RISEDRONATE SODIUM 5MG FILM-COATED TABLETS

Active substance: RISEDRONATE SODIUM

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Package leaflet: Information for the patient

Risedronate sodium 5 mg film-coated tablets
Risedronate sodium

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•  eep this leaflet. You may need to read it again.
K
•  f you have any further questions, ask your
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doctor or pharmacist.
•  his medicine has been prescribed for you only.
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Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
•  f you get any side effects, talk to your doctor
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or pharmacist. This includes any possible side
effects not listed in this leaflet.

What is in this leaflet
1 What Risedronate sodium is and what it is
used for
2 What you need to know before you take
Risedronate sodium
3 How to take Risedronate sodium
4 Possible side effects
5 How to store Risedronate sodium
6 Contents of the pack and other
information
1 What Risedronate sodium is and what it is

used for

What Risedronate sodium is

Risedronate sodium 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.
It is more likely that early menopausal women
and patients on long-term steroid treatment get
osteoporosis.
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 sodium is used for

The treatment of osteoporosis:
• n postmenopausal women.
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The prevention of osteoporosis:
• n women with an increased risk of osteoporosis
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(including low bone mass, early menopause and a
family history of osteoporosis)
• n postmenopausal women undergoing long-term
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steroid treatment at high doses. Bone mass is
withheld or increased.

2 What you need to know before you take

Risedronate sodium

Do not take Risedronate sodium:

• f you are allergic to risedronate sodium or any of the
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other ingredients of this medicine (listed in section 6)
• f your doctor has told you that you have a condition
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called hypocalcaemia (a low blood calcium level)
• f you may be pregnant, are pregnant or planning to
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become pregnant
• f you are breast-feeding
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• f you have severe kidney problems.
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Warnings and precautions
Talk to your doctor or pharmacist before taking
Risedronate sodium
• f you are unable to stay in an upright position
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(sitting or standing) for at least 30 minutes.
• f you have abnormal bone and mineral metabolism
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(for example lack of vitamin D, parathyroid hormone
abnormalities, both leading to a low blood calcium
level).

AAAF2143

• f you have had problems in the past with your
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oesophagus (the tube that connects your mouth
with your stomach). For instance you may have
had pain or difficulty in swallowing food or you
have previously been told that you have Barratt‘s
oesophagus (a condition associated with changes in
the cells that line the lower oesophagus).
• f you have been told by your doctor that you have
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an intolerance to some sugars (such as lactose).
• f you have had or have pain, swelling or numbness
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of the jaw or a “heavy jaw feeling” or loosening of a
tooth.
• f you are under dental treatment or will undergo
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dental surgery, tell your dentist that you are being
treated with Risedronate sodium.
Your doctor will advise you on what to do when taking
Risedronate sodium if any of the above applies to you.

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 Risedonate sodium

Medicinal products containing one of the following
lessen the effect of Risedronate sodium if taken at the
same time:
•  alcium
c
•  agnesium
m
•  luminium (for example some indigestion mixtures)
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• ron.
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Take these medicines at least 30 minutes after your
Risedronate sodium tablet.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Risedronate sodium with food and drink

It is very important that you do NOT take your
Risedronate sodium 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 sodium”). Take food and drinks (other than
plain water) at least 30 minutes after your Risedronate
sodium tablet.

Pregnancy and breast-feeding

Do not take Risedronate sodium if you may be
pregnant, are pregnant or planning to become
pregnant (see section 2, “Do not take Risedronate
sodium”). The potential risk associated with the use of
Risedronate sodium in pregnant women is unknown.
Do not take Risedronate sodium if you are breastfeeding (see section 2, “Do not take Risedronate
sodium”).

Driving and using machines

Risedronate sodium is not known to affect your ability
to drive and use machines.

Risedronate sodium 5 mg film-coated tablets
contain 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.

3 How to take Risedronate sodium
Dosage

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 Risedronate sodium tablet (5 mg of
risedronate sodium) once a day.

When to take the Risedronate sodium tablet

Take your tablet at least 30 minutes before the first
food, drink (other than plain water) or other medicine
of the day.
If you are unable to take your Risedronate sodium
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
 etween meals: Risedronate sodium should be taken
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at least 2 hours before and at least 2 hours after any
food, medicinal product or drink (other than plain
water).

colours/plates:
1. black
item no:

AAAF2143

dimensions: 170 x 380

print proof no:

2

pharmacode:

origination date: 5.4.13
approved for print/date

min pt size:

5.
6.

9.5.13

Technical Approval
date sent:

revised by:
supplier:

3.
4.

8.5, 9.5, 10.5 pt

originated by:
revision date:

2.

Iceland

approved:

11.4.13

Non Printing Colours
1.
2.
3.

