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ACTONEL 30MG FILM-COATED TABLETS

Active substance(s): RISEDRONATE SODIUM

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Package leaflet: Information for the patient

• 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
age 18 due to insufficient data on safety and efficacy.

What is in this leaflet
1. What Actonel is and what it is used for
2. What you need to know before you take Actonel
3. How to take Actonel
4. Possible side effects
5. How to store Actonel
6. 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.
Paget’s disease occurs when this process, called remodeling,
happens too quickly and in a disordered way. The new bone that
is produced is weaker than normal and the affected bones may
become enlarged, painful and may fracture. Actonel changes the
bone remodeling process back to normal, returning the strength to
the bone structure.
What Actonel is used for
Treatment of Paget’s disease of the bone (osteitis deformans).

2. What you need to know before you take
Actonel
Do not take Actonel

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• 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.

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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.
Actonel contains a small amount of lactose (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 (30 mg of risedronate sodium) once
a day.
The recommended treatment duration is usually 2 months.
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
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:
• 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.
• 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.
• 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.
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10001427
IS Actonel 30mg UK WE15

10000707

United Kingdom

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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.

MPMS-No.:

98965654-XXX
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Techn. Drawing
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Placeholder for Sticker,
varnish free area)
● Colours
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Placement
● Code of goods
● Version
● Braille
● Barcode (EAN, ...)
approved QA-Label Control


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Word by word checked and approved by local regulatory
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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.

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.

If you forget to take Actonel
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).
Do NOT take two tablets in one day to make
up for the tablet you missed.
If you stop taking Actonel
Please talk to your doctor if you consider stopping treatment
before the end of prescribed duration.
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:
• Symptoms of a severe allergic reaction such as:
– Swelling of the 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 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.
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).

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

5. How to store Actonel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton and blister after EXP. The expiry date refers to the last
day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Actonel contains
The active substance is risedronate sodium. Each tablet contains
30 mg risedronate sodium, equivalent to 27.8 mg risedronic acid.
The other ingredients are:
Tablet core: lactose monohydrate (see section 2), crospovidone,
magnesium stearate and cellulose microcrystalline.
Film coating: hypromellose, macrogol, hydroxypropylcellulose,
colloidal anhydrous silica and titanium dioxide [E171].
What Actonel looks like and contents of the pack
Actonel 30 mg film-coated tablets are oval white tablets with the
letters “RSN” on one side and “30 mg” on the other side. The
tablets are supplied in blister packs of 1x3, 1x14, 28 (2x14)
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Warner Chilcott UK Limited,
Old Belfast Road,
Millbrook,
Larne,
County Antrim,
BT40 2SH
Manufacturer:
Warner Chilcott Deutschland GmbH,
Dr.-Otto-Röhm-Str. 2–4,
64331 Weiterstadt,
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
Belgium: Actonel 30 mg filmomhulde tabletten,
Actonel 30 mg comprimé pelliculé,
Actonel 30 mg Filmtabletten
France: Actonel 30 mg comprimé pelliculé
Germany: Actonel 30 mg Filmtabletten
Greece: Actonel 30 mg επικαλυμμένα με λεπτ υμένιο δισκία
Ireland: Actonel 30 mg film-coated tablets
Italy: Actonel 30 mg compresse rivestite con film
Luxembourg: Actonel 30 mg comprimé pelliculé
The Netherlands: Actonel 30 mg omhulde tabletten
Spain: Actonel 30 mg comprimidos recubiertos con película
Sweden: Actonel 30 mg filmdragerade tabletter
United Kingdom: Actonel 30 mg film-coated tablets
This leaflet was last approved in: November 2014

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10001427

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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.
The additional following adverse events has also been observed
in a clinical study in patients with Paget’s disease: vision difficulties,
breathing difficulties, coughing, inflammation of the large intestine,
surface of the eye damage, cramps, dizziness, dryness of the eye,
flu-like symptoms, muscle weakness, abnormal growth of cells,
a frequent need to pass water at night, unusual lumps or swellings,
chest pain, rash, runny nose, ringing in the ears and weight loss.

Leaflet: Page 2

Replace SAP-No.:

10001427
IS Actonel 30mg UK WE15

10000707

United Kingdom

3

21.07.2014 s+b/hp
11.11.2014 s+b/hp/hp
210 x 320 mm
9 pt
2 of 2
PMS Black ■

Leserichtung
80 mm von oben

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

MPMS-No.:

98965654-XXX
Diecut

––––––––––––

Techn. Drawing
(Size, perforation, label,
Placeholder for Sticker,
varnish free area)
● Colours
● Pharma Code (Laetus),
Placement
● Code of goods
● Version
● Braille
● Barcode (EAN, ...)
approved QA-Label Control


Variation (Colloidal anhydrous silica)

Word by word checked and approved by local regulatory
Datum/Date: ................................................................. Unterschrift/Sign: ....................................................................................................

Expand view ⇕

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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