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DROLATE is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. DROLATE prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures. Your doctor has prescribed DROLATE to treat your osteoporosis. DROLATE reduces the risk of spine and hip fractures. DROLATE is a once weekly treatment. What is osteoporosis? Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis. Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility. How can osteoporosis be treated? As well as your treatment with DROLATE, your doctor may suggest you make changes to your lifestyle to help your condition, such as: □ Stopping smoking: Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones. □ Exercise: Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme. □ Eating a balanced diet: Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and Vitamin D)
□ If you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6) □ If you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing □ If you cannot stand or sit upright for at least 30 minutes □ If your doctor has told you that you have low blood calcium. If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given. Take special care with DROLATE: Talk to your doctor or pharmacist before taking DROLATE if: □ You suffer from kidney problems □ You have any swallowing or digestive problems □ Your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus) □ You have been told that you have low blood calcium □ You have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care □ You have cancer □ You are undergoing chemotherapy or radiotherapy □ You are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer □ You are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of such conditions as asthma, rheumatoid arthritis, and severe allergies □ You are or have been a smoker (as this may increase the risk of dental problems). You may be advised to have a dental check-up before starting treatment with DROLATE. It is important to maintain good oral hygiene when being treated with DROLATE. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience anyproblems with your mouth or teeth such as loose teeth, pain or swelling. Irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking DROLATE. These side effects may worsen if patients continue to take DROLATE after developing these symptoms. Children and adolescents DROLATE should not be given to children and adolescents less than 18 years of age. Taking other medicines with DROLATE: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of DROLATE if taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to take DROLATE. Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as DROLATE. Taking DROLATE with food and drink: It is likely that food and beverages (including mineral water) will make DROLATE less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to take DROLATE. Pregnancy and breastfeeding: DROLATE is only intended for use in postmenopausal women. You should not take DROLATE if you are or think you may be pregnant, or if you are breast-feeding. Driving and using machines: There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic acid that may affect your ability to drive or operate machinery. Individual responses to DROLATE may vary. (See section 4.). Important information about some of the ingredients of DROLATE: DROLATE contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take DROLATE tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take one DROLATE tablet once a week. Follow these instructions carefully to make sure you will benefit from DROLATE. 1. Choose the day of the week that best fits your schedule. Every week, take one DROLATE tablet on your chosen day. It is very important to follow instructions 2, 3, 4 and 5 to help the DROLATE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach). 2. After getting up for the day and before taking any food, drink, or other medicine, swallow your DROLATE tablet whole with a full glass of water only (not mineral water) (not less than 200 ml), so that DROLATE is adequaetly absorbed . □ Do not take with mineral water (still or sparkling). □ Do not take with coffee or tea. □ Do not take with juice or milk. Do not crush or chew the tablet or allow it to dissolve in your mouth because of the possibility of mouth ulceration. 3. Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day. 4. Do not take DROLATE at bedtime or before getting up for the day. 5. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking DROLATE and contact your doctor. 