Package leaflet: Information for the patient

V

Aetonel 30mg

risedronalB sodium

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.

•    I f 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.

•    I f you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Actonel is and what it is used for

2.    What you need to know before you take Actonel

3.    How to take Actonel

4.    Possible side effects

5.    How to store Actonel

6.    Contents of the pack and other information 1. What Actonel is and what it is used What Actonel is

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

What Actonel is used for

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

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2. What you need to know before you take Actonel

@ Do not take Actonel

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•    I f you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6)

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

•    I f you may be pregnant, are pregnant or planning to become pregnant

•    I f you are breast feeding

•    I f you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Actonel

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

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

•    I f 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).

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

•    I f you have had or have pain, swelling or numbness of the jaw or a "heavy jaw feeling" or loosening of a tooth.

•    I f you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Actonel.

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

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

•    calcium

•    magnesium

•    aluminium (for example some indigestion mixtures)

•    iron.

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

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

Actonel with food and drink

It is very important that you do NOT take your Actonel 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 Actonel").

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

Pregnancy and breast-feeding

Do NOT take Actonel if you may be pregnant, are pregnant or planning to become pregnant (see section 2, "Do not take Actonel").

The potential risk associated with the use of risedronate sodium (active substance in Actonel) in pregnant women is unknown.

Do NOT take Actonel if you are breast-feeding (see section 2,

"Do not take Actonel").

Driving and using machines

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

Actonel contains a small amount of lactose (see section 2, "Warnings and precautions").

3. How to take Actonel

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 Actonel 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 Actonel tablet

IT IS BEST to take your Actonel 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 Actonel 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. Actonel should be taken at least 30 minutes before going to bed.

HOW to take the Actonel tablet

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

•    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.

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If you take more Actonel than you should

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

If you forget to take Actonel

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

If you stop taking Actonel

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 Actonel 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, "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 longterm 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)

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

•    Pain in your bones, muscles or joints.

•    Headache.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Actonel

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 Actonel 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 Actonel looks like and contents of the pack

Actonel 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

Warner Chilcott UK Limited,

Old Belfast Road,

Millbrook,

Larne,

County Antrim, BT40 2SH

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

•    I nflammation 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).

•    I nflammation 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)

•    I nflammation 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 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.

Manufacturer:

Warner Chilcott Deutschland GmbH,

Dr.-Otto-Rohm-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 comprime pellicule,

Actonel 30 mg Filmtabletten

France: Actonel 30 mg comprime pellicule

Germany: Actonel 30 mg Filmtabletten

Greece: Actonel 30 mg sniKaXu^sva (ts Xsnxo u^svio SiaKia

Ireland: Actonel 30 mg film-coated tablets

Italy: Actonel 30 mg compresse rivestite con film

Luxembourg: Actonel 30 mg comprime pellicule

The Netherlands: Actonel 30 mg omhulde tabletten

Spain: Actonel 30 mg comprimidos recubiertos con pelfcula

Sweden: Actonel 30 mg filmdragerade tabletter

United Kingdom: Actonel 30 mg film-coated tablets

This leaflet was last approved in: November 2014

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SAP-Nr.:

Product:

Country:

Version:

Constructed:

Modified:

Size:

Smallest font size (x pt): Pages:

Colours:

10001427

IS Actonel 30mg UK WE15

United Kingdom

3

21.07.2014    s+b/hp

11.11.2014    s+b/hp/hp 210 x 320 mm

9 pt 2 of 2

PMS Black ■

Reason for change:

Variation (Colloidal anhydrous silica)