very common

(

can occur in

more than 1 in 10

patients treated)

 

Common

(can occur in

 up to 1 in 10 patients treated)

Uncommon

(can occur in

up to 1 in 100 patients treated)

Cardiac disorders

 

 

Bradycardia

Ear and labyrinth disorders

 

 

Tinnitus

Nervous system disorders

 

Headache*, dizziness/vertigo, somnolence

Syncope*

Vascular disorders

 

 

Hypotension* (including orthostatic hypotension)

Gastrointestinal disorders

Dry mouth

Diarrhoea, nausea/vomiting/dyspepsia

 

Skin and subcutaneous tissue disorders

 

Erythema, pruritus

Angioedema

Reproductive system and breast disorders

 

 

 

General disorders and administration site conditions

 

Asthenia

Oedema

Musculoskeletal and connective tissue disorders

 

Back pain

Neck pain

Psychiatric disorders

 

Insomnia

Nervousness

* The frequency was not increased compared with placebo.

 

Reporting of suspected undesirable effects.

The reporting of suspected undesirable effects after authorisation is of great importance. It enables continuous monitoring of the medicinal product’s risk-benefit ratio. Healthcare professionals are asked to report every suspected case of an undesirable effect

 

To report any side effect(s):

- National Pharmacovigilance Center (NPC)

o    Fax: +966-11-205-7662

o    SFDA Call Center: 19999

o    E-mail: npc.drug@sfda.gov.sa

o    Website: https://ade.sfda.gov.sa

 


However, in some cases acute doses of up to 19.6 mg were taken without a fatal development. The reported signs and symptoms of overdose are: headache, sedation, somnolence, hypotension, dizziness, asthenia, bradycardia, dry mouth, vomiting, fatigue and upper abdominal pain. In the case of a heavy overdose, close monitoring is recommended, particularly for disorders of consciousness and respiratory depression.

 

In the case of a 2-year old child who had accidentally ingested an unknown quantity of moxonidine (potentially 14 mg), sedation, coma, hypotension, miosis and dyspnoea occurred. Gastrolavage, a glucose infusion, controlled respiration and immobilisation led to complete remission of the symptoms within 11 hours.

 

On the basis of animal trials at high doses, the following symptoms are also possible: orthostatic dysregulation, paradoxical hypertension, tachycardia and hyperglycaemia.

 

Treatment of intoxication:

A specific antidote is not known. If there is a fall in blood pressure, circulatory support, for example with administration of fluid and dopamine, may be indicated. Bradycardia can be treated with atropine.

 

α-receptor antagonists can reduce or annul the paradoxical hypertensive effect of moxonidine overdose.


Pharmacotherapeutic group: Imidazoline receptor agonist, moxonidine

ATC code: C02AC05

 

In various animal models, moxonidine proved to be a highly effective antihypertensive. The available data from experimental studies clearly show that the site of action for the antihypertensive effect of moxonidine is the central nervous system (CNS). It has been established that moxonidine in the brain stem binds selectively to I1-imidazoline receptors. These imidazoline receptors are concentrated in the rostral ventrolateral medulla, an area of decisive significance in central control of the peripheral sympathetic nervous system. The binding of moxonidine to the I1-imidazoline receptor has an inhibiting effect on the activity of the sympathetic nerves (demonstrated in sympathetic nerve endings of the heart, internal organs and kidneys). In humans, through a reduction in the sympathetic nerve activity, moxonidine leads to a reduction in systemic vascular resistance and consequently to a lowering of arterial blood pressure. The effects of moxonidine on mortality and cardiovascular morbidity during treatment of essential hypertension are currently unknown.

Moxonidine differs from other available centrally acting antihypertensives in a lesser affinity for central alpha-2 receptors compared with I1-imidazoline receptors; the undesirable effects of fatigue and dry mouth are attributed to the interaction with alpha-2 receptors. Because of the high selectivity for imidazoline receptors, undesirable effects such as sedation and dry mouth resulting from the interaction with alpha-2 receptors - the most commonly occurring undesirable effects of centrally acting antihypertensives - are clearly less pronounced.

Published data prove that in hypertensive patients with left ventricular hypertrophy (LVH) who have had an angiotensin-II-antagonist (AIIA) administered together with moxonidine to lower blood pressure, improved LVH reduction is achieved compared with the free combination of a thiazide and a calcium channel blocker.

In a two-month clinical study, moxonidine, in comparison with placebo, improved the insulin-sensitivity index of overweight and insulin-resistant patients with moderate hypertension by 21%.


