Pentasa® 500mg Slow Release Tablets

(mesalazine)

Patient Information Leaflet

This medicine is available using the above name but will be referred to as Pentasa throughout this leaflet. This leaflet has been written to help you get the best effect from your medicine.

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.

To treat an attack of colitis, your doctor will usually prescribe a dose of 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.

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

|4) POSSIBLE SIDE EFFECTS|

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.

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.

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

|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.

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

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

Reporting of side effects:

If you get any side effects talk to your doctor or pharmacist.

This includes any side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: 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 PENTASA|

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Store in the original package.

•    Do not use Pentasa 500mg Slow Release Tablets after the expiry date stated on the pack and blister. The expiry date refers to the last day of that month.

•    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 Pentasa contains

Each tablet contains 500mg of the active ingredient, mesalazine (also known as 5-aminosalicyclic acid or 5-ASA). Other ingredients in Pentasa Slow Release Tablets 500mg are povidone, ethylcellulose, microcrystalline cellulose, magnesium stearate and talc.

POM

Pentasa 500mg Slow Release Tablets

PL No. 17211/1173

Product: Pentasa 500mg Slow Release Tablets Colours: Black

PLPI: 17211/1173 Item Code: PEN2003I/B

Dimensions: 210mm x 400mm Proof: 2