Alendronic Acid 70 Mg Tablets
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UK/H/1032/01/IB/015
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID 70 MG TABLETS
(alendronate monosodium trihydrate)
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 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your 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:
other ingredients your stomach).
• If you are allergic (hypersensitive) to alendronate monosodium trihydrate or any of the of Alendronic Acid 70 mg Tablets.
• If you have certain disorders of the oesophagus (the tube that connects your mouth with
• If you are unable to stand or sit upright for at least 30 minutes.
• If your doctor has told you that you have low blood calcium.
Take special care with Alendronic Acid 70 mg Tablets:
It is important to talk to your doctor if you have any of the following conditions:
• you suffer from kidney problems
• you have any allergies
• you have trouble swallowing or digestive problems
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
• 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. Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid 70 mg Tablets . These side effects may worsen if patients continue to take Alendronic Acid 70 mg Tablets after developing these symptoms.
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
• you should talk to your doctor defore you take non-steroidal anti-inflammatory drugs (NSAID’s) while taking Alendronic Acid 70 mg Tablets.
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:
Alendronate should not be given to children and adolescents.
Pregnancy and breast-feeding:
Alendronic Acid 70 mg Tablets must 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.
3. HOW TO TAKE ALENDRONIC ACID 70 MG TABLETS
Your doctor has decided on the dose that is suited to you. The length of your course of treatment will depend on what condition you are suffering from. Your doctor will monitor and reassess your treatment. 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 10 mg tablet of alendronate which is taken once a day. One Alendronic Acid 70 mg Tablet is taken 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.
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 200 ml or 7 fl. oz.).
Do not crush or 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 up for the 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 your 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 your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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 or throat, or difficulty breathing or swallowing.
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. Side effects may occur with certain frequencies, which are defined as follows:
affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in
Very common:
Common:
Uncommon: 1,000
Rare:
Very rare:
affects 1 to 10 users in
10,000
affects less than 1 user
in 10,000
Side effects sometimes seen are:
Very Common:
• bone, muscle and/or joint pain which is sometimes severe.
Common:
• stomach pain, constipation, diarrhoea, flatulence, ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing, acid regurgitation, swollen abdomen, swallowing difficulties, pain upon swallowing and digestive problems
• joint swelling
• hair loss, itching
• headache, dizziness
• tiredness, swelling in the hands or legs.
Uncommon:
• rash, reddening of the skin, itching
• feeling sick, being sick, swelling of the stomach wall, black or bloody stools, thinning irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach
• blurred vision, pain, inflammation or redness in the eye
• transient flulike symptoms such as aching muscles, generally feeling unwell and sometimes fever usually at the start of treatment
• taste disturbance.
Rare :
• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing
• symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
• stomach or peptic ulcers (sometimes severe or with bleeding)
• narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach)
• rash made worse by sunlight; severe skin reactions
• pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms
• 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.
• Mouth, throat ulcers when the tablets have been chewed or sucked.
Tell your doctor or pharmacist promptly about these or any other unusual symptoms.
It will help if you make a note of what you experienced, when it started and how long it lasted.
If any of the side effects become 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
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.
6. FURTHER INFORMATION
What Alendronic Acid 70 mg Tablets contain
- The active substance is alendronate monosodium trihydrate and each tablet contains 70 mg alendronic acid as alendronate monosodium trihyderate.
- 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, flat and marked with a “70” on one side.
Alendronic Acid 70 mg Tablets are available in blisters of 2, 4, 8, 12 & 40 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Laboratorios DAVUR, S.L.U, C/Anabel Segura 11, Edifico Albatros B, 1a planta, Alcobendas, 28108 Madrid, Spain.
Manufacturer: Teva Pharma S.L.U, Poligono Industrial Malpica, calle C, 50016 - Zaragoza, Spain.
This leaflet was last approved in {12/2012}.
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