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PENTASA 500MG SLOW RELEASE TABLETS

Active substance(s): MESALAZINE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

PENTASA® 500mg SLOW RELEASE TABLETS
(mesalazine)
Patient Information Leaflet
This product is known as the above name but will be referred to as Pentasa throughout this leaflet.

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.

WARNING!

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
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.

NEW MANUFACTURER
TABLET DESCRIPTION

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.

Colour
Swatch

Black

WARNING!

DATE:
DATE:
08/09/14
TVT CHECKED

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.

To treat an attack of colitis, your doctor will usually prescribe a dose up to 4g masalazine, to be taken as
eight tablets a day in two or three divided doses.
6464/0603A

DATE OF PROOF:

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

CODE:

DT
ARTWORKER:
PRODUCT:

Pentasa 500mg slow release tabs

Q.A.
APPROVED:
05-0440
CUSTOMER: Waymade

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.

PRE-PRESS NO.:

CUSTOMER
APPROVED:

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

PROOF HISTORY:
v.1 - waymade - 08/09/14

Notes:
Leaflet Flat Size = 148 x 317
May 2013

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Common side effects (affecting less than 1 in 10 people) include:
• vomiting
• stomach pain
• nausea
• 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
• lupus erythematosis (an auto-immune disorder
red blood cells)
effecting the skin)
• tingling or numbness in the hands and feet
• allergic lung reactions (including breathing
problems)

changes in kidney function or kidney failure
• inflammation of the heart or area
surrounding the heart
• inflammation of the liver and liver failure
• inflammation of the pancreas

WARNING!

Very rare side effects (affecting less than 1 in 10,000 patients) include:
• muscle pain
• raised liver enzymes
• fever
• hair loss (reversible)
• skin rash or blisters e.g. Erythema Multiforme or
• joint pain
Steven-Johnson syndrome
• allergic reactions



5. How to store Pentasa
Do not use after the expiry date printed on the carton, carton label or blister label.
Pentasa 500mg slow release Tablets should be stored below 25°C. Store in the original package.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist.

PL No: 6464/0603

TVT CHECKED

This product is manufactured by Ferring A/S, 2720 Vanlose, Denmark, or, Pharbil Pharma GmbH,
Reichenberger Strasse 43, Bielefeld, Germany, or, Ferring International Center SA, Chemin de la
Vergognausaz 50, 1162 St. Prex, Switzerland and/or Ferring GmbH, Wittland 11, 24109 Kiel, Germany and
is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon Essex.
Leaflet revision and issue date (Ref.) 08.09.2014

NEW MANUFACTURER
TABLET DESCRIPTION

PENTASA is a registered trademark of FERRING B.V.

6464/0603A

08/09/14

POM

CODE:

DT

DATE OF PROOF:

Pentasa 500mg slow release Tablets are available in blister packs of 50 and 100 tablets.

Pentasa 500mg slow release tabs

ARTWORKER:

DATE:

Pentasa 500mg slow release Tablets also contain the following:
povidone, ethyl cellulose, magnesium stearate, microcrystalline cellulose, and talc.

PRODUCT:

05-0440
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

6. Further information
Your medicine is called Pentasa 500mg slow release Tablets. It contains 500mg of the active ingredient
mesalazine in a white-grey to pale brown, specked, round, slow release tablet, scored and marked ‘500’ and
‘mg’ on one side and ‘PENTASA’ on the other side.

Colour
Swatch

Black

WARNING!






DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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

PROOF HISTORY:
v.1 - waymade - 08/09/14

Notes:
Leaflet Flat Size = 148 x 317
May 2013

27mm

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).

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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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