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MESALAZINE 1G SUPPOSITORIES

Active substance(s): MESALAZINE

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Pentasa® 1g Suppositories /
Mesalazine 1g Suppositories
(mesalazine)

Patient Information
This medicine is available as any of the above names but will
be referred as Pentasa throughout the following 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 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.

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
sulfasalazine
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.

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.
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

5. How to store Pentasa

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

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton and blister label. The expiry date refers to the last
day of that month.
Do not store above 25°C. Store in the original package.
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.
If your medicine have become discoloured or show any other
signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.

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 up to 1 in 100 people) include:

• vomiting
• nausea
• headache

• stomach pain
• diarrhoea

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.
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.

6. Further information
What Pentasa contains
Each suppository contains 1g mesalazine (also known as 5aminosalicylic acid or 5-ASA).
Also contains povidone, macrogol 6000, magnesium stearate
and talc.
What Pentasa looks like and contents of the pack
The suppositories are oblong, compressed, white to light tan
speckled suppositories.
Each carton contains:
• 14 suppositories presented in blister strips of 7
suppositories per strip, together with 14 finger protectors for
use when inserting the suppository
• 28 suppositories presented in blister strips of 7
suppositories per strip, together with 28 finger protectors for
use when inserting the suppository.
PL 15814/1176

POM

Manufactured by Ferring GmbH, Wittland, Kiel, Germany.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 25.11.2015.
Pentasa is a registered trademark of Ferring BV, The
Netherlands.
To request a copy of this leaflet in Braille, large print or audio
please call 01923 332 796.

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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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