Alendronic Acid 70 Mg Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER
Alendronic Acid 70 mg Tablets
Alendronic acid (as alendronate sodium 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 pharmacist.
• This medicine has been prescribed for you. Do 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 your doctor or pharmacist.
In this leaflet:
1. What Alendronic Acid 70mg Tablets are and what they are used for.
2. 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. Further information.
1. What Alendronic Acid 70mg Tablets are and what theyl are used for 1
Alendronic acid belongs to a group of non-hormonal medicines called bisphosphonates.
Alendronic Acid 70mg Tablets are used to:
• prevent 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 70mg Tablets not only prevent the loss of bone that occurs in women after the menopause but actually helps rebuild bone and reduces the risk of spine and hip fractures.
In addition to your treatment with Alendronic Acid 70mg Tablets, your doctor may recommend that you make lifestyle changes to help your condition. These are:
• Stop smoking: Smoking may increase the rate at which you lose bone and, therefore, may increase the risk of fracture.
• Take exercise: Bones need exercise to stay strong and healthy. Consult you doctor before you begin an exercise programme.
• Eat a balanced diet: Your doctor can advise you about your diet or whether you should take any dietary supplements.
|2. Before you take Alendronic Acid 70mg Tablets
Do not take Alendronic Acid 70mg Tablets if:
• you are allergic (hypersensitive) to alendronic acid or any of the ingredients of Alendronic Acid 70mg Tablets (see Section 6: Further Information)
• you have certain disorders of the oesophagus (the feeding tube that connects your mouth to your stomach)
• you are unable to stand or sit upright for at least 30 minutes
• your doctor has told you that you may have low blood calcium.
If any of these apply to you, do not take Alendronic Acid
70mg Tablets.
Talk to your doctor before taking Alendronic Acid 70mg
Tablets if:
• you suffer from kidney problems
• you have any swallowing or digestive problems
• you have gum disease
• you have a planned dental extraction.
A dental examination should be considered before you start treatment with Alendronic Acid 70mg Tablets if you have any of the following conditions:
• you have cancer
• you are undergoing chemotherapy or radiotherapy
• you are taking corticosteroids
• you do not receive routine dental care
• you have gum disease
Appropriate preventative dental care, as recommended by the dentist, should be followed during treatment.
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.
If taken at the same time, other medicines which are taken by mouth ( including antacids and calcium supplements) can have an effect on alendronic acid. Therefore, you must wait at least 30 minutes after taking alendronic acid before taking any other medicines which are taken by mouth (see Section 3: How to take Alendronic Acid 70mg Tablets).
Taking Alendronic Acid 70mg Tablets with food and drink
If taken at the same time, food and drink (including mineral water) can have an effect on alendronic acid. Alendronic acid is effective only if taken when you stomach is empty. Therefore, you must wait at least 30 minutes after taking Alendronic Acid 70mg Tablets before taking food or drink.
Pregnancy and breast-feeding
You should not take alendronic acid 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 medication.
Driving and using machines
Alendronic Acid 70mg Tablets should not affect you ability to drive or operate machinery.
Children
Alendronic Acid 70mg Tablets should not be given to children.
|3.How to take Alendronic Acid 70mg Tablets
Alendronic Acid 70mg Tablets are for oral use.
Always take Alendronic Acid 70mg Tablets exactly as your doctor has told you. You should check with you doctor or pharmacist if you are not sure.
You may have previously been prescribed a 10mg tablet of alendronic acid which is taken once a day, however, the usual dose of Alendronic Acid 70mg Tablets is one 70mg tablet once weekly.
It is very important that you follow the steps listed below to help the Alendronic Acid 70mg Tablet reach you stomach quickly, help reduce potential for irritation of your oesophagus and to help make sure you benefit from Alendronic Acid 70mg Tablets.
I.Choose the day of the week that best fits your schedule. Every week, take one Alendronic Acid 70mg Tablet on your chosen day.
2.After getting up for the day and at least 30minutes before taking your first food, drink, or other medicines (including antacids and calcium supplements), swallow your Alendronic Acid 70mg Tablet with a full glass of plain tap water only (not less than 200 ml or 7 fl.oz.). Alendronic
Acid 70mg T ablets are effective only if taken when your stomach is empty.
