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ACTONEL ONCE WEEKLY 35MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Actonel® Once Weekly 35mg Tablets
risedronate sodium

The name of your medicine is Actonel Once Weekly 35mg Tablets
but will be referred to as Actonel Once Weekly 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.
What is in this leaflet:
1. What Actonel Once Weekly is and what it is used for
2. What you need to know before you take Actonel Once Weekly
3. How to take Actonel Once Weekly
4. Possible side effects
5. How to store Actonel Once Weekly
6. Contents of the pack and other information

1. WHAT ACTONEL ONCE WEEKLY IS AND WHAT
IT IS USED FOR





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
Weekly.

Your doctor will advise you on what to do when taking Actonel Once
Weekly 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.
Other medicines and Actonel Once Weekly
Medicines containing one of the following lessen the effect of Actonel
Once Weekly if taken at the same time:

calcium

magnesium

aluminium (for example some indigestion mixtures)

iron.

What Actonel Once Weekly is

Take these medicines at least 30 minutes after your Actonel Once
Weekly tablet.

Actonel Once Weekly 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.

Tell your doctor or pharmacist if you are taking or have recently taken
or might take any other medicines, including medicines obtained
without a prescription.

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 Weekly 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 WEEKLY
Do not take Actonel Once Weekly

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 Weekly:

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).

Taking Actonel Once Weekly with food and drink
It is very important that you do NOT take your Actonel Once Weekly
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 Weekly”).
Take food and drinks (other than plain water) at least 30 minutes after
your Actonel Once Weekly tablet.
Pregnancy and breast-feeding
Do NOT take Actonel Once Weekly if you may be pregnant, are
pregnant or planning to become pregnant (see section 2, “Do not take
Actonel Once Weekly”). The potential risk associated with the use of
risedronate sodium (active substance in Actonel Once Weekly) in
pregnant women is unknown.
Do NOT take Actonel Once Weekly if you are breast-feeding (see
section 2, “Do not take Actonel Once Weekly”).
Actonel Once Weekly should only be used to treat postmenopausal
women and men.
Driving and using machines
Actonel Once Weekly is not known to affect your ability to drive and
use machines.
Actonel Once Weekly contains a small amount of lactose (see section
2, “Warnings and precautions”).

3. HOW TO TAKE ACTONEL ONCE WEEKLY
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 Weekly 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 Weekly 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 Weekly
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
Weekly tablet. Also, write in the dates you will take the tablet.

WHEN to take the Actonel Once Weekly tablet
Take your Actonel Once Weekly 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 Weekly 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.
If you take more Actonel Once Weekly than you should
If you or somebody else has accidentally taken more Actonel Once
Weekly tablets than prescribed, drink one full glass of milk and seek
medical attention.
If you forget to take Actonel Once Weekly
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 Weekly
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 Weekly and contact a doctor
immediately if you experience any of the following:

Symptoms of a severe allergic reaction such as;
o
Swelling of face, tongue or throat
o
Difficulties in swallowing
o
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).

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.
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 ONCE WEEKLY




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 Weekly 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, crospovidone, magnesium
stearate and microcrystalline cellulose.
Film coating: Yellow iron oxide (E172), hydroxypropylcellulose,
hypromellose, macrogol 8000, macrogol 400, silicon dioxide, titanium
dioxide (E171) and red iron oxide (E172).
What Actonel Once Weekly looks like and contents of the pack
Actonel Once Weekly 35mg Tablets are light orange, oval marked
RSN on one side and 35mg on the reverse. It is supplied in blister
packs of 4 tablets.
Manufacturer
The manufacturer of Actonel Once Weekly is Warner Chilcott
Deutschland GmbH, Dr.-Otto-Röhm-Strasse 2-4, 64331 Weiterstadt,
Germany and procured from within the EU by the product licence
holder: CD Pharma Limited, Unit 3, Manor Point, Manor Way,
Borehamwood, Herts WD6 1EE.
Actonel Once Weekly 35mg Tablets
PL No. 20492/0003

POM

For more information on osteoporosis contact
National Osteoporosis Society
Camerton
Bath
BA2 OPJ
UK
Tel:01761 471771
Fax:01761 471104
Helpline:0845 4500230
Date of preparation: 07th August 2013

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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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