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RISEDRONATE SODIUM ONCE A WEEK 35MG TABLETS

Active substance(s): RISEDRONATE SODIUM

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S0973 LEAFLET Actonel 20150521



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.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

ACTONEL ONCE A WEEK 35mg TABLETS
(risedronate sodium)
Your medicine is known as Actonel once a week 35mg tablets but
will be referred to as Actonel once a week tablets throughout the
following 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

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

1. What Actonel Once a Week is and what it is used for

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

2. What you need to know before you take Actonel Once a Week



calcium

3. How to take Actonel Once a Week



magnesium

4. Possible side effects



aluminium (for example some indigestion mixtures)



iron.

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.

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.
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”).

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.

Take food and drinks (other than plain water) at least 30 minutes
after your Actonel Once a Week tablet.

Osteoporosis can also occur in men due to a number of causes
including ageing and/or a low level of the male hormone,
testosterone.

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.

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

Pregnancy and breast-feeding

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”).

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



Take ONE Actonel Once a Week tablet (35 mg of risedronate
sodium) once a week.

If you are breast-feeding



If you have severe kidney problems.

Choose one day of the week that best fits your schedule. Every
week, take the Actonel Once a Week tablet on your chosen day.

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).

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:

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

Rare side effects (may affect up to 1 in 1,000 people)

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.



Inflammation of the tongue (red swollen, possibly painful),
narrowing of the oesophagus (the tube that connects your
mouth with your stomach).

HOW to take the Actonel Once a Week tablet



Abnormal liver tests have been reported. These can only be
diagnosed from a blood test.



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.

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



Swallow it whole. Do not suck or chew it.



Hair loss



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



Liver disorders, some cases were severe

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.

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 the 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.
5. HOW TO STORE ACTONEL ONCE A WEEK


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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.

Do not use this medicine after the expiry date which is stated on
the pack.



If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



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.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

 Severe skin reactions that can include blistering of the skin.
Tell your doctor promptly if you experience the following side
effects:

What Actonel Once a Week contains


Each film-coated tablet contains 35mg of the active ingredient,
risedronate sodium equivalent to 32.5mg risedronic acid.



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”).

Actonel Once a Week Tablets also contain the following
inactive ingredients: lactose monohydrate, microcrystalline
cellulose, crospovidone magnesium stearate, Dri-Klear,
Chroma-tone DDB-7536W white, yellow ferric oxide (E172) and
red ferric oxide (E172).



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).

What Actonel Once a Week looks like and contents of the pack
Actonel Once a Week Tablets are oval, light orange tablets marked
‘RSN’ on one side and 35mg on the other.
Actonel Once a Week Tablets are available as blister packs of 4
tablets.
Product License Holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Procter & Gamble
Pharmaceuticals Germany GmbH, Dr Otto Roehm-Str 2-4, D-64331
Weiterstadt, Germany.
And
Warner Chilcott Deutschland GmbH, Dr Otto Roehm-Str 2-4, D64331 Weiterstadt, Germany
POM

PL No. 19488/0973

For more information on osteoporosis contact:
National Osteoporosis Society,
Camerton, Bath, BA2 0PJ, UK
Phone +44 (0)1761 471771
Fax +44 (0)1761 471104
Helpline 0845 450 0230
www.nos.org.uk
Leaflet revision date: 21 May 2015
Actonel is a registered trade mark of Procter & Gamble Company,
USA.
S0973 LEAFLET Actonel 20150521



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).

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



If you have had or have pain, swelling or numbness of the jaw
or a “heavy jaw feeling” or loosening of a tooth.



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





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

If you are under dental treatment or will undergo dental surgery,
tell your dentist that you are being treated with Risedronate
Once a Week.



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.

Your doctor will advise you on what to do when taking Risedronate
Once a Week if you have any of the above.

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

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

S0973 LEAFLET Risedronate 20150521

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

RISEDRONATE SODIUM ONCE A WEEK 35mg
TABLETS
Your medicine is known as Risedronate Sodium once a week 35mg
tablets but will be referred to as Risedronate once a week
throughout the following leaflet.



