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Document: leaflet MAH GENERIC_PL 06464-2738 change

• leaflet MAH GENERIC_PL 06464-2738
• leaflet MAH GENERIC_PL 16363-0231
• leaflet MAH GENERIC_PL 30306-0364
• leaflet MAH GENERIC_PL 42357-0113

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GB 727-0580-APIL

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.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor orpharmacist.

In this leaflet:

1.    What Risedronate sodium 30 mg is and what it is used for

2.    Before you take Risedronate sodium 30 mg

3.    How to take Risedronate sodium 30 mg

4.    Possible side effects

5.    How to store Risedronate sodium 30 mg

6.    Further information

1.    WHAT RISEDRONATE SODIUM 30 MG IS AND WHAT IT IS USED FOR

Risedronate sodium 30 mg belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases.

Risedronate sodium 30 mg is 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 remodelling, 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 30 mg changes the bone remodelling process back to normal, returning the strength to the bone structure.

2.    BEFORE YOU TAKE RISEDRONATE SODIUM 30 MG

Do not take Risedronate sodium 30 mg if:

•    you are allergic to risedronate sodium or any of the other ingredients of Risedronate sodium 30 mg (see section 6, “What Risedronate sodium 30 mg contains”);

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

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

•    you are breast-feeding;

•    you have severe kidney problems.

Take special care and talk to your doctor before you start taking Risedronate sodium 30 mg if:

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

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

•    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);

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

•    you have or ever had pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth;

•    you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate sodium 30 mg.

Your doctor will advise you on what to do when taking Risedronate sodium 30 mg if you have any of the above.

These tablets should not be taken by children under 18 years of age.

Taking other medicines

Medicines containing any of the following lessen the effect of Risedronate sodium 30 mg 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 sodium 30 mg tablet.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Risedronate sodium 30 mg with food and drink

It is very important that you do not take your Risedronate sodium 30 mg tablet with food or drinks (other than plain water) so that it can work properly. Products containing any of the following: calcium (including dairy products such as milk), magnesium, aluminium (for example, some indigestion mixtures) or iron lessen the effect of this medicine.

These products should be taken at a different time to Risedronate sodium 30 mg tablets.

Pregnancy and breast-feeding

Do not take Risedronate sodium 30 mg if you may be pregnant, are pregnant or are planning to become pregnant (see section 2, “Do not take Risedronate sodium 30 mg”). The potential risk associated with the use of risedronate sodium in pregnant women is unknown.

Do not take Risedronate sodium 30 mg if you are breast-feeding (see section 2, “Do not take Risedronate sodium 30 mg”).

Ask your doctor for advice before taking any medicine.

Driving and using machines

Risedronate sodium 30 mg is not known to affect your ability to drive and use machines.

Important information about some of the ingredients of Risedronate sodium 30 mg

Risedronate sodium 30 mg contains a small amount of lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Risedronate sodium 30 mg.

3. HOW TO TAKE RISEDRONATE SODIUM 30 MG

Dosage

Always take Risedronate sodium 30 mg exactly as your doctor has told you. You should check with your doctor if you are not sure.

These tablets should not be taken by children under 18 years of age.

Usual dose:

Take one Risedronate sodium 30 mg 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 30 mg with food or drinks (other than plain water) so that it can work properly.

When to take the Risedronate sodium 30 mg 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.

If you are unable to take your Risedronate sodium 30 mg 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 30 mg should be taken at least 30 minutes before going to bed.

How to take the Risedronate sodium 30 mg

•    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 30 mg than you should

If you or somebody else has accidentally taken more Risedronate sodium 30 mg tablets than prescribed, drink one full glass of milk and seek medical attention.

If you forget to take Risedronate sodium 30 mg

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 two tablets in one day to make up for the tablet you missed.

If you stop taking Risedronate sodium 30 mg

Do not stop the treatment prematurely because Paget’s disease is a long-term disease. Please talk to your doctor before you consider stopping treatment.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Risedronate sodium 30 mg can cause side effects, although not everybody gets them.

Stop taking, Risedronate sodium 30 mg and contact a doctor immediately if you

experience any of the following:

•    Symptoms characteristic of severe tissue swelling (angioedema reaction):

-    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, “Take special care and talk to your doctor before you start taking Risedronate sodium 30 mg”).

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

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 (affects 1 to 10 users in 100):

•    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 (affects 1 to 10 users in 1000):

•    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

30 mg”), 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 (affects 1 to 10 users in 10000):

•    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.

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.

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.

If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE RISEDRONATE SODIUM 30 MG

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

No special storage conditions required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Risedronate sodium 30 mg contains

The active substance is risedronate sodium.

Each tablet contains 30 mg risedronate sodium, equivalent to 27.8 mg risedronic acid.

The other ingredients are:

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

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

What Risedronate sodium 30 mg looks like and contents of the pack

Risedronate sodium 30 mg film-coated tablets are white to off-white coloured tablets debossed with the letter “J” on one side and “30” on the other.

The tablets are supplied in blister packs of 28 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Waymade Healthcare Pic trading as Sovereign Medical.

Sovereign House,

Miles Gray Road,

Basildon.

Essex. SS14 3FR.

United Kingdom.

Manufacturer:

PSI supply nv.

Axxes Business Park, Guldensporenpark 22 - Block C, 9820 Merelbeke.

Belgium.

Waymade Healthcare Pic.

Sovereign House,

Miles Gray Road,

Basildon.

Essex. SS14 3FR.

United Kingdom.

This leaflet was last approved in: November 2012

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