6. After swallowing your DROLATE tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. DROLATE is effective only if taken when your stomach is empty. If you take more DROLATE than you should: If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down. If you forget to take DROLATE: If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day. If you stop taking DROLATE: It is important that you take DROLATE for as long as your doctor prescribes the medicine. Since it is not known how long you should take DROLATE, you should discuss the need to stay on this medicine with your doctor periodically to determine if DROLATE is still right for you. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, DROLATE tablets can cause side effects, although not everybody gets them. See your doctor immediately if you notice any of the following side effects, which may be serious and for which you may need urgent medical treatment: Common (may affect up to 1 in 10 people): □ Heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing. Rare (may affect up to 1 in 1,000 people): □ Allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; severe skin reactions. □ Pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms □ Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone. □ Bone, muscle and/or joint pain which is severe. Other side effects: Very common (may affect more than 1 in 10 people): □ Bone, muscle and/or joint pain which is sometimes severe. Common (may affect up to 1 in 10 people): □ Joint swelling □ Abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence □ Hair loss; itching □ Headache; dizziness □ Tiredness; swelling in the hands or legs. Uncommon (may affect up to 1 in 100 people): □ Nausea; vomiting □ Irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach □ Black or tar-like stools □ Blurred vision; pain or redness in the eye □ Rash; redness of the skin □ Transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment □ Taste disturbance. Rare (may affect up to 1 in 1000 people): □ Symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth □ Stomach or peptic ulcers (sometimes severe or with bleeding) □ Narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach) □ Rash made worse by sunlight □ Mouth ulcers when the tablets have been chewed or sucked. Very rare (may affect up to 1 in 10,000 people): □ Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
Keep out of the reach and sight of children. □ Do not store above 30 °C. □ Do not use DROLATE after the expiry date which is stated on the carton and on the blister, after (EXP).- Date. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
□ The active substance is Alendronic acid. Each DROLATE Tablet contains Alendronic acid 70 mg, as Sodium Alendronate. □ The other ingredients are:Lactose monohydrate, Microcrystalline cellulose and Colloidal silicon dioxide, Croscarmellose sodium, Magnesium stearate
The Jordanian pharmaceutical manufacturing company. P.O. BOX 151, Um Al-Amad 16197, Jordan Saudi Arabia: To report any side effect(s): The National Pharmacovigilance Center (NPC): Fax: +966-11-205-7662, SFDA Call Center: 19999, E-mail: npc.drug@sfda.gov.sa, Website: http://ade.sfda.gov.s
یحتوي قرص درولیت على المادة الفعالة، حمض الألندرونك (تسمى عادة بالألیندرونات) وھي تنتمي إلى مجموعة الأدویة غیر الھرمونیة التي تسمى البایفوسفونیت. یعمل درولیت على منع فقدان العظام الذي یحدث للنساء بعد مرورھن في سن الیأس ویساعد في إعادة بناء العظام. وھو یقلل من خطر الإصابة بكسور العمود الفقري والورك. وصف الطبیب لك درولیت لعلاج ھشاشة العظام. یعمل درولیت على تقلیل خطر الإصابة بكسور العمود الفقري والورك. المعالجة باستخدام درولیت تكون مرة واحدة .ً أسبوعیا ما ھو مرض ھشاشة العظام؟ ھشاشة العظام ھو عبارة عن ترقق وضعف في العظام، ویكون شائع لدى النساء بعد سن الیأس. یتوقف المبیضین عن إنتاج ھرمون الأستروجین الأنثوي في سن الیأس والذي یساعد في الحفاظ على صحة الھیكل العظمي للنساء. وكنتیجة لذلك، یحدث فقدان للعظم وتصبح العظام ضعیفة. یزداد خطر الإصابة بھشاشة العظام عند وصول النساء إلى سن الیأس بوقت مبكر. ً لا یكون لھشاشة العظام أي أعراض في عادة الفترة المبكرة، وإذا لم تتم معالجتھا فإنھا تؤدي إلى تكسر العظام. وبالرغم من أن ھذه الكسور قد ً، الأ ان الكسور التي تحدث في تكون مؤلمة عادة عظام العمود الفقري قد لا یتم ملاحظتھا حتى تتسبب في الانحناء. یمكن أن یحدث كسر العظام خلال النشاط الیومي الاعتیادي، مثل رفع الأشیاء أو الاصابة الطفیفة والتي بشكل عام لا تتسبب ً ما یحث كسر بكسر العظام الطبیعیة. وعادة العظام في الورك أو العمود الفقري أو الرسغ ولا یقتصر فقط على الألم بل قد یؤدي إلى مشاكل كبیرة مثل الوضع المنحني (سنام الأرملة) وفقدان الحركة. كیف یمكن علاج مرض ھشاشة العظام؟ قد یقترح علیك طبیبك تغیرات في نمط حیاتك خلال علاجك باستخدام درولیت للمساعدة في علاج حالتك الصحیة مثل: □ التوقف عن التدخین: یظھر بأن التدخین یؤدي إلى زیادة معدل فقدان العظام وبالتالي قد یزید من خطر الإصابة بكسور العظام. □ التمارین الریاضیة: تحتاج العضلات والعظام إلى التمارین الریاضیة لتبقى قویة وصحیة. اتصل بطبیبك قبل البدء بأي برنامج ریاضي. □ اتباع نظام غذائي متوازن: قد ینصحك طبیبك باتباع نظام غذائي متوازن أو اتخاذ أي مكملات غذائیة (خاصة الكالسیوم وفیتامین د).
