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PACKAGE LEAFLET: INFORMATION FORTHE USER

ALENDRONIC

ACID

10 mg TABLETS

(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, 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.

What is in this leaflet:

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.

1. WHAT ALENDRONIC ACID IS AND WHAT IT IS USED FOR

doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.

Children and adolescents:

Alendronic Acid should not be given to children and adolescents.

Other medicines and Alendronic Acid

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, or any of the following:

•    calcium supplements

•    antacids for indigestion

•    corticosteroid medicines, such as prednisolone or dexamethasone, used to reduce inflammation; as it is important that you have a good dietary intake of calcium and vitamin D

•    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 sodium alendronate.

Wait at least 30 minutes after taking Alendronic Acid before taking any other medicines.

Alendronic Acid with food and drink

If taken at the same time it is likely that food and drink (including mineral water) will interfere with the absorption of Alendronic Acid. Therefore you should take Alendronic Acid with plain water at least 30 minutes before any food or drink

Alendronic Acid contains the active substance sodium alendronate.

Your medicine is in the form of a tablet. Alendronic Acid belongs to a group of medicines called bisphosphonates. Bisphosphonates can be used to help bone disease such as osteoporosis. Alendronic Acid can treat osteoporosis in men and post-menopausal women, by stopping bones becoming thin and weak. Alendronic Acid can treat and prevent osteoporosis in patients at risk of bone loss, who are on long-term steroid treatment.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID

Do not take Alendronic Acid:

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

•    if you have problems with your food pipe (oesophagus) causing difficulty swallowing

•    if you are unable to stand or sit upright for at least 30 minutes

•    if you know you have very low blood levels of calcium (hypocalcaemia).

Warnings and precautions

Talk to your doctor or pharmacist before taking Alendronic Acid:

•    if you suffer from kidney problems

•    if you have any swallowing or digestive or gut problems, irritation, inflammation or ulceration of the gullet (oesophagus -the tube that connects your mouth with your stomach)

•    if you have pain on swallowing

•    if you have been told you have low blood levels of calcium or you suffer from vitamin D deficiency. This needs to be treated before you start taking Alendronic Acid

•    if you have poor dental health, gum disease, a planned dental extraction or you do not receive routine dental care

•    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)

•    if you have cancer

•    if you are undergoing chemotherapy or radiotherapy

•    if you are taking corticosteroids (such as prednisone or dexamethasone)

•    if 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

Pregnancy and breast-feeding

Do not take Alendronic Acid if you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with alendronate that may affect your ability to drive or operate machinery. Individual responses to Alendronic Acid may vary (see section 4 ).

Alendronic Acid contains lactose. If you

have been told by your doctor that you have an intolerance to some sugars, such as lactose monohydrate, contact your doctor before taking this medicinal product.

3. HOW TO TAKE ALENDRONIC ACID

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults and the elderly

The recommended dose is 10 mg once a day.

Use in patients with kidney problems

Alendronic Acid is not recommended for patients with severe kidney problems.

Use in children and adolescents

Alendronic Acid should not be given to children and adolescents.

Method of administration

•    Swallow the tablet whole while standing upright. Take with a full glass (not less than 200 mls or 7 fl. oz.) of plain water (not mineral water).

*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 or let the tablet dissolve in your mouth.

•    Take on an empty stomach, as soon as you get out of bed in the morning, before you eat or drink anything.

•    Do not take at bedtime and do not lie down for at least 30 minutes after taking Alendronic Acid.

•    Wait at least 30 minutes after swallowing the tablet before you eat, drink or take any other medicines.

Stop taking this medicine and tell your doctor if you notice:

•    soreness, pain and difficulty swallowing

•    pain in the centre of the chest

•    heartburn, either new or worse than usual

•    ulcers in your mouth and throat.

If you take more Alendronic Acid than you should

Drink a full glass of milk and contact your doctor or nearest hospital casualty department immediately. Take any remaining tablets and the container with you. Do not make yourself vomit, and do not lie down. In case of an overdose, you may experience an upset stomach, heartburn, stomach pain, nausea, vomiting, vomiting blood, blood in the bowel motions.

If you forget to take Alendronic Acid

Take the tablet on the morning after you remember. Do not take two tablets on the same day but return to taking one tablet once a day.

If you stop taking Alendronic Acid

Always talk to your doctor or pharmacist before stopping taking Alendronic Acid.

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.

Stop taking this medicine and tell your doctor immediately if you experience any of the following symptoms:

Rare (may affect up to 1 in 1,000 people):

•    allergic reactions such as hives, swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing (angioedema)

•    rare cases of potentially life-threatening skin rashes have been reported with the use of alendronate, appearing as a skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or severe skin reactions which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell (toxic epidermal necrolysis)

•    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

•    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

•    stomach or peptic ulcers (sometimes severe or with bleeding).

Contact your doctor and dentist if you experience such symptoms.

Other possible side effects

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):

•    heartburn, difficulty swallowing, pain upon swallowing, 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

•    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

•    unusual weakness, 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 1,000 people):

•    symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth

•    narrowing of the gullet (oesophagus -the tube that connects your mouth with your stomach)

•    rash made worse by sunlight

•    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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5.    HOW TO STORE ALENDRONIC ACID

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the label, carton and blister after 'EXP'. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Alendronic Acid contains

Each tablet contains 10 mg of the active ingredient alendronic acid as sodium alendronate. It also contains lactose monohydrate; cellulose, microcrystalline; croscarmellose sodium; povidone and magnesium stearate.

What Alendronic Acid looks like and contents of the pack

Alendronic Acid 10 mg Tablets are white, oval shaped tablets embossed 'AD10' on one side and 'G' on the reverse.

Alendronic Acid 10 mg Tablets are available in blister packs and bottles of 10, 14, 28, 30, 50, 56, 98, 100, 112 or 250 tablets.

Not all pack sizes and types may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, eN6 1TL, United Kingdom.

Manufacturer

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last revised in: 05/2013    00000000 10005106

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Job No. 37008130v2 product category Alendronic Acid market UK

created 26-APR-2013 modified 07-MAY-2013

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