Pentasa Suppositories 1g
® Ref: 0929/190315/1/F
Pentasa® Suppositories 1g
(mesalazine)
Patient Information Leaflet
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.
* 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
ft Before you use Pentasa
ft How to use Pentasa
ft Possible side effects
ft How to store Pentasa
ft Further Information
^ 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.
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
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.
Pentasa Suppositories 1g
(mesalazine)
Patient Information Leaflet (continued)
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:
|
* vomiting |
* stomach pain |
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* nausea |
* diarrhoea |
|
* headache |
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.
How to store Pentasa
Expiry Date
Do not use this medicine after date shown on the carton label or blister strip. Only keep this medicine if your doctor tells you to. You should return any left over suppositories to your pharmacist.
If your suppositories become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
How to Store
* Do not store above 25°C
* Store in the original package
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
Important
Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people it may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any question or are not sure about anything, ask your doctor or pharmacist (chemist) He/she will have additional information about this medicine and will be able to advise you
[p Further information
What Pentasa contains
Each suppository contains 1g of mesalazine as the active ingredient. The suppositories also contain povidone, macrogol 6000, magnesium stearate, and talc.
What Pentasa looks like and the contents of the pack
Pentasa are oval, compressed, white to pale grey specked suppositories. They are available in packs of 10 or 28 suppositories.
Manufacturer and Licence Holder
Pentasa is manufactured by Ferring Portuguesa Produtos Farmaceuticos, Sociedade Unipessoal, LdA, Rua Prof, Henrique de Barros, Edificio Sagres, Piso 8, Sala A 2685-338 Prior Velho, Portugal and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
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.
POM PL 15184/0929
Pentasa is a registered trademark of FERRING B.V.
Revision date: 19/03/15