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PENTASA SACHET 4 G PROLONGED RELEASE GRANULES

Active substance(s): MESALAZINE

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Sachet 4g prolonged release granules
Mesalazine
Information for patients
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
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- 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.

E-MS-3048
200x300mm

- If you get any side effect, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:


While you are on treatment with this medicine, your
doctor will normally arrange blood and urine tests to
check your kidney function especially at the beginning
of treatment.
Other medicines and Pentasa Sachet
Tell your doctor or pharmacist if you are using,
or have recently used, any other medicines including medicines obtained without a prescription
This is especially important if you are taking any of
the following:
• azathioprine (used after transplantations or to treat
auto-immune diseases)
• 6-mercaptopurine or thioguanine (chemotherapy, used
to treat leukaemia)
• certain agents that inhibit blood clotting (medicines for
thrombosis or to thin your blood).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.

1. What PENTASA Sachet is and what it is used for
2. What you need to know before you take PENTASA Sachet
4. Possible side effects
5. How to store PENTASA Sachet

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6. Contents of the pack and other information
1. WHAT PENTASA SACHET IS AND WHAT IT IS
USED FOR
PENTASA Sachet is used for the treatment of mild to
moderate attacks of ulcerative colitis and to help
maintain freedom from further attacks.
Ulcerative colitis is an inflammatory bowel disease in
which the lining of the intestine becomes inflamed and
develops many tiny breaks in its surface (ulcers) which
may bleed.



PENTASA Sachet contains granules that slowly release
the active ingredient (mesalazine). This helps reduce the
inflammation and the painful symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PENTASA SACHET
Do not take PENTASA Sachet
• if you are allergic (hypersensitive) to mesalazine or any
of the other ingredients of this medicine (see Section 6)
• if you are allergic to other salicylates e.g. acetylsalisylic acid
• if you have severe liver and/or kidney problems
Warnings and precautions
Talk to your doctor or pharmacist before taking Pentasa
Sachet:
• if you are allergic to sulphasalazine (risk of allergy to
salicylates)
• if you currently have or have previously had liver or
kidney disease
• if you have a medical condition that can make you prone
to bleeding

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• if you have an active peptic ulcer (stomach ulcer or
duodenal ulcer)
• if you are on medication that may affect kidney function
e.g. Non-steroidal anti-inflammatory drugs (NSAIDs) such
as aspirin
• if you have lung problems, in particular asthma
• if you suddenly develop abdominal cramps, abdominal
pain, fever, severe headache and rash. In such
circumstances you should stop taking Pentasa immediately.

There is limited experience with the use of mesalazine
during pregnancy and breast-feeding. Blood disorders
have been reported in newborns of mothers being
treated with this medicine. The newborn may develop
allergic reactions after breast-feeding, e.g. diarrhoea. If
the newborn develops diarrhoea, breast-feeding should
be discontinued.

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3. How to take PENTASA Sachet

Driving and using machines
This medicine is not known to affect the ability to drive
and/or use machines.
3. HOW TO TAKE PENTASA SACHET
Always take PENTASA Sachet exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Adults:
To treat an attack of colitis, your doctor will usually prescribe
a dose of up to 4 g mesalazine a day to be taken either
once a day or in divided doses. This may be taken as one
PENTASA Sachet 4g or two Pentasa sachet 2g once daily.
PENTASA Sachet 1g might also be used to provide the
dose that is most suited to you.
To help maintain freedom from further attacks,
doctor will usually prescribe 2 g mesalazine a day
administered as one PENTASA Sachet 2g or two
PENTASA Sachet 1g once daily.

Children 6 years of age and older:
The dose for children will be calculated by your doctor
and depends on the child’s weight. It is generally
recommended that half the adult dose is given to children
up to 40 kg of body weight and the normal adult dose to
children above 40 kg of body weight.
You should take the granules orally (by mouth),
immediately after opening the sachet, as described
below. Do not chew the granules.
1. Open the foil sachet.
2. Empty the contents of the sachet onto the
tongue.
3. Wash the granules down immediately with some
water or orange juice ensuring that none remain
in the mouth.

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PENTASA

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If you take more PENTASA Sachet than you should
In the event of overdose, contact your doctor or nearest
casualty department immediately.

If you forget to take PENTASA Sachet
If you have forgotten to take a dose, then take it as soon
as you remember, and then take the next dose at the
usual time. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

1 in 10 people:

may affect up to

• diarrhoea
• abdominal pain
• nausea
• vomiting
• headache
• rash

There have been very few reports of a severe allergic
reaction which might lead to swelling of the face and neck
and/or difficulty in breathing or swallowing (Quincke’s
oedema). If this happens contact your doctor or nearest
casualty department immediately.
Allergic reactions and fever may occasionally occur.
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 via
UK: The Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE PENTASA SACHET

Keep out of the reach and sight of children.

may affect up to
1 in 1,000 people:
• inflammation of some areas of the heart (myocarditis and
pericarditis) which can cause shortness of breath and
chest pain or palpitations (rapid or irregular heart beats)
• inflammation of the pancreas (symptoms include back
and/or stomach pain)
• dizziness
• flatulence (passing wind)
may affect up to

1 in 10,000 people:
• anaemia and other blood disorders (decrease in the
numbers of certain blood cells, which can cause
unexplained bleeding, bruising, fever or sore throat)
• liver disorders (symptoms include jaundice (yellowing of
the skin and/or eyes) and/or pale bowel motions)
• kidney disorders (symptoms include blood in the urine,
and/or oedema (swelling due to build up of fluid))
• peripheral neuropathy (a condition affecting the nerves of
the hands and feet symptoms include tingling and
numbness)
• allergic and fibrotic lung reactions, inflammation of the lining
of the lungs or lung scarring (symptoms include coughing,
bronchospasm, chest discomfort or pain on breathing,
breathing difficulties, bloody and/or excessive phlegm)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation which can affect different parts of the body
such as joints, skin, kidneys, heart etc. (symptoms
include painful joints, fatigue, fever, abnormal or unex
plained bleeding (e.g. nose bleeds), bruising, purple
discoloration of the skin, spots under the skin)
• accumulation of fluid around the heart (pericardial
effusion) which can cause chest pain or pressure
• change in urine colour
• semen with a low concentration of sperm (oligospermia)
(this is reversible)
• severe diarrhoea and abdominal pain because of an
allergic reaction to this medicine within the bowel.

There have been very few reports of benign intracranial
hypertension (build up of fluid around the brain) in
adolescents. Symptoms include headache, nausea,
vomiting, and/or visual or hearing disturbances.

Do not use this medicine after the expiry date which is
stated on the carton and foil sachet. The expiry date
refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste.' Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What PENTASA Sachet contains
The active substance is mesalazine, each sachet contains
4g mesalazine. The other ingredients are ethylcellulose
and povidone.
What PENTASA Sachet looks like and contents of the pack
This medicine contains prolonged release granules. The
granules are white-grey to pale white- brown.

This medicine is presented in aluminium foil sachets in packs
of: 20, 30, 50 or 100.
Marketing Authorisation Holder
PL 03194/0117
Ferring Pharmaceuticals Ltd.
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
PA 1009/6/8
Ferring Ireland Ltd., United Drug House, Magna Drive,
Magna Business Park, Citywest Road, Dublin 24,
Ireland.
Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
Quintasa Sachet: Denmark
Pentasa Sachet: Ireland, Spain, Sweden,
United Kingdom
Pentasa Xtend: Germany
Pentasa:
Slovenia, Cyprus, Greece

This leaflet was last revised in October 2014.

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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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