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Sawai Pharmaceutical Co.,Ltd.
Internal
Revised: 6/2016
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
ALENDRONATE Tablets 35mg "SAWAI"
Active ingredient:
Alendronate sodium hydrate
Dosage form:
white tablet, major axis: 10.3 mm, minor axis: 5.6 mm, thickness: 3.7 mm
Print on wrapping:
アレンドロン酸錠35 mg「サワイ」, ALENDRONATE Tab.35 mg「SAWAI」
Effects of this medicine
This medicine suppresses bone resorption by inhibiting osteoclastic functions, thereby increasing bone density and making bones resistant to fractures.
It is usually used to treat osteoporosis.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have disorders that delay passage through the esophagus [esophageal stenosis, achalasia (achalasia of esophagus), etc.], hypocalcemia.
If you cannot keep your body in an upright position or stand for more than 30 minutes.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is
(( to be written by a healthcare professional))
In general, for adults, take 1 tablet (35 mg of alendronate) at a time with approximately 180 mL of water, once a week at the time of awakening in the morning. Avoid lying down, eating/drinking (except water) and taking other medicines for at least 30 minutes after taking this medicine. Strictly follow the instructions.
Do not take this medicine with drinks other than water (including mineral water high in calcium/magnesium content), foods or other medicines.
This medicine may cause ulcer in your mouth or throat, do not chew this medicine or dissolve it in the mouth.
If you miss a dose, take 1 tablet in the morning after the day you notice. Take the next dose on a prespecified day of the week, and then continue your regular dosing schedule. You should never take two doses at one time.
If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
Try to ingest enough calcium through meals, etc.
Consult with your doctor, and receive dental checkup before starting this medicine if needed. If possible, have your dental treatment, such as tooth extraction, completed before taking this medicine.
Maintain your oral hygiene by brushing your teeth and receive dental checkup regularly while taking this medicine.
When you visit a dentist, tell the dentist that you are taking this medicine and try to avoid treatments such as tooth extraction as much as possible.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include gastric pain/epigastric pain and gastric distress/stomach heaviness/stomach discomfort. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
swallowing difficulty, pain on swallowing, vomiting of blood [esophageal/intraoral disorder, gastric/duodenal disorder]
general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [liver dysfunction, jaundice]
fever, redness and swelling of skin/mucosa with rash or blisters, conjunctival hyperemia [toxic epidermal necrolysis, mucocutaneous ocular syndrome]
jaw pain, loose teeth, gum swelling [jaw bone necrosis/jaw osteomyelitis ]
otitis externa, ear discharge (otorrhea), ear pain [osteonecrosis of the external ear canal]
pain in the thigh or inguinal region [atypical subtrochanteric and proximal femoral shaft fractures]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
Discard the remainder. Do not store them. Ask your pharmacy or medical institution on how to discard the remainder.
For healthcare professional use only :
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