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PENTASA 500MG SLOW RELEASE TABLETS

Active substance(s): MESALAZINE

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PATIENT INFORMATION LEAFLET
®

PENTASA 500mg SLOW RELEASE TABLETS
(mesalazine)
This product is available as the above name but will be referred to as Pentasa throughout
the remainder of this 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 500mg 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 your 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 50ml) then stir and drink immediately.
To treat an attack of colitis, your doctor will usually prescribe a dose of up to 4g
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 2g
mesalazine, to be taken as four 500mg 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.
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
rash with or without itching

stomach pain
diarrhoea
headache

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 effecting the
skin)
allergic lung reactions (including
breathing problems)
changes in kidney function or
kidney 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 StevenJohnson 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.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly on 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.
5. HOW TO STORE PENTASA
• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in the original package to protect from light.
• Do not take after the expiry date on the packaging. The expiry date refers to the last day
of that month.
• If you are unsure about the storage, ask your pharmacist. It is best to return all old and
unused medication to your pharmacist for safe disposal.
• If the tablets have become discoloured or show any other signs of 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
Your medicine is called Pentasa 500mg slow release Tablets.
The tablets should be taken by mouth.
• each slow release tablet contains 500mg of the active ingredient, mesalazine (also
known as 5-aminosalicylic acid or 5-ASA).
• other ingredients in Pentasa are magnesium stearate, povidone, ethylcellulose, talc and
microcrystalline cellulose.

• the tablets are light-grey to light-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 with 10 tablets per strip.
PL No: 15814/1014

POM

Manufactured by Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. Procured from within
the EU and repackaged by the Product Licence holder: OPD Laboratories Ltd, Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 02.09.2015.
Pentasa is a registered trademark of Ferring BV, The Netherlands.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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