Document: leaflet MAH BRAND_PL 03194-0045 change

• leaflet MAH BRAND_PL 03194-0045
• leaflet MAH BRAND_PLPI 15184-0929
• leaflet MAH BRAND_PLPI 33532-0266
• leaflet MAH BRAND_PLPI 33532-0656

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PENTASA® Suppositories 1g

(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 Suppositories. Each suppository contains mesalazine 1g 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 ulcerative colitis. Sometimes ulcerative colitis only affects the back passage (rectum), this is known as ulcerative proctitis. Pentasa suppositories are used to treat ulcerative proctitis and are intended for rectal use only.

The suppositories release the active ingredient slowly 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

•    are under the age of 15 years

Take special care with Pentasa

You should consult your doctor before using these suppositories 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

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

While you are using Pentasa your doctor may occasionally want to check your kidney function.

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)

•    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.

3. How to use PENTASA

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

The suppository should be inserted into the back passage (rectum) only. It is intended to be left in place for as long as possible and is therefore best inserted before going to sleep.

To treat an attack of proctitis your doctor will usually prescribe one suppository to be used daily for two to four weeks.

To help prevent further attacks it may be used for longer.

How to insert the suppository

You should make sure that you empty your bowels before inserting the suppository.

a.    Tear along the perforation to remove one suppository blister from a blister strip

b.    Put a protector on the finger with which you will insert the suppository

c.    Remove the suppository from the blister before insertion. This is done by pushing the suppository through the printed foil

d.    Insertion may be made easier if you moisten the suppository with water first

e.    Insert the suppository gently and fully into the back passage.

It may help to lie down on one side and raise the other knee

f.    Remain still for a few minutes after insertion to help keep the suppository in place. If it comes out within 10 minutes, a new one should be inserted

g.    Dispose of the empty blister and used finger protector safely and wash your hands

If you use more Pentasa than you should

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

If you forget to use Pentasa

If you forget to use a dose, use the next dose as soon as you remember, unless it is less than 6 hours until your next dose. Do not use 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.

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

STOP taking Pentasa if you notice:

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

•    skin disorder due to an allergic reaction or infection (Erythema Mulitforme or Stevens-Johnson syndrome). Symptoms include severe rash, blisters or red splotches on the skin.

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

•    change in 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 immediately.

Common side effects (affecting upto 1 in 100 people) include:

Rare side effects (affecting between 1 in 100 and 1 in 10,000) include:

• tingling or numbness in the hands and feet	• inflammation of the liver and liver failure
• inflammation of the heart or area surrounding the heart	• Lupus erythematosis (an auto-immune disorder affecting the skin)
• inflammation of the pancreas	• kidney failure

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

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

• raised liver enzymes	• muscle pain
• hair loss (reversible)	• joint pain

If any of the side effects get serious or if you experience any other side effects not listed on this leaflet, you should contact your doctor or pharmacist immediately.

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 suppository contains 1g of the active ingredient, mesalazine (also known as 5-aminosalicylic acid or 5-ASA). It also contains the following inactive ingredients: povidone, magnesium stearate, macrogol and talc.

What Pentasa looks like and the contents of the pack

The suppositories are oblong, compressed, white to light tan speckled suppositories. Each carton contains 28 suppositories presented in blister strips of 7 suppositories per strip, together with 28 finger protectors for use when inserting the suppository.

Marketing Authorisation Holder:

Ferring Pharmaceuticals Ltd.

Drayton Hall,

Church Road,

West Drayton,

UB7 7PS (UK)

Manufactured by: Ferring GmbH, Wittlandl 1, D-24109 Kiel, Germany

PENTASA Suppositories 1g PL 3194/0045. This leaflet was last revised in February 2014. PENTASA is a registered trademark.