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PENTASA 1 G SUPPOSITORIES

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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® 1g SUPPOSITORIES
(mesalazine)
Patient Information Leaflet

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 Suppositories. Each suppository contains mesalazine 1g 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 ulcerative colitis. Sometimes
ulcerative colitis only affects the back passage (rectum), this is known as ulcerative proctitis. Pentasa
suppositories are used to treat ulcerative proctitis and are intended for rectal use only.

WARNING!

Take special care with Pentasa
You should consult your doctor before using these suppositories 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.
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.

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.
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.

UK PIL DATED NOVEMBER 2009

The suppository should be inserted into the back passage (rectum) only. It is intended to be left in place for as
long as possible and is therefore best inserted before going to sleep.

06464/2996A

10/07/13
DATE OF PROOF:

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.

CODE:

DATE:

DT
ARTWORKER:
PRODUCT:

Pentasa 1g Suppositories

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0440

While you are using Pentasa your doctor may occasionally want to check your kidney function.

To treat an attack of proctitis your doctor will usually prescribe one suppository to be used daily for two to four
weeks.
To help prevent further attacks it may be used for longer.
How to insert the suppository
You should make sure that you empty your bowels before inserting the suppository.
a.
b.
c.
d.
e.
f.
g.

Tear along the perforation to remove one suppository blister from a blister strip
Put a protector on the finger with which you will insert the suppository
Remove the suppository from the blister before insertion. This is done by pushing the suppository
through the printed foil
Insertion may be made easier if you moisten the suppository with water first
Insert the suppository gently and fully into the back passage. It may help to lie down on one side and
raise the other knee
Remain still for a few minutes after insertion to help keep the suppository in place. If it comes out within
10 minutes, a new one should be inserted
Dispose of the empty blister and used finger protector safely and wash your hands.

Colour
Swatch

Black

WARNING!

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
• are under the age of 15 years.
DATE:

CUSTOMER
APPROVED:

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

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

Notes:

This product is known by the above name, but will be referred to as Pentasa in this leaflet.
Read all of this leaflet carefully before you start using this medicine.
•Keep this leaflet, you may need to use it again.
•If you have 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.2 - waymade - 10/07/13

Leaflet Flat Size = 148 x 317

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.

If you use more Pentasa than you should
If you accidentally use too many suppositories, you should go to your nearest emergency department or
contact your doctor immediately.
Take the pack and any remaining suppositories with you.
27mm

If you forget to use Pentasa
If you forget to use a dose, use the next dose as soon as you remember, unless it is less than 6 hours until
your next dose. Do not use a double dose to make up for the forgotten one.

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

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, wheeziness or coughing
(signs of an allergic reaction).
• skin disorder due to an allergic reaction or infection (Erythema Mulitforme or Stevens-Johnson
syndrome). Symptoms include severe rash, blisters or red splotches on the skin.
• 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).
If you experience any of the above side effects, you should contact your doctor or go to the nearest hospital
immediately.
Common side effects (affecting up to 1 in 100 people) include:



vomiting
nausea
headache

stomach pain
diarrhoea

WARNING!







tingling or numbness in hands and feet



inflammation of the heart or area
surrounding the heart
inflammation of the pancreas







inflamation of the liver and liver failure
Lupus-erythematosos (an auto-immune
disorder affecting the skin)
kidney failure

If you experience any of the above side effects, you should contact your doctor or go to the nearest hospital
immediately.
Very rare side effects (affecting less than 1 in 10,000 people) include:






raised liver enzymes
hair loss (reversible)

muscle pain
joint pain

10/07/13

DT

DATE:








5. How to store Pentasa
Do not use after the expiry date printed on the carton, or blister label.
Pentasa 1g Suppositories should not be stored above 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 suppositories, please take them back to the pharmacist for
safe disposal. Only keep the suppositories if your doctor tells you to.
If the suppositories become discoloured or show any other signs of deterioration, you should seek
the advice of your pharmacist.

6. Further information
Your medicine is called Pentasa 1g Suppositories. It is for rectal use only.
Pentasa 1g Suppositories are oval, compressed, white speckled suppositories. They are presented in blister
strips of 7 suppositories per strip. Each carton contains 28 suppositories with 28 finger protectors for inserting
the suppository.
UK PIL DATED NOVEMBER 2009

CODE:

06464/2996A

DATE OF PROOF:

ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Pentasa 1g Suppositories

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

If any of the side effects get serious or if you experience any other side effects not listed on this leaflet, you
should contact your doctor or pharmacist immediately.

Each suppository contains 1gram of the active ingredient mesalazine (also known as 5-aminosalicylic acid or
5-ASA).
Other ingredients in Pentasa 1g Suppositories are:
povidone, magnesium stearate, talc and macrogol 6000.
POM

PL No: 06464/2996

This product is manufactured by Pharbil Pharma GmbH, Reichenberger Str. 43, 33605 Bielefeld, Germany
and procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 09.07.2013
PENTASA is a registered trademark of FERRING B.V.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

Rare side effects (affecting between 1 in 100 and 1 in 10,000 people) include:

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.

Notes:

4. Possible Side Effects
Like all medicines, Pentasa can cause side effects, although not everyone gets them.

PROOF HISTORY:
v.2 - waymade - 10/07/13

Leaflet Flat Size = 148 x 317

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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