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MESALAZINE 1 G SUPPOSITORIES

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500000/PL1a

Pentasa® 1 g Suppositories
(mesalazine)

Patient Information Leaflet
The name of your medicine is Pentasa® 1 g Suppositories.
Throughout the remainder of this leaflet it will be referred to as
Pentasa®.
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
Each suppository contains mesalazine 1 g 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
suphasalazine
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
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 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

6) FURTHER INFORMATION
What Pentasa® contains
Each suppository contains 1 g 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 6000 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 pale yellow finger protectors for use
when inserting the suppository.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackaged by Ginova UK Ltd, both of St James’
House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by: Pharbil Pharma GmbH – Reichenberger
Str. 43, 33605 Bielefeld, Germany.
Pentasa® 1 g Suppositories
PL No: 18067/0401

POM

Pentasa® is a registered trademark of Ferring B.V
This leaflet was last approved on 23rd October 2012.

• 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 liver
and liver failure

• inflammation of the heart
or area surrounding the
heart

• Lupus erythematosis (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

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 sight and reach of children.
• Do not store above 25ºC.
• Store in original packaging.
• Do not use after the expiry date detailed on the pack.
• Return any old or unused medicines to your
pharmacist for disposal.
• If the suppositories become discoloured or show signs
of any deterioration, consult your doctor or pharmacist
who will tell you what to do.

500000/PL1a

500000/PL1a

Mesalazine 1 g Suppositories

Patient Information Leaflet
The name of your medicine is Mesalazine 1 g Suppositories.
Throughout the remainder of this leaflet it will be referred to as
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.
- 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
1) WHAT MESALAZINE IS AND WHAT IT IS USED FOR
Each suppository contains mesalazine 1 g 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
suphasalazine
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 Mesalazine 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 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.
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
Like all medicines, Mesalazine 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 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 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

6) FURTHER INFORMATION
What Mesalazine contains
Each suppository contains 1 g 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 6000 and talc.
What Mesalazine 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 pale yellow finger protectors for use
when inserting the suppository.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackaged by Ginova UK Ltd, both of St James’
House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by: Pharbil Pharma GmbH – Reichenberger
Str. 43, 33605 Bielefeld, Germany.
Mesalazine 1 g Suppositories
PL No: 18067/0401

POM

This leaflet was last approved on 23rd October 2012.

• 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 liver
and liver failure

• inflammation of the heart
or area surrounding the
heart

• Lupus erythematosis (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

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 MESALAZINE
• Keep out of sight and reach of children.
• Do not store above 25ºC.
• Store in original packaging.
• Do not use after the expiry date detailed on the pack.
• Return any old or unused medicines to your
pharmacist for disposal.
• If the suppositories become discoloured or show signs
of any deterioration, consult your doctor or pharmacist
who will tell you what to do.

500000/PL1a

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