Alendronic Acid 70mg Tablets
Out of date information, search anotherRead all of this leaflet carefully before
you start 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 and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.
In this Leaflet
1. What Alendronic Acid 70 mg Tablets are and what they are used for
2. Before you take Alendronic Acid 70 mg Tablets
3. How to take Alendronic Acid 70 mg Tablets
4. Possible side effects
5. How to store Alendronic Acid 70 mg Tablets
6. Further Information
1. WHAT ALENDRONIC ACID 70 MG TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient, alendronate monosodium trihydrate, belongs to a group of medicines called "bisphosphonates". It works by preventing the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. Alendronic Acid is used to treat the following condition:
- Postmenopausal osteoporosis.
2. BEFORE YOU TAKE ALENDRONIC ACID 70 MG TABLETS
If any of the following applies to you, speak to your doctor or pharmacist before you start taking Alendronic Acid 70 mg Tablets as they may not be suitable for you.
Do not take Alendronic Acid 70 mg Tablets:
- If you are allergic {hypersensitive) to alendronate monosodium trihydrate or any of the other ingredients of Alendronic Acid 70 mg Tablets.
- If you have certain disorders of the Oesophagus (the tube that connects your mouth with your stomach).
- If you are unable to stand or sit upright for at least 30 minutes.
- If your doctor has told you that you have very low blood calcium.
- If you are or think you may be pregnant.
- If you are breast-feeding.
Take special care with Alendronic Acid 70 mg Tablets:
It is important to tell your doctor before taking Alendronic Acid 70mg Tablets:
- If your doctor has told you that you have Barrett's oesophagus (a condition associated with the changes in the cells that line the oesophagus)
- you suffer from kidney problems
- you have any allergies
- you have trouble swallowing or digestive problems
- you have been told you have low blood calcium levels,
- you have poor dental health, gum disease , a planned dental extraction or you don’t receive routine dental care
- you have cancer,
- you are undergoing chemotherapy or radiotherapy,
- you are taking corticosteroids { such as prednisone or dexamethasone),
- you are or have been a smoker ( as this may increase the risk of dental problems)
You may be advised to have a dental check-up before starting treatment with Alendronic Acid 70 mg tablets.
It is important to maintain good oral hygiene when being treated with Alendronic Acid 70 mg tablets. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
- After swallowing your tablet, wait at least 30 minutes before taking any other medication for the day. Alendronic Acid 70 mg Tablets are only effective if taken when your stomach is empty.
Taking Alendronic Acid 70 mg Tablets with food and drink:
Patients must wait at least 30 minutes after taking alendronate before taking any food or drink.
Children and adolescents
Alendronic acid should not be given to children and adolescents.
Pregnancy and breast-feeding:
Alendronic Acid 70 mg Tablets can not be used during pregnancy and if you are breast-feeding.
Driving and using machines:
Your medicine does not usually affect your ability to drive or operate machinery.
Other precautions you should take:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE ALENDRONIC ACID 70 MG TABLETS
Your doctor has decided on the dose which is suited to you. The length of your course of treatment will depend on what condition you are suffering from. Always take Alendronic Acid 70 mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You may have previously been prescribed a 1 0 mg tablet of alendronate which is taken once a day. One Alendronic Acid 70 mg Tablet is ta ken once a week.
It is very important that you follow actions 2, 3, 4 and 5 described below. This will help the Alendronic Acid 70 mg Tablet reach your stomach quickly and help reduce the risk of irritating your oesophagus.
Name of the Artwork: Leaflet -Alendronic Acid Artwork code: P0010/00 Dimenion:
Open: 138 x 275 mm Folded: 138 x 34.38 mm,± 0.5
1. Choose the day of the week that best fits your schedule. Every week, take your Alendronic Acid 70 mg Tablet on your chosen day.
2. After getting up for the day and before taking your first food, drink or other medication, swallow your Alendronic Acid 70 mg Tablet with a full glass of plain water only(not less than 200ml or 7fl.oz.}.
Do not chew or allow the tablet to dissolve in your mouth.
