Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
alendronate sodium trihydrate, Quantity: 91.35 mg (Equivalent: alendronic acid, Qty 70 mg)
Arrotex Pharmaceuticals Pty Ltd
alendronate sodium
Tablet, uncoated
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; mannitol
Oral
4 tablets
(S4) Prescription Only Medicine
Treatment of osteoporosis. Osteoporosis must be confirmed by the finding of low bone mass of at least two standard deviations below the gender specific mean for young adults, or by the presence of osteoporotic fracture.
Visual Identification: White, oval biconvex tablet engraved "APO" on one side and "ALE 70" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2006-08-28
APO-ALENDRONATE ONCE WEEKLY _Alendronate sodium_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about alendronate. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Alendronate is used to treat osteoporosis. It belongs to a group of medicines called bisphosphonates. Osteoporosis is a disease which causes bones to become more porous, gradually making them weaker, more brittle and likely to break. _UNDERSTANDING BONE_ Bone is living, growing tissue. Throughout life, our bodies are breaking down old bone and rebuilding new bone in a continuous cycle. _HOW IT WORKS_ Alendronate works by slowing down the process of old bone being removed, which allows the bone- forming cells time to rebuild normal bone. Alendronate helps prevent the loss of bone and helps to rebuild bone, making bone less likely to break. This helps to prevent or reverse the progression of osteoporosis. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed alendronate for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of alendronate in children. BEFORE YOU TAKE THIS MEDICINE ALENDRONATE CAN IRRITATE OR BURN YOUR MOUTH OR FOOD PIPE (ALSO CALLED THE OESOPHAGUS). The chances of this happening should be reduced if you follow the instructions for taking alendronate in this leaflet. _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • al Διαβάστε το πλήρες έγγραφο
1 AUSTRALIAN PRODUCT INFORMATION APO- ALENDRONATE (ALENDRONATE SODIUM) TABLETS 1 NAME OF THE MEDICINE Alendronate sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains alendronate sodium equivalent to 70 mg alendronic acid. 3 PHARMACEUTICAL FORM Tablets. APO- Alendronate _ONCE WEEKLY_ 70 mg Tablets: white, oval, biconvex tablets, engraved APO on one side and ALE 70 on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis. Osteoporosis must be confirmed by the finding of low bone mass of at least two standard deviations below the gender specific mean for young adults, or by the presence of osteoporotic fracture. 4.2 DOSE AND METHOD OF ADMINISTRATION APO- Alendronate _ONCE WEEKLY_ 70 mg Tablets are intended for oral administration. DOSAGE TREATMENT OF OSTEOPOROSIS The recommended dosage is one Alendronate Once Weekly (70 mg) tablet once weekly. Alendronate must be taken at least 30 minutes before the first food, beverage or medication of the day with plain water only. Other beverages (including mineral water), food and some medications are likely to reduce the absorption of alendronate (see section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). Alendronate should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for oesophageal irritation, an alendronate tablet should be swallowed with a full glass of water. Patients should not crush, chew or suck on the tablet because of a potential for stomatitis or oropharyngeal ulceration. Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of oesophageal adverse experiences (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 2 SEVERE OESOPHAGEAL ULCERATION HAS BEEN REPORTED IN PATIENTS TAKING THIS DRUG (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Διαβάστε το πλήρες έγγραφο