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PENTASA MESALAZINE 1G ENEMA

Active substance(s): MESALAZINE

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Pentasa® Mesalazine 1g Enema
(mesalazine)
Your medicine is known by the above name, but will be referred to as
Pentasa throughout this:
Patient Information Leaflet
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 get 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
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).
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

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, 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.

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 enema should be used in the back passage (rectum) only. Usually
your doctor will ask you to use one enema at bedtime.
How to use the enema
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).

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.

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

4. Hold the container as shown in the picture.

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 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 does occur,
you should speak to a doctor or pharmacist for advice as soon as possible.

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

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

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 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 or wheeziness (signs of an allergic reaction).
 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).
 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
 headache
 nausea
 stomach pain
 rash with or without itching
 diarrhoea
Rare side effects (affecting less than 1 in 1,000 patients) include:
 blood disorders (e.g. low levels of
red blood cells)
 tingling or numbness in the hands
and feet
 inflammation of the heart or area
surrounding the heart
 inflammation of the liver and liver
failure

 lupus erythematosis (an
autoimmune disorder
affecting the skin)
 allergic lung reactions
(including breathing
problems)
 changes in kidney function
or kidney failure
 inflammation of the
pancreas

 Do not store above 25°C.
 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 all medicines out of the sight and reach of children.
 If the enema suspension become discoloured or show signs of any
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6) Further information
What Pentasa contains
Each bottle contains 1g of the active ingredient, mesalazine (also known
as 5-aminosalicylic acid or 5-ASA). Each 100ml bottle contains 1g
mesalazine. The mesalazine settles out as a separate layer.
Also contains: disodium edetate dihydrate, sodium metabisulphite, sodium
acetate trihydrate, purified water and hydrochloric acid concentrated to
adjust the acidity of the product to a level which is suitable for
administration.
What Pentasa looks like and contents of the pack
Pentasa Mesalazine 1g Enema is a colourless to faint yellow suspension
presented in a polyethylene bottle fitted with a tip and valve for rectal
application, supplied in nitrogen-filled aluminium-foil bags.
Each pack contains 7 x 100ml individually foil-wrapped enema bottles and
7 polythene bags for disposal of the empty enema bottle after use.
PL 10383/2053

Pentasa® Mesalazine 1g Enema

POM

Who makes and repackages your medicine?
This product is manufactured by Ferring Portuguesa – Productos
Farmaceuticos, Sociedade Unipessoal, LDA. Rua Alexandre Herculano,
Edificio 1 – Piso 6, 2795-240 Linda-a-Velha, Portugal. Procured from
within the EU and repackaged by the Product Licence Holder: Primecrown
Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5
5QS.
Leaflet date: 30.08.2013
Pentasa® is a registered trade mark of Ferring B.V., The Netherlands

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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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