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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)

The active substance of Uroleph belongs to the group of
anticholinergics. These medicines are used to
reduce the activity of an overactive bladder. This enables
you to wait longer before having to go to the
bathroom and increases the amount of urine that can be
held by your bladder.
Uroleph is used to treat the symptoms of a condition called
overactive bladder. These symptoms include:
having a strong, sudden urge to urinate without prior
warning, having to urinate frequently or wetting
yourself because you could not get to the bathroom in time.


Do not take Uroleph:
- if you have an inability to pass water or to empty your
bladder completely (urinary retention)
- if you have a severe stomach or bowel condition
(including toxic megacolon, a complication
associated with ulcerative colitis)
- if you suffer from the muscle disease called myasthenia
gravis, which can cause an extreme
weakness of certain muscles
- if you suffer from increased pressure in the eyes, with
gradual loss of eye sight (glaucoma)
- if you are allergic to solifenacin or any of the other
ingredients of this medicine (listed in section 6)
- if you are undergoing kidney dialysis
- if you have severe liver disease
- if you suffer from severe kidney disease or moderate
liver disease AND at the same time are being treated
with medicines that may decrease the removal of Uroleph
from the body (for example, ketoconazole). Your doctor or
pharmacist will have informed you if this is the case.
Inform your doctor if you have or ever had any of the above
mentioned conditions before treatment with Uroleph starts.
Warnings and precautions
Talk to your doctor or pharmacist before taking Uroleph
- if you have trouble emptying your bladder (= bladder
obstruction) or have difficulty in passing urine (e.g. a thin
urine flow). Risk of accumulation of urine in the bladder
(urinary retention) is much higher.
- if you have some obstruction of the digestive system
(constipation).
- if you are at risk of your digestive system slowing down
(stomach and bowel movements). Your doctor will have
informed you if this is the case.
- if you suffer from severe kidney disease.
- if you have moderate liver disease.
- if you have a stomach tear (hiatus hernia) or heartburn.
- if you have a nervous disorder (autonomic neuropathy).
Children and adolescents
Uroleph is not to be used in children or adolescents under
18 years.
Inform your doctor if you have or ever had any of the above
mentioned conditions before treatment with Uroleph starts.
Before starting Uroleph , your doctor will assess whether
there are other causes for your need to pass urine
frequently (for example heart failure (insufficient pumping
power of the heart) or kidney disease). If you have a urinary
tract infection, your doctor will prescribe you an antibiotic (a
treatment against particular bacterial infections).

Other medicines and Uroleph
Please tell your doctor or pharmacist if you are taking or
have recently taken or might take other medicines.
It is especially important to inform your doctor if you are
taking:
- other anticholinergic medicines, effects and side effects of
both medications can be enhanced.
- cholinergics as they can reduce the effect of Uroleph.
- medicines, like metoclopramide and cisapride, which
make the digestive system work faster where the Uroleph
can reduce their effect.
- medicines, like ketoconazole, ritonavir, nelfinavir,
itraconazole, verapamil and diltiazem, which decrease the
rate at which Uroleph is broken down by the body
- medicines like rifampicin, phenytoin and carbamazepine,
as they may increase the rate at which Uroleph is broken down by the body.
- medicines such as bisphosphonates, that can cause or
exacerbate inflammation of the gullet (oesophagitis).
Uroleph with food, drink
Uroleph can be taken with or without food, depending on
your preference.
Pregnancy and breast-feeding
You should not use Uroleph if you are pregnant unless
clearly necessary.
Do not use Uroleph if you are breast-feeding as solifenacin
may get into your breast milk.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Uroleph may cause blurred vision and sometimes
sleepiness or tiredness. If you suffer from any of these side
effects, do not drive or operate machinery.
Uroleph contains lactose. If you have been told by your
doctor that you have a rare hereditary problem of galactose
intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption you should not use this medicine.


Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you. Check
with your doctor or pharmacist if you are not sure.
Instructions for proper use
You should swallow the whole tablet with some liquid. It can
be taken with or without food, according to your preference.
Do not crush the tablets.
The usual dose is 5 mg per day, unless your doctor told you
to take 10 mg per day.
If you take more Uroleph than you should
If you have taken too much Uroleph or if a child has
accidentally taken Uroleph , contact your doctor or
pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth,
dizziness, drowsiness and blurred vision, perceiving
things that are not there (hallucinations), over- excitability,
seizures (convulsions), difficulty breathing, elevated heart
rate (tachycardia), accumulation of urine in the bladder
(urinary retention) and dilated pupils (mydriasis).
If you forget to take Uroleph
If you forget to take a dose at the usual time, take it as soon
as you remember, unless it is time to take your next dose.
Never take more than one dose per day. If you are in doubt,
always consult your doctor or pharmacist.
If you stop taking Uroleph
If you stop taking Uroleph , your symptoms of overactive
bladder may return or worsen. Always consult your doctor, if
you are considering stopping the treatment.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.


Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you experience an allergic attack, or a severe skin
reaction (e.g. blistering and peeling of the skin), you must
inform your doctor or pharmacist immediately.
Angioedema (skin allergy that results in the swelling that
occurs in the tissue just below the surface of the skin)
with airway obstruction (difficulty in breathing) has been
reported in some patients on solifenacin succinate (Uroleph
). If angioedema occurs, solifenacin succinate (Uroleph
) should be discontinued immediately and appropriate
therapy and/or measures should be taken.
Uroleph may cause the following other side effects:
Very common (may affect more than 1 in 10 people)
- dry mouth
Common (may affect up to 1 in 10 people)
- blurred vision
- constipation, nausea, indigestion with symptoms such as
abdominal fullness, abdominal pain, burping, nausea, and
heartburn (dyspepsia), stomach discomfort
Uncommon (may affect up to 1 in 100 people)
- urinary tract infection, bladder infection
- sleepiness, impaired sense of taste (dysgeusia)
- dry (irritated) eyes
- dry nasal passages
- reflux disease (gastro-oesophageal reflux), dry throat
- dry skin
- difficulty in passing urine
- tiredness, accumulation of fluid in the lower legs (oedema)
Rare (may affect up to 1 in 1,000 people)
- lodging of a large amount of hardened stool in the large
intestine (faecal impaction)
- build up of urine in the bladder due to inability to empty
the bladder (urinary retention)
- dizziness, headache
- vomiting- itching, rash
Very rare (may affect up to 1 in 10,000 people)
- hallucinations, confusion
- allergic rash
Not known (frequency cannot be estimated from the
available data)
- decreased appetite, high levels of blood potassium which
can cause abnormal heart rhythm
- increased pressure in the eyes
- changes in the electrical activity of the heart (ECG),
irregular heartbeat, feeling your heartbeat, faster heart beat
- voice disorder
- liver disorder
- muscle weakness
- renal disorder
Reporting of side effects
If you get any side effects, talk to your doctor, nurse, or
pharmacist. This includes any possible side effects not
listed in this leaflet.


• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the carton and label after “EXP”. The expiry date
refers to the last day of that month.
• Store below 30°C.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.


The active substance is solifenacin succinate 5 mg or
10 mg
The other ingredients of Uroleph 5 mg Film Coated Tablets
are Lactose monohydrate (Pharmatose 200 M), Maize
Starch, Hydroxypropyl Methyl cellulose (Methocel E6),
Magnesium Stearate (Parteck LUB MST), Opadry Yellow
(03F220149).
The other ingredients of Uroleph 10 mg Film Coated
Tablets are Lactose monohydrate (Pharmatose 200 M),
Maize Starch, Hydroxypropyl Methyl cellulose (Methocel
E6), Magnesium Stearate (Parteck LUB MST), Opadry Pink
(03F240130).


Uroleph 5 mg Film Coated Tablets: Light Yellow, round, biconvex film-coated tablet with Plain on one side and ‘C7’ on other side. Uroleph 10 mg Film Coated Tablets: Light pink, round, biconvex film-coated tablet with Plain on one side and ‘C7’ on other side. Uroleph 5mg and 10mg film coated tablets are available in blister pack of 28 tablets.

Middle East Pharmaceutical Industries Co Ltd (Avalon
Pharma)
P.O.Box 4180 Riyadh 11491, Kingdom of Saudi Arabia
2nd Industrial City, Riyadh, Kingdom of Saudi Arabia
Tel: +966 (11) 2653948 -2653427
Fax: +966 (11) 2654723


10/2022
  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 يوروليف على مادة فعالة تنتمي إلى مجموعة مضادات الكولين،
وتُستخدم هذه الأدوية لتقليل فرط نشاط المثانة، حيث تمكّنك من الانتظار
لفترة أطول قبل الاضطرار إلى الذهاب إلى الحمام، وتزيد من كمية
البول التي يمكن أن تحتجزها مثانتك.
يُستخدم يوروليف لعلاج أعراض حالة تسمى فرط نشاط المثانة، وتشمل
هذه الأعراض:
وجود رغبة قوية ومفاجئة في التبول دون سابق إنذار، أو الشعور
بالحاجة إلى التبول المتكرر، أو أن تتبول لا إراديًّا؛ لأنك لم تتمكن من
الوصول إلى الحمام في الوقت المناسب.

