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PENTASA 500 MG SLOW RELEASE TABLETS

Active substance(s): MESALAZINE / MESALAZINE / MESALAZINE

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T06702

PENTASA® 500 mg Slow Release Tablets
(mesalazine)

The name of your medicine is Pentasa 500 mg Slow release tablets but will be
referred as Pentasa throughout the following:
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 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

1. What Pentasa is and what it is used for

The name of this medicine is Pentasa Slow Release Tablets. Each tablet contains
mesalazine 500 mg as the active ingredient. Mesalazine belongs to a group of
medicines called salicylates.
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.
The tablets release the active ingredient slowly which then acts locally to reduce the
inflammation and help relieve or stop the pain.

2. Before you take Pentasa
Do Not take 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

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.
• If you experience any chest pain, an increased heartbeat and excess tiredness
while using this medicine, stop using this medicine and seek medical advice as
soon as possible.
• 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.
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:
• 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, as they will
need to decide if this medicine is suitable for you.

3. How to take Pentasa

Always take Pentasa exactly as your doctor has told you. You should check with our
doctor or pharmacist if you are not sure.
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 50 ml) then stir and drink
immediately.
To treat an attack of colitis, your doctor will usually prescribe a dose of up to 4 g
mesalazine, 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 2 g
mesalazine, to be taken as four 500 mg tablets once a day.

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.

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.

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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.

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).
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 people) include:
• vomiting
• nausea

• stomach pain
• diarrhoea

• rash with or without itching

• headache

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

• lupus erythematosus (an
auto-immune 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

• muscle pain

• hair loss (reversible)

• fever

• joint pain

• skin rash or blisters e.g.
Erythema Multiforme or
Steve-Johnson syndrome

• allergic reactions

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.

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 at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Pentasa

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.
If the tablets become discoloured or show any other signs of deterioration, you
should seek the advice of your doctor or 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 slow release tablet contains the active ingredient mesalazine 500 mg. It also
contains the following inactive ingredients: povidone, ethylcellulose,
microcrystalline cellulose, magnesium stearate and talc.

What Pentasa looks like and the contents of the pack

The tablets are white/grey to pale brown, specked, round tablets, scored and
marked ‘500 mg’ on one side and ‘PENTASA’ on the other side. Each carton
contains 100 tablets presented in blister strips of 10 tablets per strip.

Manufacturer and Product Licence Holder

This product is manufactured by Ferring GmbH, Wittland 11, D-24109 Kiel,
Germany. It is procured from within the EU by the Product Licence Holder:
Swinghope Ltd, Commerce Way, Edenbridge TN8 6ED, UK and Repackaged by
YMD Pharma Limited, Commerce Way, Edenbridge TN8 6ED, UK.

POM

PL No: 10380/1621

Leaflet revision date: 24/01/2017
PENTASA® is a registered trademark of Ferring BV, Netherlands.
Blind or partially sighted?
Is this leaflet hard to see or read?
Call 02030969700 to obtain the leaflet in a format suitable for you.

T06702

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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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