672-2664D

PENTASA® MESALAZINE 1g ENEMA (mesalazine)

Patient Information Leaflet

27mm

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 use Pentasa

3.    How to use Pentasa

4.    Possible side effects

5.    How to store Pentasa

6.    Further Information

M o

LL O CO

a § °

^ U1 n

1.    WHAT PENTASA IS AND WHAT IT IS USED FOR

The name of this medicine is Pentasa Mesalazine 1g Enema in the form of a suspension and will be referred to as Pentasa Mesalazine Enema in this leaflet. 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

CO Q_ ID Q_ O <

< S-

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 does 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)

•    Azathioprine 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 Pentasa 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 the back passage (rectum) only. Usually your doctor will 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

SF o o i

!£(£<>

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

t 9

< M

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 Enema may cause permanent staining on contact with clothing or fabrics.

V

Colour

Swatch

WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY    WARNING!

ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY    USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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 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 or wheeziness (signs of an allergic reaction).

•    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).

•    Chest pain, an increased 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.

m

g a:

o g 2 “ £ S ° <<9S

£ £ £ W

< < ffl u>

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

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:

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.

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.

cc

< k

a <

m CC 1C D-= u_

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE PENTASA

•    Do not use after the expiry date printed on the carton, or foil pack

•    Pentasa Mesalazine 1g Enema should not be stored above 25°C. Keep foil packed bottles in the outer carton in order to protect them from light.

•    KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor tells you to stop taking this medicine, please take it back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

•    If your medicine shows any signs of deterioration, you should seek the advice of your pharmacist.

6.    FURTHER INFORMATION

Pentasa Mesalazine 1g 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 the disposal of the empty enema bottle after use.

Each bottle contains 1gram of the active ingredient mesalazine (also known as 5-aminosalicylic acid or 5-ASA) in 100ml of liquid. The mesalazine settles out as a separate layer.

Other ingredients in Pentasa Mesalazine 1g Enema are:

disodium edetate, sodium metabisulphite, sodium acetate, purified water and hydrochloric acid to adjust the acidity of the product to a level which is suitable for administration.

POM

PL No: 18799/2751

(/)

CO 11-

< z

a i--i £

This product is manufactured by Ferring-Leciva A.S., K Rybniku 475, 252 42 Jesenice near Prague, Czech Republic and procured from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Leaflet revision (Ref.) 15.06.2015

PENTASA is a registered trademark of FERRING A/S

Colour

Swatch

WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY    WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT

ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY    USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.