PENTASA Suppositories 1g
(mesalazine)
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet, you may need to use it again.
- If you have further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same.
Your medicine is called PENTASA Suppositories 1g. It is for rectal use only.
- PENTASA Suppositories 1g are oval, compressed, white to pale brown, specked suppositories. They are presented in blister strips of 7 suppositories per strip. Each carton contains 28 suppositories together with 28 finger protectors for use when inserting the suppository.
- Each suppository contains 1g of the active ingredient, mesalazine (also known as 5-aminosalicylic acid or 5-ASA).
- Other ingredients in this medicine are povidone, magnesium stearate, talc and macrogol.
Marketing Authorisation Holder:
Manufactured by:
What PENTASA Suppositories 1g are and what they are used for
This medicine is for rectal use only. Mesalazine, the active ingredient in the suppositories belongs to a group of medicines known as salicylates. It has a healing effect upon the inflammation (swelling, redness and pain) caused in the
intestine by conditions such as ulcerative colitis. Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine becomes inflamed and develops many tiny breaks in its surface (ulcers) which may bleed. Ulcerative colitis sometimes affects only the rectum (back passage), when it is known as ulcerative proctitis. This medicine slowly releases mesalazine which acts locally to help reduce this inflammation, and reduce or eliminate your painful symptoms.
Uses:
The suppositories are used for the treatment of ulcerative proctitis and to help maintain freedom from further attacks.
Before you use PENTASA Suppositories 1g
Do not use this medicine:
- if you have severe liver and/or kidney problems
- if you are under 15 years of age
- if you are allergic to any of the ingredients listed
- if you are allergic to other salicylates e.g. aspirin
Take special care with this medicine:
Please consult your doctor before using the suppositories:
- if you currently have, or have previously had liver or kidney disease
- if you are on medication that may affect kidney function e.g. azathioprine or taking a medicine for pain and/or inflammation containing non-steroidal anti-inflammatory drugs (also known as NSAIDs) e.g. indomethacin
- if you are on treatment with either azathioprine or 6-mercaptopurine as there can be an increased risk of blood disorders.
While you are on treatment with this medicine, 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, nurse or pharmacist for advice as soon as possible.
Pregnancy:
If you are pregnant or planning a pregnancy, ask your doctor or pharmacist for advice before using this medicine.
Breast-feeding:
If you are breast-feeding ask your doctor or pharmacist for advice before using this medicine.
How to use PENTASA Suppositories 1g
This medicine should be inserted into the rectum (back passage) only.
There is no special time of day to insert this medicine. It is intended to remain in place for as long as possible. It is therefore usually best to insert a suppository before going to sleep.
Adults
Usually your doctor will prescribe one PENTASA Suppository daily for two to four weeks for the treatment of an attack of ulcerative proctitis, or for longer to help prevent another attack.
You should go to the toilet to empty your bowels and bladder (if necessary) before inserting the suppository.
- 1. Tear along the perforation to remove one suppository blister from a blister strip
- 2. Put a protector on the finger with which you will insert the suppository
- 3. Remove the suppository from the blister before insertion. This is done by pushing the suppository through the printed foil
- 4. Insertion may be made easier if you moisten the suppository with water first
- 5. Insert the suppository gently and fully into the back passage. It may help to lie down on one side and raise the other knee
- 6. 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
- 7. Dispose of the empty blister and used finger protector safely and wash your hands.
If you use more of this medicine than you should:
In the event of an overdose, contact your doctor or the nearest hospital casualty department at once.
If you forget to use this medicine:
If you have forgotten to insert a suppository, use one as soon as you remember and then use the next one at the usual time. However, if this would mean using two suppositories with a gap of less than 6 hours between them, do not use the forgotten one.
Possible side effects
Like all medicines, this medicine can have side effects.
Following rectal administration local reactions such as itching, rectal discomfort and urge may occur.
Commonly occurring side effects which may occur include headache, nausea, vomiting, diarrhoea, abdominal pain and rash. Patients whose symptoms of colitis have been made worse with the use of sulphasalazine may experience similar problems with this medicine.
Some other side effects reported rarely include: change in urine colour, anaemia and other blood disorders, inflammation of the joints, pancreas, liver, heart or kidney, other liver or kidney disorders, hair loss, muscle or joint pain, peripheral neuropathy (a condition affecting the nerves of the hands and feet). Allergic reactions and fever may occasionally occur.
You should tell your doctor at once if you suffer from the symptoms of these rare unwanted effects which include: abnormal or unexplained bleeding (e.g. nose bleeds), bruising, purple discoloration of the skin, blistering and peeling skin
(sometimes severe), spots under the skin, fever or a sore throat, excessive tiredness, shortness of breath, wheezing, coughing, bloody and/or excessive phlegm, chest pain or palpitations (rapid or irregular heart beats), swollen ankles, pale bowel motions, dark, cloudy or bloody urine, pain in the stomach or loins, tingling and numbness, burning, pain or aching in the hands or feet.
If you experience one or more of these side effects, or any other undesirable effects, please inform your doctor or pharmacist.
Storing PENTASA Suppositories 1g
Keep out of the reach and sight of children.
Do not store above 25ºC. Store this medicine in the original package.
Do not use after the expiry date marked on the packaging.
If you are unsure about the storage, ask your pharmacist. It is best to return all old and unused medication to your pharmacist for safe disposal.
PENTASA Suppositories 1g PL 3194/0045.
This leaflet was revised in February 2005.
The National Association for Colitis and Crohn’s Disease is an organisation which can provide information and support to patients with inflammatory bowel disease.
You can contact them at
PENTASA is a registered trademark.
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