RISEDRONATE SODIUM 30 MG FILM-COATED TABLETS

Active substance: RISEDRONATE SODIUM HEMIPENTAHYDRATE

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Package Leaflet: Information for the user
Risedronate sodium 30 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.
- 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 sign 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 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 30 mg film-coated tablets
4. Possible side effects
5. How to store Risedronate sodium
6. Content of the pack and other information
1. What Risedronate sodium is and what it is used for
Risedronate sodium 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 sodium changes the bone
remodeling process back to normal, returning the strength to the bone structure.
Risedronate sodium 30 mg film-coated tablets are used to treat the following:
Treatment of Paget‟s disease of the bone (osteitis deformans).
2. What you need to know before you take Risedronate sodium
Do NOT take Risedronate sodium
• If you are allergic to risedronate sodium or any of the other ingredients of Risedronate
sodium tablets (listed in section 6, “Content of the pack and other information”)
• 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.
Warning and precautions:
Talk to your doctor or pharmacist before taking Risedronate sodium:
• 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).
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• 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 sodium.
Your doctor will advise you on what to do when taking Risedronate sodium 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 Risedronate sodium
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Medicines containing one of the following lessen the effect of Risedronate sodium 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 tablet.
Taking 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, “Taking
other medicines”).
Take food and drinks (other than plain water) at least 30 minutes after your Risedronate
sodium tablet.
Pregnancy, breast-feeding and fertility
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 (active substance in Risedronate sodium tablets)
in pregnant women is unknown.
Do NOT take Risedronate sodium if you are breast-feeding (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 tablets contains lactose
Risedronate sodium tablets contain lactose monohydrate (a type of sugar). If you have been
told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Risedronate sodium 5 mg film-coated tablets
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Dose
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose:
Take one 30 mg Risedronate sodium tablet once a day.
The recommended treatment duration is usually 2 months.

WHEN to take the Risedronate sodium tablet
Take your Risedronate sodium 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:
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.
OR:
In the evening: at least 2 hours after your last food, drink (other than plain water) or medicine
of the day. Risedronate sodium should be taken at least 30 minutes before going to bed.
HOW to take the Risedronate sodium 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. Do not take your tablet with
mineral water or drinks other than 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 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 (to be completed as
appropriate nationally).
If you FORGET to take Risedronate sodium
Do not take two tablets on one day to make up for the tablet you missed.
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).
If you STOP taking Risedronate sodium
Please talk to your doctor if you consider stopping treatment before the end of prescribed
duration.
If you have any further questions on the use of this medicine,, ask your doctor or pharmacist.
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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:
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, “Take special care and talk to your doctor
before you start taking Risedronate sodium”).
• Symptoms from 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 (may affect 1 to 10 in 100 people)
• Indigestion, feeling sick, vomiting, 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 1 to 10 in 1,000 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, “Take special care and
talk to your doctor before you start taking Risedronate sodium”), 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 1 to 10 in 10,000 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.
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

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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.
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.
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 sodium
• Keep this medicine 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.
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. Content of the pack and other information
What Risedronate sodium contains
The active substance is risedronate sodium.
Each film-coated tablet contains 30 mg risedronate sodium (as risedronate sodium
hemipentahydrate), equivalent to 27.8 mg risedronic acid.
The other ingredients are:
Tablet core: Lactose monohydrate, microcrystalline cellulose, crospovidone (type A),
hydroxyl propyl cellulose and magnesium stearate.
Film coating: hypromellose, macrogol 400, hydroxy propyl cellulose and titanium dioxide
(E171).
What Risedronate sodium looks like and contents of the pack
Risedronate sodium 30 mg film-coated tablets are white to off-white colored, circular shaped
film coated biconvex tablets debossed with „L‟ on one side and „30‟ on the other side.
Risedronate sodium 30 mg film-coated tablets are available in blister packs of 3, 14 (1 x 14)
and 28 (2 x 14) tablets.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
Manufacturer
Pfizer Service Company BVBA, Hoge Wei 10, 1930, Zaventem. Belgium
or
Pfizer PGM, Zone industrielle, 29, route des Industries, 37530 Pocé -Sur-Cisse,
France
or
Pfizer Italia s.r.l., Località Marino Del Tronto, 63100 - Ascoli Piceno (AP), Italy.

This leaflet was last revised in: June 2013
Company Reference: gxRI 3_0 UK 30mg

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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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