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Risedronate Sodium 30mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

[product name] 30 mg film-coated tablets

Risedronate sodium

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 further 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

In this leaflet:

1. What [product name] is and what it is used for

2. Before you take [product name]

3. How to take [product name]

4. Possible side effects

5. How to store [product name]

6. Further information

1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR

What [product name] is

[product name] 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.

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. [product name] changes the bone remodeling process back to normal, returning the strength to the bone structure.

What [product name] is used for

Treatment of Paget's disease of the bone (osteitis deformans).

2. BEFORE YOU TAKE [product name]

Do not take [product name]

- if you are allergic (hypersensitive) to risedronate sodium or any of the other ingredients of [product name](see section 6 ”What [product name] contains”).

- 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 are planning to become pregnant.

- if you are breast-feeding.

- if you have severe kidney problems.

Take special care and talk to your doctor BEFORE you start taking [product name]

• 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 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 [product name]

Your doctor will advise you on what to do when taking [product name] if you have any of the above. Children

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

Taking other medicines

Medicines containing one of the following lessen the effect of [product name] if taken at the same time: calcium magnesium

aluminium (for example some indigestion mixtures) iron

Take these medicines at least 30 minutes after taking [product name]

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

Taking [product name] with food and drink

It is very important that you do NOT take your [product name] 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, “Taking other medicines”).

Take food and drinks (other than plain water) at least 30 minutes after your [product name] tablet.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do NOT take [product name] if you may be pregnant, are pregnant or are planning to become pregnant (see section 2 “Do not take [product name]”). ]”). The potential risk associated with the use of risedronate sodium (active substance in [product name]) in pregnant women is unknown.

Do NOT take [product name] if you are breast-feeding (see section 2, “Do not take [product name]”). Driving and using machines

[product name] is not known to affect your ability to drive or use machines.

Important information about some of the ingredients of [product name]

[product name] contains a small amount of lactose. If you have been told by your doctor that you have an intolorance to some sugars, contact your doctor before taking this medicinal product (see section 2, “Take special care and talk to your doctor before you start taking [product name]”).

3. HOW TO TAKE [PRODUCT NAME]

Dosage

Always take [product name] exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Usual dose

Take ONE [product name] (30 mg risedronate sodium) once a day.

The recommended treatment duration is usually 2 months

When to take your [product name] tablet:

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 in particular instance you are unable to take your [product name] tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:

EITHER:

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

OR:

In the evening: at least 2 hours after your last food, drink (other than plain water) or other medicine of the day. [product name] should be taken at least 30 minutes before going to bed.

How to take your [product name] 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 the tablet.

Do not lie down for 30 minutes after taking the 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 [product name] than you should

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

If you forget to take [product name]

If you have forgotten to take your tablet at your regular time, you can take it at next possible time according to the instruction above before (i.e.breakfast, between meals, or in the evening)

Do not take two tablets in one day to make up for the tablet you missed.

If you stop taking [product name]

Please talk to your doctor if you consider stopping treatment before end of prescribed duration.

4. POSSIBLE SIDE EFFECTS

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

Stop taking [product name] and contact a doctor immediately if you experience any of the

following:

Symptoms of a severe allergic reaction such as;

• Swelling of the 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 [product name]”).

Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new/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 1,000):

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 [product name]”), 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 10,000):

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.

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.

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

Allergic reactions of the skin such as urticaria (hives), skin rash, swelling of the face, lips, tongue and/or neck, difficulty in swallowing or breathing. Servere skin reactions including vesiculation (blistering) under the skin ; inflammation of small blood vessels, characterised by palpable red spots on the skin (leukocytoclastic vasculitis); a serious illness called Stevens Johnson syndrome (SJS) with blistering of the skin, mouth, eyes and other moist body surfaces (genitals); a severe illness called toxic epidermal necrolysis (TEN) which causes a red rash over many parts of the body and/or loss of the outer layer of skin.

Hair loss. Allergic reactions (hypersensitivity). Serious liver disorders, mainly if you are treated with other medicinal products known to cause liver problems. Inflammation of the eye which causes pain and redness.

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 has 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via <to be comleted nationally> . By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE [PRODUCT NAME]

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use [product name] after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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 [product name] 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: Starch, pregelatinised (maize); Cellulose, microcrystalline; Crospovidone; Magnesium stearate.

Film coating: Hypromellose, Lactose monohydrate, titanium dioxide (E171), Macrogol 4000.

What [product name] looks like and contents of the pack

[product name] are white round biconvex film-coated tablets with diameter of 11.2 mm, 4.5 mm in thickness and embossed with “30” on one the side. It is supplied in blister packs of 14, 28 tablets

Not all packsizes may be marketed.

Marketing Authorisation Holder

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini, Attiki Greece

Manufacturer

Batch releasers