Pentasa ® 1 g

Mesalazine, the active ingredient in PENTASA ® 1 g ENEMA, belongs to a group of medicines known as salicylates. PENTASA ® 1 g ENEMA acts locally to help reduce the inflammation, and reduce or eliminate painful symptoms affecting the last part of the colon and rectum (back passage).

Do not use PENTASA ® 1 g ENEMA:

• If you are hypersensitive (allergic) to salicylates (for instance aspirin) or any of the ingredients (see “What PENTASA ® 1 g ENEMA contains”).
• If you suffer from a severe liver or kidney disorder.

Take special care with PENTASA ® 1 g ENEMA:

• If you are allergic to sulphasalazine, as you are likely to have an increased risk of being allergic to salicylates as well.
• If you have a liver disorder. Your doctor may need to test your liver function before prescribing and during your treatment with PENTASA ® 1 g ENEMA.
• Your doctor may need to test your kidney function during your treatment with PENTASA ® 1 g ENEMA to ensure your kidneys are working properly.
• If you develop unexplained bleeding (e.g. nose bleeds), bruises, purple discolouration of the skin, sore throat, fever, chest pains, rapid or irregular heartbeat and shortness of breath; contact your doctor immediately.

While you are on treatment with PENTASA ® 1 g ENEMA, you should avoid becoming dehydrated (this is when your body loses too much water). This can occur due to severe or prolonged attacks of vomiting and or diarrhoea, high fever or heavy sweating. Should this occur, ask your doctor or pharmacist for advice as soon as possible.

Pregnancy and Breastfeeding

If you are pregnant, planning a pregnancy or breastfeeding, ask your doctor or pharmacist for advice before using PENTASA ® 1 g ENEMA. Women on treatment with PENTASA ® 1 g ENEMA should not breastfeed their infants.

Driving and using machines:

It is unknown if treatment with PENTASA ® 1 g ENEMA affects the ability to drive and/or use machines; however take care until you know how PENTASA ® 1 g ENEMA affects you.

Using other medicines with PENTASA ® 1 g ENEMA:

Always tell your healthcare professional if you are taking any other medicine on a regular basis, including complementary or traditional medicines, the use of PENTASA ® 1 g ENEMA with these medicines may cause undesirable interactions. Tell your doctor or pharmacist if you are currently using:

• Medicines that may affect your kidney function e.g. azathioprine or 6-mercaptopurine.

Always use PENTASA ® 1 g ENEMA exactly as your doctor has told you. You should make sure with your doctor or pharmacist if you are uncertain. PENTASA ® 1 g ENEMA should be inserted into the rectum (back passage). It should not be taken by mouth.

Adults: Usually your doctor will tell you to use one enema at bedtime.

Instruction for use and handling

1. PENTASA ® 1 g ENEMA is protected by a foil bag which should be removed just before use.
2. A visit to the toilet is recommended before administration of PENTASA ® 1 g ENEMA.
3. Immediately before use, take the enema bottle out of the aluminium foil bag and shake it well.
4. To break the seal, twist the nozzle clockwise one full turn (the nozzle should then be in the same direction as before turning).
5. Put your hand into one of the plastic disposal bags provided in the pack.
6. Hold the container as shown in the picture.
7. 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.
8. Once the bottle is empty, withdraw the tip with the bottle still compressed.
9. 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.
10. Roll the plastic disposal bag over the empty bottle. Discard it and wash your hands.

Please note: Bed-linen and underwear should be protected in case of spillage, since PENTASA ® 1 g ENEMA might discolour the fabric. Should that happen, leave the clothes to soak immediately.

If you forget to use PENTASA ® 1 g ENEMA:

If you have forgotten to use a PENTASA ® 1 g ENEMA before bedtime, use one the next morning if it is convenient. Otherwise, use one as usual the next night.

If you use more PENTASA ® 1 g ENEMA than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. Take the PENTASA ® 1 g ENEMA bottle and this leaflet with you so that the doctor may know what you have used.

PENTASA ® 1 g ENEMA may have side effects. There have been reports of a severe allergic reaction which have led to swelling of the face and neck and/or difficulty in breathing or swallowing. If this happens, contact your doctor or nearest casualty department immediately.

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

The following are frequent side effects:

• diarrhoea
• abdominal pain
• nausea
• vomiting
• headache
• rash

The following are less frequent side effects:

• inflammation of some areas of the heart (myocarditis and pericarditis) which can cause shortness of breath and chest pain or palpitations (rapid or irregular heartbeats)
• inflammation of the pancreas (symptoms include back and/or stomach pain)
• anaemia and other blood disorders (decrease in the numbers of certain blood cells, which can cause unexplained bleeding, bruising, fever or sore throat)
• liver disorders (symptoms include jaundice (yellowing of the skin and/or eyes) and/or pale bowel motions)
• kidney disorders (symptoms include blood in the urine and/or oedema (swelling due to build-up of fluid))
• peripheral neuropathy (a condition affecting the nerves of the hands and feet, symptoms include tingling and numbness)
• Hypersensitivity lung reactions (symptoms include coughing, shortness of breath, bloody and/or excessive phlegm)
• Reversible hair loss
• muscle or joint pain
• inflammation which can affect different parts of the body such as joints, skin, kidneys, heart etc. (symptoms include painful joints, fatigue, fever, abnormal or unexplained bleeding (e.g. nose bleeds), bruising, purple discolouration of the skin, spots under the skin)
• change in urine colour.

Not all side effects reported for PENTASA ® 1 g ENEMA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

• Store at or below 25 °C.

• Protect from light. Do not freeze.

• Do not remove from the foil bag and outer carton until required for use.

• KEEP ALL MEDICINE OUT OF REACH OF CHILDREN.

• Do not use PENTASA ® 1 g ENEMA after the expiry date printed on the bottle and foil bag.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

• Return all unused medicine to your pharmacist.