ACTONEL ONCE A WEEK 35MG TABLETS

Active substance: RISEDRONATE SODIUM

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

ACTONEL® ONCE A WEEK 35mg TABLETS
(risedronate sodium)
Patient Information Leaflet

Your medicine will be referred to as Actonel Once a Week throughout this leaflet.

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.

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WARNING!

Warnings and precautions
Talk to your doctor or pharmacist before taking Actonel 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
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 a Week.
Your doctor will advise you on what to do when taking Actonel Once a Week if you have any of the above.

05/11/13

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

UK PIL DATED JANUARY 2013
REPORTING OF SIDE EFFECTS

6464/2061D

DATE OF PROOF:

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 or have recently taken or might take any other medicines,
including medicines obtained without a prescription.

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PRODUCT:

Actonel Once a Week 35mg tabs

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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.

Taking Actonel Once a Week with food and drink
It is very important that you do NOT take your Actonel Once a Week 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 a
Week”).
Take food and drinks (other than plain water) at least 30 minutes after your Actonel Once a Week tablet.
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 post-menopausal women and men.
Driving and using machines
Actonel Once a Week is not known to affect your ability to drive and use machines.
Important information about some of the ingredients of Actonel Once a Week
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.

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WARNING!

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Notes:

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.

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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

PROOF HISTORY:
v.2 - waymade - 05/11/13

Leaflet Flat Size = 148 x 400

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WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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 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 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.

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.

WARNING!

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.

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.

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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.

05/11/13

ARTWORKER:

PRE-PRESS NO.:

05-0269

Q.A.
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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).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

UK PIL DATED JANUARY 2013
REPORTING OF SIDE EFFECTS

6464/2061D




CODE:

Actonel Once a Week 35mg tabs
PRODUCT:

CUSTOMER: Waymade

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





5. How to store Actonel Once a Week
Actonel Once a Week 35mg tablets have no special storage requirements.
Do not use after the expiry date printed on the carton label or blister strip after EXP. The expiry
date refers to the last day of that month.
Keep all medicines out of the sight and reach of children.
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.
If the tablets become discoloured or show any other signs of deterioration, you should consult
your pharmacist who will advise you what to do.

6. Contents of the pack and other information
Your medicine is called Actonel Once a Week 35mg tablets. Each film-coated tablet contains 35mg of the
active ingredient risedronate sodium (equivalent to 32.5mg of risedronic acid) in an, oval, light peach tablet
marked 'RSN' on one side and marked with ‘35mg’ on the reverse.
Actonel Once a Week 35mg tablets also contain the following inactive ingredients:
lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate,
hydroxypropylcellulose, hypromellose, macrogol 8000, macrogol 400, silicon dioxide, titanium dioxide
(E171), red iron oxide (E172) and yellow iron oxide (E172).
Actonel Once a Week 35mg tablets are available as blister packs of 4 tablets.
POM

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PL No: 6464/2061

This product is manufactured by Procter & Gamble Pharmaceuticals Germany GmbH, Dr-Otto-Rohm-Str.
2-4, 64331 Weiterstadt, Germany and is procured from within the EU and repackaged by the Product
Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 31.10.2013
Actonel is a registered trademark of Procter & Gamble Pharmaceuticals.
For more information on osteoporosis, contact:
National Osteoporosis Society, Camerton, Bath, BA2 0PJ UK
Phone: +44 (0) 1761 471771
Fax: +44 (0) 1761 471104 Helpline: 0845 450 0230

www.nos.org.uk

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WARNING!

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.

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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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

If you stop taking Actonel Once a Week
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.

PROOF HISTORY:
v.2 - waymade - 05/11/13

Leaflet Flat Size = 148 x 400

If you forget to take Actonel Once a Week
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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