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Pentasa® Slow Release 500mg Tablets

(mesalazine)

Patient Information Leaflet

The name of your medicine is Pentasa® Slow Release 500mg Tablets but it will be referred as Pentasa throughout this leaflet.

In this leaflet:

1.    What Pentasa is and what it is used for

2.    Before you take Pentasa

3.    How to take Pentasa

4.    Possible side effects

5.    How to store Pentasa

6.    Further Information

1.    What Pentasa is and what it is used for

The name of this medicine is Pentasa Slow Release Tablets. Each tablet contains mesalazine 500mg as the active ingredient. Mesalazine belongs to a group of medicines called salicylates.

Pentasa is used to treat mild to moderate inflammation of the gut caused by a condition called ulcerative colitis. It can also be used to control the condition and prevent it from coming back.

The tablets release the active ingredient slowly which then acts locally to reduce the inflammation and help relieve or stop the pain.

2.    Before you take Pentasa Do Not take Pentasa if you:

•    are allergic to mesalazine or any of the other ingredients in Pentasa.

•    are allergic to any other salicylates e.g. aspirin

•    have severe liver or kidney problems

•    are under the age of 15 years

Take special care with Pentasa

You should consult your doctor before taking these tablets if:

•    you experience any unexplained bleeding, bruising, skin rashes, fever or sore throat while using this medicine, stop using this medicine and seek medical advice as soon as possible.

•    If you experience any chest pain, an increased heartbeat and excess tiredness while using this medicine, stop using this medicine and seek medical advice as soon as possible.

•    you currently have, or have previously had liver or kidney disease

•    you are on any medication that may affect kidney function e.g. azathioprine

•    you have ever had an allergy to a medication called sulphasalazine

If you suffer from kidney problems you will require regular check ups by your doctor.

You should make sure that you don't become dehydrated, while you are taking this medicine. This can occur after severe or prolonged attacks of vomiting and/or diarrhoea, high fever or heavy sweating. If this does occur, you should speak to a doctor or pharmacist for advice as soon as possible.

Taking with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking any of the following:

•    Non-steroidal anti-inflammatories (NSAIDS)

•    Azathioprine or 6-mercaptopurine

Pregnancy and Breastfeeding

If you are pregnant, are planning to become pregnant or are breastfeeding you should speak to your doctor or pharmacist before taking this medicine, as they will need to decide if this medicine is suitable for you.

3. How to take Pentasa

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

The tablets should be taken by mouth either whole or broken up, they should not be crushed or chewed. If you have difficulty swallowing the tablets you can disperse them in a small quantity of cold water (approximately 50ml) then stir and drink immediately.

To treat an attack of colitis, your doctor will usually prescribe a dose up to 4g mesalazine, to be taken as eight tablets once a day or in two or three divided doses.

To help prevent further attacks, your doctor will usually prescribe a dose of 2g mesalazine, to be taken as four 500mg tablets once a day.

If you take more Pentasa than you should

If you accidentally take too many tablets, you should go to your nearest emergency department or contact your doctor immediately. Take the pack and any remaining tablets with you.

If you forget to take Pentasa

If you forget to take a dose, take the next dose as soon as you remember, unless it is less than 3 hours until your next dose.

Do not take a double dose to make up for the forgotten one.

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

4. Possible side effects

Like all medicines, Pentasa can cause side effects, although not everyone gets them.

STOP taking Pentasa if you notice:

•    itching, skin rashes, swelling of the face, lips or throat, difficulty in breathing or wheeziness (signs of an allergic reaction).

•    unexplained bleeding, bruising, skin rashes, fever or sore throat (signs of a blood disorder).

•    a change in the colour or amount of urine produced (signs of kidney problems).

If you experience any of the above side effects you should contact your doctor or go to the nearest hospital emergency department immediately.

5.    How to store Pentasa

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Store in the original package.

•    Do not take after the expiry date stated on the carton and on the blister.

•    Do not remove the tablets from the blister pack until you are ready to take the medicine.

•    If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

•    Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.

6.    Further Information

Common side effects (affecting less than 1 in 10 people) include:

Rare side effects (affecting less than 1 in 1,000 patients) include:

What Pentasa contains

•    Each slow release tablet contains 500mg mesalazine

•    Other ingredients in Pentasa are povidone, ethylcellulose, microcrystalline cellulose, magnesium stearate and talc.

What Pentasa looks like and the contents of the pack

•    The tablets are white grey to pale brown, speckled, round tablets, scored and marked '500 mg' on one side and 'PENTASA' on the reverse.

•    Each carton contains 50 tablets and 100 tablets presented in blister strips of 10 tablets per strip

Manufactured by:

Ferring GmbH - Wittland 11, D-24109 Kiel, Germany.

Procured from within the EU & repackaged by Product

Licence holder: Kosei Pharma UK Ltd., 956 Buckingham

Avenue, Slough, SL1 4NL.

Pentasa® Slow Release 500mg Tablets

PL No: 39352/0277    _

Pentasa® is a trademark of Farmaceutisk Laboratorium Ferring A/S.

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

• raised liver enzymes	• muscle pain
• hair loss (reversible)	• fever
• joint pain	• skin rash or blisters e.g. Erythema Multiforme or Steven-Johnson syndrome
• allergic reactions

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.