Do not take the tablet with:
• mineral water
• coffee or tea
• juice
Do not chew or allow the Alendronic Acid Tablet to dissolve in your mouth.
2. After swallowing your Alendronic Acid 70mg Tablet do not lie down. Stay fully upright (sitting, standing or walking) for at least 30 minutes and do not lie down until after your first food of the day.
3. Do not take Alendronic Acid 70mg Tablets at bedtime or before getting up for the day.
If patients do not drink a full glass of water with their Alendronic Acid 70mg Tablet and/or if they lie down within 30 minutes after taking their tablet or before their first food of the day, the following reactions may occur: irritation or ulceration of the oesophagus (the feeding tube that connects your mouth with your stomach) which can cause chest pain, heartburn, difficulty or pain upon swallowing and/or scarring leading to narrowing of the oesophagus.
If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid 70mg Tablets and contact your doctor.
If you take more Alendronic Acid 70mg T ablets 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. Do not lie down.
If you forget to take Alendronic Acid 70mg T ablets If you miss a dose, take one Alendronic Acid 70mg 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. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Alendronic Acid 70mg T ablets It is important that you continue taking Alendronic Acid 70mg T ablets for as long as your doctor prescribes the medicine. 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
Most patients do not experience any side effects from taking Alendronic Acid 70mg Tablets. However, like all medicines, Alendronic Acid 70mg Tablets can cause side effects although not everybody gets them.
Common (affecting more than 1 person in 100, but less than 1 in 10)
• headache
• abdominal pain, indigestion, constipation, diarrhoea, flatulence, full or bloated feeling in the stomach, acid reflux
• difficulty swallowing, ulceration of the oesophagus which can cause chest pain, heartburn or difficulty or pain when swallowing
• bone, muscle or joint pain.
Uncommon (affecting more than 1 person in 1,000, but less than 1 in 100)
• nausea, vomiting, black or bloody stools
• irritation or inflammation of the stomach or oesophagus
• rash, itching (pruritus), reddening of the skin (erythema).
Rare (affecting more than 1 person in 10,000, but less than 1 in 1,000)
• eye pain, reduced or hazy vision and/or black floating spots
• narrowing of the oesophagus
• mouth ulcers (when the tablets have been chewed or sucked)
• stomach or peptic ulcers (sometimes severe or with bleeding) although it is not known whether or not these were caused by treatment with Alendronic Acid 70mg Tablets
• jaw problems associated with delayed healing and
infection, often following tooth extraction (see “Take special care with Alendronic Acid 70mg Tablets” in
Section 2)
• allergic reactions such as hives or rarely, swelling of the face, lips, tongue and/or throat possibly causing difficulty in breathing or swallowing (angioedema)
• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever, usually at the start of treatment
• rash made worse by sunlight
• symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.
Very rare (affecting less than 1 person in 10,000, including
isolated reports)
• severe skin reactions including Stevens-Johnson syndrome (severe allergic reaction that can result in skin blistering, fever and eye damage) and toxic epidermal necrolysis (skin becomes intensely red and peels off in the manner of a second degree burn, often accompanied with blisters).
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 70mg T ablets
• Keep out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
Use-by date
Do not use Alendronic Acid 70mg T ablets 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.
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 protect the environment.
6.Further information
What Alendronic Acid 70mg Tablets contain
• The active substance is alendronic acid (as alendronate sodium trihydrate). Each tablet contains 70mg alendronic acid.
• The other ingredients are: magnesium stearate, mannitol powder and microcrystalline cellulose (PH102).
What Alendronic Acid 70mg Tablets look like and contents of the pack
Alendronic Acid 70mg Tablets are white, oval biconvex tablets, marked with “APO” on one side and “ALE 70” on
the other side.
Alendronic Acid 70mg Tablets are supplied in blister packs containing 2 or 4 tablets packed in a carton together with a patient leaflet. Pack sizes consist of 2, 4, 8, 12 or 40 tablets. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medley Pharma Limited Unit 2A Olympic Way Sefton Business Park Liverpool L30 1RD
Manufacturer:
Katwijk Farma BV, Archimedesweg 2, 2333 CN Leiden,
The Netherlands
Leaflet last revised: October 2014 397/01