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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)

1. What Glacera is and what it is used for?
The name of this medicine is Glacera. The active ingredient is Pioglitazone which belongs to a group of medicines called anti-diabetic.
Glacera contains Pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus. This is the diabetes that usually develops in adulthood.
Glacera helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Glacera may be used on its own or in combination with metformin and / or a sulphonylurea which are also oral anti-diabetic medicines.
Glacera may also be used in combination with insulin.


Do not take Glacera

  • If you are hypersensitive (allergic) to Pioglitazone or any of the other ingredients of Glacera.
  • If you have heart failure or have had heart failure in the past.
  • If you have liver disease.
  • If you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting).

Take special care with Glacera
Tell your doctor before you start to take this medicine

  • If you retain water (fluid retention) or have heart failures problems in particular if you are over 75 years old.
  • If you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
  • If you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased possibility of becoming pregnant because you may ovulate again when you take Glacera. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
  • If you have a problem with your liver or heart. Before you start taking Glacera you will have a blood sample taken to check your liver function. This check may be repeated at intervals. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glacera and insulin experienced the development of heartfailure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

If you take Glacera with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
You may also experience a reduction in blood count (anaemia).

Broken bones
A higher number of bone fractures was seen in women (but not in men) taking Pioglitazone. Your doctor will take this into account when treating your diabetes.
Children
Use in children under 18 years is not recommended.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You can usually continue to take other medicines whilst you are being treated with Glacera. However, certain medicines are especially likely to affect the amount of sugar in your blood:

  • Gemfibrozil (used to lower cholesterol)
  • Rifampicin (used to treat tuberculosis and other infections)

Tell your doctor or pharmacist if you are taking any of these. Your blood sugar will be checked, and your dose of Glacera may need to be changed.

Taking Glacera with food and drink
You may take your tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy, breast-feeding and Glacera
Tell your doctor if

  • You are, you think you might be or are planning to become pregnant.
  • You are breast-feeding or if you are planning to breast-feed your baby.

Your doctor will advise you to discontinue this medicine.

Driving and using machines
Pioglitazone will not affect your ability to drive or use machines but take care if you experience abnormal vision.

Important information about some of the ingredients of Glacera
This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Glacera.


One tablet of 15 mg, 30 mg or 45 mg of Pioglitazone should be taken once daily. If necessary your doctor may tell you to take a different dose.
If you have the impression that the effect of Glacera is too weak, talk to your doctor. When Glacera is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Your doctor will ask you to have blood tests periodically during treatment with Glacera. This is to check that your liver is working normally.
If you are following a diabetic diet, you should continue with this while you are taking Glacera. Your weight should be checked at regular intervals; if your weight increases, inform yourdoctor.

If you take more Glacera than you should
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. Your blood sugar could fall below the normal level and can be increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.

If you forget to take Glacera
Take Glacera daily as prescribed. However if you miss a dose, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Glacera
Glacera should be used every day to work properly. If you stop using Glacera, your bloodsugar may go up. Talk to your doctor before stopping this treatment.

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


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

The following side effects have been experienced by some patients taking Glacera
Common (affects 1 to 10 users in 100)

  • Weight gain.
  • Respiratory infection.
  • Numbness.
  • Abnormal vision.
  • Bone fracture.

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

  • Inflammation of the sinuses (sinusitis).
  • Difficulty sleeping (insomnia).

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

  • Blurred vision due to swelling (or fluid) in the back of the eye. If you experience thesesymptoms for the first time or if they get worse tell your doctor as soon as possible.
  • Increase in liver enzymes.

