PACKAGE LEAFLET: INFORMATION FOR THE USER

Actonel® Once Weekly 35mg Tablets

risedronate sodium

The name of your medicine is Actonel Once Weekly 35mg Tablets but will be referred to as Actonel Once Weekly throughout this leaflet.

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 Weekly is and what it is used for

2.    What you need to know before you take Actonel Once Weekly

3.    How to take Actonel Once Weekly

4.    Possible side effects

5.    How to store Actonel Once Weekly

6.    Contents of the pack and other information

1. WHAT ACTONEL ONCE WEEKLY IS AND WHAT IT IS USED FOR

What Actonel Once Weekly is

Actonel Once Weekly 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 Weekly 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 WEEKLY

Do not take Actonel Once Weekly

•    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 Actonel Once Weekly:

•    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 Actonel Once Weekly.

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

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

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

Taking Actonel Once Weekly with food and drink

It is very important that you do NOT take your Actonel Once Weekly 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 Once Weekly”).

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

Pregnancy and breast-feeding

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

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

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

Driving and using machines

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

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

3. HOW TO TAKE ACTONEL ONCE WEEKLY

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 Weekly 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 Weekly 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 Weekly 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 Weekly tablet. Also, write in the dates you will take the tablet.

WHEN to take the Actonel Once Weekly tablet

Take your Actonel Once Weekly 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 Weekly 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 Actonel Once Weekly than you should

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

If you forget to take Actonel Once Weekly

If you have forgotten to take your tablet on your chosen day, take it on the day you remember. Return to taking one tablet once a week on the day the tablet is normally taken.

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

If you stop taking Actonel Once Weekly

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 Weekly and contact a doctor immediately if you experience any of the following:

•    Symptoms of a severe allergic reaction such as;

o    Swelling of face, tongue or throat

o    Difficulties in swallowing

o 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.

5. HOW TO STORE ACTONEL ONCE WEEKLY

•    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 Once Weekly 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, crospovidone, magnesium stearate and microcrystalline cellulose.

Film coating: Yellow iron oxide (E172), hydroxypropylcellulose, hypromellose, macrogol 8000, macrogol 400, silicon dioxide, titanium dioxide (E171) and red iron oxide (E172).

What Actonel Once Weekly looks like and contents of the pack

Actonel Once Weekly 35mg Tablets are light orange, oval marked RSN on one side and 35mg on the reverse. It is supplied in blister packs of 4 tablets.

Manufacturer

The manufacturer of Actonel Once Weekly is Warner Chilcott Deutschland GmbH, Dr.-Otto-Rohm-Strasse 2-4, 64331 Weiterstadt, Germany and procured from within the EU by the product licence holder: Cd Pharma Limited, Unit 3, Manor Point, Manor Way, Borehamwood, Herts WD6 1EE.

Actonel Once Weekly 35mg Tablets

PL No. 20492/0003

For more information on osteoporosis contact

National Osteoporosis Society

Camerton

Bath

BA2 OPJ UK

Tel:01761 471771 Fax:01761 471104 Helpline:0845 4500230

Date of preparation: 07^th August 2013