□ إذا كنت تعاني من حساسیة لحمض الألندرونك أو لأي من مكونات الدواء الأخرى (المذكورة بقسم ٦.( □ إذا كنت تعاني من مشاكل في المريء (المريء- أنبوب یربط الفم بالمعدة) مثل ضیق أو صعوبة في البلع. □ إذا كنت لا تستطیع الوقوف أو الجلوس في وضع مستقیم لمدة ۳۰ دقیقة على الأقل. □ إذا أخبرك طبیبك بأنك تعاني من انخفاض مستوى الكالسیوم في الدم. ً من ھذه إذا كنت تعتقد بأنھ ینطبق علیك أیا الحالات، فلا تتناول الأقراص وتحدث إلى طبیبك ً واتبع تعلیماتھ. أولا الاحتیاطات عند استعمال درولیت: تحدث إلى طبیبك أو الصیدلي قبل تناول درولیت إذا: □ كنت تعاني من مشاكل في الكلى □ كنت تعاني من مشاكل في البلع والھضم □ أخبرك طبیبك بأنك تعاني من المريء باریت ( وھو حالة مرضیة ترتبط بتغیرات في الخلایا المبطنة للمريء السفلي) □ تم إخبارك بأنك تعاني من انخفاض الكالسیوم في الدم □ تعاني من ضعف في صحة الأسنان، أو أمراض في اللثة، أو خلع الأسنان المخطط لھ أو عدم تلقي عنایة روتینیة للأسنان. □ كنت تعاني من مرض السرطان □ كنت تخضع للعلاج الكیمیائي أو العلاج الإشعاعي □ كنت تتناول الأدویة المثبطة لتكوین الأوعیة الدمویة (مثل بیفاسیزوماب، أو الثالیدوماید) التي تستخدم لعلاج السرطان. □ كنت تتناول أدویة الكورتیكوستیروید (مثل بریدنیزون أو دیكسامیثازون) التي تستخدم لعلاج حالات مثل الربو، التھاب المفاصل الروماتیدي والحساسیة الشدیدة □ كنت من المدخنین (لأن ذلك قد یزید من خطر التعرض لمشاكل الأسنان) قد تنصح بفحص أسنانك قبل البدء بالمعالجة باستخدام درولیت. ً عند بدء من المھم الحفاظ على نظافة الفم جیدا العلاج باستخدام درولیت. یجب عمل فحص لأسنانك بشكل روتیني خلال المعالجة باستخدام درولیت، ویجب الاتصال مع طبیبك أو طبیب الأسنان إذا واجھت أي مشاكل في الفم أو الأسنان مثل فقدان الأسنان، أو آلام أو تورم. قد یحدث تھیج أو التھاب أو تقرح في المريء ً ما یكون (الأنبوب الذي یربط الفم بالمعدة) وغالبا مصحوب مع أعراض ألم الصدر أو الحرقة أصعوبة أو ألم عند البلع وخاصة إذا لم یتناول المریض كوب كامل من الماء و/أو إذا استلقى لمدة أقل من ۳۰ دقیقة بعد تناول درولیت. قد تتفاقم ھذه الأعراض إذا استمر المریض بتناول درولیت بعد تطور ھذه الأعراض. الأطفال والمراھقین: لا یجب إعطاء درولیت للأطفال والمراھقین الذین تقل أعمارھم عن ۱۸ سنة. تناول أدویة أخرى مع درولیت أخبر طبیبك أو الصیدلي إذا كنت تتناول أو ً أو قد تتناول أي أدویة أخرى. تناولت مؤخرا من المحتمل أن تتداخل مكملات الكالسیوم ومضادات الحموضة وبعض الأدویة التي تؤخذ عن طریق الفم مع امتصاص درولیت عند تناولھا بنفس الوقت. وبالتالي من المھم اتباع النصیحة المذكورة في قسم ۳ ،طریقة استخدام درولیت. قد تتسبب بعض الأدویة التي تستخدم للروماتیزم أو للآلام طویلة الأمد والتي تدعى مضادات الالتھاب غیر الستیرویدیة (حمض أسیتیل سالیسیلیك أو الأیبوبروفین) بحدوث مشاكل في الجھار الھضمي. وبالتالي، یجب توخي الحذر عند تناول ھذه الأدویة مع درولیت بالوقت نفسھ. تناول درولیت مع الطعام والشراب: من المحتمل أن یؤدي تناول الطعام والمشروبات (بما في ذلك المیاه المعدنیة) إلى تقلیل فعالیة درولیت في حال تم تناولھا بنفس الوقت. وبالتالي من المھم اتباع النصیحة المذكورة في قسم ۳ ، طریقة استخدام درولیت. الحمل والرضاعة: یھدف درولیت فقط للاستخدام في النساء ما بعد سن الیأس. لا تستخدم درولیت إذا كنت تعتقدي ً أو مرضعة. بأنك حاملا تأثیر المستحضر على القیادة واستخدام الآلات: كانت ھناك أعراض جانبیة تم الإبلاغ عنھا مع حمض الألندرونك ( تشمل عدم وضوح الرؤیا ودوخة وألم شدید في العظام أوالعضلات أوالمفاصل) والتي قد تؤثر على القدرة على القیادة أو تشغیل الألات. قد تختلف الاستجابة الفردیة لدرولیت. (انظر قسم ٤.( معلومات ھامة حول بعض مكونات درولیت: یحتوي درولیت على اللاكتوز، إذا أخبرك طبیبك بأنك تعاني من عدم القدرة على تحمل بعض أنواع السكریات فإنھ یجب علیك استشارة طبیبك قبل تناول ھذا الدواء
