Skip to Content

NORASA 500 MG GASTRO-RESISTANT TABLETS

Active substance(s): MESALAZINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORASA 500mg gastro-resistant tablets
Mesalazine
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 further 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 gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take NORASA 500mg
3. How to take NORASA 500mg
4. Possible side effects
5. How to store NORASA 500mg
6. Further information
1.

WHAT NORASA 500mg IS AND WHAT IT IS USED FOR

The name of this medicine is NORASA 500mg gastro-resistant tablets. This type of medicine
is an “anti-inflammatory agent”.
It is used to treat ulcerative colitis, a disease which causes the lining of the large bowel
(colon) to become red and swollen (inflamed). This medicine acts locally in the bowel to
reduce this swelling (inflammation).

2.

BEFORE YOU TAKE NORASA 500mg

Do not use this medicine if you;
• are allergic (hypersensitive) to Mesalazine or any of the other ingredients of NORASA
500mg (see section 6)
• are allergic to aspirin or other salicylates
• have severe kidney or liver problems
• have an ulcer of the stomach or duodenum
• have been told there is a problem with the clotting of your blood
• are under the age of 18

Version 2013/07

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.
3.

HOW TO TAKE NORASA 500mg

Version 2013/07

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.
4.

POSSIBLE SIDE EFFECTS

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

Version 2013/07

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.
5.

HOW TO STORE NORASA 500mg gastro-resistant tablets

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 30ºC.
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 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

Version 2013/07

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

Expand view ⇕

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.

Hide