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Package leaflet: Information for the patient

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Actonel

risedronate sodium

©SBEKr NVActavis

an Actavis Company

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.

What is in this leaflet

1.    What Actonel Once a Week is and what it is used for

2.    What you need to know before you take Actonel Once a Week

3.    How to take Actonel Once a Week

4.    Possible side effects

5.    How to store Actonel Once a Week

6.    Contents of the pack and other information

1. What Actonel Once a Week is and what it is used for

What Actonel Once a Week is

Actonel Once a Week 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.

What Actonel Once a Week is used for

Treatment of osteoporosis in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures. Treatment of osteoporosis in men at high risk of fractures.

2. What you need to know before you take Actonel Once a Week

Do not take Actonel Once a Week

•    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

A Talk to your doctor or pharmacist before taking Actonef Once a Week :

• 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 ofa tooth.

•    If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Actonel Once

a Week .

Your doctor will advise you on what to do when taking Actonel Once a Week if you have any of the above.

Children and adolescents

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

Other medicines and Actonel Once a Week

Medicines containing one of the following lessen the effect of Actonel Once a Week 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 Once a Week tablet.

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

Actonel Once a Week with food and drink

Pregnancy and breast-feeding

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

Do NOT take Actonel Once a Week if you are breast-feeding (see section 2, "Do not take Actonel Once a Week").

Actonel Once a Week should only be used to treat postmenopausal women and men.

Driving and using machines

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

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

3. How to take Actonel Once a Week

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 Once a Week tablet (35 mg of risedronate sodium) once a week.

Choose one day of the week that best fits your schedule. Every week, take the Actonel Once a Week tablet on your chosen day. For your convenience, so that you take your tablet on the right day every week, there is a feature included with the Actonel Once a Week pack:

There are boxes/spaces on the back of the blister card. Please mark the day of the week you have chosen to take your Actonel Once a Week tablet. Also, write in the dates you will take the tablet.

WHEN to take the Actonel Once a Week tablet

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

HOW to take the Actonel Once a Week tablet

• Take the tablet whilst you are in an upright
position (you may sit or stand) to avoid	1 1
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• Swallow it with at least one glass (120 ml)	/fwX
of plain water.
• Swallow it whole. Do not suck or chew it.	Jj
• Do not lie down for 30 minutes after taking
your tablet.
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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 Actonel Once a Week than you should

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

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 Actonel Once a Week and contact a doctor immediately if you experience any of the following:

•    Symptoms of a severe allergic reaction such as;

•    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, "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)

•    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 (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.

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

• 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 Once a Week 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 (see section 2), crospovidone A, magnesium stearate and cellulose microcrystalline.

Film coating: hypromellose, macrogol, hydroxypropylcellulose and colloidal anhydrous silica, titanium dioxide [E171], iron oxide yellow [E172], iron oxide red [E172].

What Actonel Once a Week looks like and contents of the pack

Actonel Once a Week 35 mg film-coated tablets are oval light-orange 11.7 x 5.8 mm tablets with the letters "RSN" on one side and "35 mg" on the other side. The tablets are supplied in blister packs of 1,2, 4, 10, 12 or 16 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Warner Chilcott UK Ltd. (UK and IE)

Old Belfast Road Millbrook, Larne, County Antrim BT40 2SH, United Kingdom Actavis Group PTC ehf. (Malta)

Rejkyavikurvegur 76-78 220 Hafnarfjordur Iceland 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:

Austria: Actonel einmal wochentlich 35 mg Filmtabletten Belgium: Actonel 35 mg Wekelijks filmomhulde tabletten, Actonel 35 mg hebdomadaire comprime pellicule, Actonel 35 mg Wochentlich Filmtabletten Cyprus: Actonel OAW / «pla tpopa ir|v e(35o|ja5a» Denmark: Optinate Septimum 35 mg filmovertrukne tabletter Finland: Optinate Septimum 35 mg kalvopaallysteiset tabletit France: Actonel 35 mg comprime pellicule Germany: Actonel einmal wochentlich 35 mg Filmtabletten Greece: Actonel OAW / «pia cJ>opa xr|v e(35opa5a» Hungary: Actonel 35 mg filmtabletta Iceland: Optinate Septimum 35 mg filmuhu5a3ar toflur Ireland: Actonel Once a Week 35mg film coated tablets Italy: Actonel 35 mg compresse rivestite con film Latvia: Actonel 35 mg apvalkotas tabletes Luxembourg: Actonel 35 mg hebdomadaire comprime pellicule

Malta: Actonel "Once a Week" 35mg film-coated tablet The Netherlands: Actonel Wekelijks 35 mg, filmomhulde tabletten

Portugal: Actonel 35 mg comprimidos revestidos por pelfcula Spain: Actonel semanal 35 mg comprimidos recubiertos con pelfcula

Sweden: Optinate Septimum 35 mg filmdragerade tabletter United Kingdom: Actonel Once a Week 35mg film-coated tablets

This leaflet was last revised in: October 2014

5. How to store Actonel Once a Week

•    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.