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PACKAGE LEAFLET: INFORMATION FOR THE USER

Risedronate sodium 30 mg film-coated tablets

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.

•    Ifyou have any further questions, askyour doctor orpharmacist.

•    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.

What is in this leaflet:

1.    What Risedronate sodium film-coated tablets are and what they are used for

2.    What you need to know before you take Risedronate sodium film-coated tablets

3. How to take Risedronate sodium film-coated tablets

4.    Possible side effects

5.    How to store Risedronate sodium film-coated tablets

6. Contents of the pack and other information

1.    What Risedronate sodium film-coated tablets are and what they are used for

Risedronate sodium film-coated tablets belong to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases.

Risedronate sodium film-coated tablets are used to treat Paget's disease of the bone.

Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone. Paget's disease occurs when this process, called remodeling, happens too quickly and in a disordered way.

The new bone that is produced is weaker than normal and the affected bones may become enlarged, painful and may fracture. Risedronate sodium film-coated tablets change the bone remodeling process back to normal, returning the strength to the bone structure.

2.    What you need to know before you take Risedronate sodium film-coated tablets Do not take Risedronate sodium film-coated tablets

•    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).

•    Ifyoumaybepregnant, are pregnant or planning to become pregnant.

•    Ifyou are breast-feeding.

•    Ifyouhave severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Risedronate sodium film-coated tablets

•    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).

•    Ifyou 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 been told by your doctor that you have an intolerance to some sugars (such as lactose).

•    Ifyou have or ever had 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 sodium film-coated tablets.

Your doctor will advise you on what to do when taking Risedronate sodium film-coated tablets ifyou have any of the above.

Children and adolescents

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

Other medicines and Risedronate sodium film-coated tablets

Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines.

Medicines containing one of the following lessen the effect of Risedronate sodium film-coated tablets iftakenatthe same time:

•    calcium

•    magnesium

•    aluminium (for example some indigestion mixtures)

•    iron.

Take these medicines at least 30 minutes after your Risedronate sodium film-coated tablet. Risedronate sodium film-coated tablets with food and drink

It is very important that you do not take your Risedronate sodium film-coated 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 sodium film-coated tablets”).

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

Pregnancy and breast-feeding

Do not take Risedronate sodium film-coated tablets ifyou are pregnant, think you might be pregnant or planning to have a baby (see section 2, “Do not take Risedronate sodium film-coated tablets”). The potential risk associated with the use of risedronate sodium in pregnant women is unknown.

Do not take Risedronate sodium film-coated tablets ifyou are breast-feeding. (see section

2,    “Do not take Risedronate sodium film-coated tablets”).

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

Risedronate sodium film-coated tablets are not known to affect your ability to drive and use machines.

Risedronate sodium film-coated tablets contain lactose.

Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Risedronate sodium film-coated tablets.

3.    How to take Risedronate sodium film-coated tablets

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

Recommended dose:

Take one Risedronate sodium film-coated tablet once a day.

Usually 2 months will be enough to treat your Paget's disease. However, another course of treatment may be required.

It is very important that you do not take Risedronate sodium film-coated tablets with food or drinks (other than plain water) so that it can work properly.

When to take the Risedronate sodium film-coated tablets

It is best to take your tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.

Ifyou are unable to take your Risedronate sodium film-coated tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:

•    Between meals: at least 2 hours after your last food, drink (other than plain water) or medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet.

•    In the evening: at least 2 hours after the last food, drink (other than plain water) or medicine of the day. Risedronate sodium film-coated tablets should be taken at least 30 minutes before going to bed.

How to take the Risedronate sodium film-coated tablets

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

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

•    Swallow it 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 taking enough from your diet.

If you take more Risedronate sodium film-coated tablets than you should

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

If you forget to take Risedronate sodium film-coated tablets

If you have forgotten to take your tablet, you can take it before breakfast, between meals, or in the evening according to the instructions above.

Do not take a double dose to make up a forgotten tablet.

If you stop taking Risedronate sodium film-coated tablets

Do not stop the treatment prematurely because Paget's disease is a long disease. 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 sodium film-coated tablets and contact a doctor immediately

if you experience any of the following:

•    Symptoms characteristics of severe tissue swelling (angioedema reaction)

• Swelling of face, tongue or throat

•    Difficulties in swallowing

• Hives and difficulties in breathing

•    Severe skin reactions involving blisters under the skin.

Tell your doctor as soon as possible 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, “Take special care and talk to your doctor before you start taking Risedronate sodium film-coated tablets”).

•    Symptoms from 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.

Other side effects are:

Common side effects (may effect up to 1 in 10 people)

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

•    Painin your bones, muscles orjoints.

•    Headache.

Uncommon side effects (may effect up to 1 in 100 people)

•    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, “Take special care and talk to your doctor before you start taking Risedronate sodium film-coated tablets”), 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 effect up to 1 in 1000 people)

•    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.

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.

The additional following adverse events have also been observed in a clinical study in patients with Paget's disease: vision difficulties, breathing difficulties, coughing,

inflammation of the large intestine, surface of the eye damage, cramps, dizziness, dryness of the eye, flu-like symptoms, muscle weakness, abnormal growth of cells, a frequent need to pass water at night, unusual lumps or swellings, chest pain, rash, runny nose, ringing in the ears and weight loss.

During postmarketing experience the following have been reported (unknown frequency)

•    Eye inflammation.

•    Osteonecrosis (deathofbonetissue) inthejaw.

•    Inflammation ofbloodvessels.

•    Hair loss.

•    Allergic reactions such as urticaria (skinrash), swelling of the face, lips, tongue and/or neck, difficulty in swallowing or breathing.

•    Severe skin reactions including vesiculation (blistering) under the skin.

•    Liver disorders, some cases were severe.

Reporting ofside effects

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 Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety ofthis medicine.

5.    How to store Risedronate sodium film-coated tablets

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 carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage condition.

Do not throw away any medicines via wastewater or household waste.Ask your pharmacist how to throw awaymedicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Risedronate sodium film-coated tablets contain

The active substance is risedronate sodium. Each tablet contains 30 mg risedronate sodium, equivalentto 27.8 mgrisedronic acid.

The other ingredients are:

Tablet core: lactose monohydrate, crospovidone, magnesium stearate and microcrystalline cellulose.

Film coating: hypromellose, macrogol, hydroxypropyl cellulose, colloidal anhydrous silica, titanium dioxide E171.

What Risedronate sodium film-coated tablets look like and contents of the pack

Risedronate sodium film-coated tablets are white to off-white, round, tablets of 9.1 mm diameter, debossed with the letter “J” on one side and “30” on the other.

The tablets are supplied in blister packs of 14 or 28 tablets.

Not all pack sizes may be marketed.

MarketingAuthorisation Holder and Manufacturer

Marketing Authorisation Holder:

Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

Manufacturer:

PSI supply nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

This leaflet was last approved in November 2013.