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Package leaflet: Information for the user

RISEDRONATE 35 mg FILM-COATED TABLETS

risedronate sodium

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 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 any side effects not listed in this leaflet.

What is in this leaflet:

1.    What Risedronate is and what it is used for

2.    What you need to know before you take Risedronate

3.    How to take Risedronate

4.    Possible side effects

5.    How to store Risedronate

6.    Contents of the pack and other information.

1.    What Risedronate is and what it is used for

What Risedronate is

Risedronate belongs to a group of nonhormonal medicines called bisphosphonates which are used to treat bone diseases.

It works directly on your bones to make them stronger and therefore less likely to break. Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone.

Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain.

Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis - related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it.

What Risedronate is used for

The treatment of osteoporosis:

•    in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures

•    in men.

2.    What you need to know before you take Risedronate

Do not take Risedronate

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

•    If your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level)

•    If you may be pregnant, are pregnant or planning to become pregnant

•    If you are breast-feeding

•    If you have severe kidney problems.

Warnings and precautions Talk to your doctor before you take Risedronate

•    If you are unable to stay in an upright position (sitting or standing) for at least 30 minutes.

•    If you have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level).

•    If you have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have had pain or difficulty in swallowing food or you have previously been told that you have Barrett's oesophagus (a condition associated

with changes in the cells that line the lower oesophagus).

•    If you have had or have pain, swelling or numbness of the jaw or a 'heavy jaw feeling' or loosening of a tooth.

•    If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate

Your doctor will advise you on what to do when taking Risedronate if you have any of the above.

Children and adolescents

Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.

Other medicines and Risedronate

Medicines containing one of the following lessen the effect of Risedronate if taken at the same time:

•    calcium

•    magnesium

•    aluminium (for example some indigestion mixtures)

•    iron.

Take these medicines at least 30 minutes after your Risedronate tablet.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Taking Risedronate with food and drink

It is very important that you do NOT take your Risedronate tablet with food or drinks (other than plain water) so that it can work properly. In particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, 'Other medicines and Risedronate').

Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablet.

Pregnancy and breast-feeding

Pregnancy

Do NOT take Risedronate if you may be pregnant, are pregnant or planning to become pregnant (see section 2, 'Do not take Risedronate'). The potential risk associated with the use of risedronate sodium in pregnant women is unknown.

Breast-feeding

Do NOT take Risedronate if you are breast-feeding (see section 2, 'Do not take Risedronate').

Risedronate should only be used to treat postmenopausal women.

If you are pregnant or breast-feeding, think you are pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Risedronate is not known to affect your ability to drive and use machines.

Risedronate contains polydextrose (which contains glucose and sorbitol)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Risedronate

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

Dosage

The recommended dose is ONE Risedronate tablet (35 mg of risedronate sodium) once a week.

Choose one day of the week that best fits your schedule. Every week, take the Risedronate tablet on your chosen day.

When to take the Risedronate tablet

Take your Risedronate tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.

How to take the Risedronate tablet

•    Take the tablet whilst you are in an upright position (you may sit or stand) to avoid heartburn.

•    Swallow the tablet with at least one glass (120 ml) of plain water.

•    Swallow the tablet whole. Do not suck or chew it.

•    Do not lie down for 30 minutes after taking your tablet.

Your doctor will tell you if you need calcium and vitamin supplements, if you are not getting enough from your diet.

If you take more Risedronate than you should

If you or somebody else has accidentally taken more Risedronate tablets than prescribed, drink one full glass of milk and seek medical attention.

Substantial overdose may decrease serum calcium level in your blood. Signs and symptoms of hypocalcaemia such as, 'pins and needles' sensation, fatigue, anxiety and muscle cramps may also occur in some of these patients.

If you forget to take Risedronate

If you have forgotten to take your tablet on your chosen day, take it on the day you remember. Return to taking one tablet once a week on the day the tablet is normally taken. Do NOT take two tablets in one day to make up for the tablet you missed.

If you stop taking Risedronate

If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.

If you have any further questions on the use of this medicine, 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 Risedronate and contact a doctor immediately if you experience any of the following:

•    Symptoms of a severe allergic reaction such as;

*    Swelling of face, tongue or throat

*    Difficulties in swallowing

*    Hives and difficulties in breathing

•    Severe skin reactions that can include blistering of the skin.

Tell your doctor promptly if you experience the following side effects:

•    Eye inflammation, usually with pain, redness and light sensitivity.

•    Bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, 'Warnings and precautions').

•    Symptoms from the oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn.

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.

However in clinical studies the other side effects that were observed were usually mild and did not cause the patient to stop taking their tablets.

Common side effects (may affect up to 1 in 10 patients)

•    Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea.

•    Pain in your bones, muscles or joints.

•    Headache.

Uncommon side effects (may affect up to 1 in 100 patients)

•    Inflammation or ulcer of the oesophagus (the tube that connects your mouth with your stomach) causing difficulty and pain in swallowing (see also section 2, 'Warnings and precaution'), inflammation of the stomach and duodenum (bowel draining the stomach).

•    Inflammation of the coloured part of the eye (iris) (red painful eyes with a possible change in vision).

Rare side effects (may affect up to 1 in 1,000 patients)

•    Inflammation of the tongue (red swollen, possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach).

•    Abnormal liver tests have been reported. These can only be diagnosed from a blood test.

•    An allergic inflammation of blood vessels (leukocytoclastic vasculitis)

Rarely, at the beginning of treatment, a patient's blood calcium and phosphate levels may fall. These changes are usually small and cause no symptoms.

Not known side effects (frequency cannot be estimated from the available data);

•    Hair loss.

•    Liver disorders, some cases were severe.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Risedronate

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 after 'EXP¹. The expiry date refers to the last day of that month.

This medicine 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 protect the environment.

6.    Contents of the pack and other information

What Risedronate contains

The active substance is risedronate sodium. Each film-coated tablet contains 35 mg risedronate sodium, equivalent to 32.5 mg risedronic acid.

The other ingredients are:

Tablet core: mannitol, cellulose microcrystalline, crospovidone, silica colloidal anhydrous, and magnesium stearate.

Film-coating: Titanium dioxide (E171), polydextrose (contains glucose and sorbitol), hypromellose, macrogol 8000, triacetin, iron oxide yellow (E172) and iron oxide red (E172).

What Risedronate looks like and contents of the pack

Light orange film-coated tablet, round, biconvex, bevelled edge debossed with M on one side of the tablet and 714 on the other side.

Risedronate film-coated tablets are available in blister packs of 1,2, 4, 10, 12, 16, 24,

28 tablets, in calendar packs of 4 tablets and in bottle packs of 1,2, 4, 10, 12, 16, 24,

28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan,

Potters Bar,

Hertfordshire, EN6 1TL,

United Kingdom

Manufacturer:

Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13 Ireland

Mylan Hungary Kft Mylan utca 1.,

Komaron

2900

Hungary

This leaflet was last revised in 02/2015.