یجب علیك الالتزام بتعلیمات طبیبك أو الصیدلاني في كیفیة تناول الدواء. علیك مراجعة .ً طبیبك أو الصیدلي إذا لم تكن متأكدا .ً تناول قرص درولیت واحد مرة واحدة أسبوعیا اتبع ھذه التعلیمات بعنایة للتأكد من أنك سوف تستفید من درولیت. ۱ .علیك اختیار یوم واحد من أیام الأسبوع الذي ً من ً واحدا یناسب جدولك الخاص. تناول قرصا ً في الیوم الذي اخترتھ. درولیت أسبوعیا من المھم اتباع التعلیمات المذكورة في النقاط ۲ ، ۳،٤ ،٥ للمساعدة في وصول قرص درولیت إلى المعدة بشكل سریع وللمساعدة في تقلیل فرصة حدوث تھیج للمريء (المريء – أنبوب یربط الفم بالمعدة). ۲ .عند الوصول إلى الیوم المقرر وقبل تناول الطعام أو الشراب أو أدویة أخرى، یجب علیك تناول قرص درولیت بأكملھ مع كوب كامل من الماء فقط (لیس میاه معدنیة) (لا تقل عن ۲۰۰ مل)، بحیث یتم امتصاص درولیت بشكل كافي. □ لا تتناولھ مع میاه معدنیة (الثابتة أو الفوراة) □ لا تتناولھ مع القھوة أو الشاي □ لا تتناولھ مع العصیر أو الحلیب لا تسحق أو تمضغ قرص الدواء أو تدعھ یذوب في فمك بسبب احتمالیة حدوث تقرحات في الفم. ۳ .لا تستلقي، بل یجب علیك البقاء بشكل مستقیم (الجلوس أو الوقوف، المشي) لمدة ۳۰ دقیقة على الأقل بعد ابتلاع القرص. علیك أن لا تستلقي حتى تتناول وجبة الطعام الأولى من یومك. ٤ .لا تنناول درولیت عند الذھاب إلى النوم أو قبل الاستیقاظ لذلك الیوم. ٥ .توقف عن تناول درولیت واستشر طبیبك إذا عانیت من صعوبة أو ألم عند البلع، أو ألم في الصدر أو تعاني من حرقة المعدة أو تفاقمھا. ٦ .بعد تناول قرص درولیت، انتظر ۳۰ دقیقة على الأقل قبل تناول أول وجبة طعام أو تناول شراب أو أدویة أخرى بما في ذلك مضادات الحموضة، و مكملات الكالسیوم والفیتامینات. یكون درولیت فعال عند تناولھ على معدة فارغة. الجرعة الزائدة من درولیت: إذا تناولت الكثیر من أقراص درولیت عن طریق الخطأ، فإنھ یجب علیك شرب كوب كامل من ً. لا تجبر نفسك الحلیب والاتصال بطبیبك مباشرة على التقیؤ ولا تستلقي. نسیان تناول جرعة درولیت: إذا نسیت تناول الجرعة، فإنھ یجب علیك تناولھا ً في حال تذكرھا. لا تتناول قرصین في صباحا نفس الیوم. ارجع إلى تناول قرص واحد مرة ً وفي ً اساسا واحدة في الأسبوع كما كان مقررا الیوم الذي أخترتھ. التوقف عن تناول درولیت: من المھم تناول درولیت طوال الفترة التي یصفھا لك طبیبك. یجب علیك مناقشة حاجة البقاء لاستخدام درولیت مع طبیبك بشكل دوري لتحدید ما إذا كان من المناسب استخدامھ، لأن الفترة التي یجب أن تتناول فیھا درولیت غیر معروفة. استشر طبیبك أو الصیدلي، إذا كانت لدیك أي أسئلة حول استخدام ھذا الدوا
