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RISEDRONATE SODIUM 30 MG FILM-COATED TABLETS

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

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GB 727-0580-APIL
PACKAGE LEAFLET: INFORMATION FOR THE
USER

Risedronate sodium 30 mg
film-coated tablets
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects become severe, or if
you notice any side effects not listed in this
leaflet, please tell your doctor orpharmacist.
In this leaflet:
1. What Risedronate sodium 30 mg is and what
it is used for
2. Before you take Risedronate sodium 30 mg
3. How to take Risedronate sodium 30 mg
4. Possible side effects
5. How to store Risedronate sodium 30 mg
6. Further information
1. WHAT RISEDRONATE SODIUM 30 MG IS
AND WHAT IT IS USED FOR
Risedronate sodium 30 mg belongs to a group
of non-hormonal medicines called
bisphosphonates which are used to treat bone
diseases.
Risedronate sodium 30 mg is used to treat
Paget’s disease of the bone.
Bone is a living tissue. Old bone is constantly
removed from your skeleton and replaced with
new bone. Paget’s disease occurs when this
process, called remodelling, happens too
quickly and in a disordered way.
The new bone that is produced is weaker than
normal and the affected bones may become
enlarged, painful and may fracture.
Risedronate sodium 30 mg changes the bone
remodelling process back to normal, returning
the strength to the bone structure.
2. BEFORE YOU TAKE RISEDRONATE SODIUM
30 MG
Do not take Risedronate sodium 30 mg if:
• you are allergic to risedronate sodium or any
of the other ingredients of Risedronate
sodium 30 mg (see section 6, “What
Risedronate sodium 30 mg contains”);

• your doctor has told you that you have a
condition called hypocalcaemia (a low blood
calcium level);
• you may be pregnant, are pregnant or are
planning to become pregnant;
• you are breast-feeding;
• you have severe kidney problems.
Take special care and talk to your doctor
before you start taking Risedronate sodium
30 mg if:
• you are unable to stay in an upright position
(sitting or standing) for at least 30 minutes;
• you have abnormal bone and mineral
metabolism (for example lack of vitamin D,
parathyroid hormone abnormalities, both
leading to a low blood calcium level);
• you have had problems in the past with your
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 Barrett's oesophagus (a condition
associated with changes in the cells that line
the lower oesophagus);
• you have been told by your doctor that you
have an intolerance to some sugars (such as
lactose);
• you have or ever had pain, swelling or
numbness of the jaw or a “heavy jaw
feeling” or loosening of a tooth;
• you are under dental treatment or will
undergo dental surgery, tell your dentist that
you are being treated with Risedronate
sodium 30 mg.
Your doctor will advise you on what to do when
taking Risedronate sodium 30 mg if you have
any of the above.
These tablets should not be taken by children
under 18 years of age.
Taking other medicines
Medicines containing any of the following lessen
the effect of Risedronate sodium 30 mg if taken
at the same time:
• calcium;
• magnesium;
• aluminium (for example some indigestion
mixtures);
• iron.
Take these medicines at least 30 minutes after
your Risedronate sodium 30 mg tablet.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

Taking Risedronate sodium 30 mg with food
and drink
It is very important that you do not take your
Risedronate sodium 30 mg tablet with food or
drinks (other than plain water) so that it can
work properly. Products containing any of the
following: calcium (including dairy products
such as milk), magnesium, aluminium (for
example, some indigestion mixtures) or iron
lessen the effect of this medicine.
These products should be taken at a different
time to Risedronate sodium 30 mg tablets.
Pregnancy and breast-feeding
Do not take Risedronate sodium 30 mg if you
may be pregnant, are pregnant or are planning
to become pregnant (see section 2, “Do not take
Risedronate sodium 30 mg”). The potential risk
associated with the use of risedronate sodium in
pregnant women is unknown.
Do not take Risedronate sodium 30 mg if you
are breast-feeding (see section 2, “Do not take
Risedronate sodium 30 mg”).
Ask your doctor for advice before taking any
medicine.
Driving and using machines
Risedronate sodium 30 mg is not known to
affect your ability to drive and use machines.
Important information about some of the
ingredients of Risedronate sodium 30 mg
Risedronate sodium 30 mg contains a small
amount of lactose.
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking Risedronate sodium
30 mg.
3. HOW TO TAKE RISEDRONATE SODIUM
30 MG
Dosage
Always take Risedronate sodium 30 mg exactly
as your doctor has told you. You should check
with your doctor if you are not sure.
These tablets should not be taken by children
under 18 years of age.
Usual dose:
Take one Risedronate sodium 30 mg tablet
once a day.
Usually 2 months will be enough to treat your
Paget’s disease. However, another course of
treatment may be required.
It is very important that you do not take
Risedronate sodium 30 mg with food or drinks
(other than plain water) so that it can work
properly.
When to take the Risedronate sodium 30 mg
It is best to 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 30 mg tablet at this time, you may take
it on an empty stomach, at the same time every
day, in one of the following ways:
• Between meals: at least 2 hours after your
last food, drink (other than plain water) or
medicine. Do not eat or drink (other than
plain water) for 2 hours after taking the
tablet.
• In the evening: at least 2 hours after the last
food, drink (other than plain water) or
medicine of the day. Risedronate sodium 30
mg should be taken at least 30 minutes
before going to bed.
How to take the Risedronate sodium 30 mg
• 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 Risedronate sodium 30 mg
than you should
If you or somebody else has accidentally taken
more Risedronate sodium 30 mg tablets than
prescribed, drink one full glass of milk and seek
medical attention.
If you forget to take Risedronate sodium 30 mg
If you have forgotten to take your tablet, you can
take it before breakfast, between meals, or in
the evening according to the instructions above.

