Skip to Content

PENTASA SACHET 1G PROLONGED RELEASE GRANULES

Active substance(s): MESALAZINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PENTASA

Size
200x300mm

Sachet 1g prolonged release granules
Mesalazine
Information for patients

Fiber direction



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:

= Folding
=Folding
line
line


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.

1. What PENTASA Sachet is and what it is used for
2. What you need to know before you take PENTASA Sachet

5. How to store PENTASA Sachet

52 mm

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

40 mm



• 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.

2 mm

30 mm

4. Possible side effects

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.

8 mm

2009053015

3. How to take PENTASA Sachet





Interleaved code 2 of 5 center 130 mm



Drawring
E-MS-3048









= No
printtext
=No
area
area

66,5
mm mm
66,5




6767
mm mm






66,5
mm mm
66,5



Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist.
This includes any 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
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

This leaflet was last approved 03/2015.

Expand view ⇕

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.

Hide