The following additional side effects have been experienced by some patients when Glacera is taken with other antidiabetic medicines:

Very common (affects more than 1 user in 10)

  • Decreased blood sugar (hypoglycaemia)
  • Localised swelling (oedema)

Common (affects 1 to 10 users in 100)

  • Headache
  • Dizziness
  • Flatulence
  • Joint pain
  • Impotence
  • Blood in urine
  • Small reduction in red blood cell count
  • Back pain
  • Shortness of breath
  • Heart failure (when taken with insulin)

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

  • Spinning sensation (vertigo)
  • Sweating
  • Tiredness
  • Sugar in urine, proteins in urine
  • Increased appetite
  • Increase in enzymes

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.


- Keep out of the reach and sight of children.
- Store below 30 °C.
- Do not use Glacera after the expiry date which is stated on the blister or the package.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


What Glacera contains?
• The active substance is Pioglitazone. Each tablet contains Pioglitazone Hydrochloride equivalent to Pioglitazone 15 mg or 30 mg .
• The other ingredients are lactose (200 mesh), Carboxymethyl Cellulose Calcium, Hydroxypropyl Cellulose LF and Magnesium Stearate.


What Glacera looks like and contents of the pack? Tablets: 15 mg Tablet : White to off white, circular, flat beveled edge, uncoated tablet de-bossed with “RC 3” on one side, and a plain on the other side. 30 mg Tablet : White to off white, circular, flat beveled edge, uncoated tablet de-bossed with “RC 4” on one side, and a plain on the other side.

Marketing Authorisation Holder and Manufacturer
Medical and Cosmetic Products Company Ltd. (Riyadh Pharma)
P.O.Box 442, Riyadh 11411
Fax: +966 11 265 0505
Email: contact@riyadhpharma.com
For any information about this medicinal product, please contact the local representative of marketing authorisation holder:
Saudi Arabia
Marketing department
Riyadh
Tel: +96611 265 0111
Email: marketing@riyadhpharma.com


6/2015
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

اسم هذا الدواء جلاسيرا. الماده الفعاله هي بيوجليتازون التي تنتمي إلى مجموعة أدويه تسمى مخفضات مستوى السكر في الدم.

جلاسيرا يحتوي على بيوجليتازون. وهو عباره عن دواء خافض لمستوى السكر في الدم ويستخدم لعلاج مرضى السكري من نوع (2) (الغير معتمد على الأنسولين). هذا النوع من داء السكري الذي يتطور عادةً في مرحلة البلوغ.

جلاسيرا يساعد على التحكم بمستوى السكر في دمك إذا كنت مصاباً بداء السكري نوع (2) وذلك عن طريق مساعدة جسمك للاستفاده بشكل أفضل من  الأنسولين الذي ينتجه الجسم.

من الممكن تناول جلاسيرا بمفرده أو مع الميتفورمين و/أو سلفونايل يوريا وهذه الأدويه تعتبر من مخفضات مستوى السكر في الدم التي يتم تناولها عن طريق الفم.

من الممكن استخدام الجلاسيرا مع الأنسولين.

موانع استعمال جلاسيرا

  • إذا كنت تعاني من حساسيه مفرطه (حساسيه) للبيوجليتازون أو لأي من محتويات جلاسيرا.
  • إذا كنت تعاني من قصور قلبي أو كان لديك قصور قلبي في السابق.
  • إذا كان لديك مرض كبدي.
  • إذا كنت تعاني من الحماض الكيتوني لمرضى السكري (مضاعفات لداء السكري تسبب فقدان الوزن بشكل سريع، غثيان أو تقيؤ).

