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ACTONEL ONCE A WEEK 35MG FILM-COATED TABLETS

Active substance(s): RISEDRONATE SODIUM / RISEDRONIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ACTONEL® ONCE A WEEK
35mg FILM-COATED TABLETS
(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.
2.
3.
4.
5.
6.

What Actonel is and what it is used for
What you need to know before you take Actonel
How to take Actonel
Possible side effects
How to store Actonel
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
fractures.

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.

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.
Page 1 of 2

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.

Common side effects (may affect up to 1 in 10 people)


If you take more Actonel than you should

Indigestion, feeling sick, stomach ache, stomach cramps or
discomfort, constipation, feelings of fullness, bloating,
diarrhoea.
Pain in your bones, muscles or joints.
Headache.

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

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

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.





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.

4. Possible side effects

During post-marketing experience, the following
have been reported (unknown frequency):

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:

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.







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.

Hair loss
Liver disorders, some cases were severe.

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: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store Actonel










KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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.

Page 2 of 2

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.

Manufacturer

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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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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