Children and adolescents

What is in this leaflet

Other medicines and Risedronate Once a Week

1. What Risedronate Once a Week is and what it is used for

Medicines containing one of the following lessen the effect of
Risedronate Once a Week if taken at the same time:

2. What you need to know before you take Risedronate Once a
Week



calcium

3. How to take Risedronate Once a Week



magnesium

4. Possible side effects



aluminium (for example some indigestion mixtures)

5. How to store Risedronate Once a Week



iron.

6. Contents of the pack and other information

Take these medicines at least 30 minutes after your Risedronate
Once a Week tablet.

1. WHAT RISEDRONATE ONCE A WEEK IS AND WHAT IT IS
USED FOR
What Risedronate Once a Week is
Risedronate 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 Risedronate 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
RISEDRONATE ONCE A WEEK
Do not take Risedronate Once a Week

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

Take ONE Risedronate Once a Week tablet (35 mg of risedronate
sodium) once a week.



If you are breast-feeding

Choose one day of the week that best fits your schedule. Every
week, take the Risedronate Once a Week tablet on your chosen
day.

 If you have severe kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate
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).

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:

For your convenience, so that you take your tablet on the right day
every week, there is a feature included with the Risedronate 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
Risedronate Once a Week tablet. Also, write in the dates you will
take the tablet.

WHEN to take the Risedronate Once a Week tablet

Rare side effects (may affect up to 1 in 1,000 people)

Take your Risedronate Once a Week tablet at least 30 minutes
before the first food, drink (other than plain water) or other medicine
of the day.



Inflammation of the tongue (red swollen, possibly painful),
narrowing of the oesophagus (the tube that connects your
mouth with your stomach).

HOW to take the Risedronate Once a Week tablet



Abnormal liver tests have been reported. These can only be
diagnosed from a blood test.



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.

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



Swallow it whole. Do not suck or chew it.



Hair loss



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



Liver disorders, some cases were severe

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 Risedronate Once a Week than you should
If you or somebody else has accidentally taken more Risedronate
Once a Week tablets than prescribed, drink one full glass of milk
and seek medical attention.
If you forget to take Risedronate 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.

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 the 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.
5. HOW TO STORE RISEDRONATE ONCE A WEEK


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

If you stop taking Risedronate Once a Week



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

Do not use this medicine after the expiry date which is stated on
the pack.



If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop taking Risedronate 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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

 Severe skin reactions that can include blistering of the skin.
Tell your doctor promptly if you experience the following side
effects:

What Risedronate Once a Week contains


Each film-coated tablet contains 35mg of the active ingredient,
risedronate sodium equivalent to 32.5mg risedronic acid.



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”).

Risedronate Once a Week Tablets also contain the following
inactive ingredients: lactose monohydrate, microcrystalline
cellulose, crospovidone magnesium stearate, Dri-Klear,
Chroma-tone DDB-7536W white, yellow ferric oxide (E172) and
red ferric oxide (E172).



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).

What Risedronate Once a Week looks like and contents of the
pack
Risedronate Once a Week Tablets are oval, light orange tablets
marked ‘RSN’ on one side and 35mg on the other.
Risedronate Once a Week Tablets are available as blister packs of
4 tablets.
Product License Holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Procter & Gamble
Pharmaceuticals Germany GmbH, Dr Otto Roehm-Str 2-4, D-64331
Weiterstadt, Germany.
And
Warner Chilcott Deutschland GmbH, Dr Otto Roehm-Str 2-4, D64331 Weiterstadt, Germany
POM

PL No. 19488/0973

For more information on osteoporosis contact:
National Osteoporosis Society,
Camerton, Bath, BA2 0PJ, UK
Phone +44 (0)1761 471771
Fax +44 (0)1761 471104
Helpline 0845 450 0230
www.nos.org.uk
Leaflet revision date: 21 May 2015
S0973 LEAFLET Risedronate 20150521

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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