الاحتياطات عند استعمال جلاسيرا

أخبر طبيبك قبل البدء بتناول هذا الدواء

  • إذا كنت تحتفظ بالمياه (احتباس السوائل) أو لديك مشاكل بالقصور القلبي خصوصاً إذا كان عمرك يزيد عن 75 سنه.
  • إذا كان لديك نوع خاص من أمراض السكري في العين يسمى الوذمه البقعيه (تورم في الجزء الخلفي من العين).
  • إذا كان لديكِ خراجات على المبايض (متلازمة المبيض المتعدد التكيسات). قد يكون هناك زياده لاحتمالية الحمل لأنه من الممكن أن تحدث الإباضه عند تناولكِ جلاسيرا. إذا انطبق عليكِ هذا، استخدمي وسائل منع الحمل المناسبه لتجنب إمكانية حدوث الحمل الغير مخطط له.
  • إذا كان لديك مشاكل في وظائف الكبد أو القلب، قبل البدء بتناول جلاسيرا سيتطلب منك أخذ عينه من الدم لفحص وظيفة الكبد. قد يتم تكرار هذا الفحص على فترات. بعض المرضى الذين يعانون من داء السكري نوع (2) طويل الأمد و أمراض قلبيه أو سكته دماغيه سابقه لمن عولجوا بجلاسيرا والأنسولين لوحظ لديهم تطور في القصور القلبي. أخبر طبيبك في أسرع وقت ممكن إذا واجهت علامات قصور قلبيه مثل ضيق في التنفس أو زياده سريعه في الوزن أو تورم في مكان معين (وذمه).

إذا تناولت جلاسيرا مع أدويه أخرى لداء السكري، فمن المرجح أن نسبة السكر في دمك قد تنخفض عن المستوى العادي ( انخفاض شديد بمستوى السكر في الدم).

قد يواجهك أيضاً انخفاض في تعداد الدم ( فقر الدم: الأنيميا).

تكسر العظم

لوحظ معدل عالي من كسور العظام لدى النساء ( لكن ليس لدى الرجال) الذين يتناولون بيوجليتازون. سوف يأخذ طبيبك هذا الأمر في الاعتبار عند معالجتك من داء السكري.

الأطفال

ينصح بعدم استعماله لدى الأطفال الذين تقل أعمارهم عن 18 سنه.

التداخلات الدوائيه من أخذ هذا المستحضر مع أي أدويه أخرى

يرجى إخبار الطبيب أو الصيدلي إذا كنت تتناول أو تناولت مؤخراً أية أدويه أخرى، بما في ذلك الأدويه التي تم الحصول عليها دون وصفه طبيه.

يمكنك الاستمرار عادةً بتناول الأدويه الأخرى خلال فترة علاجك بالجلاسيرا. ومع ذلك، هناك بعض الأدويه  من المرجح بصفه خاصه أن تؤثر على كمية السكر في الدم:

      - جمفبروزيل (يستخدم لخفض الكوليسترول)

      - ريفامبيسين ( يستخدم لعلاج السل وأمراض أخرى)

أخبر الطبيب أو الصيدلي إذا كنت تتناول أياً من هذه الأدويه. سوف يتم فحص مستوى السكر في دمك، وقد تحتاج إلى تغيير جرعة الجلاسيرا.

تناول جلاسيرا مع الطعام أو الشراب

يمكنك تناول أقراص جلاسيرا مع أو بدون الطعام. يجب ابتلاع الأقراص مع كوب من الماء.

الحمل والرضاعه

أخبري طبيبك إذا:

        - كنتِ حاملاً، أو تعتقدين بأنكِ حاملاً، أو تخططين لتصبحي حاملاً.

        ــ  إذا كنتِ مرضعه أو إذا كنتِ تخططين لإرضاع طفلك.

سوف ينصحك طبيبك بالتوقف عن تناول هذا الدواء.

تأثير جلاسيرا على القياده واستخدام الآلات

بيوجليتازون لن يؤثر على مقدرتك للقياده أو استخدام الآلات ولكن يجب أخذ الحيطه عند الشعور بعدم وضوح الرؤيه.

معلومات هامه حول بعض مكونات جلاسيرا

هذا الدواء يحتوي على اللاكتوز. إذا أخبرك طبيبك بأن لديك حساسيه مفرطه لبعض السكريات، اتصل بطبيبك قبل تناول جلاسيرا.

https://localhost:44358/Dashboard

يجب تناول حبه واحده من بيوجليتازون 15 ملجم ،30 ملجم أو 45 ملجم مره واحده يومياً. إذا لزم الأمر سوف يخبرك طبيبك بتناول جرعه مختلفه.

