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ACTONEL ONCE A WEEK 35MG FILM-COATED TABLETS

Active substance(s): RISEDRONATE SODIUM / RISEDRONIC ACID / RISEDRONATE SODIUM / RISEDRONIC ACID / 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. See section 4.

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.

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

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

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

Children and adolescents

If you forget to take Actonel

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.

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 a double dose to make up for a
forgotten tablet.

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:


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.
The recommended dose is 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.



Tell your doctor promptly if you experience the
following side effects:





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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)


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.

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.



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 possible 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.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name: Actonel Once
a Week 35mg Film-Coated
Tablets
Reference No: 08929/0478

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 medicine becomes discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist.
If your doctor decides to stop your treatment, take any
leftover medicine back to the pharmacy.
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.

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): 08.05.17
Actonel® is a registered trademark of Warner Chilcott
Company, LLC.

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Expand Transcript

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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