كغیره من الأدویة، فقد یسبب درولیت أعراضا ً، بالرغم من أنھا لاتحدث للجمیع. جانبیة ً من راجع طبیبك على الفور إذا لاحظت أیا الأعراض الجانبیة التالیة والتي قد تكون خطیرة وتتطلب علاج طبي عاجل: الأعراض الجانبیة الشائعة (قد تؤثر على شخص واحد من بین ۱۰ أشخاص): □ حرقة المعدة، صعوبة في البلع، ألم عند البلع، تقرح المريء (المريء – ھو الأنبوب الذي یربط الفم بالمعدة) والذي قد یؤدي إلى ألم في الصدر، حرقة المعدة أو الصعوبة أو الألم عند البلع. الأعراض الجانبیة النادرة (قد تؤثر على شخص واحد من بین ۱۰۰۰ شخص): □ تفاعلات تحسسیة مثل الشرى، تورم الوجھ و/أو الشفاه و/أو اللسان و/أو الحلق والذي قد یسبب صعوبة في التنفس والبلع، تفاعلات جلدیة شدیدة. □ ألم في الفم و/أو الفك ، ورم وتقرحات داخل الفم، اخدرار أو الشعور بثقل في الفك أو فقدان الأسنان. قد تكون ھذه علامات لتلف العظام في ً ببطء التئام الفك (نخر العظم) والتي ترتبط عادة ً ما تكون بعد خلع الجروح والعدوى وغالبا الأسنان. یجب علیك الاتصال بطبیبك أو طبیب الأسنان إذا واجھت مثل ھذه الأعراض. □ قد یحدث كسر غیر اعتیادي في عظمة الفخذ بصورة نادرة وخاصة في المرضى الذین یتناولون علاج مطول لھشاشة العظام. اتصل بطبیبك إذا واجھت ألم أو ضعف أو الشعور بعدم الارتیاح في الورك أو الفخذ أو الأریبة (أعلى الفخذ) لأن ذلك قد یكون مؤشر مبكر على احتمالیة وجود كسر في عظمة الفخذ. □ ألم شدید في العظام و/أو العضلات و/أو المفاصل. الأعراض الجانبیة الأخرى: ً (قد تؤثر على الأعراض الجانبیة الشائعة جدا أكثر من شخص واحد من بین ۱۰ أشخاص): □ ألم قد یكون في بعض الحالات شدید في العظام و/أو العضلات و/أو المفاصل. الأعراض الجانبیة الشائعة (قد تؤثر على شخص واحد من بین ۱۰ أشخاص): □ تورم المفاصل □ ألم البطن، شعور غیر مریح في المعدة أو تجشؤ بعد تناول الطعام، إمساك، الشعور بامتلاء أو انتفاخ المعدة، إسھال، تطبل البطن □ تساقط الشعر، حكة □ صداع، دوخة □ تعب، تورم الیدین والقدمین الأعراض الجانبیة غیر الشائعة (قد تؤثر على شخص واحد من ۱۰۰ شخص) □ غثیان، تقیؤ □ تھیج أو التھاب المريء (المريء - أنبوب الذي یصل الفم بالمعدة) أو المعدة □ براز أسود اللون مثل القطران □ عدم وضوح الرؤیا، ألم أو احمرار العین □ طفح جلدي، احمرار الجلد □ أعراض عابرة شبیھة بأعراض الانفلونزا مثل، ألم العضلات، الشعور بالتوعك العام ً عند بدء وبعض الأحیان حمى والتي تظھر عادة المعالجة □ اضطراب التذوق الأعراض الجانبیة النادرة (قد تؤثر على شخص واحد من بین ۱۰۰۰ شخص): □ أعراض انخفاض مستویات الكالسیوم في الدم والتي تشمل تقلص أو تشنج العضلات و/أو الشعور بالوخز في الأصابع أو حول الفم □ قرحة المعدة أ, القرحة الھضمیة (بعض الأحیان تكون شدیدة أو مع نزیف) □ تضیق المريء (المريء – أنبوب یصل الفم بالمعدة) □ طفح جلدي یتفاقم من أشعة الشمس □ تقرحات الفم عند مضغ أو امتصاص الأقراص ً (قد تؤثر على ما الأعراض الجانبیة النادرة جدا یصل إلى شخص واحد من بین ۱۰۰۰۰ شخص): □ تحدث إلى طبیبك إذا كنت تعاني من ألم في الأذن و/ أو إفرازات من الأذن و/ أو التھاب في الأذن. قد تكون ھذه علامات على تلف العظام في الأذن.
□ یحفظ بعیدا □ لا یحفظ بدرجة حرارة أعلى من ۳۰°م. □ لا ینبغي استعمال درولیت بعد تاریخ انتھاء الصلاحیة الموجود على العلبة وعلى شریط الدواء. لا ینبغي التخلص من الأدویة من خلال میاه الصرف الصحي أو المنزلي. اسأل الصیدلاني عن كیفیة التخلص من الأدویة التي لم تعد مطلوبة. سوف تساعد ھذه الاجراءات على حمایة البیئة
المادة الفعالة ھي حمض الألندرونك. كل قرص من درولیت یحتوي ۷۰ ملغم من حمض الألندرونك، على ھیئة صودیوم الندرونیت. المكونات الأخرى ھي: لاكتوز مونوھیدرات، سلیلوز بلوري مكروي وثاني أكسید السیلیكون الغروي، كروسكارمیلوز الصودیوم، ستیارات المغنیزیوم.
