Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alendronate sodium
Zentiva Pharma UK Ltd
M05BA04
Alendronate sodium
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200
Top of page cut-off to middle of registration mark: 44 mm. PAGE 1: FRONT FACE (INSIDE OF REEL) Pharma code 540 A dental examination should be considered before you start treatment with Alendronic Acid if you have any of the conditions below: • You have cancer • You are undergoing chemotherapy or radiotherapy • You are taking steroids • You don’t receive routine dental care • You have gum disease • You smoke. Appropriate preventive dental care, as recommended by the dentist, should be followed during treatment. If you do develop difficulty or pain when swallowing, pain behind the breastbone (centre of the chest), or new or worsening heartburn, stop taking your tablets and contact your doctor. OTHER MEDICINES AND ALENDRONIC ACID Do NOT take any other oral medication at exactly the same time as taking Alendronic Acid Tablets. If you are taking any other medicines, you should take your dose of Alendronic Acid at least 30 minutes before you take your other medication. Talk to your doctor before you take non-steroidal anti-inflammatory drugs (NSAID’s) while taking Alendronic Acid. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. ALENDRONIC ACID WITH FOOD AND DRINK These tablets should be taken on an empty stomach, as food and drink can greatly reduce the effectiveness of the medicine. Take the tablets at least 30 minutes before your first meal of the day. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. DRIVING AND USING MACHINES In some cases Alendronic Acid 10 mg Tablets may cause adverse reactions that may affect your ability to drive or operate machinery (like problems with sight). Do NOT drive or operate machinery if you are affected. HOW TO TAKE ALENDRONIC ACID Always take this medicine exactly as your doctor has told you. Check with your doctor Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronic Acid 10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg alendronic acid (as sodium alendronate trihydrate). Excipients: Each tablet contains 103.95 mg lactose monohydrate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, capsule-shaped, stamped "AN 10" on one side and "Arrow logo" on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of post-menopausal osteoporosis. Alendronate Sodium 10 mg tablets reduces the risk of vertebral and hip fractures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only. The recommended dosage is 10 mg once daily. 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 Alendronic Acid on an individual patient basis, particularly after 5 or more years of use. _To permit adequate absorption of alendronate: _ Alendronic Acid 10 mg Tablets 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)_: • Alendronic Acid 10 mg Tablets should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.oz.). • Patients should only swallow Alendronic Acid 10 mg Tablets 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 until after their first food of the day which should be at least 30 minutes after taking the tablet. • Patients should not Read the complete document