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ACTONEL ONCE A WEEK 35 MG FILM-COATED TABLETS

Active substance(s): RISEDRONATE SODIUM / RISEDRONATE SODIUM / RISEDRONATE SODIUM

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Package leaflet: Information for the patient

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
 hat Actonel Once a Week is and what it is used for
1. W
2. W
 hat 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 nonhormonal 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.
The recommended dose is ONE Actonel Once a Week tablet (35 mg 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 (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.

Please turn over...

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.

Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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.

Malta
ADR Reporting:
www.medicinesauthority.gov.mt/adrportal

Do not take a double dose to make up for a forgotten
tablet.

5. How to store Actonel Once a Week

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.
Very rare (may affect up to 1 in 10,000 people)
• Talk to your doctor if you have ear pain, discharge from the ear, and/or
an ear infection. These could be signs of bone damage in the ear.
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:
United Kingdom
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.
• 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 Once a Week contains
The active substance is risedronate sodium. Each tablet contains 35 mg
risedronate sodium, equivalent to 32.5 mg risedronic acid.
The other ingredients are:
Tablet core: lactose monohydrate (see section 2), crospovidone A,
magnesium stearate and cellulose microcrystalline.
Film coating: hypromellose, macrogol, hydroxypropylcellulose and
colloidal anhydrous silica, titanium dioxide [E171], iron oxide yellow
[E172], iron oxide red [E172].
What Actonel Once a Week looks like and contents of the
pack
Actonel Once a Week 35 mg film-coated tablets are oval light-orange
11.7 x 5.8 mm tablets with the letters “RSN” on one side and “35 mg” on
the other side. The tablets are supplied in blister packs of 1, 2, 4, 10, 12
or 16 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Warner Chilcott UK Ltd. (UK and IE)
Old Belfast Road
Millbrook, Larne, County Antrim,
BT40 2SH, United Kingdom
Actavis Group PTC ehf., (Malta)
Reykjavikurvegur 76-78,
220 Hafnarfjordur,
Iceland
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:
Austria: Actonel einmal wöchentlich 35 mg Filmtabletten
Belgium: Actonel 35 mg Wekelijks filmomhulde tabletten,
Actonel 35 mg hebdomadaire comprimé pelliculé,
Actonel 35 mg Wöchentlich Filmtabletten
Cyprus: Actonel OAW / ‘’μία φορά την εβδομάδα’’
Denmark: Optinate Septimum 35 mg filmovertrukne tabletter
Finland: Optinate Septimum 35 mg kalvopäällysteiset tabletit
France: Actonel 35 mg comprimé pelliculé
Germany: Actonel einmal wöchentlich 35 mg Filmtabletten
Greece: Actonel OAW / ‘’μία φορά την εβδομάδα’’
Hungary: Actonel 35 mg filmtabletta
Iceland: Optinate Septimum 35 mg filmuhúðaðar töflur
Ireland: Actonel Once a Week 35 mg film-coated tablets
Italy: Actonel 35 mg compresse rivestite con film
Luxembourg: Actonel 35 mg hebdomadaire comprimé pelliculé
Malta: Actonel “Once a Week” 35 mg film-coated tablet
The Netherlands: Actonel Wekelijks 35 mg, filmomhulde tabletten
Portugal: Actonel 35 mg comprimidos revestidos por película
Spain: A
 ctonel semanal 35 mg comprimidos recubiertos con película
Sweden: Optinate Septimum 35 mg filmdragerade tabletter
United Kingdom: Actonel Once a Week 35 mg film-coated tablets
This leaflet was last revised in December 2015
AAAI5653

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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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