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PENTASA PROLONGED RELEASE GRANULES 2G SACHET

Active substance(s): MESALAZINE

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Pentasa® prolonged release
granules 2g sachet

2711
20.06.15[2]

(mesalazine)
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.
Your medicine is available using the above name but will be referred to as
Pentasa Sachet throughout the following 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 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
- if you have an active peptic ulcer (stomach ulcer or duodenal ulcer)
- if you are on medication that may affect kidney function e.g. Nonsteroidal 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.
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 via the Yellow Card Scheme at:
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 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.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pentasa Sachet contains
Each sachet contains 2g 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: 60.
Manufacturer and Product Licence holder
Manufactured by Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2711

Leaflet revision and issue (Ref) 20.06.15[2]
Pentasa is a trademark of Ferring B.V.

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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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