PENTASA® Mesalazine Enema

(mesalazine)

Patient Information

In this leaflet :

1.    What Pentasa is and what it is used for

2.    Before you use Pentasa

3.    How to use 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 Mesalazine Enema in the form of a suspension. Each bottle contains mesalazine 1g in 100ml of liquid as the active ingredient. Mesalazine belongs to a group of medicines called salicylates.

Pentasa is used to treat inflammation in the gut caused by conditions such as active ulcerative colitis where it is affecting the last part of the colon and rectum (back passage).

The enema releases the active ingredient which then acts locally to reduce the inflammation and help relieve or stop the pain.

2.    BEFORE YOU USE PENTASA

Do Not use 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

Pentasa is not suitable for use in children Take special care with Pentasa

You should consult your doctor before using these enemas if:

•    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 doctors.

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 whilst using this medicine, stop using this medicine and seek medical help as soon as possible.

You should make sure that you don’t become dehydrated, while you are using this medicine. This can occur after severe or prolonged attacks of vomiting and/or diarrhoea, high fever or heavy sweating.

If this dose occur, you should speak to a doctor or pharmacist for advice as soon as possible.

Using 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)

•    Azathioprin or 6-mercaptopurine

Pregnancy and Breastfeeding

If you are pregnant, 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 USE PENTASA

Always use Pentaaa exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The enema should be used in tbe back passage (rectum ) only. Usually your docto r wia ask you to use one enema at bedtime

How to use the enema

1. Immediately before use take the enema bottle out of the aluminium foil pack and shake it well

2. To break the seal twist the nozzle clockwise one full turn (the nozzle should then be in the same direction as before turning)

3. Put your hand in one of the plastic disposal bags provided in the pack

4. Hold the container as shown in the picture.

5. To administer the enema, lie on your left side with the left leg straight and the right leg bent forward for balance. Carefully insert the applicator tip into the rectum. Maintain sufficient steady hand pressure while dispersing the bottle content. The bottle content should be applied within max 30-40 seconds.

6. Once the bottle is empty, withdraw the tip with the bottle still compressed

7. The enema should be retained in the bowel. Remain relaxed in the administration position for 5-10 minutes or until the urge to pass the enema has disappeared

8. Roll the plastic disposal bag over the empty bottle. Discard it and wash your hands.

Please note: Pentasa Mesalazine may cause permanent staining on contact with clothing or fabrics.

If you use more Pentasa than you should

If you accidentally use too much, you should go to your nearest emergency department or contact your doctor immediately. Take the carton with you.

If you forget to use Pentasa

If you forget to use a dose, use the next dose in the morning if it is convenient. Otherwise, use one as usual the next night. Do not use a double dose, to make up for the forgotten one

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

4.POSSIBLE SIDE EFFECTS

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

Following rectal administration local reactions such as itching, rectal discomfort and urge mayoccur.

STOP taking Pentasa if you noti ce:

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

•    Unexplained bleeding, bruising, skin rashes, fever or sore throat (sig ns of biood disorder).

•    Change in colour or amosnt of urine produced (signs of kidney problems).

•    bhest pain, an increase in heartbeat or excess tiredness (signs of heart problems).

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

6. FURTHER INFORMATION

What Pentasa contains

Each bottle contains 1g of the active ingredient, mesalazine (also known as 5-aminosalicyclic acid or 5-ASA) in 100mls of liquid. The mesalazine settles out as a separate layer. It also contains the following inactive ingredients: disodium edetate, sodium metabisulphite, sodium acetate, hydrochloric acid and purified water.

What Pentasa looks like and the contents of the pack

The enema is a colourless to faint yellow suspension presented in a polythene bottle. Each pack contains 7 individually foil-wrapped enema bottles and 7 polythene bags for disposal of the empty enema bottle after use.

Marketing Authorisation Holder

Lerring Pharmaceuticals Ltd., Drayton Hall, bhurch Road, West Drayton,UB7 7PS, UK.

Manufactured by

Lerring A/S, DK-2720 Vanlose, Copenhagen, Denmark. PENTASA Mesalazine Enema PL 03194/0027 This leaflet was revised in May 2013.

PENTASA is a registered trademark

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

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

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

• blood disorders (e.g low levels of red blood cells)	• lupus erythematosis (an autoim -mune disorder effecting 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) 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

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°b.

Keep the foil packed bottles in the outer carton in order to protect them from light.

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.