□ أقراص درولیت ۷۰ ھي أقراص بیضاء إلى سكریة اللون، مسطحة، ثنائیة التحدب، بیضاویة الشكل ومحززة من جانب واحد و جلیة من الجانب الآخر. □ علب تحتوي على ٤ أقراص من أقراص درولیت ۷۰ المحفوظة في أشرطة.
الشركة الأردنیة لإنتاج الأدویة. ص.ب. ۱٥۱ -أم العمد ۱٦۱۹۷ - الأردن. المملكة العربیة السعودیة: للإبلاغ عن الأعراض الجانبیة: المركز الوطني للتیقظ الدوائي: فاكس: ۹٦٦۱۱۲۰٥۷٦٦۲ ،+مركز الاتصال بالھیئة العامة للغذاء و الدواء في السعودیة: ۱۹۹۹۹ ،البرید الإلكتروني: ،Npc.drug@sfda.gov.sa الموقع الإلكتروني: https://ade.sfda.gov.sa
DROLATE is indicated in adults for the treatment of postmenopausal osteoporosis. DROLATE reduces the risk of vertebral and hip fractures.
Posology
The recommended dosage is one 70 mg tablet once weekly.
Patients should be instructed that if they miss a dose of DROLATE Once Weekly, they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of 'Drolate' on an individual patient basis, particularly after 5 or more years of use.
Elderly
In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dosage adjustment is necessary for the elderly.
Renal impairment
No dosage adjustment is necessary for patients with creatinine clearance greater than 35 ml/min. Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Paediatric population
The safety and efficacy of DROLATE in children less than 18 years of age has not been established. This medicinal product should not be used in children less than 18 years of age. Currently available data for alendronic acid in the paediatric population is described in section 5.1.
Method of administration
Oral use.
To permit adequate absorption of alendronate:
DROLATE must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5).
To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see section 4.4):
- DROLATE should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml).
- Patients should only swallow DROLATE whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
- Patients should not lie down for at least 30 minutes after taking DROLATE and until after the first food of the day.
- DROLATE should not be taken at bedtime or before arising for the day.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see section 4.4).
DROLATE Once Weekly 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis
Upper gastro-intestinal adverse reactions
Alendronate can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastro-intestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastro-intestinal tract other than pyloroplasty (see section 4.3). In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate. Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain, new or worsening heartburn (see section 4.8).
The risk of severe oesophageal adverse experiences appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to, and understood by the patient (see section 4.2). Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
While no increased risk was observed in extensive clinical trials, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some severe and with complications (see section 4.8).
Osteonecrosis of the jaw
Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
The following risk factors should be considered when evaluating an individual's risk of developing osteonecrosis of the jaw:
• potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above) and cumulative dose
• cancer, chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors, smoking
• a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status.
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling.
Osteonecrosis of the external auditory canal
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms such as pain or discharge, or chronic ear infections.
Musculoskeletal pain
Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have rarely been severe and/or incapacitating (see section 4.8). The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping treatment. A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate.
Atypical fractures of the femur
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique, fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a complete femoral fracture. Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Renal impairment
Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, (see section 4.2).
Bone and mineral metabolism
Causes of osteoporosis other than oestrogen deficiency and ageing should be considered.
Hypocalcaemia must be corrected before initiating therapy with alendronate (see section 4.3). Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting this medicinal product. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with DROLATE.
Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased. These are usually small and asymptomatic. However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption).
Ensuring adequate calcium and vitamin D intake is particularly important in patients receiving glucocorticoids.
Lactose
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronate. Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).
No other interactions with medicinal products of clinical significance are anticipated. A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronate. No adverse experiences attributable to their concomitant use were identified.
Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Although specific interaction studies were not performed, in clinical studies alendronate was used concomitantly with a wide range of commonly prescribed medicinal products without evidence of clinical adverse interactions
Pregnancy
There are no or limited amount of data from the use of alendronate in pregnant women. Studies in animals have shown reproductive toxicity. Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia (see section 5.3).
DROLATE should not be used during pregnancy.
Breast-feeding
It is unknown whether alendronate/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. DROLATE should not be used during breast-feeding.
Fertility
Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use (see section 5.2). There are no data on foetal risk in humans. However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied..
DROLATE has no or negligible direct influence on the ability to drive and use machines. Patients may experience certain adverse reactions (for example blurred vision, dizziness and severe bone muscle or joint pain (see section 4.8)) that may influence the ability to drive and use machines.
Summary of the safety profile
In a one-year study in postmenopausal women with osteoporosis the overall safety profiles of DROLATE Once Weekly 70 mg (n=519) and alendronate 10 mg/day (n=370) were similar.