إذا كان لديك انطباع بأن تأثير جلاسيرا ضعيف للغايه، تحدث إلى طبيبك.

عند تناول جلاسيرا مع أدويه أخرى تستخدم لعلاج داء السكري (مثل: الأنسولين، كلوربروباميد، جليبينكلاميد، جليكلازايد، تولبيوتاميد) سوف يخبرك طبيبك إذا كنت بحاجه إلى تناول جرعات أصغر من هذه الأدويه.

سوف يسألك طبيبك لإجراء فحوصات دوريه للدم خلال فترة علاجك بالجلاسيرا. وهذا للتأكد من أن الكبد لديك يعمل بشكل طبيعي.

إذا كنت تتبع نظام غذائي خاص بمرضى السكري، فيجب عليك الاستمرار بهذا النظام خلال فترة تناولك للجلاسيرا.

يجب فحص وزنك على فترات منتظمه، عند زيادة وزنك أبلغ طبيبك.

إذا استعملت جلاسيرا أكثر مما يجب

إذا تناولت عدد كبير من أقراص جلاسيرا عن طريق الخطأ، أو تناولها أي شخص آخر، أو تناول طفل دواءك، اتصل فوراً بالطبيب أو الصيدلي. من الممكن أن  يعمل على تخفيض مستوى السكر في الدم عن المستوى الطبيعي وبالإمكان زيادته عن طريق تناول السكر.

ينصح بأن تحمل معك قطع من السكر، الحلويات، البسكويت أو عصير فاكهه ُمحلى.

نسيان استعمال جلاسيرا

تناول جلاسيرا يومياً كما وصف لك. ومع ذلك إذا نسيت تناول جرعه، استمر بتناول الجرعه التاليه كالمعتاد. ولا تحاول تناول جرعه مضاعفه لتعويض الجرعه التي نسيت تناولها.

التوقف عن تناول جلاسيرا

يجب تناول جلاسيرا كل يوم لتخفيض مستوى السكر بشكل صحيح. إذا توقفت عن تناول جلاسيرا، قد ترتفع نسبة السكر في دمك. تحدث إلى طبيبك قبل التوقف عن العلاج.

إذا كانت لديك أية أسئله أخرى حول استخدام هذا العلاج، اسأل طبيبك أو الصيدلي.

كما في جميع الأدويه، من الممكن أن يسبب جلاسيرا أعراض جانبيه، على الرغم من أنها لا تحدث لجميع المرضى.

الآثار الجانبيه التاليه لوحظت لدى بعض المرضى الذين يتناولون جلاسيرا

الأعراض الشائعه (تؤثر على 1 إلى 10 أشخاص من 100 شخص)

  • زيادة الوزن.
  • عدوى تنفسيه.
  • تخدر.
  • عدم وضوح في الرؤيه.
  • تكسر العظم.

الأعراض الغير شائعه (تؤثر على 1 إلى 10 أشخاص لكل 1000 شخص)

  • التهاب الجيوب الأنفيه.
  • صعوبة في النوم (أرق).

الأعراض الغير معروفه ( لا يمكن تقدير حدوثها من البيانات المتوفره)

  • عدم وضوح في الرؤيه بسبب تورم (أو سائل) في الجزء الخلفي من العين. إذا واجهت هذه الأعراض في بداية العلاج أو أصبحت حالتك أسوء أخبر طبيبك في أقرب وقت ممكن.

الآثار الجانبيه الإضافيه التاليه والتي لوحظت لدى بعض المرضى الذين يتناولون جلاسيرا مع أدويه أخرى لعلاج داء السكري

الأعراض الشائعه جداً ( تؤثر على أكثر من 1 لكل 10 أشخاص)

  • انخفاض مستوى السكر في الدم (انخفاض شديد بمستوى السكر في الدم).
  • تورم في مكان معين (وذمه).

