Alendronic Acid 70 Mg Tablets
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Package leaflet: Information for the patient
Alendronic Acid 70 mg Tablets (Alendronic acid (as sodium alendronate))
Read all of this 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 any further questions, please ask your doctor or pharmacist.
- 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. This included any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Alendronic Acid 70 mg Tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information
1. What Alendronic Acid 70 mg Tablets are and what they are used for
Alendronic acid belongs to a group of non-hormonal medicines called bisphosphonates.
Alendronic Acid 70 mg Tablets are used to:
- prevent the loss of bone (osteoporosis) that occurs in women after they have been through the menopause,
- reduce the risk of spine and hip fractures.
About osteoporosis:
At the menopause the female body stops making oestrogen, which can result in bone loss and weakening (osteoporosis).
Initially, osteoporosis may have no obvious symptoms. However, if left untreated it can result in fractures (broken bones) occurring as a result of normal, everyday activities and instances which might not normally cause a fracture. Common fractures include: hip, spine, or wrist and can lead not only to pain but also to considerable deformity and disability (such as height loss, stooped posture, or ‘dowager’s hump’, and loss of mobility).
Alendronic Acid 70 mg Tablets not only prevent the loss of bone that occurs in women after the menopause but actually helps to rebuild bone and reduces the risk of spine and hip fractures.
In addition to your treatment with Alendronic Acid 70 mg Tablets, your doctor may recommend that you make some lifestyle changes to help your condition. These are:
- Stop smoking: Smoking may increase the rate at which you lose bone and, therefore, may increase your risk of fracture.
- Take exercise: Bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.
- Eat a balanced diet: Your doctor can advise you about your diet or whether you should take any dietary supplements.
2. What you need to know before you take Alendronic Acid 70 mg Tablets
Do not take Alendronic Acid 70 mg Tablets if:
- you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
- you have certain problems with your oesophagus (the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
- you are unable to stand or sit upright for at least 30 minutes
- your doctor has told you that you have low blood calcium.
If any of these apply to you, do not take Alendronic Acid 70 mg Tablets. Talk to your doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronic Acid 70 mg Tablets if:
- you suffer from kidney problems
- you have any 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 been told you have low blood calcium
- you have poor dental health, gum disease, a planned dental extraction, poorly fitting dentures 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.
Bone fractures of the thigh after minimal or without preceding hurt (stress fractures) have been reported in patients treated with alendronic acid for long time. If you experience thigh pain please tell your doctor. Your doctor will decide if treatment with Alendronic Acid 70 mg Tablets should be stopped.
Irritation, inflammation or ulceration of the 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.
Other medicines and Alendronic Acid 70 mg Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronic Acid 70 mg Tablets if taken at the same time. Therefore, it is important that you follow the advice given in section 3. How to take Alendronic Acid 70 mg Tablets.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Alendronic Acid 70 mg Tablets.
Alendronic Acid 70 mg Tablets with food and drink
It is likely that food and beverages (including mineral water) will make Alendronic Acid 70 mg Tablets less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. How to take Alendronic Acid 70 mg Tablets.
Children/Adolescents
Alendronic acid 70 mg Tablets should not be given to children and adolescents.
Pregnancy, breast-feeding and fertility
Alendronic Acid 70 mg Tablets are only intended for use in postmenopausal women.
You should not take Alendronic Acid 70 mg Tablets if you:
- are pregnant, planning to become pregnant or if you think you may be pregnant
- are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic Acid 70 mg Tablets that may affect your ability to drive or operate machinery. Individual responses to Alendronic acid 70 mg Tablets may vary (See 4. Possible side effects). Do not drive or use any machines until you know how this medicine affects you.
3. How to take Alendronic Acid 70 mg Tablets
Alendronic Acid 70 mg Tablets are for oral use.
Always take Alendronic Acid 70 mg Tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take one Alendronic Acid 70 mg Tablet once a week.
