Informations for option: Norasa 500 Mg Gastro-Resistant Tablets, show other option

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1. Norasa 500 Mg Gastro-Resistant Tablets
2. Norasa 500 Mg Gastro-Resistant Tablets

Take special care with this medicine if you;

•    suffer from any kidney or liver problem (even if it is not severe)

•    have asthma

•    have a history of side effects from medicines containing a drug called sulphasalazine.

If you suffer from any of the above conditions, talk to your doctor before using this medicine. During treatment, your doctor may want to keep you under close medical supervision.

Further precautions

During treatment your doctor may want to keep you under close medical supervision, where you will have regular blood and urine tests.

Taking other medicines

Please tell your doctor if you take or use any of the medicines mentioned below as the effect of these medicines may change (interactions):

•    sulphonylureas (blood glucose-lowering medicines, such as glibenclamide)

•    probenecid or sulphinpyrazone (medicines used to treat gout)

•    spironolactone or furosemide (medicines used to treat hypertension or heart disorders)

•    rifampicin (a medicine used to treat tuberculosis)

•    methotrexate (a medicine used to treat cancer and rheumatoid arthritis)

•    glucocorticoids (anti-inflammatory agents, sometimes called ‘steroids’, e.g. prednisolone)

•    coumarin-type anticoagulants (medicines used to prevent the blood clotting or ‘thin the blood’)

•    medicines containing azathioprine or 6-mercaptopurine (used to treat certain immune disorders)

•    non-steroidal anti-inflammatory drugs (medicines used to treat pain, for example medicines containing aspirin, ibuprofen or diclofenac).

Please tell you doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without prescription.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, or think you may be pregnant.

You should only use NORASA 500mg during pregnancy if your doctor tells you to.

Breast Feeding

If you are breast feeding consult your doctor before taking NORASA 500mg as this medicine passes into breast milk. If your baby develops diarrhoea, breast feeding should be discontinued.

Driving and using machines

There are no effects on the ability to drive and use machines.

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole, without crushing or chewing, with plenty of water.

Although uncommon, it is possible that you may sometimes pass complete (undissolved) tablets in your stool because of your condition.

Adults and the elderly

Unless otherwise prescribed by your doctor, the usual dose is:

For acute episodes of ulcerative colitis

500 to 1000 mg (one to two tablets) three times a day

To prevent a relapse of ulcerative colitis 500 mg (one tablet) three times a day

Children and adolescents under 18 years

NORASA 500mg is not recommended in this age group

Duration of treatment

How long you need to take this medicine will depend on your condition. Your doctor will decide this and will discuss it with you. To obtain the maximum benefit from this medicine, it must be taken regularly as prescribed.

If you take more NORASA 500mg than you should

If you have taken too many tablets, seek immediate advice from your doctor or nearest hospital emergency (casualty) department.

If you forget to take NORASA 500mg

Do not take a larger than normal dose of NORASA 500mg next time, but continue treatment at the prescribed dosage.

If you stop taking NORASA 500mg

Do not stop taking this product until you have talked to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, NORASA 500mg can cause side effects, although not everybody gets them.

Stop taking the medicine and contact your doctor immediately if you experience the following:

-    a skin rash with flaking, boils, or sore lips or mouth

-    fever

-    pain in your muscles or joints

-    chest tightness or breathing difficulties

-    unusual bleeding (e.g. nose bleeds), bruising or sore throat

-    severe stomach pain or diarrhoea

The following side effects may also occur:

Rare side effects (affecting less than 1 in every 1000 patients)

•    stomach pains, diarrhoea, wind, feeling sick (nausea), being sick (vomiting)

•    headache, dizziness.

Very rare side effects, (affecting less than 1 in every 10,000 patients)

•    kidney problems (such as inflammation and scarring of the kidney), sometimes with water retention and swelling of the limbs, or pain in the region between your ribs and hip bone

•    muscular pain, joint pain.

•    skin rashes

•    fever, sore throat or feeling generally unwell (malaise) because low blood cell count

•    difficulty breathing because of inflammation of the lungs due to an allergic reaction or asthma.

•    chest pain, breathlessness or water retention and swelling of the limbs because of an effect on the heart

•    severe stomach pain due to inflammation of the pancreas or inflammation of the bowel (intestine)

•    changes to your blood counts

•    stomach pain and jaundice (yellowing of the skin and eyes) caused by liver problems including hepatitis (inflammation of the liver)

•    hair loss (alopecia)

•    numbness and tingling (pins and needles) in the hands and feet

•    a temporary fall in your sperm count (number of sperm in your semen) which goes back to normal on discontinuing the medicine

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

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the box after "Do not use after” or "Exp.”.

Store below 30°C.

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.

What these tablets contain

The active substance is Mesalazine.

One tablet of NORASA 500mg gastro-resistant tablets contains 500 mg Mesalazine. The other ingredients are:

microcrystalline cellulose (E460), povidone, colloidal anhydrous silica, crospovidone, magnesium stearate (E 472B), hydroxypropylmethylcellulose (E464), methacrylic acid copolymer type A, methacrylic acid copolymer type B, polyethylene glycol, triethyl citrate, talc, titanium dioxide (E171), iron oxide yellow (E172).

What NORASA 500mg gastro-resistant tablet looks like and the contents of the pack

Yellow (ochre), oblong tablet with a smooth surface.

NORASA 500mg gastro-resistant tablet is available in pack sizes of 10, 90 or 300 tablets. Further Information on Ulcerative Colitis

Your doctor and pharmacist will be able to give you information on this condition. You may also wish to contact the National Association for Colitis and Crohn’s Disease for further details and information on local support groups.

Marketing Authorization Holder and Manufacturer

Disphar International B.V.

Winkeldkamp 6 7255 PZ Hengelo (Gld)

The Netherlands

NORASA 500mg gastro-resistant tablet has been registered under number: PL 17468/0006

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany:    NORASA 500mg gastroresistant tablets

United Kingdom: NORASA 500mg gastroresistant tablets This leaflet was last approved in 08/2010.

Version 2013/07