- إذا كنت تعاني من عدم القدرة على التبول أو إفراغ مثانتك تمامًا
)احتباس البول(.
- إذا كنت تعاني من حالة شديدة في المعدة أو الأمعاء )بما في ذلك
تضخم القولون السمي؛ من المضاعفات المرتبطة بالتهاب القولون
التقرحي(.
- إذا كنت تعاني من مرض عضلي يسمى الوهن العضلي الوبيل، والذي
يمكن أن يسبب حالة شديدة من ضعف عضلات معينة
- إذا كنت تعاني من ضغط متزايد في العينين مع فقدان تدريجي للبصر
)الجلوكوما(.
- إذا كانت لديك حساسية من سوليفيناسين، أو أي من المكونات الأخرى
.) لهذا الدواء )المدرجة في القسم 6
- إذا كنت تخضع لغسيل الكلى.
- إذا كان لديك مرض كبدي شديد.
- إذا كنت تعاني من مرض كلوي حاد أو مرض كبدي متوسط، ويتم
علاجك في نفس الوقت بأدوية قد تقلل من إزالة يوروليف من الجسم
)على سبيل المثال، كيتوكونازول(. سيخبرك طبيبك أو الصيدلي إذا كانت
تنطبق عليك هذه الحالة.
أخبر طبيبك إذا كنت أو كان لديك في أي وقت مضى أي من الحالات
المذكورة أعلاه قبل بدء العلاج بدواء يوروليف .
التحذيرات والاحتياطات
تحدث إلى طبيبك أو الصيدلي قبل تناول يوروليف
- إذا كانت لديك مشكلة في إفراغ المثانة )انسداد المثانة(، أو لديك
صعوبة في التبول )مثل تدفق البول الرقيق(، أو أن خطر تراكم البول في
المثانة )احتباس البول( أعلى بكثير.
- إذا كان لديك بعض الانسداد في الجهاز الهضمي )الإمساك(.
- إذا كنت معرضًا لخطر تباطؤ الجهاز الهضمي )حركات المعدة
والأمعاء(. سيخبرك طبيبك إذا كانت تنطبق عليك هذه الحالة.
- إذا كنت تعاني من مرض كلوي حاد.
- إذا كان لديك مرض كبدي متوسط.
- إذا كان لديك تمزق في المعدة )فتق فجوة( أو حرقة في المعدة.
- إذا كنت تعاني من اضطراب عصبي )الاعتلال العصبي اللاإرادي(.
الأطفال والمراهقون
لا يُستخدم يوروليف للأطفال أو المراهقين تحت سن 18 سنة.
أخبر طبيبك إذا كنت أو كانت لديك في أي وقت مضى أي من الحالات
المذكورة أعلاه قبل بدء العلاج بدواء يوروليف.
قبل البدء في استخدام يوروليف ، سيقوم طبيبك بتقييم ما إذا كانت هناك
أسباب أخرى لحاجتك إلى التبول بشكل متكرر،على سبيل المثال فشل
القلب أو، قوة ضخ القلب غير الكافية، أو أمراض الكلى. إذا كنت مصابًا
بعدوى في المسالك البولية، فسيصف لك طبيبك مضادًا حيويًّا )علاج ضد
عدوى بكتيرية معينة.

يرجى إخبار طبيبك أو الصيدلي إذا كنت تتناول أو تناولت مؤخرًا أو قد
تتناول أي أدوية أخرى.
من المهم بشكل خاص إبلاغ طبيبك إذا كنت تتناول:
- الأدوية الأخرى المضادة للكولين، ما قد يزيد من كل التأثيرات و
الأعراض الجانبية لهذه الأدوية.
- الأدوية الكولينية؛ لأنها يمكن أن تقلل من تأثير يوروليف .
- الأدوية، مثل ميتوكلوبراميد وسيسابريد، والتي تجعل الجهاز الهضمي
يعمل بشكل أسرع حيث يمكن أن يقلل يوروليف من تأثيرها.
- الأدوية، مثل كيتوكونازول، ريتونافير، نلفينافير، إيتراكونازول،
فيراباميل وديلتيازيم، والتي تقلل من معدل تكسُّر يوروليف في الجسم.
- الأدوية مثل ريفامبيسين، فينيتوين وكاربامازيبين، لأنها قد تزيد منمعدل تكسُّر يوروليف في الجسم.
- الأدوية مثل البايفوسفونيت، التي يمكن أن تسبب أو تؤدي إلى تفاقم
التهاب المريء )التهاب المريء(.
يوروليف مع الطعام والشراب
يمكن تناول يوروليف مع الطعام أو بدونه، حسب ما تفضله.
الحمل والرضاعة الطبيعية
يجب ألا تستخدمي يوروليف إذا كنتِ حاملاً إلا إذا كان ذلك ضروريًّا
بشكل واضح.
لا تستخدمي يوروليف إذا كنتِ تقومين بالرضاعة الطبيعية، لأن
سوليفيناسين قد يفرز في حليب الثدي الخاص بك.
إذا كنتِ حاملاً أو تقومين بالرضاعة الطبيعية، أو تعتقدين أنك حامل أو
تخططين لإنجاب طفل، فتحدّثي مع طبيبك أو الصيدلي للحصول على
المشورة قبل تناول هذا الدواء.
القيادة واستخدام الماكينات
قد يسبب يوروليف عدم وضوح الرؤية، وأحيانًا النعاس أو التعب. إذا
كنت تعاني من أي من هذه الأعراض الجانبية، فلا يمكنك القيام بالقيادة
أو تشغيل الماكينات.
يحتوي يوروليف على اللاكتوز. إذا أخبرك طبيبك أن لديك مشكلة
وراثية نادرة من عدم تحمل الجالاكتوز أو نقص اللاكتاز أو سوء
امتصاص الجلوكوز والجالاكتوز، يجب ألا تستخدم هذا الدواء.