3. After swallowing your Alendronic Acid 70 mg Tablet do not lie down -stay fully upright (or sat upright) for at least 30 minutes and do not lie down until after your first food of the day
4. Do not take Alendronic Acid 70 mg Tablets at bedtime or before getting upforthe day.
5. If you develop difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid 70 mg Tablets and contact your doctor.
6. After swallowing your Alendronic Acid 70 mg Tablet, wait at least 30 minutes before taking your first food, drink or other medication of the day, including antacids, calcium supplements and vitamins. Alendronic Acid 70 mg Tablets are only effective if taken when your stomach is empty.
If you take more Alendronic Acid 70 mg Tablets than you should:
If you (or someone else) accidentally take too many Alendronic Acid 70 mg Tablets, drink a full glass of milk and contact your doctor or pharmacist immediately.
If you forget to take Alendronic Acid 70 mg Tablets:
If you forget to take a dose, take one Alendronic Acid 70 mg Tablet on the morning after you remember. Do not take a double dose to make up for forgotten individual doses.
If you stop taking Alendronic Acid 70 mg Tablets:
Always contact you doctor or pharmacist before you stop taking Alendronic Acid 70 mg Tablets. Alendronic Acid 70 mg Tablets can treat your osteoporosis only if you continue to take the tablets.
If you have any further questions on the use of this product, ask you doctor or pharmacist.
Uncommon - more than one in a thousand people but less than one in a hundred:
- Rash, reddening of the skin, itching
- feeling sick, being sick
- swelling of the stomach wall, black or bloody stools, inflammation of the food passage, wearing away of the food passage.
Rare - more than one in ten thousand people but less than one in a thousand:
- allergic reaction including hives and swelling of the lips, tongue and throat, fever, discomfort, muscle pains, rash (occasionally made worse by sunlight), reduced blood calcium levels
- difficulty in swallowing, ulcers of the mouth, stomach and other peptic ulcers (some with bleeding)
- eye pain, diminished or hazy vision and/or seeing black floating spots
Jaw problems such as pain in the jaw (and / or mouth), numbness or a feeling of heaviness in the jaw, or loosening of a tooth, or swelling or sores inside the mouth. These could be signs of bone damage in the jaw ( known as "osteonecrosis" ) and may be also associated with delayed healing and infection, often following tooth extraction. Contact your doctor or dentist if anything like this happens to you.
Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ALENDRONIC ACID 70 MG TABLETS
4. POSSIBLE SIDE EFFECTS
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Alendronic Acid 70 mg Tablets after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of the 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.
Like all medicines, Alendronic Acid 70 mg Tablets can cause side effects, although not everybody gets them. These are usually mild but some patients may experience digestive disturbances which may be severe.
If the following happens, stop taking the tablets and tell your doctor Immediately or go to the accident and emergency department at your nearest hospital:
- An allergic reaction (angioedema): swelling of the face, lips, tongue orthroat, or difficulty breathing orswallowing problems.
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Side effects sometimes seen are:
Common - more than one in a hundred people but less than one in ten :
- Stomach pain, constipation, diarrhea, flatulence, oesophageal ulcer, acid regurgitation, swollen abdomen, swallowing difficulties, digestive problems
- bone, muscle or joint pain
- headache
6. FURTHER INFORMATION
What Alendronic Acid 70 mg Tablets contain
- The active substance is alendronate monosodium trihydrate and each tablet contains 70 mg of alendronate monosodium trihydrate.
- The other ingredients are microcrystalline cellulose, crospovidone and magnesium stearate.
What Alendronic Acid 70 mg Tablets look like and contents of the pack
Each tablet is white, oval, biconvex and marked with a "70" on one side.
Alendronic Acid 70 mg Tablets are available in blisters of 4 tablets.
Marketing Authorisation holder:
Somex Pharma, Seven Kings, Ilford, Essex IG3 8BS, UK. Manufacturer:
Somex Pharma, Seven Kings, Ilford, Essex IG3 8RA, UK. This leaflet was last updated in 11/2011
Code: TN00003031 P0010 / 00