Follow these instructions carefully to make sure you will benefit from this medicine.
1. Choose the day of the week that best fits your schedule. Every week, take one Alendronic Acid 70 mg Tablet on your chosen day.
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It is very important that you follow instructions 2, 3, 4 and 5to help the tablet reach your stomach quickly and help reduce the chance of irritating your oesophagus.
2. After getting up for the day and before taking any food, drink, or other medicines, swallow your Alendronic acid 70 mg Tablet whole with a full glass of water only (not mineral water)(not less than 200 ml or 7 fl. oz.).
- Do not take with mineral water (still or sparkling)
- Do not take with coffee or tea
- Do not take with juice or milk.
Do not crush or chew your tablet or allow it to dissolve in your mouth.
3. Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet. 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 upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid 70 mg Tablets and contact your doctor.
6. After swallowing your tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Alendronic Acid 70 mg Tablets are effective only if taken when your stomach is empty.
If you take more Alendronic Acid 70 mg Tablets than you should
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.
If you forget to take Alendronic Acid 70 mg Tablets
If you miss a dose, take one Alendronic acid 70 mg Tablet the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.
If you stop taking Alendronic Acid 70 mg Tablets
It is important that you continue taking Alendronic Acid 70 mg Tablets for as long as your doctor prescribes the medicine. 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 medicine, ask your doctor or pharmacist.
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 oesophagus,
- rash made worse by sunlight; severe skin reactions involving blistering of mucous membranes of your mouth, nose, eyes or genitals. Stop taking this medicine and contact your doctor right away if you experience such symptoms,
- 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 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 you get any side effects , talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet.
5. How to store Alendronic acid 70 mg Tablets
- Keep this medicine out of the sight and reach of children.
- This medicinal product does not require any special storage conditions.
Use-by date:
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
4. Possible side effects
6. Contents of the pack and other information
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported.
Very common (occurring in at least 1 of 10 patients treated)
Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated) Uncommon (occurring in at least 1 of 1,000 and less than 1 of 100 patients treated)
Rare (occurring in at least 1 of 10,000 and less than 1 of 1,000 patients treated)
Very rare (occurring in less than 1 of 10,000 patients treated)
Very common:
- bone, muscle and/or joint pain which is sometimes severe.
Common:
- heartburn; difficulty swallowing; pain upon swallowing; ulceration of the oesophagus which can cause chest pain, heartburn or difficulty or pain upon swallowing,
- joint swelling,
- abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
- hair loss; itching,
- headache; dizziness,
- tiredness; swelling in the hands or legs.
Uncommon:
- nausea; vomiting,
- irritation or inflammation of the oesophagus or stomach,
- black or tar-like stools,
- blurred vision; pain or redness in the eye,
- rash, itching (pruritus), redness of the skin (erythema),
- transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever, usually at the start of treatment,
- taste disturbance.
What Alendronic Acid 70 mg Tablets contains
The active substance is alendronic acid (as sodium alendronate). Each tablet contains 70 mg alendronic acid.
The other ingredients are: magnesium stearate, mannitol and microcrystalline cellulose (PH 102).
What Alendronic Acid 70 mg Tablets looks like and contents of the pack
Alendronic Acid 70 mg Tablets are white, oval biconvex tablets, marked with “APO” on one side and “ALE 70” on the other side.
Alendronic Acid 70 mg Tablets are supplied in blister packs containing 2 or 4 tablets packed in a carton together with a patient leaflet. Pack sizes consists of 2, 4, 8, 12, or 40 tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Apotex Europe B.V.
Darwinweg 20 2333 CR Leiden The Netherlands
Manufacturer:
Apotex Nederland B.V.
Archimedesweg 2 2333 CN Leiden The Netherlands
Distributor:
Apotex UK Limited 6 Ridgeway Court Grovebury Road,
Leighton Buzzard, LU7 4SF, UK
This leaflet was last revised in February 2013.
