Actonel Once A Week 35mg Film-Coated Tablets

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Document: leaflet MAH BRAND_PLPI 08929-0478 change


_(risedronate sodium)_


Your medicine is available using the name Actonel Once a Week 35mg film-coated tablets, but will be referred to as Actonel 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 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 for

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 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 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 fra ctures.

2. What you need to know before you take Actonel

Do not take Actonel

■    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.

A Warnings and precautions

Talk to your doctor or pharmacist before taking Actonel:

■    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.

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 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").

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

Driving and using machines

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

Actonel contains a small amount of lactose monohydrate

(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 (35mg of risedronate sodium) once a week.

Choose one day of the week that best fits your schedule. Every week, take the Actonel 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 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 tablet. Also, write in the dates you will take the tablet.

WHEN to take the Actonel tablet

Take your Actonel 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 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 (120ml) 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 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 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

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 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 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 (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.

Reporting of side effects:

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

You can also report side effects directly via: Yellow Card Scheme Website:

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Actonel


■    Do not use this medicine after the expiry date marked on the carton and blister labels. The expiry date refers to the last day of that month.

■    This medicinal product does not require any special storage conditions.

■    If your tablets appear to be discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.

■    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

■    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. Contents of the pack and other information

What Actonel contains

The active substance is called risedronate sodium.

Each film-coated tablet contains 35mg risedronate sodium, equivalent to 32.5mg risedronic acid.

The tablets also contain the following additional ingredients: lactose monohydrate, crospovidone, magnesium stearate, microcrystalline cellulose, Dri-Klear [hypromellose, macrogol 400, hydroxypropyl cellulose, macrogol 8000 and silicon dioxide], Chroma-Tone White DDB-7536W [titanium dioxide (E171), hypromellose], ferric oxide yellow (E172) and ferric oxide red (E172).

What Actonel looks like and contents of the pack

Actonel are oval, light orange, film-coated tablets with 'RSN' on one side and '35 mg' on the reverse.

Your tablets are available in packs of 4 tablets.


Manufactured by: Warner Chilcott Germany GmbH,

Dr. -Otto-Rohm-Str., 2-4, 64331, Weiterstadt, Germany.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceuticals Ltd.,

Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0478 POM

Leaflet revision and issue date (Ref): 23.02.15

Actonel® is a registered trademark of Warner Chilcott Company, LLC.

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