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PENTASA 1G SUPPOSITORIES

Active substance(s): MESALAZINE

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Pentasa® 1g Suppositories
(mesalazine)
Your medicine is known by the above name, but will be referred to as
Pentasa throughout this:
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
2) Before you use Pentasa
3) How to use Pentasa
4) Possible side effects
5) How to store Pentasa
6) Further Information

1) What Pentasa is and what it is used for
The name of this medicine is Pentasa 1g Suppositories. Each suppository
contains mesalazine 1g as the active ingredient. Mesalazine belongs to a
group of medicines called salicylates.

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.

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 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.

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.

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
• 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.

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.

4) Possible side effects

6) Further information

Like all medicines, Pentasa can cause side effects, although not everyone
gets them.

What Pentasa contains
Each suppository contains 1g of the active ingredient, mesalazine (also
known as 5-aminosalicylic acid or 5-ASA).

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
• 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 heart or
area surrounding the heart
• inflammation of the
pancreas

• inflammation of the liver
and liver failure
• Lupus erythematosis (an
auto-immune disorder
affecting the skin)
• 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) include:
• raised liver enzymes
• hair loss (reversible)

• muscle pain
• 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.

5) How to store Pentasa
• Keep out of the reach and sight of children.
• Do not store above 25°C. Store in the original package in order to protect
from light.
• Do not use after the expiry date marked on the packaging.
• If your doctor tells you to stop taking Pentasa 1g Suppositories, please
take them back to the pharmacist for safe disposal. Only keep the
suppositories if your doctor tells you to.
• If the suppositories become discoloured or show signs of any
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

Other ingredients in this medicine are povidone, magnesium stearate, talc,
and macrogol 6000.
What Pentasa looks like and contents of the pack
Pentasa 1g Suppositories 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.
PL 10383/1807

Pentasa® 1g Suppositories

POM

Who makes and repackages your medicine?
This product is manufactured by Ferring GmbH, Wittland 11, D-24109 Kiel,
Germany. Procured from within the EU and repackaged by the Product
Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue
Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 05.11.2015
Pentasa is a registered trademark of Ferring BV, The Netherlands.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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