PENTASA SUPPOSITORIES 1G
Active substance(s): MESALAZINE / MESALAZINE / MESALAZINE
Read all of this leaflet carefully before you start using this
− 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
− 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
In this leaflet :
What Pentasa is and what it is used for
Before you use Pentasa
How to use Pentasa
Possible side effects
How to store Pentasa
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
• 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
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 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.
You should make sure that you empty your bowels before inserting
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
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
SMP Leaflet 200x200mm
PENTASA® Suppositories 1g
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.
• raised liver enzymes
• muscle pain
• hair loss (reversible)
• joint pain
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
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.
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.
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:
• stomach pain
Rare side effects (affecting between 1 in 100 and 1 in 10,000)
• tingling or numbness in
the hands and feet
• inflammation of the liver
and liver failure
• inflammation of the heart
or area surrounding the
• Lupus erythematosis (an
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
Do not store above 25ºC.
Store in original packaging and do not use after the expiry date
detailed on the pack.
Keep out of reach and sight of children.
Return any old or unused medicines to your pharmacist for disposal.
What Pentasa contains
Each suppository contains 1g of the active ingredient, mesalazine
(also known as 5-aminosalicylic acid or 5-ASA). It also contains the
following inactive ingredients: povidone, magnesium stearate,
macrogol 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.
Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.
UB7 7PS (UK)
PENTASA Suppositories 1g PL 3194/0045.
This leaflet was last revised in )HEUXDU\ 201.
PENTASA is a registered trademark.
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
Very rare side effects (affecting less than 1 in 10,000 people)
SMP Leaflet 200x200mm
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.
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.