الأعراض الشائعه ( تؤثر على 1إلى 10 أشخاص لكل 100 شخص)

  • صداع.
  • دوخه.
  • نفخه.
  • آلام المفاصل.
  • عجز جنسي.
  • دم في البول.
  • نقص صغير في عدد كريات الدم الحمراء.
  • آلام الظهر.
  • صعوبه في التنفس.
  • قصور في وظائف القلب (عندما تؤخذ مع الأنسولين).

الأعراض الغير شائعه (تؤثر على 1 إلى 10 أشخاص لكل 1000 شخص)

  • الاحساس بالدوار (دوار).
  • تعرق.
  • تعب.
  • سكر في البول، بروتينات في البول.
  • زيادة الشهيه.
  • زياده في الإنزيمات.

إذا كانت أياً من هذه الآثار الجانبيه خطيره أو لاحظت أية أعراض جانبيه ليست مدرجه في هذه النشره، يرجى إخبار طبيبك أو الصيدلي.

- يحفظ بعيدا عن متناول الأطفال.

- يحفظ في درجة حرارة أقل من 30 درجة مئوية.

-يجب عدم استعمال جلاسيرا بعد تاريخ انتهاء الصلاحيه المذكور على الشريط أو العبوه.

- التخلص من الأدويه يجب أن لا يكون عن طريق مياه الصرف الصحي أو النفايات المنزليه. اسأل الصيدلي عن كيفية التخلص من الأدويه التي لم تعد تحتاجها. هذة التدابير مساعده في حماية البيئه.

- الماده الفعاله هي بيوجليتازون. كل قرص يحتوي بيوجليتازون هيدروكلورايد ما يعادل بيوجليتازون 15 ملجم أو 30ملجم بيوجليتازون.

المواد الإضافيه هي لاكتوز (200 mesh)، كاربوكسي ميثايل سيليلوز الكالسيوم، هيدروكسي بروبايل سيليلوز إل إف و مغنيسيوم ستيريت.

أقراص:

أقراص 15 ملجم لونه أبيض إلى أبيض مطفي، مدور، سطحه مشطوف الحواف، غير مغلفه مطبوع عليها "RC3 " على جهه واحده والجهه الأخرى منبسطه.

أقراص 30 ملجم لونه أبيض إلى أبيض مطفي، مدور، سطحه مشطوف الحواف، غير مغلفه مطبوع عليها "RC4 " على جهه واحده والجهه الأخرى منبسطه.

 

شركة المنتجات الطبيه والتجميليه المحدوده (الرياض فارما)

ص.ب. 442 الرياض 11411

فاكس: 966112650505+

البريد الإلكتروني: contact@riyadhpharma.com

لأية معلومات عن هذا المنتج الطبي، يرجى الاتصال على صاحب الترخيص والتسويق:

المملكة العربية السعودية

قسم التسويق

الرياض

تلفون: 966112650111+

البريد الإلكتروني: marketing@riyadhpharma.com

يونيو 2015
 Read this leaflet carefully before you start using this product as it contains important information for you

GLACERA 15mg TABLET

The active substance is Pioglitazone. Each tablet contains Pioglitazone Hydrochloride equivalent to Pioglitazone 15 mg Full list of excipients, see section 6.1

Glacera 15 mg tablets: White to off white, circular, flat beveled edge, uncoated tablet de-bossed with “RC 3” on one side, and a plain on the other side

Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:

As monotherapy
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercisefor whom metformin is inappropriate because of contraindications or intolerance

as dual oral therapy in combination with
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.

As triple oral therapy in combination with
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
- Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).


Posology
Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily. The dose may be increased in increments up to 45 mg once daily.
In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycaemia, the dose of insulin should be decreased.