https://localhost:44358/Dashboard

احرص دائمًا على تناول هذا الدواء تمامًا كما هو موصوف في هذه
النشرة، أو كما يخبرك طبيبك أو الصيدلي. استشِر طبيبك أو الصيدلي
إذا لم تكن متأكدًا.
تعليمات الاستخدام السليم:
يجب أن تبتلع القرص بأكمله بمساعدة الماء أو سائل آخر. يمكن تناوله
مع الطعام أو بدونه، حسب ما تفضله. لا تسحق الأقراص.
الجرعة المعتادة هي 5 ملغ في اليوم، ما لم يخبرك طبيبك بتناول 10
ملغ في اليوم.
إذا تناولت يوروليف أكثر مما ينبغي
إذا كنت قد تناولت الكثير من يوروليف أو إذا تناول طفل يوروليف عن
طريق الخطأ، فاتصل بطبيبك أو الصيدلي على الفور.
قد تشمل أعراض الجرعة الزائدة: الصداع، جفاف الفم، الدوخة، النعاس،
عدم وضوح الرؤية، إدراك الأشياء غير الموجودة )الهلوسة(، الاستثارة
الزائدة، النوبات )التشنجات(، صعوبة التنفس، ارتفاع معدل ضربات
القلب )عدم انتظام دقات القلب(، تراكم البول في المثانة )احتباس البول(،
واتساع حدقة العين )توسع الحدقة(.
إذا نسيت تناول يوروليف
إذا نسيت تناول الجرعة في الوقت المعتاد، فتناولها بمجرد أن تتذكرها،
إلا إذا حان وقت تناول الجرعة التالية. لا تأخذ أكثر من جرعة واحدة في
اليوم. إذا كنت في شك، فاستشر طبيبك أو الصيدلي دائمًا.
إذا توقفت عن تناول يوروليف
إذا توقفت عن تناول يوروليف ، فقد تعود أعراض فرط نشاط المثانة
لديك أو تتفاقم. استشر طبيبك دائمًا إذا كنت تفكر في إيقاف العلاج.
إذا كان لديك أي أسئلة أخرى حول استخدام هذا الدواء، فاسأل طبيبك
أو الصيدلي.

مثل جميع الأدوية، يمكن أن يسبب هذا الدواء آثارًا جانبية، على الرغم
من عدم حدوثها لدى الجميع.
إذا كنت تعاني من نوبة حساسية، أو رد فعل جلدي شديد )مثل ظهور
تقرحات وتقشر الجلد(، يجب عليك إبلاغ طبيبك أو الصيدلي على الفور.
تم الإبلاغ عن وذمة وعائية )حساسية الجلد التي تؤدي إلى التورم الذي
يحدث في الأنسجة الموجودة أسفل سطح الجلد مباشرة( مع انسداد
مجرى الهواء )صعوبة في التنفس( لدى بعض المرضى الذين يتناولون
سوليفيناسين سكسينات )يوروليف (. في حالة حدوث وذمة وعائية،
يجب التوقف عن تناول سوليفيناسين سكسينات )يوروليف ( على الفور،
واتخاذ العلاج المناسب و / أو التدابير المناسبة.
قد يسبب يوروليف الآثار الجانبية الأخرى التالية:
شائعة جدًّا )قد تظهر لدى أكثر من 1 من كل 10 أشخاص(
- جفاف الفم
شائعة )قد تظهر لدى ما يصل إلى 1 من كل 10 أشخاص(
- عدم وضوح الرؤية
- إمساك، غثيان، عسر هضم مصحوب بأعراض مثل امتلاء البطن، آلام
في البطن، تجشؤ، غثيان، حرقة )عسر الهضم(، ألم في المعدة.
غير شائعة )قد تظهر لدى ما يصل إلى 1 من كل 100 شخص(
- التهاب المسالك البولية، التهاب المثانة.
- النعاس وضعف حاسة التذوق )عسر الذوق(.
- جفاف )تهيج( العينين.
- جفاف ممرات الأنف.
- مرض ارتجاع المريء )لارتجاع المريئي المَعدِي( وجفاف الحلق.
- جفاف الجلد.
- صعوبة في التبول.
- التعب وتراكم السوائل في أسفل الساقين )وذمة(.

