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Package leaflet: Information for the patient

Optinate 30 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 Optinate is and what it is used for

2. What you need to know before you take Optinate

3. How to take Optinate

4. Possible side effects

5. How to store Optinate

6. Contents of the pack and other information

1. What Optinate is and what it is used for

What Optinate is

Optinate 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. Optinate changes the bone remodeling process back to normal, returning the strength to the bone structure.

What Optinate is used for

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

2. What you need to know before you take Optinate

Do not take Optinate

• 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 Optinate

• 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 Optinate.

Your doctor will advise you on what to do when taking Optinate 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 Optinate

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

• calcium

• magnesium

• aluminium (for example some indigestion mixtures)

• iron.

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

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

Optinate with food and drink

It is very important that you do NOT take your Optinate 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 Optinate”).

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

Pregnancy and breast-feeding

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

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

Driving and using machines

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

Optinate contains a small amount of lactose(see section 2, “Warnings and precautions”).

3. How to take Optinate

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

The recommended dose isONE Optinate tablet (30 mg of risedronate sodium) once a day.

The recommended treatment duration is usually 2 months.

For your convenience, the days of the week are printed on the blister foil to help you remember to take your medicine.

WHEN to take the Optinate tablet

IT IS BEST to take your Optinate 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 Optinate 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) orother 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 your last food, drink (other than plain water) or other medicine of the day. Optinate should be taken at least 30 minutes before going to bed.

HOW to take the Optinate 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 Optinate than you should

If you or somebody else has accidentally taken more Optinate tablets than prescribed, drink one fullglass of milkand seek medical attention.

If you forget to take Optinate

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

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

If you stop taking Optinate

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

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 Optinate 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 promptlyif 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.

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 1,000 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.

During post-marketing experience, the following have been reported

• Very rare: 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.

• 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 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. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Optinate

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 and blister after EXP. 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 Optinate 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 (see section 2), crospovidone, magnesium stearate and cellulose microcrystalline.

Film coating:hypromellose, macrogol, hydroxypropylcellulose, colloidal anhydrous silica and titanium dioxide [E171].

What Optinate looks like and contents of the pack

Optinate 30 mg film-coated tablets are oval white tablets with the letters “RSN” on one side and “30 mg” on the other side. The tablets are supplied in blister packs of 1x3, 1x14, 28 (2x14) tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[To be completely nationally]

Manufacturer:

Warner Chilcott Deutschland GmbH,

Dr.-Otto-Röhm-Str. 2-4,

64331 Weiterstadt, Germany

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

Belgium: Actonel 30 mg filmomhulde tabletten,

Actonel 30 mg comprimé pelliculé,

Actonel 30 mg Filmtabletten

France: Actonel 30 mg comprimé pelliculé

Germany: Actonel 30 mg Filmtabletten

Greece: Actonel30 mgεπικαλυμμένα με λεπτό υμένιο δισκία

Ireland: Actonel 30 mg film-coated tablets

Italy: Actonel 30 mg compresse rivestite con film

Luxembourg: Actonel 30 mg comprimé pelliculé

The Netherlands: Actonel 30 mg omhulde tabletten

Spain: Actonel 30 mg comprimidos recubiertos con película

Sweden: Optinate 30 mg filmdragerade tabletter

United Kingdom: Actonel 30 mg film-coated tablets

This leaflet was last revised in: 14 January 2016