RISEDRONATE SODIUM 5MG TABLETS

Active substance: RISEDRONATE SODIUM

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S066 LEAFLET Actonel 20120907

PACKAGE LEAFLET: INFORMATION FOR THE USER

ACTONEL 5mg TABLETS
RISEDRONATE SODIUM 5mg TABLETS
(risedronate sodium)
Your medicine is marketed using the above names but will be
referred to as Actonel throughout the following patient information
leaflet.

Take special care and talk to your doctor BEFORE you start
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 had problems in the past with your oesophagus (the
tube that connects your mouth with your stomach). For instance
you may 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.

Read all of this leaflet carefully before you start taking this
medicine.


Keep this leaflet. You may need to read it again.



If you have any questions, ask your doctor or pharmacist.



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

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

In this leaflet:

Children

1. What Actonel is and what it is used for
2. Before you take Actonel

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

3. How to take Actonel

Taking other medicines

4. Possible side effects

Medicines containing one of the following lessen the effect of
Actonel if taken at the same time:

5. How to store Actonel
6. Further 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 is more likely to occur in women who have reached
the menopause early and also in patients treated long-term with
steroids.
The spine, hip and wrist are the most likely bones to break,
although this can happen to any bone in your body. Osteoporosisrelated 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
The treatment of osteoporosis


in postmenopausal women.

The prevention of osteoporosis




in women with an increased risk of osteoporosis (including
low bone mass, early menopause or a family history of
osteoporosis).
in postmenopausal women who have been on high doses of
steroid drugs for a long time. It maintains or increases bone
mass.



calcium



magnesium



aluminium (for example some indigestion mixtures)



iron.

Take these medicines at least 30 minutes after your Actonel tablet.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking 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,
“Taking other medicines”).
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”).
Driving and using machines
Actonel is not known to affect your ability to drive and use
machines.
Important information about some of the ingredients of Actonel
Actonel contains a small amount of lactose (see section 2, “Take
special care and talk to your doctor before you start taking
Actonel”).
3. HOW TO TAKE ACTONEL

2. BEFORE YOU TAKE ACTONEL

Dosage

Do NOT take Actonel

Always take Actonel exactly as your doctor has told you. You
should check with your doctor if you are not sure.



If you are allergic to risedronate sodium or any of the other
ingredients of Actonel (see section 6, “What Actonel contains”).



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.

Usual dose:
Take ONE Actonel tablet (5 mg of risedronate sodium) once a day.
For your convenience, the days of the week are printed on the
blister foil to help you remember to take your medicine.

WHEN to take the Actonel tablet

Common side effects (affects 1 to 10 users in 100)

IT IS BEST to take your Actonel tablet at least 30 minutes before
the first food, drink (other than plain water) or other medicine of the
day. If in particular instance you are unable to take your Actonel
tablet at this time, you may take it on an empty stomach, at the
same time every day, in one of the following ways:



Indigestion, feeling sick, stomach ache, stomach cramps or
discomfort, constipation, feelings of fullness, bloating,
diarrhoea.



Pain in your bones, muscles or joints.



EITHER
Between meals: at least 2 hours after your last food, drink
(other than plain water) or other medicine. Do not eat or drink
(other than plain water) for 2 hours after taking the tablet.



 Headache.
Uncommon side effects (affects 1 to 10 users in 1,000)


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, “Take special care and talk to
your doctor before you start taking Actonel”), 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).

OR

In the evening: at least 2 hours after your last food, drink (other
than plain water) or other medicine of the day. Actonel should
be taken at least 30 minutes before going to bed.
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 (120 ml) of plain water.



Swallow it whole. Do not suck or chew it.



Rare side effects (affects 1 to 10 users in 10,000)

Do not lie down for 30 minutes after taking your tablet.



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.

Your doctor will tell you if you need calcium and vitamin
supplements, if you are not taking enough from your diet.

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

If you take MORE Actonel than you should



Hair loss.



Liver disorders, some cases were severe.

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

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 have forgotten to take your tablet at your regular time, you
can take it at the next possible time according to the instruction
above (i.e. before breakfast, between meals, or in the evening).

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

Do NOT take two tablets in one day to make up for the tablet you
missed.
If you STOP taking Actonel

5. HOW TO STORE ACTONEL

If you stop treatment you may begin to lose bone mass. Please talk
to your doctor before you consider stopping treatment.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Actonel 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 the face, tongue or throat.

6. FURTHER INFORMATION



Difficulties in swallowing.

What Actonel contains



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, “Take special care and talk to your doctor before
you start taking Actonel”).



Symptoms from oesophagus such as pain when you swallow,
difficulties in swallowing, chest pain or new/worsened
heartburn.

Each film-coated tablet contains 5mg of the active ingredient,
risedronate sodium (equivalent to 4.64mg of risedronic acid).



Actonel also contains the following inactive ingredients: lactose
monohydrate, crospovidone, magnesium stearate and
microcrystalline cellulose, yellow iron oxide (E172),
hydroxypropylcellulose, hypromellose, macrogol 8000,
macrogol 400, silicon dioxide and titanium dioxide (E171).
What Actonel looks like and contents of the pack
Actonel is an oval yellow film-coated tablet with RSN on one side
and 5 mg on the other.
Actonel is available as blister packs of 28 tablets.
Product Licence holder

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.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

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.



Proctor & Gamble Pharmaceuticals Germany, Dr-Otto-Rohm
Str. 2-4, 64331 Weiterstadt, Germany.



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

This product is manufactured by

POM

PL No: 19488/0066

Leaflet revision date: 07 September 2012
Actonel is a registered trade mark of Proctor & Gamble
Pharmaceuticals Inc, USA.
S066 LEAFLET Actonel 20120907

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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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