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Active substance(s): MESALAZINE

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Ref: 1551/170915/1/F


Pentasa Suppositories 1g
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.
Your medicine is called Pentasa Suppositories 1g but will be referred to as
Pentasa throughout the rest of this leaflet.
In this leaflet:

What Pentasa is and what it is used for


How to use Pentasa

Before you use Pentasa


Possible side effects


How to store Pentasa


Further Information

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.


What Pentasa is and what it is used for
To help prevent further attacks it may be used for longer.

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.
* 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.

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
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
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.

While you are using Pentasa your doctor may occasionally want to check
your kidney function.

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.

Ref: 1551/170915/1/B


Pentasa Suppositories 1g
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
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

• nausea

• diarrhoea

• headache
Rare side effects (affecting between 1 in 100 and 1 in 10,000)

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.


Further Information

What Pentasa contains
Each suppository contains mesalazine 1g.
Other ingredients povidone, macrogol 6000, magnesium stearate and talc.
What Pentasa looks like and the contents of the pack
The suppositories are oblong, compressed, white to light tan speckled
suppositories. Each carton contains 28 suppositories presented in blister
strips of 7 suppositories per strip, together with 28 finger protectors for use
when inserting the suppository.
Manufacturer and Licence Holder
This medicine is manufactured by Ferring GmbH, Kiel, Germany 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.

• 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

• inflammation of the

• kidney failure

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)
• raised liver enzymes

• muscle pain

• hair loss (reversible)

• joint pain

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via: Yellow Card Scheme Website: by reporting side effects, you can help
provide more information on the safety of this medicine.


How to store Pentasa

Do not store above 25ºC.
Store in original package in order to protect from moisture.
Do not use Pentasa Suppositaries after the expiry date which is stated on
the blister and carton label. The expiry date refers to the last day of that
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

PL 15184/1551

Pentasa Supprositories 1g

Pentasa is a registered trademark of Ferring B.V.
Revision date: 17/09/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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