Alendronic Acid 70mg Tablets
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Read all of this leaflet carefully before you
start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Index
1. What Alendronic Acid tablets are and what are they used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What Alendronic Acid tablets are and what are they used for
They are part of a group of drugs known as bisphosphonates. Alendronic acid prevents the loss of bone (osteoporosis) in women that occurs after the menopause, and helps to rebuild bone. Osteoporosis if untreated can result in fractures (broken bones) of the spine and hips, and alendronic acid can reduce the risk of the fractures occurring.
2. Before you take
Do not take Alendronic Acid tablets and tell your doctor if you:
- are allergic (hypersensitive) to alendronic acid or any of the other ingredients (see section 6).
- have certain disorders of the oesophagus (sometimes called the gullet, it is the tube that connects your mouth with your stomach)
- are unable to stand or sit upright for at least 30 minutes
- doctor has told you that you have low blood calcium
- are or think you may be pregnant
- are breast-feeding
Alendronic acid should not be given to children.
It is important to tell your doctor or pharmacist before taking Alendronic Acid tablets if you:
• have bone, joint or muscle pain. Report any thigh, hip or groin pain to your doctor.
• suffer from kidney problems
• have any allergies
• have any swallowing or digestive problems
• have been told by your doctor that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
It is important to maintain good oral hygiene, receive routine dental check-ups and report any oral symptoms such as dental mobility, pain or swelling when being treated with Alendronic acid.
Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Certain medicines for rheumatism or long term pain called NSAIDs might cause digestive problems. Therefore caution should be used when these medicines are taken at the same time as Alendronic acid.
Pregnancy and breast-feeding
Alendronic Acid tablets must not be taken during pregnancy or while breast-feeding. If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Alendronic Acid may cause dizziness. If you feel dizzy, then do not drive or operate machinery.
Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.
3. How to take
Always take Alendronic Acid tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
One Alendronic Acid tablet is to be taken once a week.
Choose a day of the week to take your tablet that best fits with your normal schedule. After getting up for the day and before taking your first food, beverage or other medicine, swallow your Alendronic Acid tablet with a full glass of plain water (not less than 200ml or 7 fl.oz).
Do not take your tablet with mineral water, coffee, tea or fruit juice.
Do not chew your tablet or allow it to dissolve in your mouth.
After swallowing your tablet do not lie down, stay fully upright (sitting, standing or walking) for at least 30 minutes, and do not lie down until after your first food of the day.
Do not take Alendronic acid at bedtime or before getting up for the day.
If you develop difficulty or pain upon swallowing, chest pain or new or worsening heartburn, stop taking Alendronic acid and contact your doctor. After swallowing your Alendronic Acid tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. Alendronic acid is effective only if taken when your stomach is empty.
If you take more than you should If you have taken too may tablets drink a full glass of milk and contact your doctor or hospital Accident and Emergency department immediately. Do not make yourself vomit, and do not lie down.
If you forget to take the tablets
If you forget to take a dose of Alendronic acid take the missed tablet the morning after you remember. You should then continue with your weekly schedule using your chosen day. Do not
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take a double dose to make up for a forgotten dose.
If you stop taking the tablets
It is important that you continue taking Alendronic acid for as long as your doctor prescribes the medicine. Talk to you doctor before you stop taking the tablets and follow their advice.
4. Possible side effects
Like all medicines, Alendronic Acid tablets can cause side effects, although not everybody gets them.
Contact your doctor at once if you experience any of the following:
Swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing. You should go to your local Accident and Emergency department immediately as this may be due to a severe allergic reaction which can be life threatening.
Severe skin reactions: Stevens-Johnson syndrome (severe forms of skin rash with flushing, fever, blisters or ulcers), and toxic epidermal necrolysis (severe rash involving reddening, peeling and swelling of the skin that resembles severe burns).
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Very common
- bone, muscle and joint pain.
• Common (occurs in less than 1 in 10 users):
- headache, difficulty swallowing, tightening of the stomach muscles.
- stomach/abdominal pain, acid ingestion (heartburn), constipation, diarrhoea, indigestion, flatulence, feeling full or bloated, ulceration of the oesophagus
(the tube that connects your mouth with your stomach.
- dizziness
- physical weakness
- swelling of the tissue in the lower limbs
- joint swelling
- vertigo
- hair loss
- itching
• Uncommon (occurs in less than 1 in 100 users)
- nausea, vomiting, inflammation of the oesophagus, ulceration of the oesophagus, black and/or bloody stools
- rash and redness of the skin
- lack of taste
- inflammation or pain in the eye, also of the iris
- transient flu-like symptoms (muscle weakness, a general feeling of illness and in rare cases fever) normally in relation to the beginning of treatment
• Rare (occurs in less than 1 in 1,000 users):
- rash occasionally made worse by sunlight, low blood calcium levels
- symptoms such as stomach ulcer, some severe, with haemorrhage have been seen
but it is unclear if this is related to Alendronic Acid tablets
- mouth ulcers have occurred when the tablets have been chewed or sucked
- pain in your jaw, toothache or loose tooth (see your dentist)
• Very rare (occurs in less than 1 in 10,000
users):
Fractures of the thigh bone in patients on long-term treatment with alendronic acid. Thigh pain, weakness or discomfort may be an early indication of a possible fracture of the thigh bone.
• Unknown:
- oesophageal cancer
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist
5. How to store
Keep out of reach and sight of children. There are no special precautions for storage. Do not use Alendronic Acid tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month. 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.
6. Further information
What Alendronic Acid tablets contain
• The active substance (the ingredient that makes the tablet work) is alendronic acid 70mg (as sodium trihydrate)
• The other ingredients are Cellactose 80, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate
What Alendronic Acid tablets look like and contents of the pack
Alendronic Acid tablets are white, round, biconvex tablets.
Pack sizes of 2, 4 and 12 tablets. Not all pack sizes may be marketed.
Other Formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK
Manufacturer:
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham LL13 9UF, UK Date of revision: January 2013
Twockhasdt
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