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ACTONEL ONCE A WEEK 35MG TABLETS

Active substance(s): RISEDRONATE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
®

Actonel Once a Week 35mg tablets
(risedronate sodium)
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.
The name of your medicine is Actonel Once a Week 35mg tablets
but will be referred to as Actonel Once a Week throughout 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

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.
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.

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.

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.
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 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, have recently
taken or might take any other medicines.
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
postmenopausal women and men.
Driving and using machines
Actonel Once a Week is not known to affect your ability to drive
and use machines.
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 (35mg 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.

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
(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 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.

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.

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.

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

5. How to store Actonel Once a Week
Keep out of the sight and reach of children.
Do not take your tablets after the expiry date which is stated on
the box/blisters/label after ‘Exp’. The expiry date refers to the last
day of that month.
If the tablets become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist.
if your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep
this medicine 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 Once a Week contains
The active ingredient in Actonel once a week is risedronate
sodium. Each tablet contains 35mg risedronate sodium, as the
active ingredient, equivalent to 32.5mg risedronic acid.
Actonel once a week also contain the following inactive
ingredients: Tablet core: lactose monohydrate, crospovidone,
magnesium stearate and microcrystalline cellulose.
Film coating: Dri-Klear (hypromellose, macrogol 400,
hydroxypropyl cellulose, macrogol 8000 and silicon dioxide),
Chroma-Tone White DDB-7536W (titanium dioxide (E171), yellow
iron oxide (E172) and red iron oxide (E172).

What Actonel Once a Week looks like and contents of the
pack
Actonel once a week are oval, light-orange, film-coated tablets with
‘RSN’ on one side and ‘35mg’ on the other side.
Actonel once a week are supplied in blister packs of 4 tablets
Manufactured by: Procter & Gamble Pharmaceuticals- Germany
GmbH, Dr.-Otto-Röhm-Str. 2-4, 64331 Weiterstadt, Germany.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
®

Actonel Once a Week 35mg tablets;
PL: 18799/0800
POM
Leaflet date: 16.07.2015
Actonel is a registered trademark of the Procter & Gamble
Pharmaceuticals.

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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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