نادرة )قد تظهر لدى ما يصل إلى 1 من كل 1000 شخص(
- تواجد كمية كبيرة من البراز المتصلب في الأمعاء الغليظة )انحشار
البراز(.
- تراكم البول في المثانة بسبب عدم القدرة على تفريغ المثانة )احتباس
البول(.
- دوخة، صداع.
- قيء.
- حكة، طفح جلدي.
نادرة جدًّا )قد تظهر لدى ما يصل إلى 1 من بين 10000 شخص(
- هلوسة، ارتباك.
- طفح جلدي تحسسي.
غير معروفة )لا يمكن تقدير حدوثها من البيانات المتاحة(
- قلة الشهية، ارتفاع مستويات البوتاسيوم في الدم مما قد يؤدي إلى عدم
انتظام ضربات القلب.
- زيادة الضغط في العينين.
عدم انتظام ضربات ،)ECG( - تغيرات في النشاط الكهربائي للقلب
القلب، الشعور بضربات القلب، سرعة ضربات القلب.
- اضطراب الصوت.
- اضطراب الكبد.
- ضعف العضلات.
- اضطراب كلوي.
الإبلاغ عن الأعراض الجانبية
إذا عانيت من أي آثار جانبية، فتحدّث إلى طبيبك أو ممرضك أو
الصيدلي. ويشمل ذلك أي آثار جانبية محتملة غير مدرجة في هذه
النشرة.

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المادة الفعالة هي سوليفيناسين سكسينات 5 ملغ أو 10 ملغ.
المكونات الأخرى ليوروليف 5 ملغ أقراص مغلفة هي لاكتوز
مونوهيدرات )فارماتوز 200 م(، نشا الذرة، هيدروكسي بروبيل ميثيل
ستيرات المغنيسيوم )بارتيك لوب إم إس تي(، ،)E السليلوز )ميثوسيل 6
.)03F أوبادري أصفر ) 220149
المكونات الأخرى ليوروليف 10 ملغ أقراص مغلفة هي لاكتوز
مونوهيدرات )فارماتوز 200 م(، نشا الذرة، هيدروكسي بروبيل ميثيل
ستيرات المغنيسيوم )بارتيك لوب إم إس تي(، ،)E السليلوز )ميثوسيل 6
.)03F أوبادري وردي) 2401

كيف يبدو شكل يوروليف ، وما هي محتويات العبوة؟
يوروليف 5 ملغ أقراص مغلفة: قرص باللون الأصفر الفاتح، مستدير،
.»C7« محدب من الجانبين ٫ محفور على أحد جانبيها
يوروليف 10 ملغ أقراص مغلفة: قرص باللون الوردي الفاتح، مستدير،
.»C7« محدب من الجانبين ٫ محفور على أحد جانبي

شركة الشرق الأوسط للصناعات الدوائية المحدودة )أفالون فارما(
ص.ب. 4180 الرياض 11491 ، المملكة العربية السعودية
المدينة الصناعية الثانية، الرياض
00966 )11( 2653448 - هاتف: 2653427
00966 )11( فاكس: 2654723

10/2022
 Read this leaflet carefully before you start using this product as it contains important information for you

Uroleph 5 mg film-coated tablet Uroleph 10 mg film-coated tablet

Uroleph 5 mg film-coated tablet contains 5 mg solifenacin succinate. Excipient(s) with known effect: lactose monohydrate (107.2 mg) Uroleph 10 mg film-coated tablet contains 10 mg solifenacin succinate. Excipient(s) with known effect: lactose monohydrate (102.2 mg) For the full list of excipients, see section 6.1

Film-coated tablets. Uroleph 5 mg film-coated tablet: Light yellow, round, biconvex film-coated tablet with Plainon one side and ‘C7’ on other side. Uroleph 10 mg film-coated tablet: 10 mg tablet: Light pink, round, biconvex film-coated tablet with Plain on one side and ‘C7’ on other side.

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

 


Posology Adults, including the elderly The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily.
Pediatrics population
The safety and efficacy of Uroleph in children have not yet been established. Therefore, Uroleph should not be used in children.
2
Patients with renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg once daily (see Section 5.2). Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily (see Section 5.2). Potent inhibitors of cytochrome P450 3A4 The maximum dose of Uroleph should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4-inhibitors e.g. ritonavir, nelfinavir, itraconazole (see Section 4.5). Method of administration Uroleph should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.


Solifenacin is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions. - Patients hypersensitive to the active substance or to any of the excipients listed in 6.1. - Patients undergoing haemodialysis (see Section 5.2). - Patients with severe hepatic impairment (see Section 5.2). - Patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole (see Section 4.5).

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Uroleph. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Uroleph should be used with caution in patients with: - Clinically significant bladder outflow obstruction at risk of urinary retention. - Gastrointestinal obstructive disorders. - Risk of decreased gastrointestinal motility. - Severe renal impairment (creatinine clearance ≤ 30 ml/min; see Section 4.2 and 5.2), and doses should not exceed 5 mg for these patients. - Moderate hepatic impairment (Child-Pugh score of 7 to 9; see Section 4.2 and 5.2), and doses should not exceed 5 mg for these patients. - Concomitant use of a potent CYP3A4 inhibitor, e.g. ketoconazole (see 4.2 and 4.5).
3
- Hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis. - Autonomic neuropathy. QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and hypokalaemia. Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Angioedema with airway obstruction has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. The maximum effect of Uroleph can be determined after 4 weeks at the earliest.


