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MESALAZINE 1G SUPPOSITORIES

Active substance: MESALAZINE

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PENTASA® 1g Suppositories
(mesalazine)

Patient Information
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.

The name of your medicine is Pentasa 1g Suppositories but will
be referred to as Pentasa throughout this leaflet.

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

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 Breast-feeding
If you are pregnant, are planning to become pregnant or are breastfeeding you should speak to your doctor or pharmacist before taking
this medicine.

1. What Pentasa is and what it is used for

3. How to use Pentasa

Each suppository contains mesalazine 1g as the active ingredient.
Mesalazine belongs to a group of medicines called salicylates.

Always use Pentasa exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

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 is used to treat ulcerative proctitis and are intended for
rectal use only.

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.

The suppositories release the active ingredient slowly which then
acts locally to reduce the inflammation and help relieve or stop the
pain.

To help prevent further attacks it may be used for longer.

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

To treat an attack of proctitis your doctor will usually prescribe one
suppository to be used daily for two to four weeks.
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

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 the sight and reach of children.
Do not store above 25ºC. Store in the original package.
Do not take after the expiry date which is stated on the carton/ blister
label after ‘Exp’. The date refers to the last day of that month.

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

They should not be disposed of via wastewater or household waste.
If they are out of date, or no longer suitable for you, return them to
your pharmacist.

Following rectal administration local reactions such as itching, rectal
discomfort and urge may occur.

6. Further information

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
 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.

What Pentasa contains
The active ingredient is mesalazine (also known as 5-aminosalicylic
acid or 5-ASA).
Each suppository contains 1g mesalazine.
The excipients are: povidone, macrogol 6000, magnesium stearate,
and talc.
What Pentasa looks like and the contents of the pack
Pentasa are oblong, off-white speckled suppositories.
Each carton contains 28 suppositories presented in blister strips of 7
suppositories per strip.

Manufactured by: Pharbil Pharma GmbH, Reichenberger Str.
43, 33605 Bielefeld, Germany.
Procured from within the EU and repackaged by the product
licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU.
PENTASA® 1g Suppositories PL No: 18799/2224

POM

Leaflet date: 21.08.2013
Pentasa is a registered trademark of Ferring Pharmaceuticals.

MESALAZINE 1g Suppositories
Patient Information
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.

The name of your medicine is Mesalazine 1g Suppositories but
will be referred to as Mesalazine throughout this leaflet.

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

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
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 Breast-feeding
If you are pregnant, are planning to become pregnant or are breastfeeding you should speak to your doctor or pharmacist before taking
this medicine.

1. What Mesalazine is and what it is used for

3. How to use Mesalazine

Each suppository contains mesalazine 1g as the active ingredient.
Mesalazine belongs to a group of medicines called salicylates.

Always use Mesalazine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

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 is used to treat ulcerative proctitis and are
intended for rectal use only.

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.

The suppositories release the active ingredient slowly which then
acts locally to reduce the inflammation and help relieve or stop the
pain.

To help prevent further attacks it may be used for longer.

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

To treat an attack of proctitis your doctor will usually prescribe one
suppository to be used daily for two to four weeks.
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.

g.

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
Dispose of the empty blister and used finger protector safely
and wash your hands

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

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 upto 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

 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 the sight and reach of children.
Do not store above 25ºC. Store in the original package.
Do not take your tablets after the expiry date which is stated on the
carton/ blister label after ‘Exp’. The date refers to the last day of that
month.
The tablets should not be disposed of via wastewater or household
waste. If they are out of date, or no longer suitable for you, return
them to your pharmacist.

6. Further information
What Mesalazine contains
The active ingredient is mesalazine (also known as 5-aminosalicylic
acid or 5-ASA).
Each suppository contains 1g mesalazine.
The excipients are: povidone, macrogol 6000 , magnesium stearate,
and talc.
What Mesalazine looks like and the contents of the pack
Mesalazine are oblong, off-white speckled suppositories.
Each carton contains 28 suppositories presented in blister strips of 7
suppositories per strip.

Manufactured by: Pharbil Pharma GmbH, Reichenberger Str.
43, 33605 Bielefeld, Germany.
Procured from within the EU and repackaged by the product
licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU.
POM
MESALAZINE 1g Suppositories PL No: 18799/2224
Leaflet date: 21.08.2013

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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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