RISEDRONATE SODIUM 30 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - RISEDRONATE SODIUM 30 MG FILM-COATED TABLETS

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 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. See section 4.

What is in this leaflet

The name of your medicine is Risedronate sodium 30 mg film-coated tablets (referred to as Risedronate tablets throughout this leaflet).

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

1. what risedronate tablets is and what it is used for

What Risedronate tablets is

Risedronate tablets 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 tablets changes the bone remodeling process back to normal, returning the strength to the bone structure.

What Risedronate tablets is used for

Treatment of Paget’s disease of the bone (osteitis deformans).

2. what you need to know before you take risedronate tablets

Do not take Risedronate tablets

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.
If you are breast-feeding.
If you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Risedronate tablets.

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 tablets.

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

Children and adolescents

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

Other medicines and Risedronate tablets

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 tablets 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 tablets.

Risedronate tablets with food and drink

It is very important that you do NOT take your Risedronate tablets 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 tablets”).

Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablets.

Pregnancy and breast-feeding If you are pregnant or breastfeeding, 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 tablets if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Risedronate tablets”). The potential risk associated with the use of risedronate sodium (active substance in Risedronate tablets) in pregnant women is unknown.

Do not take Risedronate tablets if you are breast-feeding (see section 2, “Do not take Risedronate tablets”).

Driving and using machines

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

Risedronate tablets contains 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.

Risedronate contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. how to take risedronate tablets

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 is:

Take one Risedronate tablets (30 mg of risedronate sodium) once a day.

The recommended treatment duration is usually 2 months.

When to take the Risedronate tablets

It is best to take your Risedronate tablets 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 tablets 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 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 tablets should be taken at least 30 minutes before going to bed.

How to take the Risedronate tablets

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 tablets 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 tablets

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 a double dose to make up for a forgotten dose.

If you stop taking Risedronate tablets

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

4. possible side effects

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

Stop taking Risedronate tablets 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 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: 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: 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).

Rare: may affect up to 1 in 1,000 people

Inflammation of the tongue (red swollen, possibly painful), narrowing of the oesophagus (the tube hat connects your mouth with your stomach).
Abnormal liver tests have been reported. These can only be diagnosed from a blood test.

Very rare: may affect up to 1 in 10,000 people

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.

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

Hair loss
Liver disorders, some cases were severe

5. how to store risedronate tablets

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 medicine 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. contents of the pack and other information

What Risedronate tablets contains

The active substance is risedronate sodium. Each film-coated tablet contains 30 mg risedronate sodium (equivalent to 27.8 mg risedronic acid).

The other ingredients are:

Tablet core: Lactose monohydrate, crospovidone, hydroxy propyl cellulose, magnesium stearate and cellulose microcrystalline.

Film coating: Hypromellose, titanium dioxide (E171), macrogol 400, hydroxy propyl cellulose.

What Risedronate tablets looks like and contents of the pack

Film-coated tablet.

White to off-white coloured, circular shaped film coated biconvex tablets debossed with ‘L’ on one side and ‘30’ on the other side.

Transparent PVC / PE / PVdC / Aluminium blisters in a cardboard box, Packs of 14 or 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Milpharm Limited,

Ares Block, Odyssey Business Park, West End Road, Rusilp HA46QD.