PENTASA ENEMA

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

MESALAZINE

Disponible depuis:

FERRING PHARMACEUTICALS LTD

Code ATC:

A07EC

forme pharmaceutique:

ENEMA

Composition:

MESALAZINE 1 G / 100 ML

Mode d'administration:

RECTAL

Type d'ordonnance:

Required

Fabriqué par:

FERRING GmbH ,GERMANY

Groupe thérapeutique:

AMINOSALICYLIC ACID AND SIMILAR AGENTS

indications thérapeutiques:

Ulcerative colitis - Chron's disease

Date de l'autorisation:

2022-11-30

Notice patient

Patient leaflet in accordance with the Pharmacists’
Regulations (Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Pentasa Enema
1 gram
Composition:
Each enema contains: 1 gram of mesalazine
Inactive ingredients: See section 6, ‘Additional information’.
Read the entire leaflet carefully before you start using this
medicine. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult with your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to
others. It may harm them, even if it seems to you that their illness
is similar to
yours.
1. What is this medicine intended for?
For treatment of ulcerative colitis and Crohn’s disease.
Therapeutic group: Anti-inflammatory medicine of the salicylates
class.
2. Before using this medicine
Do not use this medicine if you:
are sensitive (allergic) to mesalazine or to any of the other
ingredients of
this medicine (see section 6).
are sensitive (allergic) to other salicylates (such as aspirin).
have severe liver or kidney problems.
Special warnings about using this medicine
BEFORE TREATMENT WITH THIS MEDICINE, TELL YOUR DOCTOR IF YOU:
are allergic to sulphasalazine (risk of allergy to salicylates).
currently or previously had liver or kidney disease.
have a medical condition that can make you prone to bleeding.
are taking medicines that may affect your kidney function, e.g.
nonsteroidal
anti-inflammatory drugs (NSAIDs) such as aspirin.
have a lung problem, particularly asthma.
have ever developed a severe skin rash or skin peeling, blistering
and/or
mouth sores after taking mesalazine.
Mesalazine may produce red-brown urine discoloration after a reaction
with
sodium hypochlorite (household bleach) in the toilet water. It occurs
due to a
chemical reaction and is harmless to your health.
Serious skin reactions including drug reaction with eosinophilia and
systemic
symptoms (DRESS), Stevens-Johnson syndrome, toxic epidermal necrolysis
have been repo

Résumé des caractéristiques du produit

Page 1 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Pentasa® Suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pentasa suppository contains: 1g mesalazine
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppositories. Oblong, compressed white to light tan, speckled
suppositories
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Ulcerative Proctitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
1 suppository 1-2 times daily.
Method of administration
For rectal use.
A visit to the toilet is recommended before administration of
suppositories.
See separate instructions for use.
4.3
CONTRAINDICATIONS
PENTASA is contraindicated in:
- patients with known hypersensitivity to
mesalazine,
salicylates or any of the excipients
,
listed in section 6.1
- patients with 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). Severe cutaneous adverse reactions (SCARs), including
drug reaction with
eosinophilia and systemic symptoms (DRESS),
Stevens-Johnson syndrome (SJS) and
toxic epidermal necrolysis (TEN), have been reported in association
with mesalazine
treatment. In case of acute symptoms of intolerance i.e. abdominal
cramps, abdominal pain,
fever and severe headache and/or the first appearance of signs and
symptoms of severe skin
reactions, such as skin rash, mucosal lesions, or any other signs of
hypersensitivity, the
treatment should be discontinued immediately.
Caution is recommended in patients with impaired liver function. Liver
function parameters
like ALT or AST should be assessed prior to and during treatment, at
the discretion of the
treating physician
.
The drug is not recommended for use in patients with impaired renal
function and in patients
with haemorrhagic diathesis. Baseline renal function measurement is
required in all patients
initiating treatment with mesalazine. Urinary status (dip sticks)
should be determined prior to
and during t