Special population
Elderly
No dose adjustment is necessary for elderly patients (see section 5.2). Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
Renal impairment
No dose adjustment is necessary in patients with impaired renal function (creatinine clearance> 4ml/min) (see section 5.2). No information is available from dialysed patients therefore pioglitazone should not be used in such patients.
Hepatic impairment
Pioglitazone should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Paediatric population
The safety and efficacy of Glacera in children and adolescents under 18 years of age have not been established. No data are available.

Method of administration
Pioglitazone tablets are taken orally once daily with or without food. Tablets should be swallowed with a glass of water.


Pioglitazone is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria.

Fluid retention and cardiac failure
Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure. When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually. Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve. There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure. Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin. Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema. Post marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors. Pioglitazone should be discontinued if any deterioration in cardiac status occurs. A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease. Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years. This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study.

Elderly
Combination use with insulin should be considered with caution in the elderly because of increased risk of serious heart failure.
In light of age- related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.

Bladder Cancer
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029). After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups. Available epidemiological data also suggest a small increased risk of bladder cancer in diabetic patients treated with pioglitazone in particular in patients treated for the longest durations and with the highest cumulative doses. A possible risk after short term treatment cannot be excluded.
Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment (risks include age, smoking history, exposure to some occupational or chemotherapy agents e.g. cyclophosphamide or prior radiation treatment in the pelvic region). Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Patients should be advised to promptly seek the attention of their physician if macroscopic haematuria or other symptoms such as dysuria or urinary urgency develop during treatment.

Monitoring of liver function
There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8). It is recommended, therefore, that patients treated with pioglitazone undergo periodic monitoring of liver enzymes. Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all patients. Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT> 2.5 X upper limit of normal) or with any other evidence of liver disease.
Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement. If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible. If ALT levels remain> 3 X the upper limit of normal, therapy should be discontinued. If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked. The decision whether to continue the patient on therapy with pioglitazone should be guided by clinical judgement pending laboratory evaluations. If jaundice is observed, the medicinal product should be discontinued.

Weight gain
In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention. In some cases weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored. Part of the treatment of diabetes is dietary control. Patients should be advised to adhere strictly to a calorie-controlled diet.

Haematology
There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution. Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6–4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1–2% and haematocrit
1–3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.

Hypoglycaemia
As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.

Eye disorders
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone. Many of these patients reported concurrent peripheral oedema. It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.

Others
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator. The observed excess risk of fractures for women in this data-set on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
The risk of fractures should be considered in the long term care of patients treated with pioglitazone.
As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation. These patients may be at risk of pregnancy. Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin). Glycaemic control should be monitored closely. Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Glacera tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.


Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. Coadministration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea. Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4. In vitro studies have shown no inhibition of any subtype of cytochrome P450. Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected. Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone. Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered. Close monitoring of glycaemic control should be considered (see section 4.4). Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone. The pioglitazone dose may need to be increased when rifampicin is concomitantly administered. Close monitoring of glycaemic control should be considered (see section 4.4).


Women of childbearing potential / Contraception in males and females
As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential

Pregnancy
Pregnancy category C
There are no adequate human data to determine the safety of pioglitazone during pregnancy. Foetal growth restriction was apparent in animal studies with pioglitazone. This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth. The relevance of such a mechanism in humans is unclear and pioglitazone should not be used in pregnancy.

Breast-feeding
Pioglitazone has been shown to be present in the milk of lactating rats. It is not known whether pioglitazone is secreted in human milk. Therefore, pioglitazone should not be administered to breast-feeding women.

Fertility
In animal fertility studies there was no effect on copulation, impregnation or fertility index


Glacera has no or negligible influence on the ability to drive and use machines. However patients who experience visual disturbance should be cautious when driving or using machines.


Tabulated list of adverse reactions

Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to< 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.

