Alendronic Acid 70 Mg Tablets
Out of date information, search anotherRead all ofthis leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this Leaflet
1. What Alendronic acid 70mg Tablets are and what they are used for
2. What you need to know before you take Alendronic acid 70mg Tablets
3. How to take Alendronic acid 70mg Tablets
4. Possible side effects
5. How to store Alendronic acid 70mg Tablets
6. Contents of the pack and other information
1. WHAT ALENDRONIC ACID70MG 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 70mg Tablets are used to treat the following condition:
- Postmenopausal osteoporosis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID 70MG TABLETS
If any of the following applies to you, speak to your doctor or pharmacist before you start taking Alendronic acid 70mg Tablets as they may not be suitable foryou.
Do not take Alendronic acid 70mg Tablets:
- If you are allergic (hypersensitive) to alendronate monosodium trihydrate or any of the other ingredients of Alendronic acid 70mg Tablets (listed in section 6)
- 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 low blood calcium
- If you are or think you may be pregnant.
- Ifyouarebreast-feeding.
Warnings and precautions:
Talk to your doctor or pharmacist or nurse before taking Alendronic acid 70mg Tablets if:
- 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 low blood calcium levels
- You have gum disease
- You have a planned dental extraction
- You suffer from kidney problems
- You have any allergies
- You have trouble swallowing or digestive problems
- You smoke
- You are taking steroids
- You have a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures or poorly fitting dentures.
A dental examination should be considered before you start the treatment with alendronic acid if you have any of the conditions below:
- You have cancer
- You are undergoing chemotherapy or radio therapy
- You are taking steroids
- You don't receive routine dental care.
- You have gum disease.
It is important to maintain good oral hygiene when being treated with Alendronic acid. 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 ofchest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass ofwater and/or if they lie down less than 30 minutes after taking Alendronic acid. These side effects may worsen if patients continue to take Alendronic acid after developing these symptoms.
Other medicines and Alendronic acid 70mg Tablets:
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription
You should speak to your Doctor before you take Alendronic Acid 70mg Tablets if you are currently taking a non-steroidal anti-inflammatory drug (NSAID).
- After swallowing your tablet, wait at least 30 minutes before taking any other medication for the day. Alendronic acid 70mg Tablets are only effective iftaken when your stomach is empty.
Taking Alendronic acid 70mg Tablets with food and drink:
Patients must wait at least 30 minutes after taking alendronate before taking any food or drink.
Pregnancy and breast-feeding:
Do not take Alendronic acid 70mg Tablets if you are pregnant, think you may be pregnant or are breast-feeding.
Driving and using machines:
Alendronic Acid 70mg Tablets are not expected to have any effects on your ability to drive and use machines. However in rare cases patients taking Alendronic Acid 70mg Tablets can suffer from side effects including dizziness, severe muscle joint and bone pain and eye pain or inflammation. Ifyou are affected in this way, you should contact your doctor before driving or using machinery.
3. HOWTOTAKE ALENDRONIC ACID 70MG 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. Always take Alendronic acid 70mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Children and adolescents
Alendronate should not be given to children and adolescents.
You may have previously been prescribed a10mg tablet ofalendronate which is taken once a day. One Alendronic acid 70mg 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 70mg 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 70mg Tablets 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 70mg Tablet with a full glass of plain water only (not less than 200 ml or 7 fl. oz.).
Do not chew or allow the tablet to dissolve in your mouth.
3. After swallowing your Alendronic acid 70mg 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 70mg 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 70mg Tablets and contact your doctor.
6. After swallowing your Alendronic acid 70mg 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 70mg Tablets are only effective if taken when your stomach is empty.
If you take more Alendronic acid 70mg Tablets than you should:
If you (or someone else) accidentally take too many Alendronic acid 70mg Tablets, drink a full glass of milk and contact your doctor or pharmacist immediately.
You may suffer from a stomach upset, heartburn, inflammation ofthe gullet or stomach, muscle and stomach cramps, spasms, weakness and fits. You should drink a full glass of milk and contact your nearest doctor or hospital casualty department immediately. Do not try and make yourself sick (vomit) and do not lie down.
If you forget to take Alendronic acid 70mg Tablets:
If you forget to take a dose, take one Alendronic acid 70mg 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 70mg Tablets:
Always contact your doctor or pharmacist before you stop taking Alendronic acid 70mg Tablets.
Alendronic acid 70mg 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, this medicine 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 sometimes seen are:
Very common more than one in ten people:
Bone muscle orjoint pain.
Common more than one in a hundred people but less than one in ten:
Stomach pain, constipation, diarrhoea, flatulence, oesophageal ulcer, acid regurgitation, swollen abdomen, swallowing difficulties, digestive problems, headache, dizziness, vertigo, weakness or lack of energy, swelling in the hands or legs, joint swelling, hair loss, itching.
Uncommon more than one in a thousand people but less than one in a hundred:
Rash, reddening of the skin, feeling sick, being sick, swelling of the stomach wall, black or bloody stools, inflammation of the food passage, wearing away of the food passage, changes in your sense of taste, inflammation of the eye.
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.
Symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.
Difficulty in swallowing, ulcers ofthe mouth, stomach and other peptic ulcers (some with bleeding).
Eye pain, diminished or hazy vision and/or seeing black floating spots.
Jaw problems associated with delayed healing and infection, often following tooth extraction.
Fractures of the femur.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOWTOSTORE ALENDRONIC ACID 70MG TABLETS
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Alendronic acid 70mg Tablets after the expiry date which is stated on the outer packaging. The expiry date refers to the last day ofthe month. Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTSOFTHEPACKAND OTHER INFORMATION
What Alendronic acid 70mg Tablets contain
- The active substance is alendronate monosodium trihydrate and each tablet contains 70 mg ofalendronate monosodium trihyderate
- The other ingredients are microcrystalline cellulose, crospovidone and magnesium stearate.
What Alendronic acid 70mg Tablets look like and contents ofthe pack
Each tablet is white, oval, flat and marked with a "70" on one side. Alendronic acid 70mg Tablets are available in blisters of4 tablets.
Marketing Authorisation Holderand Manufacturer
Relonchem Limited
Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK PL: 20395/0070
Date Leaflet revised: March 2015.