PENTASA MESALAZINE ENEMA 1G

Active substance: MESALAZINE

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PENTASA Mesalazine Enema
(mesalazine)

Patient Information
Read all of this leaflet carefully before you start taking
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

3. HOW TO USE PENTASA
3. HOW TO USE PENTASA

Always use Pentasa exactly as as your doctor told you. You You
Pentasa exactly your doctor has has told you.
Always use
should check with your doctor or pharmacist if you younot sure. sure.
should check with your doctor or phamacist if are are not
The enema should be used in thethe back passage (rectum) only.
The enema should be used in back passage (rectum) only.
Usually your doctor will ask you to useuse one enema at bedtime
Usually your doctor will ask you to one enema at bedtime.
Usually your doctor will ask you to use one enema at bedtime.
How to use the enema
How to use the enema
How to use the enema
a. Immediately before use, take the enema bottle
a. Immediately before use, take the enema bottle

1. Immediately before use take the enema bottle
out of the aluminium foil pack and shake it well

2. To break the seal twist the nozzle clockwise
one full turn (the nozzle should then be in the
same direction as before turning)
.

3. Put your hand in one of the plastic disposal
bags provided in the pack

The name of this medicine is Pentasa Mesalazine Enema in the
form of a suspension. Each bottle contains mesalazine 1g in 100ml
of liquid 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 active ulcerative colitis where it is affecting the
last part of the colon and rectum (back passage).

4. Hold the container as shown in the picture.

The enema releases the active ingredient 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
Pentasa is not suitable for use in children

Take special care with Pentasa
You should consult your doctor before using these enemas 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
If you suffer from kidney problems you will require regular check
ups by your doctors.
If you experience any unexplained bleeding, bruising, skin rashes,
fever or sore throat while using this medicine, stop using this
medicine and seek medical advice as soon as possible.
If you experience any chest pain, an increased heartbeat and
excess tiredness whilst using this medicine, stop using this
medicine and seek medical help as soon as possible.
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 dose occur, you should speak to a doctor or pharmacist for
advice as soon as possible.
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)
• Azathioprin or 6-mercaptopurine
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant or are
breastfeeding you should speak to your doctor or pharmacist before
taking this medicine, as they will need to decide if this medicine is
suitable for you.

5. To administer the enema, lie
on your left side with the left leg
straight and the right leg bent
forward for balance. Carefully
insert the applicator tip into the
rectum. Maintain sufficient steady
hand pressure while dispersing
the bottle content. The bottle
content should be applied within
max 30-40 seconds.
6. Once the bottle is empty, withdraw the tip with the bottle still
compressed
7. The enema should be retained
in the bowel. Remain relaxed in
the administration position for 5-10
minutes or until the urge to pass
the enema has disappeared
.

8. Roll the plastic disposal bag over the empty
bottle. Discard it and wash your hands.

Please note: Pentasa Mesalazine may
cause permanent staining on contact
with clothing or fabrics.

If you use more Pentasa than you should
If you accidentally use too much, you should go to your nearest
emergency department or contact your doctor immediately. Take
the carton with you.
If you forget to use Pentasa
If you forget to use a dose, use the next dose in the morning if it is
convenient. Otherwise, use one as usual the next night. Do not
use a double dose to make up for the forgotten one
If you have any further questions on the use of this prouct, ask
If youdoctor any further questions on the use of this product, ask
your have or pharmacist.
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

4. POSSIBLE SIDE EFFECTS
4. POSSIBLE SIDE EFFECTS

Like all medicines, SIDE EFFECTS
4. POSSIBLESIDE can cause side effects, although not
4.POSSIBLE Pentasa EFFECTS

everyone gets them.
Like all medicines, Pentasalocal reactions such as itching,
Following rectal administration can cause side effects although not
everyone gets them. may occur.
rectal discomfort and urge
STOP taking Pentasa if you notice:
Following rectal administration local reactions such as itching,
• Itching, skin rashes, swelling of the face,
rectal discomfort and urge may occur. lips or throat, difficulty in

breathing or wheeziness (signs of an allergic reaction).
STOP taking Pentasa if you skin rashes, fever or sore throat
• Unexplained bleeding, bruising, notice:
Itching,skin rashes, swelling of the face, lips or throat, difficulty in
• (signs of blood disorder).
• breathing colour or amount of urineof an allergic reaction). problems).
Change in or wheeziness (signs produced (signs of kidney
• Chest pain, an increased heartbeat or excess tiredness (signs of heart
• Unexplained bleeding, bruising, skin rashes, fever or sore throat
problems).
(signs of blood disorder).
If you experience any of the above side effects, you should contact your
•doctor or go to the nearest hospital emergency deprtment immediately.
Change in colour or amount of urine produced (signs of kidney



problems).
Common side effects (affecting less than 1 indepartmentinclude:
10 patients)

Chest pain, an increase in heartbeat or excess tiredness (signs of
heart problems).

If you experience any of the above side effects, you should contact
your doctor or go to the nearest hospital emergency department
immediately.
Common side effects (affecting less than 1 in 10 patients) include:
• vomiting
• nausea

• rash with or without itching

• headache
• stomach pain
• diarrhoea

Rare side effects (affecting less than 1 in 1,000 patients) include:
• blood disorders (e.g low
levels of red blood cells)

• lupus erythematosis (an autoim • lupus erythermatosis (an
mune disorder effecting the skin)

• tingling or numbness in the
hands and feet

• allergic lung reactions
(including breathing problems)

• inflammation of the heart or
area surrounding the heart

• changes in kidney function or
kidney failure

• inflammation of the liver
and liver failure

• inflammation of the pancreas

Very rare side effects (affecting less than 1 in 10,000 patients) include:
• raised liver enzymes
• Hair loss (reversible)
• joint pain
• allergic reactions

• muscle pain
• fever
• skin rash or blisters e.g.
Erythema Multiforme or
Steven-Johnson syndrome

If any of these side effects become severe or if you experience
any other side effects not listed you should contact your doctor or
pharmacist as soon as possible.

5. HOW TO STORE PENTASA
Do not store above 25ºC.
Keep the foil packed bottles in the outer carton in order to protect
them from light.
Do not use after the expiry date detailed on the pack.
Keep out of reach and sight of children.
Return any old or unused medicines to your pharmacist for
disposal.

6. FURTHER INFORMATION

What Pentasa contains
Each bottle contains 1g of the active ingredient, mesalazine
(also known as 5-aminosalicyclic acid or 5-ASA) in 100mls of
liquid. The mesalazine settles out as a separate layer. It also
contains the following inactive ingredients: disodium edetate,
sodium metabisulphite, sodium acetate, hydrochloric acid and
purified water.
What Pentasa looks like and the contents of the pack
The enema is a colourless to faint yellow suspension presented
in a polythene bottle. Each pack contains 7 individually foilwrapped enema bottles and 7 polythene bags for disposal of the
empty enema bottle after use.
Marketing Authorisation Holder
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West
Drayton,UB7 7PS, UK.
Manufactured by
Ferring A/S, DK-2720 Vanløse, Copenhagen, Denmark.
PENTASA Mesalazine Enema PL 03194/0027
This leaflet was revised in May 2013.
PENTASA is a registered trademark

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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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