Pentasa 2g modified-release granules sachets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Mesalazine

Dostopno od:

Ferring Pharmaceuticals Ltd

Koda artikla:

A07EC02

INN (mednarodno ime):

Mesalazine

Odmerek:

2gram

Farmacevtska oblika:

Modified-release granules

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 01050100; GTIN: 05015919755557

Navodilo za uporabo

2009053870
PENTASA
SACHET 2G PROLONGED RELEASE GRANULES
Mesalazine
INFORMATION FOR PATIENTS
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 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 medic

Lastnosti izdelka

OBJECT 1
PENTASA SACHET 2G
Summary of Product Characteristics Updated 17-May-2017 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
PENTASA Sachet 2g prolonged release granules
2. Qualitative and quantitative composition
Each sachet contains mesalazine 2 g
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release granules
White-grey to pale white-brown granules
4. Clinical particulars
4.1 Therapeutic indications
Mild to moderate ulcerative colitis
4.2 Posology and method of administration
Ulcerative colitis
ADULTS
_Active disease_
Individual dosage, up to 4 g mesalazine once daily or divided into 2-4
doses.
_Maintenance treatment_
Individual dosage. Recommended dosage, 2 g mesalazine once daily.
PAEDIATRIC POPULATION:
There is only limited documentation for an effect in children (age
6-18 years).
Children 6 years of age and older:
_Active disease:_ To be determined individually, starting with 30-50
mg/kg/day in divided doses. Maximum
dose: 75 mg/kg/day in divided doses. The total dose should not exceed
4 g/day (maximum adult dose).
_Maintenance treatment:_ To be determined individually, starting with
15-30 mg/kg/day in divided doses.
The total dose should not exceed 2 g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to
children up to a body weight of 40
kg; and the normal adult dose to those above 40 kg.
_The granules must not be chewed._
_The contents of the sachet should be emptied onto the tongue and
washed down with some water or _
_orange juice._
4.3 Contraindications
Hypersensitivity to mesalazine, any of the excipients, or salicylates.
Severe liver and/or renal impairment.
4.4 Special warnings and precautions for use
Caution is recommended when treating patients allergic to
sulphasalazine (risk of allergy to salicylates).
In case of acute symptoms of intolerance, i.e. abdominal cramps,
abdominal pain, fever, severe headache
and rash, the treatment should be discontinued immediately.
Caution is recommended in patien