Document: leaflet MAH BRAND_PLPI 33532-0266 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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Patient Information

PENTASA® Suppositories 1g

(mesalazine)

Read all of this leaflet carefully before you start using 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.

•    The name of this medicine is PENTASA Suppositories 1g but it will be referred to as Pentasa throughout the remainder of this leaflet.

•    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 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 Multiforme 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.

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.

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.

5)    HOW TO STORE PENTASA

•    Keep out of the sight and reach of children.

•    Do not store above 25^oC.

•    Store in the original package.

•    Do not use after the expiry date marked on the packaging.

•    If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.

•    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 suppository contains 1g of the active ingredient, mesalazine Other ingredients in this medicine are povidone, macrogol 6000, magnesium stearate and talc.

What Pentasa looks like and the contents of the pack

PENTASA Suppositories 1g are white to light tan, speckled suppositories.

They are provided in blister strips of 7 suppositories per strip.

Each carton contains 28 suppositories together with 28 finger protectors for use when inserting the suppository.

Manufacturer

Manufactured by: Ferring GmbH, Wittland 11, D-24109, Kiel, Germany. Procured from within the EU by the Product Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER

Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxx

Leaflet dated 26^th February 2015 Leaflet coded xxxxxxxxx

PENTASA Suppositories 1g PL 33532/0266 PENTASA® is a registered trademark of xxxxxxxxxxxxxx