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PENTASA SLOW RELEASE TABLETS 500MG

Active substance(s): MESALAZINE / MESALAZINE / MESALAZINE

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(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 take Pentasa
3.
How to take Pentasa
4.
Possible side effects
5.
How to store Pentasa
6.
Further Information

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The name of this medicine is Pentasa Slow Release Tablets.
Each tablet contains mesalazine 500mg as the active
ingredient. Mesalazine belongs to a group of medicines called
salicylates.

You should make sure that you don’t become dehydrated,
while you are taking 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.
Taking 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 :
• Azathioprine, 6-mercaptopurine or thioguanine
• Certain agents that inhibit blood clotting (medicines for
thrombosis or to thin your blood, e.g.warfarin)
Pregnancy and Breastfeeding
If you are pregnant, are planning to become pregnant or are
breastfeeding you should speak to your doctor or pharmacist
for advice before taking this medicine.

Pentasa is used to treat mild to moderate inflammation of the
gut caused by a condition called ulcerative colitis. It can also
be used to control the condition and prevent it from coming
back.

There is limited experience with the use of mesalazine
during pregnancy and breast-feeding. The newborn may
develop allergic reactions after breast-feeding, e.g. diarrhoea.
If the newborn develops diarrhoea, breast-feeding should
be discontinued.

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

3. How to take PENTASA

2. Before you take PENTASA

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

Do Not take Pentasa if you :
• are allergic to mesalazine or any of the other ingredients in
Pentasa (see section 6)
• are allergic to any other salicylates e.g. aspirin
• have severe liver or kidney problems

The tablets should be taken by mouth either whole or broken
up, they should not be crushed or chewed. If you have
difficulty swallowing the tablets you can disperse them in a
small quantity of cold water (approximately 50ml) then stir and
drink immediately.

Take special care with Pentasa
You should consult your doctor before taking these tablets 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.
• You experience any chest pain, an increased heartbeat and
excess tiredness while using this medicine, stop using this

Adults
To treat an attack of colitis, your doctor will usually prescribe
a dose of up to 4g masalazine, to be taken as eight tablets
once a day or in two or three divided doses.
To help prevent further attacks, your doctor will usually
prescribe a dose of 2g mesalazine, to be taken as four 500mg
tablets once a day.

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1. What PENTASA is and what it is used for

medicine and seek medical advice as soon as possible.
You suddenly develop abdominal cramps, abdominal pain,
fever, severe headache and rash, stop using this medicine
and seek medical advice immediately.
• you have lung problems, in particular asthma.
• 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 doctor.


SMP Leaflet 200x200mm

PENTASA® Slow Release Tablets 500mg

If you take more Pentasa than you should
If you accidentally take too many tablets, you should go to
your nearest emergency department or contact your doctor
immediately. Take the pack and any remaining tablets with
you.

• tingling or numbness in the hands and feet
• allergic and fibrotic lung reactions (including breathing
problems)
• changes in kidney function or kidney failure
• inflammation of the pancreas

If you forget to take Pentasa
If you forget to take a dose, take the next dose as soon as you
remember, unless it is less than 3 hours until your next dose.
Do not take a double dose to make up for the forgotten one.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme, website: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the
safety of this medicine.

4. Possible side effects
Like all medicines, Pentasa can cause side effects, although
not everyone gets them.
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 a blood disorder).
a change in the colour or amount of urine produced (signs
of kidney problems).

Other side effects include:

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Rare side effects
(affecting less than 1 in 1,000 patients) include:
• vomiting
• stomach pain
• nausea
• diarrhoea
• headache
• inflammation of the heart or area surrounding the heart
• dizziness
• flatulence (passing wind)
Very rare side effects
(affecting less than 1 in 10,000 patients) include:
• raised liver enzymes
• hair loss (reversible)
• joint and muscle pain
• allergic reactions and fever
• lupus erythematosis (an auto-immune disorder effecting
the skin)
• semen with a low concentration of sperm (oligospermia)
(this is reversible)
• blood disorders (e.g. low levels of red blood cells)

Do not store above 25ºC.
Store in original packaging and do not use after the expiry date
detailed on the pack.
Keep out of sight and reach of children.
Return any old or unused medicines to your pharmacist for
disposal.

6. Further information
What Pentasa contains
Each tablet contains 500mg of the active ingredient,
mesalazine. It also contains the following inactive ingredients:
povidone, ethylcellulose, microcrystalline cellulose, magnesium
stearate and talc.
What Penasa looks like and the contents of the pack
The tablets are white/grey to pale brown, specked, round
tablets, scored and marked ‘500mg’ on one side and
‘PENTASA’ on the other side. Each carton contains 100 tablets
presented in blister strips of 10 tablets per strip.

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

5. How to store PENTASA

Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.,
Drayton Hall, Church Road, West Drayton, UB7 7PS, (UK))
Manufactured by:
Ferring GmbH,
Wittland 11, D-24109 Kiel, Germany.
PENTASA Slow Release Tablets 500mg - PL 03194/0044.
This leaflet was last revised in July 2017.
PENTASA is a registered trademark.

SMP Leaflet 200x200mm

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

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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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