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PENTASA 1G PROLONGED RELEASE GRANULES SACHET

Active substance(s): MESALAZINE

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Pentasa®
1g prolonged release granules sachet
(mesalazine)
This medicine is available as the above name but will be
referred as Pentasa Sachet throughout the following
information leaflet.
Information for patients
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
− 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 you get any side effect, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet:
1. What Pentasa Sachet is and what it is used for
2. What you need to know before you take Pentasa Sachet
3. How to take Pentasa Sachet
4. Possible side effects
5. How to store Pentasa Sachet
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. aspirin
• 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 sulfasalazine (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
• 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 Sachet
immediately.
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
Please 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.
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.
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 two Pentasa Sachet 2g once a day. Pentasa
Sachet 1g might also be used to provide the dose that is
most suited to you.
To help maintain freedom from further attacks, your
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.

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, Pentasa Sachet can cause side
effects, although not everybody gets them.
The following common side effects affect between 1
and 10 of every 100 patients treated:
• diarrhoea
• abdominal pain
• nausea
• vomiting
• headache
• rash
The following rare side effects affect between 1 and 10
of every 10,000 patients treated:
• 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)
The following very rare side effects affect less than 1
of 10,000 patients treated:
• 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
unexplained 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.
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.
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
(see below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme; Website:
www.mhra.gov.uk/yellowcard
5. HOW TO STORE PENTASA SACHET
Keep out of the sight and reach of children.
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.
Do not store above 25°C. Store in the original package in
order to protect from light.
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.
If your medicine 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.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Pentasa Sachet contains
Each sachet contains 1g 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 foil sachets in packs of: 50.
PL 15814/1175

POM

Manufactured by Ferring GmbH, Wittland, Kiel, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 04.03.2016
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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