• Or
 n the evening: Risedronate sodium should be
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taken at least 2 hours after the last food, medicinal
product or drink (other than plain water) of the
day. Risedronate sodium should be taken at least
30 minutes before going to bed.

How to take the Risedronate sodium tablet

•  ake the tablet whilst you are in an upright position
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(you may sit or stand) to avoid heartburn.
•  wallow it with at least one glass (120 ml) of plain
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water.
•  wallow it whole. Do not suck or chew it.
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•  o not lie down for 30 minutes after taking your
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tablet.
Your doctor will tell you if you need calcium and
vitamin supplements, if you are not getting enough
from your diet.

If you take more Risedronate sodium than you
should

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

If you forget to take Risedronate sodium

If you forget to take Risedronate sodium tablet at the
usual time, you can take the tablet according to the
instructions above (i.e. before breakfast, between
meals or in the evening).
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Risedronate sodium
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.

•  bnormal liver tests have been reported. These can
A
only be diagnosed from a blood test.

During postmarketing experience, the
following side effects have been reported
(frequency unknown):

•  air loss
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•  iver disorders, some cases were severe
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•  nflammation of small blood vessels mainly affecting
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the skin (leukocytoclastic vasculitis)
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.
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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.

5 How to store Risedronate sodium

•  eep this medicine out of the sight and reach of
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children.
•  o not use this medicine after the expiry date which
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is stated on the label, carton and blister after EXP. The
expiry date refers to the last day of that month.
•  his medicinal product does not require any special
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storage conditions.
Do not throw away any medicine 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

4 Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Stop taking Risedronate sodium and contact a
doctor immediately if you experience any of the
following:
•  ymptoms of a severe allergic reaction, such as:
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-  welling of the face, tongue or throat
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-  ifficulties in swallowing
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-  ives and difficulties in breathing
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•  evere skin reactions that can include blistering of
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the skin.

Tell your doctor promptly if you experience the
following side effects:

•  ye inflammation, usually with pain, redness and
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light sensitivity.
•  one necrosis of the jaw (osteonecrosis) associated
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with delayed healing and infection, often following
tooth extraction (see section 2, “Warnings and
precautions”).
•  ymptoms from oesophagus such as pain when you
S
swallow, difficulties in swallowing, chest pain or new
or worsened heartburn.
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.
The side effects are stated according to the frequency
they occur. The following convention has been used:
Very common: affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon:
affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare.
affects less than 1 user in 10,000
Not known:
f
 requency cannot be estimated from
the available data

Common side effects

•  ndigestion, feeling sick, stomach ache, stomach
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cramps or discomfort, constipation, feelings of
fullness, bloating, diarrhoea.
•  ain in your bones, muscles or joints.
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•  eadache.
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What Risedronate sodium 5 mg film-coated
tablets contain

•  he active substance is risedronate sodium
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(amorphous). Each tablet contains 5 mg risedronate
sodium, equivalent to 4.64 mg risedronic acid.
•  he other ingredients are: magnesium stearate,
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crospovidone, lactose monohydrate, microcrystalline
cellulose, hypromellose (E464), colloidal anhydrous
silica, hydroxypropylcellulose (E463), macrogol 400,
macrogol 8000, titanium dioxide (E171), iron oxide
yellow (E172)

What Risedronate sodium 5 mg film-coated
tablets look like and contents of the pack

Film-coated tablet.
Yellow 8.5 mm round, biconvex, film‑coated tablet.
Pack sizes:
Blister packs: 7, 14, 28, 56, 84 film‑coated tablets
Tablet containers: 30 and 100 film‑coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis hf.
Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
Iceland
This medicinal product is authorised in the Member
States of the EEA under the following names:
Bulgaria
B
 ifodron
Germany
R
 isedronsäure-Actavis 5 mg
Filmtabletten
Italy
R
 isedronato Actavis
Netherlands
R
 isedronaat-natrium Actavis 5 mg
United Kingdom  isedronate sodium 5mg filmR
coated tablets
This leaflet was last revised in May 2013.

Uncommon side effects

•  nflammation or ulcer of the oesophagus (the tube
I
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).
•  nflammation of the coloured part of the eye (iris)
I
(red painful eyes with a possible change in vision).

Rare side effects

•  nflammation of the tongue (red swollen, possibly
I
painful), narrowing of the oesophagus (the tube that
connects your mouth with your stomach).
AAAF2143

Actavis, Barnstaple, EX32 8NS, UK

colours/plates:
1. black
item no:

AAAF2143

dimensions: 170 x 380

print proof no:

2

pharmacode:

origination date: 5.4.13
approved for print/date

min pt size:

5.
6.

9.5.13

Technical Approval
date sent:

revised by:
supplier:

3.
4.

8.5, 9.5, 10.5 pt

originated by:
revision date:

2.

Iceland

approved:

11.4.13

Non Printing Colours
1.
2.
3.

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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