PENTASA® Slow Release Tablets 1g

(mesalazine)

Patient Information

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 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 1g 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.

•    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 as whole, 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 of up to 4g mesalazine, to be taken as four 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 two 1g 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.

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

• vomiting	• stomach pain
• nausea	• diarrhoea
• rash with or without itching	• headache

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

• blood disorders (e.g. low levels of red blood cells)	• lupus erythematosis (an auto-immune disorder affecting the skin)
• tingling or numbness in the hands and feet	• allergic lung reactions (including breathing problems)
• inflammation of the heart or area surrounding the heart	• changes in kidney function or kidney failure
• inflammation of the liver and liver failure	• inflammation of the pancreas

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

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

If any of these side effects become severe or if you experience any other side effects not listed you should contact your doctor or pharmacist as soon as possible.

5.    How to store PENTASA

Do not store above 25°C.

Store in original packaging and do not use after the expiry date detailed on the pack.

Keep out of reach and sight of children.

Return any old or unused medicines to your pharmacist for disposal.

6.    Further information

What Pentasa contains

Each tablet contains 1g of the active ingredient, mesalazine (also known as 5-aminosalicylic acid or 5-ASA) It also contains the following inactive ingredients: 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, oval shaped, and embossed with ‘PENTASA’ on both sides of the tablets. Each carton contains 60 tablets presented in blister strips of 10 tablets per strip.

Marketing Authorisation Holder:

Ferring Pharmaceuticals Ltd.,

Drayton Hall,

Chruch Road,

West Drayton,

UB7 7PS (UK).

Manufactured by:

Ferring GmbH,

Wittland 11,

D-24109 Kiel,

Germany.

PENTASA Slow Release Tablets 1g - PL 03194/0108.

This leaflet was last revised in February 2014.

PENTASA is a registered trademark.