RISEDRONATE SODIUM 35MG FILM-COATED TABLETS

Active substance: RISEDRONATE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTONEL Once a Week 35mg Tablets/
Risedronate Sodium 35mg Film-Coated Tablets
(risedronate sodium)
This product is known as either of the above but will be referred
to as Actonel Once a Week 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 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
age 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 or have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
Taking 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 (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.
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 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 a Week

 Keep 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 medicinal product does not require any special storage
conditions.
 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. Further 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 tablets also contain the following inactive ingredients: lactose
monohydrate, crospovidone, magnesium stearate and
microcrystalline cellulose, hypromellose, hyprolose, macrogol 400,
macrogol 8000, silicon dioxide, titanium dioxide [E171], yellow iron
oxide [E172], and red iron oxide [E172].
Warning: This medicine contains lactose. If you have been told by
your doctor that you have an intolerance to some sugars contact your
doctor before taking this medicinal product.
What Actonel Once a Week looks like and contents of the pack
Actonel Once a Week tablets are oval, light orange, film-coated
tablets with the letters ‘RSN’ on one side and “35 mg” on the other
side.
Actonel Once a Week tablets are supplied in calendar blister packs
containing 4 or 12 tablets
Manufacturer:
Warner Chilcott Deutschland GmbH, Dr. - Otto-Rohm-Strabe 2-4,
64331 Weiterstadt, Germany.
Procured from within the EU by the Parallel Import Product licence
holder: G Pharma Limited, Salford M50 2PU.
PL 16369/1279

POM

ACTONEL Once a Week 35mg Tablets
23rd July 2013
‘Actonel’ is a registered trademark of Procter & Gamble
For more information on Osteoporosis contact:
National Osteoporosis Society,
Camerton, Bath, BA2 0PJ, UK
Tel: 01761 471771
Fax: 01761 471104
Helpline: 0845 450 0230
www.nos.org.uk

PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTONEL Once a Week 35mg Tablets/
Risedronate Sodium 35mg Film-Coated Tablets
(risedronate sodium)
This product is known as either of the above but will be referred
to as Actonel Once a Week 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 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
age 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 or have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
Taking 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 (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.
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 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 a Week

 Keep 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 medicinal product does not require any special storage
conditions.
 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. Further 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 tablets also contain the following inactive ingredients: lactose
monohydrate, crospovidone, magnesium stearate and
microcrystalline cellulose, hypromellose, hyprolose, macrogol 400,
macrogol 8000, silicon dioxide, titanium dioxide [E171], yellow iron
oxide [E172], and red iron oxide [E172].
Warning: This medicine contains lactose. If you have been told by
your doctor that you have an intolerance to some sugars contact your
doctor before taking this medicinal product.
What Actonel Once a Week looks like and contents of the pack
Actonel Once a Week tablets are oval, light orange, film-coated
tablets with the letters ‘RSN’ on one side and “35 mg” on the other
side.
Actonel Once a Week tablets are supplied in calendar blister packs
containing 4 or 12 tablets
Manufacturer:
Warner Chilcott Deutschland GmbH, Dr. - Otto-Rohm-Strabe 2-4,
64331 Weiterstadt, Germany.
Procured from within the EU by the Parallel Import Product licence
holder: G Pharma Limited, Salford M50 2PU.
PL 16369/1279

POM

ACTONEL Once a Week 35mg Tablets
23rd July 2013
‘Actonel’ is a registered trademark of Procter & Gamble
For more information on Osteoporosis contact:
National Osteoporosis Society,
Camerton, Bath, BA2 0PJ, UK
Tel: 01761 471771
Fax: 01761 471104
Helpline: 0845 450 0230
www.nos.org.uk

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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