Pharmacological interactions Concomitant medication with other medicinal products with anticholinergic properties may result in more pronounced therapeutic effects and undesirable effects. An interval of approximately one week should be allowed after stopping treatment with Solifenacin, before commencing other anticholinergic therapy. The therapeutic effect of solifenacin may be reduced by concomitant administration of cholinergic receptor agonists. Solifenacin can reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract, such as metoclopramide and cisapride. Pharmacokinetic interactions In vitro studies have demonstrated that at therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes. Therefore, solifenacin is unlikely to alter the clearance of drugs metabolised by these CYP enzymes. Effect of other medicinal products on the pharmacokinetics of solifenacin Solifenacin is metabolised by CYP3A4. Simultaneous administration of ketoconazole (200 mg/day), a potent CYP3A4 inhibitor, resulted in a two-fold increase of the AUC of solifenacin, while ketoconazole at a dose of 400 mg/day resulted in a three-fold increase of the AUC of solifenacin. Therefore, the maximum dose of Solifenacin should be restricted to 5 mg, when used simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole) (see Section 4.2). Simultaneous treatment of solifenacin and a potent CYP3A4 inhibitor is contra-indicated in patients with severe renal impairment or moderate hepatic impairment. The effects of enzyme induction on the pharmacokinetics of solifenacin and its metabolites have not been studied as well as the effect of higher affinity CYP3A4 substrates on solifenacin exposure. Since solifenacin is metabolised by CYP3A4, pharmacokinetic interactions are possible with other CYP3A4 substrates with higher affinity (e.g. verapamil, diltiazem) and CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepin). Effect of solifenacin on the pharmacokinetics of other medicinal products Oral Contraceptives Intake of solifenacin showed no pharmacokinetic interaction of solifenacin on combined oral contraceptives (ethinylestradiol/levonorgestrel). Warfarin Intake of solifenacin did not alter the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time. Digoxin Intake of solifenacin showed no effect on the pharmacokinetics of digoxin.


Pregnancy No clinical data are available from women who became pregnant while taking solifenacin. Animal studies do not indicate direct harmful effects on fertility, embryonal / foetal development or parturition (see Section 5.3). The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.
Breast-feeding No data on the excretion of solifenacin in human milk are available. In mice, solifenacin and/or its metabolites was excreted in milk, and caused a dose dependent failure to thrive in neonatal mice (see Section 5.3). The use of Uroleph should therefore be avoided during breast-feeding.
Fertility
No fertility data are available.


Since solifenacin, like other anticholinergics may cause blurred vision, and, uncommonly, somnolence and fatigue (see section 4.8. undesirable effects), the ability to drive and use machines may be negatively affected.


Summary of the safety profile Due to the pharmacological effect of solifenacin, Uroleph may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic undesirable effects is dose related. The most commonly reported adverse reaction with solifenacin was dry mouth. It occurred in 11% of patients treated with 5 mg once daily, in 22% of patients treated with 10 mg once daily and in 4% of placebo-treated patients. The severity of dry mouth was generally mild and did only occasionally lead to discontinuation of treatment. In general, medicinal product compliance was very high (approximately 99%) and approximately 90% of the patients treated with solifenacin completed the full study period of 12 weeks treatment.

Tabulated list of adverse reactions
MedDRA system organ class
Very common
≥1/10
Common
≥1/100, <1/10
Uncommon
≥1/1000, <1/100
Rare
≥ 1/10000, <1/1000
Very rare
<1/10,000
Not known (cannot be estimated from the available data)
Infections and infestations
Urinary tract infection
Cystitis
Immune system disorders
Anaphylactic reaction*
Metabolism and nutrition disorders
Decreased appetite*
Hyperkalaemia*
Psychiatric disorders
Hallucinations*
Confusional state*
Delirium*
Nervous system disorders
Somnolence
Dysgeusia
Dizziness*, Headache*
Eye disorders
Blurred vision
Dry eyes
Glaucoma*
Cardiac disorders
Torsade de Pointes*
Electrocardiogram QT prolonged*
Atrial fibrillation*
Palpitations*
Tachycardia*
Respiratory, thoracic and mediastinal disorders
Nasal dryness
Dysphonia*
Gastrointestinal disorders
Dry mouth
Constipation
Nausea
Dyspepsia
Abdominal pain
Gastro-oesophageal reflux diseases
Dry throat
Colonic obstruction
Faecal impaction, Vomiting*
Ileus*
Abdominal discomfort*
Hepatobiliary disorders
Liver disorder*
Liver function test abnormal*
Skin and subcutaneous tissue disorders
Dry skin
Pruritus*, Rash*
Erythema multiforme*, Urticaria*, Angioedema*
Exfoliative dermatitis*
Musculoskeletal and connective tissue disorders
Muscular weakness*
Renal and urinary disorders
Difficulty in micturition
Urinary retention
Renal impairment

