Alendronic Acid 70 Mg Film-Coated Tablets
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Alendronic Acid 70 mg Film-coated Tablets
Alendronic acid
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 any further questions, 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 is and what it is used for
2. Before you take Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Further information
What is Alendronic Acid?
Alendronic Acid is a film-coated tablet containing the active substance alendronate sodium.
What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.
What is Alendronic Acid used for?
Your doctor has prescribed Alendronic Acid to treat your osteoporosis. Alendronic Acid reduces the risk of spine and hip fractures.
Alendronic Acid is a once weekly treatment.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility.
How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to begin treatment. Alendronic Acid not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.
As well as your treatment with Alendronic Acid, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Stopping smoking
Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
Exercise
Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.
Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and vitamin D).
If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.
Take special care with Alendronic Acid
It is important to tell your doctor before taking Alendronic Acid
• if you suffer from kidney problems.
• if you have any swallowing or digestive problems.
• if you have low blood calcium levels.
• 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).
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. These side effects may worsen if patients continue to take Alendronic Acid after developing these symptoms.
Talk to your doctor before you take Alendronic Acid if you have or have had pain or swelling of your gums and/or jaw, numbness of the jaw, if the jaw feels heavy or if you have lost a tooth. This might be a symptom of osteonecrosis (death of bone tissue). Talk to your doctor if you suffer from cancer or if your teeth are in bad condition as this is a risk factor. If you are being treated by a dentist or if you are going to have dental surgery, tell your dentist that you are taking Alendronic Acid.
Taking other medicines
It is likely that calcium supplements,
antacids, and some oral medicines
will interfere with the absorption of Alendronic Acid if taken at the same time. Therefore, it is important that you follow the advice given in section 3 “How to take Alendronic Acid”.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Alendronic Acid with food and drink
It is likely that food and beverages (including mineral water) will make Alendronic Acid 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”.
Children and adolescents
Alendronic Acid should not be given to children and adolescents.
Pregnancy
You should not take Alendronic Acid if you are or think you may be pregnant. Alendronic Acid is only intended for use in postmenopausal women.
Breast-feeding
You should not take Alendronic Acid if you are breast-feeding. Alendronic Acid is only intended for use in postmenopausal women.
Driving and using machines
Alendronic Acid should not affect your ability to drive or operate machines.
Do not take Alendronic Acid
• if you are hypersensitive (allergic) to alendronate sodium trihydrate, other bisphosphonates or any of the other ingredients of Alendronic Acid Tablets.
• if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing.
• if you cannot stand or sit upright for at least 30 minutes.
• if your doctor has told you that you have low blood calcium.
Always take Alendronic Acid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take one 70 mg film-coated tablet once a week.
Follow these instructions carefully to make sure that you benefit from Alendronic Acid.
1) Choose the day of the week that best fits your schedule. Every week, take one Alendronic Acid tablet on your chosen day.
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It is very important to follow instructions 2), 3), 4) and 5) to help the Alendronic Acid reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
2) After getting up for the day and before taking any food, drink, or other medicine, swallow your Alendronic Acid tablet 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.
3) Do not chew the tablet or allow it to dissolve in your mouth.
4) 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.
5) Do not take Alendronic Acid at bedtime or before getting up for the day.
6) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid and contact your doctor.
7) After swallowing your Alendronic Acid, 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 is effective only if taken when your stomach is empty.
8) It is important that you continue taking Alendronic Acid for as long as your doctor prescribes the medicine. Alendronic Acid can treat your osteoporosis only if you continue to take the tablets.
If you take more Alendronic Acid 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
If you miss a dose, just take one tablet on 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 have any further questions on the use of this product, ask your doctor or pharmacist.
ulcers (sometimes severe or with bleeding) but it is not sure whether these were caused by Alendronic Acid.
Skin
Uncommon: rash; itching; redness of the skin.
Rare: rash made worse by sunlight. Very rare: severe skin reactions.
Musculoskeletal
Common: bone, muscle and/or joint pain.
Rare: Osteonecrosis (death of bone tissue), severe bone, muscle and/or joint pain. Unusual fracture of the thigh bone particularly in patients on long-term treatment of osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thing, hip or groin as this may be an early indication of a possible fracture of the thigh bone. Frequency unknown: joint swelling.
General disorders
Rare: transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment; hypersensitivity reactions including nettle rash and angio-oedema; symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.
Frequency unknown: weakness, swollen hands, ankles or feet.
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not take the tablets after the expiry date stated on the blister and the carton.
Like all medicines, Alendronic Acid can have side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported.
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)
Nervous system
Common: headache.
Frequency unknown: dizziness.
Eye disorders
Rare: blurred vision, pain or redness in the eye.
Ear and labyrinth disorders:
Frequency unknown: spinning sensation.
Digestive tract
Common: abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence; heartburn; difficulty swallowing; pain upon s wallowing; 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 Uncommon: nausea; vomiting; irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach; black or tar-like stools Rare: narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach); mouth ulcers when the tablets have been chewed or sucked; stomach or peptic
What Alendronic Acid contains
The active substance is sodium alendronate. Each film-coated tablet contains 70 mg alendronic acid (as sodium alendronate trihydrate).
The other ingredients are:
Tablet core: Microcrystalline cellulose, Colloidal anhydrous silica, Croscarmellose sodium, Magnesium stearate.
Tablets coating: Microcrystalline cellulose, Carrageenan, Macrogol.
What Alendronic Acid looks like and contents of the pack
White, round, biconvex film coated tablet, debossed with “ALN 70” on one side.
The product is packed in OPA-Aluminium-PVC/Aluminium blister and may be supplied in the following pack sizes
2 film-coated tablets 4 film-coated tablets 6 film-coated tablets 8 film-coated tablets 12 film-coated tablets 14 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d.,
Verovskova 57,1526 Ljubljana, Slovenia or
Lek S.A.,
ul. Domaniewska 50 C,
02-672 Warszawa, Poland or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or
Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany.
This leaflet was last approved in 12/2014.
SZ00000LT000
Artwork Proof Box
Ref: V017 - addition of a pack size of 14 tablets
|
Proof no. 007.0 |
Date prepared: 23/12/2014 |
Font size: 8.5pt | |
|
Colours: |
Fonts: | ||
|
■ Black |
□ |
Helvetica | |
|
□ |
□ | ||
|
Dimensions: 1 30 x 500 |
mm | ||