Download Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 06

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 06/2014
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 Tab. 35mg "TEVA"
Active ingredient:Alendronate sodium hydrate
Dosage form:white tablet, major axis: 12.0 mm, minor axis: 6.0 mm, thickness: 3.9 mm
Print on wrapping:アレンドロン酸錠 35mg「テバ」, 骨粗しょう症治療剤, t H1
Effects of this medicine
This medicine is taken up via surface of a bone into osteoclasts and induces apoptosis of osteoclasts by its inhibitory
action of mevalonate metabolic pathway in the cells, and consequently reduces bone resorption.
It is usually used to treat of 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: difficulty in swallowing such as esophageal stenosis or achalasia.
If you have: hypocalcemia.
If you are unable to remain sitting up or standing up at least for 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, once a week at the time of awakening, with
approximately 180 mL of water. You should not lie down, drink and eat anything (except for water), and not take
other medicine at least for 30 minutes after taking this medicine. Strictly follow the instructions.
・Take this medicine with water only. Never take this medicine with other than water (including mineral water of high
calcium/magnesium content). If you take this medicine with any food or other medicine, absorption of this medicine
may deteriorate.
・Never chew or dissolve this medicine in a mouth since it may cause ulcer in the mouth or throat.
・Never take this medicine at bedtime or in laying position.
・If you miss a dose, take the missed dose as soon as possible only if you have not ingested any beverage or food by
that time of the day. If you have ingested any beverage or food already, skip the missed dose for the day and take
a dose at the time of awaking the next day. Thereafter, return to your designated dosing date and 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
・You should try to ingest calcium through food.
・Try to maintain your oral hygiene.
・If possible, receive dental treatment such as tooth extraction prior to taking the medicine, upon consultation with
your doctor.
・Undergo dental checkup regularly. Inform your dentist that you are taking the medicine when you receive dental
treatment.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include nausea, constipation, diarrhea, gastric pain, gastritis, gastric
discomfort, dyspepsia, anemia and headache. 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.
・hematemesis, melena, anemia [esophageal disorder, oral disorder, gastric ulcer, duodenal ulcer]
・general malaise, loss of appetite, yellowing in skin and white of eyes [hepatic dysfunction, jaundice]
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・convulsion, tetany (muscle weakness. muscle decline), numbness [hypocalcemia]
・high fever, conjunctival hyperemia, lip erosion or genital erosion [toxic epidermal necrolysis, mucocutaneous ocular
syndrome]
・swelling, pain or pus discharge of muscle, loosen tooth, exteriorization of dentary bone [jaw necrolysis, jaw
osteomyelitis]
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 the pharmacy or medical institution how to discard them.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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