General disorders and administration site conditions
Fatigue Peripheral oedema
*observed post-marketing
To Report any side effects:
Saudi Arabia:
Other GCC States:
- Please contact the relevant competent authority


Symptoms Overdosage with solifenacin succinate can potentially result in severe anticholinergic effects. The highest dose of solifenacin succinate accidentally given to a single patient was 280 mg in a 5 hour period, resulting in mental status changes not requiring hospitalization. Treatment In the event of overdose with solifenacin succinate the patient should be treated with activated charcoal. Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced. As for other anticholinergics, symptoms can be treated as follows: - Severe central anticholinergic effects such as hallucinations or pronounced excitation: treat with physostigmine or carbachol. - Convulsions or pronounced excitation: treat with benzodiazepines. - Respiratory insufficiency: treat with artificial respiration. - Tachycardia: treat with beta-blockers. - Urinary retention: treat with catheterisation. - Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room. As with other antimuscarinics, in case of overdosing, specific attention should be paid to patients with known risk for QT-prolongation (i.e. hypokalaemia, bradycardia and concurrent administration of medicinal products known to prolong QT-interval) and relevant pre-existing cardiac diseases (i.e. myocardial ischaemia, arrhythmia, congestive heart failure).


Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04B D08. Mechanism of action Solifenacin is a competitive, specific cholinergic-receptor antagonist. The urinary bladder is innervated by parasympathetic cholinergic nerves. Acetylcholine contracts the detrusor smooth muscle through muscarinic receptors of which the M3 subtype is predominantly involved. In vitro and in vivo pharmacological studies indicate that solifenacin is a competitive inhibitor of the muscarinic M3 subtype receptor. In addition, solifenacin showed to be a specific antagonist for muscarinic receptors by displaying low or no affinity for various other receptors and ion channels tested. Pharmacodynamic effects Treatment with Solifenacin in doses of 5 mg and 10 mg daily was studied in several double blind, randomised, controlled clinical trials in men and women with overactive bladder. As shown in the table below, both the 5 mg and 10 mg doses of Solifenacin produced statistically significant improvements in the primary and secondary endpoints compared with placebo. Efficacy was observed within one week of starting treatment and stabilises over a period of 12 weeks. A long-term open label study demonstrated that efficacy was maintained for at least 12 months. After 12 weeks of treatment approximately 50% of patients suffering from incontinence before treatment were free of incontinence episodes, and in addition 35% of patients achieved a micturition frequency of less than 8 micturitions per day. Treatment of the symptoms of overactive bladder also results in a benefit on a number of Quality of Life measures, such as general health perception, incontinence impact, role limitations, physical limitations, social limitations, emotions, symptom severity, severity measures and sleep/energy. Results (pooled data) of four controlled Phase 3 studies with a treatment duration of 12 weeks
Placebo
Solifenacin
5 mg o.d.
Solifenacin 10 mg o.d.
Tolterodine2 mg b.i.d.
No. of micturitions/24 h
Mean baseline
Mean reduction from baseline
% change from baseline
n
p-value*
11.9
1.4
(12%)
1138
12.1
2.3
(19%)
552
<0.001
11.9
2.7
(23%)
1158
<0.001
12.1
1.9
(16%)
250
0.004
No. of urgency episodes/24 h
Mean baseline
Mean reduction from baseline
% change from baseline
n
p-value*
6.3
2.0
(32%)
1124
5.9
2.9
(49%)
548
<0.001
6.2
3.4
(55%)
1151
<0.001
5.4
2.1
(39%)
250
0.031
No. of incontinence episodes/24 h
Mean baseline
Mean reduction from baseline
% change from baseline
n
2.9
1.1
(38%)
781
2.6
1.5
(58%)
314
2.9
1.8
(62%)
778
2.3
1.1
(48%)
157

p-value*
<0.001
<0.001
0.009
No. of nocturia episodes/24 h
Mean baseline
Mean reduction from baseline
% change from baseline
n
p-value*
1.8
0.4
(22%)
1005
2.0
0.6
(30%)
494
0.025
1.8
0.6
(33%)
1035
<0.001
1.9
0.5
(26%)
232
0.199
Volume voided/micturition
Mean baseline
Mean increase from baseline
% change from baseline
n
p-value*
166 ml
9 ml
(5%)
1135
146 ml
32 ml
(21%)
552
<0.001
163 ml
43 ml
(26%)
1156
<0.001
147 ml
24 ml
(16%)
250
<0.001
No. of pads/24 h
Mean baseline
Mean reduction from baseline
% change from baseline
n
p-value*
3.0
0.8
(27%)
238
2.8
1.3
(46%)
236
<0.001
2.7
1.3
(48%)
242
<0.001
2.7
1.0
(37%)
250
0.010 Note: In 4 of the pivotal studies, Solifenacin 10 mg and placebo were used. In 2 out of the 4 studies also Solifenacin 5 mg was used and one of the studies included tolterodine 2 mg bid. Not all parameters and treatment groups were evaluated in each individual study. Therefore, the numbers of patients listed may deviate per parameter and treatment group. * P-value for the pair wise comparison to placebo


