ALENDRONIC ACID 70MG TABLETS
Read all of this leaflet carefully before you start taking this medicine, even if you have just had a repeat prescription. Some of the information in your previous leaflet may have changed. It is particularly important to read the section ‘HOW TO TAKE ALENDRONIC ACID 70MG TABLETS’, before taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet you will find information about:
- 1. What alendronic acid tablets are and what they are used for
- 2. Before you take alendronic acid tablets
- 3. How to take alendronic acid tablets
- 4. Possible side effects
- 5. How to store alendronic acid tablets
The name of your medicine is Alendronic Acid 70mg Tablets (referred to as alendronic acid tablets throughout this leaflet).
Alendronic acid 70mg tablets are white to off-white, oval tablets, stamped "AN 70" on one side and an "arrow logo" on the other.
Each tablet contains 70mg alendronic acid (as sodium alendronate trihydrate).
Other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
They are supplied in blister packs of 4 tablets.
The Marketing Authorisation holder is:
The Manufacturer is:
What Alendronic Acid Tablets Are And What They Are Used For
Alendronic acid belongs to a class of non-hormonal preparations called bisphosphonates. Alendronic acid prevents the loss of bone mass that occurs during the menopause. It also helps rebuild bone and therefore reduces the risk of back and hip fractures.
Your medicine is used to treat osteoporosis (brittle bones), which is common in women after the menopause.
Osteoporosis leads to thinning and weakening of the bone. It is common in women after the menopause. The menopause occurs when the ovaries stop producing the female hormone, oestrogen or when they are removed. Oestrogen helps to keep a woman’s skeleton healthy. Without oestrogen, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of her developing osteoporosis.
Early on, osteoporosis usually has no symptoms. Without treatment, osteoporosis can lead to fractures (broken bones). Although fractures usually cause pain, fractures of the bones of the spine may go unnoticed until they cause height loss. Fractures can easily occur during everyday activity, such as lifting or from minor injury that would usually not cause any harm.
Your doctor has prescribed these tablets to treat your osteoporosis or to help prevent you from developing this disease. Your doctor may also recommend you make some changes to your lifestyle which may help your condition.
Before You Take Alendronic Acid Tablets
Do not take alendronic acid tablets:
- if you are hypersensitive (allergic) to alendronic acid, other bisphosphonates or any of the other ingredients in your medicine. An allergic reaction can include a rash and problems breathing. There can also be swelling of the legs, arms, face, throat or tongue.
- if you suffer from certain disorders of the oesophagus (also called the gullet, the tube that connects your mouth with your stomach).
- if you are unable to stand or sit upright for at least 30 minutes.
- if you have a low calcium level in your blood.
- You had or have pain, swelling or numbness of the jaw, loosening of a tooth or a ‘heavy jaw feeling’.
Alendronic acid tablets must not be given to children.
Check with your doctor before you take alendronic acid tablets if you have:
- difficulty and/or pain swallowing.
- digestive problems such as stomach ulcers, inflammation of the stomach lining or the duodenum (first section of the small intestine).
- had an operation on your stomach or gullet (not including pyloroplasty where the outlet from the stomach is widened) in the last year.
- kidney problems.
Taking alendronic acid tablets with food and drink:
These tablets should be taken on an empty stomach, as food and drink (other than plain tap water) reduces the effectiveness of the medicine.
Take the tablets at least 30 minutes before your first meal of the day.
Pregnancy and breast-feeding:
Do not take these tablets if you are pregnant, think you are pregnant or are breast-feeding. Talk to your doctor or pharmacist for advice before taking any medicine.
Driving vehicles and using machines:
These tablets are not expected to affect your ability to drive or operate machines. However, in some cases it may cause problems with your sight. If affected do not drive or operate machinery.
Important information about some of the excipients:
This medicine contains lactose. If you cannot take some types of sugar, talk to your doctor before taking this medicine.
Taking alendronic acid tablets with other medicines:
Do not take calcium tablets, antacids, vitamins and/or other oral medication at the same time as taking alendronic acid tablets, as these can affect the absorption of this medicine. Wait at least 30 minutes after taking alendronic acid tablets before you take any other medicine.
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine - even those not prescribed.
How To Take Alendronic Acid Tablets
Always take these tablets exactly as your doctor has instructed you. Your particular dosage instructions will be on the label. Ask your doctor or pharmacist if you do not understand these instructions.
These tablets contain 70mg alendronic acid and must be taken once a week. These tablets are for oral use.
