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MESALAZINE SUPPOSITORIES 1G

Active substance(s): MESALAZINE

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Package Information Leaflet

Pentasa® Suppositories 1g
(mesalazine)
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.
• The name of this medicine is Pentasa® Suppositories 1g but it will be
referred to as Pentasa throughout the remainder of this leaflet.
• 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

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.

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 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.

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
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
Multiforme 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

• 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 liver and
liver failure

• inflammation of the heart or
area surrounding the heart

• Lupus erythematosus (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.
Very rare side effects (affecting less than 1 in 10,000 people) include:
• raised liver enzymes

• muscle pain

• hair loss (reversible)

• joint pain

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.
5) HOW TO STORE PENTASA





Keep out of the sight and reach of children.
Do not store above 25oC.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of the month.
• If your medicine becomes discoloured or shows any signs of
deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are no
longer required. This will help to protect the environment.
6) FURTHER INFORMATION

What Pentasa contains
Each suppository contains mesalazine 1g.
The other ingredients are magnesium stearate, talc, povidone and
macrogol 6000.
What Pentasa looks like and the contents of the pack
Pentasa suppositories are oblong, white to light tan, speckled
suppositories.
Pentasa is available in blister packs of 28 suppositories together with
28 finger protectors for use when inserting the suppository.
Manufactured by
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
Leaflet dated 22nd April 2016
Leaflet coded xxxxxxxxx
PL 33532/0656

POM

Pentasa®, FERRING® and the FERRING logo are registered trademarks
of Ferring B.V.

Package Information Leaflet

Mesalazine Suppositories 1g
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.
• The name of this medicine is Mesalazine Suppositories 1g but it will be
referred to as Mesalazine throughout the remainder of this leaflet.
• 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 Mesalazine is and what it is used for
2) Before you use Mesalazine
3) How to use Mesalazine
4) Possible side effects
5) How to store Mesalazine
6) Further Information

3) HOW TO USE MESALAZINE
Always use Mesalazine 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.

1) WHAT MESALAZINE IS AND WHAT IT IS USED FOR
The name of this medicine is Mesalazine Suppositories.
Each suppository contains mesalazine 1g as the active ingredient.
Mesalazine belongs to a group of medicines called salicylates.
Mesalazine 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. Mesalazine
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 MESALAZINE
Do Not use Mesalazine if you:
• are allergic to mesalazine or any of the other ingredients in
Mesalazine
• 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 Mesalazine
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

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 Mesalazine 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 Mesalazine
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

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.

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

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

STOP taking Mesalazine 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
Multiforme 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).

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.

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 up to 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 liver and
liver failure

• inflammation of the heart or
area surrounding the heart

• Lupus erythematosus (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.
Very rare side effects (affecting less than 1 in 10,000 people) include:
• raised liver enzymes

• muscle pain

• hair loss (reversible)

• joint pain

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.
5) HOW TO STORE MESALAZINE





Keep out of the sight and reach of children.
Do not store above 25oC.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of the month.
• If your medicine becomes discoloured or shows any signs of
deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are no
longer required. This will help to protect the environment.
6) FURTHER INFORMATION

What Mesalazine contains
Each suppository contains mesalazine 1g.
The other ingredients are magnesium stearate, talc, povidone and
macrogol 6000.
What Mesalazine looks like and the contents of the pack
Mesalazine suppositories are oblong, white to light tan, speckled
suppositories.
Mesalazine is available in blister packs of 28 suppositories together with
28 finger protectors for use when inserting the suppository.
Manufactured by
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
Leaflet dated 22nd April 2016
Leaflet coded xxxxxxxxx
PL 33532/0656

POM

FERRING® and the FERRING logo are registered trademarks of
Ferring B.V.

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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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