Absorption After intake of Solifenacin tablets, maximum solifenacin plasma concentrations (Cmax) are reached after 3 to 8 hours. The tmax is independent of the dose. The Cmax and area under the curve (AUC) increase in proportion to the dose between 5 to 40 mg. Absolute bioavailability is approximately 90%. Food intake does not affect the Cmax and AUC of solifenacin. Distribution The apparent volume of distribution of solifenacin following intravenous administration is about 600 L. Solifenacin is to a great extent (approximately 98%) bound to plasma proteins, primarily α1-acid glycoprotein. Biotransformation Solifenacin is extensively metabolised by the liver, primarily by cytochrome P450 3A4 (CYP3A4). However, alternative metabolic pathways exist, that can contribute to the metabolism of solifenacin. The systemic clearance of solifenacin is about 9.5 L/h and the terminal half life of solifenacin is 45 - 68 hours. After oral dosing, one pharmacologically active (4R-hydroxy solifenacin) and three inactive metabolites (N-glucuronide, N-oxide and 4R-hydroxy-N-oxide of solifenacin) have been identified in plasma in addition to solifenacin.

Elimination After a single administration of 10 mg [14C-labelled]-solifenacin, about 70% of the radioactivity was detected in urine and 23% in faeces over 26 days. In urine, approximately 11% of the radioactivity is recovered as unchanged active substance; about 18% as the N-oxide metabolite, 9% as the 4R-hydroxy-N-oxide metabolite and 8% as the 4R-hydroxy metabolite (active metabolite). Linearity/non-linearity Pharmacokinetics are linear in the therapeutic dose range. Other special populations Elderly No dosage adjustment based on patient age is required. Studies in elderly have shown that the exposure to solifenacin, expressed as the AUC, after administration of solifenacin succinate (5 mg and 10 mg once daily) was similar in healthy elderly subjects (aged 65 through 80 years) and healthy young subjects (aged less than 55 years). The mean rate of absorption expressed as tmax was slightly slower in the elderly and the terminal half-life was approximately 20% longer in elderly subjects. These modest differences were considered not clinically significant. The pharmacokinetics of solifenacin have not been established in children and adolescents. Gender The pharmacokinetics of solifenacin are not influenced by gender. Race The pharmacokinetics of solifenacin are not influenced by race. Renal impairment The AUC and Cmax of solifenacin in mild and moderate renally impaired patients, was not significantly different from that found in healthy volunteers. In patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) exposure to solifenacin was significantly greater than in the controls with increases in Cmax of about 30%, AUC of more than 100% and t½ of more than 60%. A statistically significant relationship was observed between creatinine clearance and solifenacin clearance. Pharmacokinetics in patients undergoing haemodialysis have not been studied. Hepatic impairment In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) the Cmax is not affected, AUC increased with 60% and t½ doubled. Pharmacokinetics of solifenacin in patients with severe hepatic impairment have not been studied.


Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, fertility, embryofetal development, genotoxicity, and carcinogenic potential. In the pre- and postnatal development study in mice, solifenacin treatment of the mother during lactation caused dose-dependent lower postpartum survival rate, decreased pup weight and slower physical development at clinically relevant levels. Dose related increased mortality without preceding clinical signs occurred in juvenile mice treated from day 10 or 21 after birth with doses that achieved a pharmacological effect and both groups had higher mortality compared to adult mice. In juvenile mice treated from postnatal day 10, plasma
10
exposure was higher than in adult mice; from postnatal day 21 onwards, the systemic exposure was comparable to adult mice. The clinical implications of the increased mortality in juvenile mice are not known.


Core tablet Lactose monohydrate (Pharmatose 200 M) Maize Starch Hydroxypropyl Methyl cellulose (Methocel E6) Magnesium Stearate (Parteck LUB MST)
Film coating (10 mg tablet)- Hypromellose, Titanium Dioxide, polyethylene glycol, Talc, red iron oxide.
Film coating (5 mg tablet)- Hypromellose, Titanium Dioxide, polyethylene glycol, Talc, yellow iron oxide.


Not applicable.


2 years

Store below 30°C.
This medicinal product does not require any special temperature storage conditions


The tablets are packed in clear Alu-PVC/PVdC blisters.
Pack sizes: 28 tablets in blister


No special requirements.


Middle East Pharmaceutical Industries Co. Ltd (Avalon-Pharma) 8146 King Muhammad V, Sulimaniyah, RIYADH 12223 - 3904 P.O. Box 4180, Riyadh 11491, Kingdom of Saudi Arabia Tel: 920010564, Fax: +966114629288

09/2022
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