Received Date:
CDL JOB No. :
Required By :

07/12/2012
57417
10/12/2012

PRODUCT NAME:

PIP CODE:
COMPONENT:
SIZE:
MARKET:
PRODUCT SITE:
SCALE:
COLOURS:

DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
PROJECT:

Risedronate Sodium
30mg Tablets 28 PIL
GB 727-0580-APIL
Leaflet
310x240 mm
Great Britain
TBC
100%
Black
Cutter
07/12/2012
9 pt
4
VK
Sovereign Medical

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................
Reject Artwork ..................................................................

Do not take two tablets in one day to make up
for the tablet you missed.
If you stop taking Risedronate sodium 30 mg
Do not stop the treatment prematurely because
Paget’s disease is a long-term disease. Please
talk to your doctor before you consider stopping
treatment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Risedronate sodium 30 mg
can cause side effects, although not everybody
gets them.
Stop taking, Risedronate sodium 30 mg and
contact a doctor immediately if you
experience any of the following:
• Symptoms characteristic of severe tissue
swelling (angioedema reaction):
- swelling of face, tongue or throat
- difficulties in swallowing
- hives and difficulties in breathing.
• Severe skin reactions that can include
blistering of the skin.

Signature ..........................................................................
Name .................................................................................
Date ...................................................................................

PAGE 1 OF 2

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, “Take special care and talk to
your doctor before you start taking
Risedronate sodium 30 mg”).
• Symptoms from the oesophagus such as
pain when you 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.
Common side effects (affects 1 to 10 users in
100):
• 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 (affects 1 to 10 users
in 1000):
• 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, “Take
special care and talk to your doctor before
you start taking Risedronate sodium
30 mg”), 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 ( affects 1 to 10 users in
10000):
• 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.
The additional following adverse events have
also been observed in a clinical study in patients
with Paget’s disease: vision difficulties,
breathing difficulties, coughing, inflammation of

the large intestine, surface of the eye damage,
cramps, dizziness, dryness of the eye, flu-like
symptoms, muscle weakness, abnormal growth
of cells, a frequent need to pass water at night,
unusual lumps or swellings, chest pain, rash,
runny nose, ringing in the ears and weight loss.

Manufacturer:
PSI supply nv.
Axxes Business Park,
Guldensporenpark 22 – Block C,
9820 Merelbeke.
Belgium.

If any of the side effects become severe, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Waymade Healthcare Plc.
Sovereign House,
Miles Gray Road,
Basildon.
Essex. SS14 3FR.
United Kingdom.

5. HOW TO STORE RISEDRONATE SODIUM
30 MG
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date
which is stated on the pack after EXP. The
expiry date refers to the last day of that month.
No special storage conditions required.
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 Risedronate sodium 30 mg contains
The active substance is risedronate sodium.
Each tablet contains 30 mg risedronate sodium,
equivalent to 27.8 mg risedronic acid.
The other ingredients are:
Tablet core: lactose monohydrate, crospovidone,
magnesium stearate and microcrystalline
cellulose.
Film coating: hypromellose, macrogol,
hydroxypropyl cellulose, colloidal anhydrous
silica and titanium dioxide (E171).
What Risedronate sodium 30 mg looks like
and contents of the pack
Risedronate sodium 30 mg film-coated tablets
are white to off-white coloured tablets debossed
with the letter “J” on one side and “30” on the
other.
The tablets are supplied in blister packs of 28 or
30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Waymade Healthcare Plc trading as
Sovereign Medical.
Sovereign House,
Miles Gray Road,
Basildon.
Essex. SS14 3FR.
United Kingdom.

This leaflet was last approved in:
November 2012

Received Date:
CDL JOB No. :
Required By :

07/12/2012
57417
10/12/2012

PRODUCT NAME:

PIP CODE:
COMPONENT:
SIZE:
MARKET:
PRODUCT SITE:
SCALE:
COLOURS:

DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
PROJECT:

Risedronate Sodium
30mg Tablets 28 PIL
GB 727-0580-APIL
Leaflet
310x240 mm
Great Britain
TBC
100%
Black
Cutter
07/12/2012
9 pt
4
VK
Sovereign Medical

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................
Reject Artwork ..................................................................
Signature ..........................................................................
Name .................................................................................
Date ...................................................................................

PAGE 2 OF 2

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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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