Absorption:

Following oral administration, moxonidine is quickly and almost completely absorbed into the upper gastrointestinal tract (tmax approx. 1 hour), it does not undergo any first-pass metabolism and is therefore 88% bioavailable. Ingestion of food has no effect on the pharmacokinetics of moxonidine.

 

Distribution:

The maximum moxonidine plasma levels are reached 30 to 180 minutes after administration of the film-coated tablets.

Following in vitro measurements, human plasma protein binding to moxonidine is only about 7.2% (Vdss = 1.8 +/- 0.4 l/kg).

 

Biotransformation:

Moxonidine is metabolised up to 10 - 20%, in fact mainly to 4,5-dehydromoxonidine and through opening of the imidazoline ring to guanidine derivative. 4,5-dehydro-moxonidine shows only 1/10 and guanidine derivative less than 1/100 of the hypotensive efficacy of moxonidine.

 

Elimination:

Moxonidine and its metabolites are eliminated almost exclusively by the kidneys. Over 90% of the applied activity dose is eliminated by the kidneys in the first 24 hours after administration; in comparison, only about 1% through faeces. Cumulative renal elimination of unchanged moxonidine in the process amounts to approximately 50-75%.

The mean plasma elimination half-life of moxonidine is 2.2 to 2.3 hours; the renal elimination half-life is 2.6 to 2.8 hours.

It has been shown that under moxonidine, in spite of the renal elimination, no accumulation occurs either with repeated application or with impaired kidney function.

 

Pharmacokinetics in hypertensive patients:

In hypertensive patients, no relevant changes were noted in the pharmacokinetics compared with healthy test subjects.

 

Pharmacokinetics in elderly patients:

The slight difference in the pharmacokinetic properties of moxonidine in healthy older patients and young adults has so far proven to be clinically irrelevant. As moxonidine does not have a tendency to accumulate, no dose adjustment is necessary, if kidney function is normal.

 

Pharmacokinetics in children:

So far no pharmacokinetic studies have been carried out on children.

 

Pharmacokinetics in patients with impaired kidney function:

There is a significant correlation between moxonidine elimination and creatinine clearance. In patients with impaired kidney function, the dose has to be adjusted to individual requirements.

In patients with moderately impaired kidney function (GFR 30-60 ml/min), the AUC is increased by 85%, clearance is reduced by 52% and steady-state plasma concentration and terminal half-life are increased approximately 2-fold or 1.5-fold compared with hypertensive patients with normal kidney function (GFR > 90 ml/min). The maximum moxonidine plasma concentrations are increased by only 1.5 to 2-fold.

 

In patients with severe kidney damage (GFR < 30 ml/min), steady-state plasma concentrations and terminal half-life are approximately three times higher. In these patients, no unexpected drug accumulation was noted after multi-dosing. In kidney patients in the terminal stage (GFR < 10 ml/min) who undergo haemodialysis, AUC and terminal half-life are increased 6-fold or 4-fold compared with hypertensive patients with normal kidney function.

 

Moxonidine is eliminated to a lesser extent through haemodialysis.


Based on the conventional studies on safety pharmacology, chronic toxicity, reproductive toxicity, genotoxicity and carcinogenic potential, the preclinical data do not indicate any particular risk for humans.

 

Experimental studies on animals have shown embryotoxic effects at maternally toxic doses.

 

Reproductive studies did not reveal any impaired fertility or teratogenic effects.

 

Embryotoxic effects were observed in rats in the dose range above 3 mg/kg of body weight daily and in rabbits above 0.7 mg/kg of body weight daily.

 

In a peri- and post-natal study on rats, development and viability of the young were impaired at doses above 1 mg/kg of body weight daily.

 

Carcinogenicity studies on rats at doses up to 3.6 mg/kg of body weight daily and on mice up to 7.5 mg/kg of body weight daily revealed no evidence of a carcinogenic risk through moxonidine.


Tablet core:

Crospovidone Type A (Ph. Eur.)

Lactose monohydrate

Magnesium stearate (Ph. Eur.) [vegetable]

Povidone (K25)

 

Film-coating:

Red iron oxide (E172)

Ethylcellulose

Hypromellose

Macrogol 6000

Talc

Titanium dioxide (E171)


Not applicable.


2 years

Do not store above 25°


PVC aluminium blister pack or PVC/PVDC aluminium blister pack

 

Original packagings with:

- 28 film-coated tablets

- 98 film-coated tablets

Not all pack sizes may be marketed


No special requirements.


Abbott Laboratories GmbH, Hannover, Germany

11/2019
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