Alendronic Acid 70 mg tablets

• 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 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 includes any possible side effects not listed in this leaflet. See section 4.

1. What Alendronic Acid is and what it is used for
2. What you need to know before you take Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Contents of the pack and other information

Alendronic acid is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Alendronic Acid 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.

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.

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.

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 are allergic to alendronate sodium trihydrate or any of the other ingredients of this medicine (listed in section 6).
• 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.

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Talk to your doctor or pharmacist before taking Alendronic Acid

It is important to tell your doctor before taking Alendronic Acid if:

• you suffer from kidney problems.
• you have, or have recently had, 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 trouble absorbing minerals in your stomach or intestines (malabsorption syndrome),
• you have been told you have low blood calcium.
• 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 angiogenesis inhibitors (such as bevacizumab, or thalidomide), which are used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of such conditions as asthma, rheumatoid arthritis, and severe allergies,
• 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.

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 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.

Alendronic Acid should not be given to children and adolescents less than 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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".

Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylesalicylic acid or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Alendronic Acid.

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".

Alendronic Acid is only intended for use in postmenopausal women. You should not take Alendronic Acid if you are or think you may be pregnant, or if you are breast-feeding.

There have been side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic Acid that may affect your ability to drive or operate machinery (See section 4).

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free.’

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 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.

It is important that you take Alendronic Acid for as long as your doctor prescribes the medicine. Since it is not known how long you should take Alendronic Acid, you should discuss the need to stay on this medicine with your doctor periodically to determine if Alendronic Acid is still right for you.

Very common (may affect more than 1 in 10 people):

• bone, muscle and/or joint pain which is sometimes severe.

Common (may affect up to 1 in 10 people):

• 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 (may affect up to 1 in 100 people):

• 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,
• blurred vision; pain or redness in the eye,
• rash; redness of the skin,
• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,
• taste disturbance.

Rare (may affect up to 1 in 1000 people):

• 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;
• mouth ulcers

Very rare (may affect up to 1 in 10,000 people):

• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme. Website:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is alendronic acid.

Each tablet contains 70 mg alendronic acid (equivalent to 91.363 mg sodium alendronate trihydrate).

• The other ingredients are: Microcrystalline cellulose, maize starch, sodium starch glycolate (Type A), povidone (Kollidon 30), and magnesium stearate.

Tablet.

White to off-white, oval, biconvex, uncoated tablets debossed with 'F' on one side and '21' on the other side. The size is 12.8 mm X 7.0 mm.

Alendronic acid tablets are available in blister packs and HDPE bottle packs.

Pack size:

Blister: 2, 4, 8, 12, 20, 30, 40, 50 and 60 tablets.

HDPE Bottle pack: 30, 50, 60 and 250 tablets.

Not all pack sizes may be marketed.

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