In two three-year studies of virtually identical design, in postmenopausal women (alendronate 10 mg: n=196, placebo: n=397) the overall safety profiles of alendronate 10 mg/day and placebo were similar.
Adverse experiences reported by the investigators as possibly, probably or definitely drug-related are presented below if they occurred in ≥1% in either treatment group in the one-year study, or in ≥1% of patients treated with alendronate 10 mg/day and at a greater incidence than in patients given placebo in the three-year studies:
One-Year Study | Three-Year Studies | |||
DROLATE Once Weekly 70 mg (n=519) % | Alendronate 10 mg/day (n=370) % | Alendronate 10 mg/day (n=196) % | Placebo (n=397) % | |
Gastro-intestinal | ||||
Abdominal pain | 3.7 | 3.0 | 6.6 | 4.8 |
Dyspepsia | 2.7 | 2.2 | 3.6 | 3.5 |
Acid regurgitation | 1.9 | 2.4 | 2.0 | 4.3 |
Nausea | 1.9 | 2.4 | 3.6 | 4.0 |
Abdominal distention | 1.0 | 1.4 | 1.0 | 0.8 |
Constipation | 0.8 | 1.6 | 3.1 | 1.8 |
Diarrhoea | 0.6 | 0.5 | 3.1 | 1.8 |
Dysphagia | 0.4 | 0.5 | 1.0 | 0.0 |
Flatulence | 0.4 | 1.6 | 2.6 | 0.5 |
Gastritis | 0.2 | 1.1 | 0.5 | 1.3 |
Gastric ulcer | 0.0 | 1.1 | 0.0 | 0.0 |
Oesophageal ulcer | 0.0 | 0.0 | 1.5 | 0.0 |
Musculoskeletal | ||||
Musculoskeletal (bone, muscle or joint) pain | 2.9 | 3.2 | 4.1 | 2.5 |
Muscle cramp | 0.2 | 1.1 | 0.0 | 1.0 |
Neurological | ||||
Headache | 0.4 | 0.3 | 2.6 | 1.5 |
Tabulated list of adverse reactions
The following adverse experiences have also been reported during clinical studies and/or post-marketing use:
Frequencies are defined as: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (<1/10,000 including isolated cases)
System organ class | Frequency | Adverse reactions |
Immune system disorders | Rare | hypersensitivity reactions including urticaria and angioedema |
Metabolism and nutrition disorders | Rare | symptomatic hypocalcaemia, often in association with predisposing conditions§ |
Nervous system disorders | Common | headache, dizziness† |
Uncommon | dysgeusia† | |
Eye disorders | Uncommon | eye inflammation (uveitis, scleritis, or episcleritis) |
Ear and labyrinth disorders | Common | vertigo† |
Very Rare | osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) | |
Gastrointestinal disorders | Common | abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation |
Uncommon | nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena† | |
Rare | oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding) § | |
Skin and subcutaneous tissue disorders | Common | alopecia†, pruritus† |
Uncommon | rash, erythema | |
Rare | rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis‡ | |
Musculoskeletal and connective tissue disorders | Very Common | musculoskeletal (bone, muscle or joint) pain which is sometimes severe†§ |
Common | joint swelling† | |
Rare | osteonecrosis of the jaw‡§; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction) | |
General disorders and administration site conditions | Common | asthenia†, peripheral oedema† |
Uncommon | transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment† | |
§See section 4.4 †Frequency in Clinical Trials was similar in the medicinal product and placebo group. *See sections 4.2 and 4.4 ‡This adverse reaction was identified through post-marketing surveillance. The frequency of rare was estimated based on relevant clinical trials. | ||
Saudi Arabia: To report any side effect(s): National Pharmacovigilance Center (NPC):
Fax: +966-11-205-7662,
SFDA Call center: 19999,
E-mail: npc.drug@sfda.gov.sa,
Website: https://ade.sfda.gov.sa
Symptoms
Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
Management
No specific information is available on the treatment of overdose with alendronate. Milk or antacids should be given to bind alendronate. Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright
Pharmacotherapeutic group: Bisphosphonate, for the treatment of bone diseases
ATC Code: M05B A04
Mechanism of action
The active ingredient of DROLATE, alendronate sodium, is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. Preclinical studies have shown preferential localisation of alendronate to sites of active resorption. Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected. The bone formed during treatment with alendronate is of normal quality.
Clinical efficacy and safety
Treatment of post-menopausal osteoporosis
Osteoporosis is defined as BMD of the spine or hip 2.5 SD below the mean value of a normal young population or as a previous fragility fracture, irrespective of BMD.
