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• Risedronat Jubilant 35 mg film-coated tablet PL
• Risedronat Jubilant 35 mg film-coated tablet ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Risedronat Jubilant 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 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.

What is in this leaflet:

1. What Risedronat Jubilant is and what it is used for

Risedronat Jubilant belongs to a group of non-hormonal 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.

Risedronat Jubilant is used for the treatment of osteoporosis:

2. What you need to know before you take Risedronat Jubilant

Do not take Risedronat Jubilant

• 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 or pharmacist before taking Risedronat Jubilant

• 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 or have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have or 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).

• 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 Risedronat Jubilant.

Your doctor will advise you on what to do when taking Risedronat Jubilant if you 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 Risedronat Jubilant

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

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

• calcium

• magnesium

• aluminium (for example some indigestion mixtures)

• iron.

Take these medicines at least 30 minutes after your Risedronat Jubilant tablet.

Risedronat Jubilant with food and drink

It is very important that you do not take your Risedronat Jubilant 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 Risedronat Jubilant”).

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

Pregnancy and breast-feeding

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

Do not take Risedronat Jubilant if you are breast-feeding. (see section 2, “Do not take Risedronat Jubilant”).

Risedronat Jubilant should only be used to treat postmenopausal women and men.

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

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

Risedronat Jubilant contains lactose.

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

3. How to take Risedronat Jubilant

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

Recommended dose:

Take one Risedronat Jubilant tablet once a week.

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

When to take the Risedronat Jubilant tablet

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

How to take the Risedronat Jubilant tablet

• 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 Risedronat Jubilant than you should

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

If you forget to take Risedronat Jubilant

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 a double dose to make up for a forgotten tablet.

If you stop taking Risedronat Jubilant

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 Risedronat Jubilant and contact a doctor immediately if you experience any of the following:

• Swelling of the face, tongue or throat

• Difficulties in swallowing

• Hives and difficulties in breathing

Tell your doctor as 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 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.

Other side effects are:

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

• 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 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, “Warnings and precautions”), 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 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.

Very rare side effects (may affect up to 1 in 10000 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.

During post-marketing experience the following have been reported (unknown frequency)

• Hair loss.

• Liver disorders, some cases were severe.

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.

Reporting of side 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 national reporting system]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Risedronat Jubilant

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 away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Risedronat Jubilant contains

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

The other ingredients are:

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

Film coating: iron oxide yellow E172, iron oxide red E172, hypromellose, macrogol, hydroxypropyl cellulose, colloidal anhydrous silica, titanium dioxide E171.

What Risedronat Jubilant looks like and contents of the pack

Risedronat Jubilant film-coated tablets are light-orange coloured, round, tablets of 9.1 mm diameter, debossed with the letter “J” on one side and “35” on the other.

The tablets are supplied in blister packs of 4 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

To be completed nationally

Manufacturer:

PSI supply nv

Axxes Business Park

Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium

This medicinal product is authorised in the Member States of the EEA under the following names

Italy: Risedronato Pensa

Sweden: Risedronat Jubilant 35 mg filmdragerade tabletter

The Netherlands: Risedronaatnatrium Jubilant 35 mg filmomhulde tabletten

This leaflet was last revised in 10 February 2016