MESALAZINE 1G SUPPOSITORIES

Active substance: MESALAZINE

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S1685 LEAFLET Pentasa 20130322

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

PENTASA 1g SUPPOSITORIES
(mesalazine)

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:

Your medicine is known as Pentasa 1g Suppositories but will be
referred to as Pentasa throughout the following leaflet.



Non-steroidal anti-inflammatories (NSAIDS)



Azathioprine or 6-mercaptopurine

Read all of this leaflet carefully before you start using this
medicine.

Pregnancy and Breastfeeding



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.

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.

In this leaflet:

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

1. What Pentasa is and what it is used for

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

2. Before you use Pentasa
3. How to use Pentasa

How to insert the suppository

4. Possible side effects

You should make sure that you empty your bowels before inserting
the suppository.

5. How to store Pentasa
6. Further Information

a. Tear along the perforation to remove one suppository blister
from a blister strip

1. WHAT PENTASA IS AND WHAT IT IS USED FOR

b. Put a protector on the finger with which you will insert the
suppository

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.

c. Remove the suppository from the blister before insertion. This is
done by pushing the suppository through the printed foil

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.

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

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



are under the age of 15 years

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.

have severe liver or kidney problems



d. Insertion may be made easier if you moisten the suppository
with water first

Take special care with Pentasa

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.

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.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

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

What Pentasa contains

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).



Each suppository contains 1g of the active ingredient,
mesalazine.



It also contains the following inactive ingredients:
polyvinylpyrrolidone, polyethylene glycol 6000, magnesium
stearate 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.
Product Licence holder

If you experience any of the above side effects, you should contact
your doctor or go to the nearest hospital immediately.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Common side effects (affecting upto 1 in 100 people) include:

Manufacturer



vomiting



nausea

This product is manufactured by Pharbil Pharma GmbH,
Reichenberger Str 43, 33605 Bielefeld, Germany.



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.
5. HOW TO STORE PENTASA


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store your above 25°C.



Store in the original package.



Do not use after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.



Return any old or unused medicines to your pharmacist for
disposal.

POM

PL No: 19488/1685

Leaflet revision date: 22 March 2013
Pentasa is a registered trademark of Ferring Pharmaceuticals Ltd,
UK.
S1685 LEAFLET Pentasa 20130322

S1685 LEAFLET Mesalazine 20130322

PACKAGE LEAFLET: INFORMATION FOR THE USER

MESALAZINE 1g SUPPOSITORIES
(mesalazine)
Your medicine is known as Mesalazine 1g Suppositories but will be
referred to as Mesalazine Suppositories 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:

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 SUPPOSITORIES
Always use Mesalazine Suppositories 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.

1. What Mesalazine Suppositories are and what they are used for

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

2. Before you use Mesalazine Suppositories

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

3. How to use Mesalazine Suppositories
4. Possible side effects
5. How to store Mesalazine Suppositories

How to insert the suppository

6. Further Information

You should make sure that you empty your bowels before inserting
the suppository.

1. WHAT MESALAZINE SUPPOSITORIES ARE AND WHAT
THEY ARE USED FOR

a. Tear along the perforation to remove one suppository blister
from a blister strip

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.

b. Put a protector on the finger with which you will insert the
suppository

Mesalazine Suppositories are 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 SUPPOSITORIES

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

Do Not use Mesalazine Suppositories if you :


are allergic to mesalazine or any of the other ingredients in
Mesalazine Suppositories



are allergic to any other salicylates e.g. aspirin



have severe liver or kidney problems



If you use more Mesalazine Suppositories 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.

are under the age of 15 years
If you forget to use Mesalazine Suppositories

Take special care with Mesalazine Suppositories
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 Suppositories your doctor may
occasionally want to check your kidney function.

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

6. FURTHER INFORMATION

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

What Mesalazine Suppositories contain

Following rectal administration local reactions such as itching, rectal
discomfort and urge may occur.
STOP taking Mesalazine Suppositories if you notice:


itching, skin rashes, swelling of the face, lips or throat, difficulty
in breathing, wheeziness or coughing (signs of an allergic
reaction).



Each suppository contains 1g of the active ingredient,
mesalazine.



It also contains the following inactive ingredients:
polyvinylpyrrolidone, polyethylene glycol 6000, magnesium
stearate and talc.

What Mesalazine Suppositories look like and the contents of
the pack



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).

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.



change in colour or amount of urine produced (signs of kidney
problems).

Product Licence holder

If you experience any of the above side effects, you should contact
your doctor or go to the nearest hospital immediately.

The suppositories are oblong, compressed, white to light tan
speckled suppositories.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Common side effects (affecting upto 1 in 100 people) include:


vomiting

Manufacturer



nausea



headache

This product is manufactured by Pharbil Pharma GmbH,
Reichenberger Str 43, 33605 Bielefeld, Germany.



stomach pain



diarrhoea

POM

PL No: 19488/1685

Leaflet revision date: 22 March 2013
S1685 LEAFLET Mesalazine 20130322

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.
5. HOW TO STORE MESALAZINE SUPPOSITORIES


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store your above 25°C.



Store in the original package.



Do not use after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.



Return any old or unused medicines to your pharmacist for
disposal.

Expand view ⇕

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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