The therapeutic equivalence of alendronate Once Weekly 70 mg (n=519) and alendronate 10 mg daily (n=370) was demonstrated in a one-year multicentre study of post-menopausal women with osteoporosis. The mean increases from baseline in lumbar spine BMD at one year were 5.1% (95% CI: 4.8, 5.4%) in the 70 mg once-weekly group and 5.4% (95% CI: 5.0, 5.8%) in the 10 mg daily group. The mean BMD increases were 2.3% and 2.9% at the femoral neck and 2.9% and 3.1% at the total hip in the 70 mg once weekly and 10 mg daily groups, respectively. The two treatment groups were also similar with regard to BMD increases at other skeletal sites.
The effects of alendronate on bone mass and fracture incidence in post-menopausal women were examined in two initial efficacy studies of identical design (n=994) as well as in the Fracture Intervention Trial (FIT: n=6,459).
In the initial efficacy studies, the mean bone mineral density (BMD) increases with alendronate 10 mg/day relative to placebo at three years were 8.8%, 5.9% and 7.8% at the spine, femoral neck and trochanter, respectively. Total body BMD also increased significantly. There was a 48% reduction (alendronate 3.2% vs placebo 6.2%) in the proportion of patients treated with alendronate experiencing one or more vertebral fractures relative to those treated with placebo. In the two-year extension of these studies BMD at the spine and trochanter continued to increase and BMD at the femoral neck and total body were maintained.
FIT consisted of two placebo-controlled studies using alendronate daily (5 mg daily for two years and 10 mg daily for either one or two additional years):
• FIT 1: A three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture. In this study alendronate daily reduced the incidence of ≥1 new vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%). In addition, a statistically significant reduction was found in the incidence of hip fractures (1.1% vs. 2.2%, a reduction of 51%).
• FIT 2: A four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture. In this study, a significant difference was observed in the analysis of the subgroup of osteoporotic women (37% of the global population who correspond with the above definition of osteoporosis) in the incidence of hip fractures (alendronate 1.0% vs. placebo 2.2%, a reduction of 56%) and in the incidence of ≥1 vertebral fracture (2.9% vs. 5.8%, a reduction of 50%).
Laboratory test findings
In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 and 10%, respectively, of patients taking alendronate 10 mg/day versus approximately 12 and 3% of those taking placebo. However, the incidences of decreases in serum calcium to <8.0 mg/dl (2.0 mmol/l) and serum phosphate to ≤2.0 mg/dl (0.65 mmol/l) were similar in both treatment groups.
Paediatric population:
Alendronate sodium has been studied in a small number of patients with osteogenesis imperfecta under the age of 18 years. Results are insufficient to support the use of alendronate sodium in paediatric patients with osteogenesis imperfecta.
Absorption
Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast. Bioavailability was decreased similarly to an estimated 0.46% and 0.39% when alendronate was administered one hour or half an hour before a standardised breakfast. In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.
Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast. Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.
In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20% to 44%).
Distribution
Studies in rats show that alendronate transiently distributes to soft tissues following 1 mg/kg intravenous administration but is then rapidly redistributed to bone or excreted in the urine. The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans. Concentrations of drug in plasma following therapeutic oral doses are too low for analytical detection (<5 ng/ml). Protein binding in human plasma is approximately 78%.
Biotransformation
There is no evidence that alendronate is metabolised in animals or humans.
Elimination
Following a single intravenous dose of [14C] alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces. Following a single 10 mg intravenous dose, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min. Plasma concentrations fell by more than 95% within six hours following intravenous administration. The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton. Alendronate is not excreted through the acidic or basic transport systems of the kidney in rats, and thus it is not anticipated to interfere with the excretion of other medicinal products by those systems in humans.
Renal impairment
Preclinical studies show that the drug that is not deposited in bone is rapidly excreted in the urine. No evidence of saturation of bone uptake was found after chronic dosing with cumulative intravenous doses up to 35 mg/kg in animals. Although no clinical information is available, it is likely that, as in animals, elimination of alendronate via the kidney will be reduced in patients with impaired renal function. Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Studies in rats have shown that treatment with alendronate during pregnancy was associated with dystocia in dams during parturition which was related to hypocalcaemia. In studies, rats given high doses showed an increased incidence of incomplete foetal ossification. The relevance to humans is unknown.
q Lactose monohydrate,
q Microcrystalline cellulose and colloidal silicon dioxide,
q Croscarmellose odium,
q Magnesium stearate.
Not applicable
Do not store above 30ºC
DROLATE 70 Tablets are packed in boxes of 4 Tablets blistered in white opaque PVC/ PVDC (250/40)/Aluminium Foil Blisters.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements
