Skip to Content

UK Edition. Click here for US version.



PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user

Risedronate Sodium 30mg film-coated tablets
Risedronate sodium

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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Risedronate is and what it is used for
2. What you need to know before you take Risedronate
3. How to take Risedronate
4. Possible side effects
5. How to store Risedronate
6. Contents of the pack and other information

1. What Risedronate is and what it is used for
What Risedronate is
Risedronate 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.
Paget’s disease occurs when this process, called remodeling, 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 changes the bone remodeling
process back to normal, returning the strength to the bone structure.
What Risedronate is used for
• Treatment of Paget´s disease of the bone (osteitis deformans).

2. What you need to know before you take Risedronate
Do not take Risedronate
- 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 are planning to become
- if you are breast-feeding.
- if you have severe kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate:
• 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 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).
• 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 Risedronate.
Your doctor will advise you on what to do when taking Risedronate if you
have any of the above.

Other medicines and Risedronate
Medicines containing one of the following lessen the effect of Risedronate
if taken at the same time:
• calcium
• magnesium
• aluminium (for example some indigestion mixtures)
• iron
Take these medicines at least 30 minutes after taking Risedronate.
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Taking Risedronate with food and drink
It is very important that you do NOT take your Risedronate 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”).
Take food and drinks (other than plain water) at least 30 minutes after
your Risedronate tablet.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Do NOT take Risedronate if you may be pregnant, are pregnant or are
planning to become pregnant (see section 2 “Do not take Risedronate”).
The potential risk associated with the use of risedronate sodium (active
substance in Risedronate) in pregnant women is unknown.
Do NOT take Risedronate if you are breast-feeding (see section 2
“Do not take Risedronate”).
Driving and using machines
Risedronate is not known to affect your ability to drive and use machines.
Risedronate contains lactose
Risedronate 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 this medicinal product (see section 2, “Warnings
and precautions”).

3. How to take Risedronate
Always take this medicine exactly as your doctor has told you.You should
check with your doctor or pharmacist if you are not sure.
Usual dose
Take ONE Risedronate (30mg risedronate sodium) once a day.
The recommended treatment duration is usually 2 months.
When to take your Risedronate tablet:
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 in particular instance you are unable to take your Risedronate 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 other 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 your last food, drink (other than plain
water) or other medicine of the day. Risedronate should be taken at least
30 minutes before going to bed.

How to take your Risedronate tablet:
Children and adolescents
Take the tablet whilst you are in an upright position (you may sit or
Risedronate sodium is not recommended for use in children below 18 stand) to avoid heartburn.
years of age due to insufficient data on safety and efficacy.

Swallow it with at least one glass (120 ml) of plain water.
Swallow it whole. Do not suck or chew the tablet.
Do not lie down for 30 minutes after taking the 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 than you should
If you or somebody else has accidentally taken more Risedronate tablets
than prescribed, drink one full glass of milk and seek medical attention.
If you forget to take Risedronate
If you have forgotten to take your tablet at your regular time, you can take
it at the next possible time according to the instruction above (i.e. before
breakfast, between meals, or in the evening).
Do not take two tablets in one day to make up for the tablet you missed.
If you stop taking Risedronate
Please talk to your doctor if you consider stopping treatment before end
of prescribed duration.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Risedronate and contact a doctor immediately if you
experience any of the following:
Symptoms of a severe allergic reaction such as;
• Swelling of the 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/worsened heartburn.
Very rare:
• Talk to your doctor if you have ear pain, discharge from the ear, and/
or an ear infection. These could be signs of bone damage in the ear.
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.
Uncommon side effects (affects 1 to 10 users in 1,000):
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 (affects 1 to 10 users in 10,000):
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.
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.
During post-marketing experience, the following have been reported
(unknown frequency);
Allergic reactions of the skin such as urticaria (hives), skin rash, swelling
of the face, lips, tongue and/or neck, difficulty in swallowing or breathing.
Severe skin reactions including vesiculation (blistering) under the skin;
inflammation of small blood vessels, characterised by palpable red spots
on the skin (leukocytoclastic vasculitis); a serious illness called Stevens
Johnson syndrome (SJS) with blistering of the skin, mouth, eyes and
other moist body surfaces (genitals); a severe illness called toxic

epidermal necrolysis (TEN) which causes a red rash over many parts of
the body and/or loss of the outer layer of skin. Hair loss. Allergic reactions
(hypersensitivity). Serious liver disorders, mainly if you are treated with
other medicinal products known to cause liver problems. Inflammation of
the eye which causes pain and redness.
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 has 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.
Reporting of side effects
If you get any side effects, talk to your doctor or 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 (website: By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Risedronate

Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
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 Risedronate contains
- The active substance is Risedronate sodium. Each tablet contains
30mg risedronate sodium, equivalent to 27.8mg risedronic acid.
- The other ingredients are:
Tablet core: Starch, pregelatinised (maize); Cellulose, microcrystalline;
Crospovidone; Magnesium stearate.
Film coating: Hypromellose, Lactose monohydrate, Titanium dioxide
(E171), Macrogol 4000.
What Risedronate looks like and contents of the pack
Risedronate are white round biconvex film-coated tablets with diameter
of 11.2mm, 4.5mm in thickness and embossed with “30” on one side.
They are supplied in blister packs containing 14 and 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder & Manufacturer
Pharmathen SA
6 Dervenakion str,
15351 Pallini
Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
GU32 3QG
United Kingdom
This leaflet was last revised in


+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.