Adverse reaction

Frequency of adverse reactions of pioglitazone by treatment regimen

 Mono- therapy

Combination

with metformin

with sulpho-

nylurea

withmetformin and sulpho- nylurea

withinsulin

Infections and infestations

 

upper respiratory tract infection

common

common

common

common

common

bronchitis

 

 

 

 

common

sinusitis

uncommon

uncommon

uncommon

uncommon

uncommon

Neoplasms benign, malignant

and unspecified (including

cysts and polyps)

 

bladder cancer

uncommon

uncommon

uncommon

uncommon

uncommon

Blood and lymphatic system disorders

 

anaemia

 

common

 

 

 

Immune System Disorders

 

hypersensitivity and allergic reactions1

not known

not known

not known

not known

not known

Metabolism and nutrition disorders

 

hypo-glycaemia

 

 

uncommon

very common

common

appetite increased

 

 

uncommon

 

 

Nervous system disorders

 

hypo-aesthesia

common

common

common

common

common

headache

 

common

uncommon

 

 

dizziness

 

 

common

 

 

insomnia

uncommon

uncommon

uncommon

uncommon

uncommon

Eye disorders

 

visual disturbance2

common

common

uncommon

 

 

macular oedema3

not known

not known

not known

not known

not known

Ear and labyrinth disorders

 

vertigo

 

 

uncommon

 

 

Cardiac disorders

 

heart failure4

 

 

 

 

common

Respiratory, thoracic and mediastinal disorders

 

dyspnoea

 

 

 

 

common

Gastrointestinal disorders

 

flatulence

 

uncommon

common

 

 

Skin and subcutaneous tissue disorders

 

sweating

 

 

uncommon

 

 

Musculoskeletal and connective tissue disorders

 

fracture bone5

common

common

common

common

common

arthralgia

 

common

 

common

common

back pain

 

 

 

 

common

Renal and urinary disorders

 

haematuria

 

common

 

 

 

glycosuria

 

 

uncommon

 

 

proteinuria

 

 

uncommon

 

 

Reproductive system and breast disorders

 

erectile dysfunction

 

common

 

 

 

General disorders and administration site conditions

 

oedema

 

 

 

 

very common

fatigue

 

 

uncommon

 

 

Investigations

 

weight increased6

common

common

common

common

common

blood creatine phospho-kinase increased

 

 

 

common

 

increased lactic dehydro-genase

 

 

uncommon

 

 

alanine aminotransferase increased7

not known

not known

not known

not known

not known

 

Description of selected adverse reactions

1.     Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported. These reactions include anaphylaxis, angioedema, and urticaria.

2.     Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.

3.     Oedema was reported in 6–9% of patients treated with pioglitazone over one year in controlled clinical trials. The oedema rates for comparator groups (sulphonylurea, metformin) were 2–5%. The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.

4.     In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin. In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin. However, this did not lead to an increase in mortality in this study. In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥65 years compared with those less than 65 years (9.7% compared to 4.0%). In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65 years. Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.

5.     A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone- treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration. A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).

In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).

6.     In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2–3 kg over one year. This is similar to that seen in a sulphonylurea active comparator group. In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg. In comparator groups addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.

7.     In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups. Mean levels of liver enzymes decreased with treatment with pioglitazone. Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience. Although in very rare cases fatal outcome has been reported, causal relationship has not been established.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

To report any side effects:

- National Pharmacovigilance and Drug Safety Center (NPC)

  • Fax: +966-11-205-7662
  • To contact national Pharmacovigilance management: +966-11-2038222 ext.: 2353 – 2356 – 2317 – 2354 – 2334 – 2340
  • Toll-free: 8002490000
  • E-mail: npc.drug@sfda.gov.sa
  • Website: www.sfda.gov.sa/npc

In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily. The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Hypoglycaemia may occur in combination with sulphonylureas or insulin. Symptomatic and general supportive measures should be taken in case of overdose


Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Pioglitazone effects may be mediated by a reduction of insulin resistance. Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals. Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.
Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus. The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations. A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c≥ 8.0% after the first six months of therapy). Kaplan-Meier analysis showed shorter time to treatment
failure in patients treated with gliclazide, compared with pioglitazone. At two years, glycaemic control (defined as HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide. In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year. The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide. In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months. Patients receiving pioglitazone had a mean reduction in HbA1cof 0.45% compared with those continuing on
insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity. Two-year clinical studies have shown maintenance of this effect.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics. Pioglitazone was associated with significant weight gain. Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass. Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity. In most clinical trials, reduced total plasma triglycerides and free fatty acids, and
increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels, compared with placebo, metformin or gliclazide. Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide. In a 20- week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides. These effects were independent of pioglitazone's effects on glycaemia and were statistically significantly different to glibenclamide.
In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and preexisting major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years. The study population had an average age of 62 years; the average duration of diabetes was 9.5 years. Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea. To be eligible patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease. Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke. Approximately half of the study population had at least two of the cardiovascular history entry criteria. Almost all subjects
(95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates). Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone. However, the incidences of oedema, weight gain and heart failure were increased. No increase in mortality from heart failure was observed.

Paediatric population
The European Medicines Agency has waived the obligation to submit the results of studies with Glacera in all subsets of the paediatric population in Type 2 Diabetes Mellitus. See section 4.2 for information on paediatric use.


Absorption
Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration. Proportional increases of the plasma concentration were observed for doses from 2–60 mg. Steady state is achieved after 4–7 days of dosing. Repeated dosing does not result in accumulation of the compound or metabolites. Absorption is not influenced by food intake. Absolute bioavailability is greater than 80%.

Distribution
The estimated volume of distribution in humans is 0.25 l/kg.
Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).

Biotransformation
Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups. This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree. Three of the six identified metabolites are active (M-II, M-III, and M-IV). When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite MIII contribute equally to efficacy. On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450. There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man. Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).

Elimination
Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%). In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces. The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.

Elderly
Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.

Patients with renal impairment
In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar. Thus free (unbound) pioglitazone concentration is unchanged.

Patients with hepatic impairment
Total plasma concentration of pioglitazone is unchanged, but with an increased volume ofdistribution. Intrinsic clearance is therefore reduced, coupled with a higher unbound fraction ofpioglitazone.


In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys. In addition, increased fatty deposition and infiltration were observed. These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure. Foetal growth restriction was apparent in animal studies with pioglitazone. This was attributable to the
action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays. An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
The formation and presence of urinary calculi with subsequent irritation and hyperplasia waspostulated as the mechanistic basis for the observed tumourigenic response in the male rat. A 24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder. Dietary acidification significantly decreased but did not abolish the incidence of tumours. The presence of microcrystals exacerbated
the hyperplastic response but was not considered to be the primary cause of hyperplastic changes. The relevance to humans of the tumourigenic findings in the male rat cannot be excluded.
There was no tumourigenic response in mice of either sex. Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated with pioglitazone for up to 12 months.
In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon. The relevance of this finding is unknown.

Environmental Risk Assessment (ERA):
No environmental impact is anticipated from the clinical use of pioglitazone.


Lactose (200 mesh )
Carboxymethyl Cellulose Calcium.
Hydroxypropyl Cellulose LF.
Magnesium Stearate.


Not Applicable


2 years

Store below 30 °C.


Aluminium foil blister as a pack of 10 tablets


Not Applicable


Marketing Authorisation Holder and Manufacturer Medical and Cosmetic Products Company Ltd. (Riyadh Pharma) P.O.Box 442, Riyadh 11411 Fax: +966 11 265 0505 Email: contact@riyadhpharma.com For any information about this medicinal product, please contact the local representative of marketing authorisation holder: Saudi Arabia Marketing department Riyadh Tel: +966 11 265 0111 Email: marketing@riyadhpharma.com

10/2017
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