The following instructions are very important to ensure you get the most benefit from your medicine. It is important that you follow the instructions to help the tablet reach your stomach quickly and help reduce the potential for the medicine to irritate your oesophagus (the tube that connects your mouth with your stomach).
Choose the day of the week that suits you best. Then take one alendronic acid 70mg tablet on the selected day each week.
Take your medicine on an empty stomach immediately on rising in the morning, with a whole glass of plain tap water (not tea, coffee, mineral water or juice).
The tablet must be swallowed whole. You must not chew, suck or allow the tablet to dissolve in your mouth.
After taking the tablets, do not eat or lie down for 30 minutes. You must stay upright (sitting, standing or walking).
Wait at least 30 minutes after taking your tablets before you eat your first food of the day, drink or take any other medicine.
Do not take your tablets at bedtime or before getting out of bed.
If you find it difficult and/or painful to swallow, have chest pain or new or worsening heartburn, stop taking the tablets and contact your doctor without delay.
Adults (including the elderly):
One 70mg tablet once a week.
Children:
Not recommended.
If you take more alendronic acid 70mg tablets than you should:
If you or someone else takes too many tablets, drink a full glass of milk and contact your doctor or your nearest hospital casualty department immediately. Do not make yourself vomit and do not lie down. An overdose can cause painful muscle spasms, tiredness, weakness, exhaustions and fits. It can also cause an upset stomach, indigestion and painful inflammation of the upper digestive system.
If you have forgotten to take alendronic acid tablets:
If you forget to take a tablet, take one tablet on rising the next morning. Do not take two tablets on the same day. Then return to taking one tablet per week on the day that you originally decided upon.
If you are undergoing dental treatment or are to undergo dental surgery, tell your dentist that you are taking Alendronic Acid 70mg Tablets.
Possible Side Effects
As with all medicines, alendronic acid tablets can have side effects.
Some people may develop an allergic reaction to these tablets. If you have the following rare side effects, stop taking alendronic acid tablets and see a doctor straight away:
- Difficulty in breathing, with or without swelling of the face, lips, and throat,
- You have very bad itching of the skin (with raised spots or hives).
The following side effects have also been reported:
Common (affects more than 1 person in 100): headache, stomach pain, indigestion, constipation, diarrhoea, wind, feeling full or bloated, pain in the muscle, bone and/or joints.
Also reported is irritation or ulceration of the oesophagus (the tube that connects your mouth to your stomach). This can cause chest pain, difficulty or pain on swallowing, heartburn or stomach acid reflux. These side effects can be prevented if you follow the instructions on how to take the tablets. Oesophageal reactions are more likely to happen when a full glass of water is not drunk when taking the tablet. They are also more likely if you lie down less than 30 minutes after taking the tablet or if you lie down before you eat your first food of the day. Oesophageal reactions may worsen if you continue to take alendronic acid after developing symptoms suggesting irritation of the oesophagus. Speak to your doctor if you think you have a problem with your oesophagus.
Uncommon (affects less than 1 in 100 people): nausea (feeling sick), vomiting, gastritis (symptoms include burning ache or pain in your upper abdomen that may become either worse or better when you eat), inflammation and/or erosion of the gullet, black tarry stools, rash, itching.
Rare (affects less than 1 in 1,000 people): severe eye pain, stomach and other peptic ulcers, gastrointestinal bleeding (symptoms include blood in your vomit or black tarry stools) have also been reported, although it is not known whether or not these are caused by alendronic acid.
Very rare (affects less than 1 in 10,000 people): severe allergic skin reactions (red, swollen or scalded skin with blistering of the lips, eyes, mouth, nose and genitals), which may be accompanied by fever, swollen glands or joint pain.
At the start of treatment, there have been rare reports of generally feeling unwell (malaise), fever and increased sensitivity of the skin to sunlight or artificial UV light (photosensitivity).
Pain and/or inflammation of the jaw have also been reported.
Blood calcium and phosphate levels may be affected by these tablets. It is therefore important that you inform your doctor that you are taking alendronic acid tablets if you have a blood test.
If you experience these or any other unusual effects not mentioned in this leaflet please inform your doctor or pharmacist. If your symptoms are severe or last for more than a few days, contact your doctor immediately.
How To Store Alendronic Acid Tablets
Keep all medicines out of the reach and sight of children.
Do not store above 25°C. Store in the original package.
Do not use this medicine after the expiry date printed on the packaging.
For environmental and safety reasons, left-over or out-of-date medicine should be returned to the pharmacy for disposal.
This package insert was last updated March 2007.
LF00000002
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