ENTUMIN

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

CLOTIAPINE

Boleh didapati daripada:

TARO INTERNATIONAL LTD, ISRAEL

Kod ATC:

N05AX09

Borang farmaseutikal:

TABLETS

Komposisi:

CLOTIAPINE 40 MG

Laluan pentadbiran:

PER OS

Jenis preskripsi:

Required

Dikeluarkan oleh:

DELPHARM L’AIGLE, FRANCE

Kumpulan terapeutik:

CLOTIAPINE

Kawasan terapeutik:

CLOTIAPINE

Tanda-tanda terapeutik:

For the treatment of severe mental and emotional disorders (Neuroleptic).

Tarikh kebenaran:

2017-07-31

Risalah maklumat

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ENTUMIN
®
40 mg
Tablets
Active ingredient and its quantity:
Each tablet contains:
Clotiapine 40 mg
For the list of inactive ingredients see section 2 "Important
information about some of this
medicine's ingredients" and 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 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 the treatment of severe mental and emotional disorders
(neuroleptic).
THERAPEUTIC GROUP:
Antipsychotic
2. BEFORE USING THIS MEDICINE
X
DO NOT USE THIS MEDICINE:
•
If you are sensitive (allergic) to the active ingredient (clotiapine)
or to any of the other
ingredients in this medicine (see section 6).
•
In states of unconsciousness or severe CNS depression.
•
If you have a predisposition to seizures.
•
If you have increased intraocular pressure (narrow angle glaucoma).
•
If you are breastfeeding.
•
In children below the age of 16 years.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
! BEFORE USING ENTUMIN, TELL YOUR DOCTOR IF:
•
You suffer from any of the following problems: prostate disease,
intestinal, renal, cardiac
(including a disorder known as QT interval prolongation) or hepatic
disorder, Parkinson's
disease, low blood pressure (hypotension), dementia.
•
Any of your family members has a history of blood clots, since blood
clot formation has been
already associated with such medicines.
ADDITIONAL WARNINGS:
•
Immediately contact a doctor if you develop fever.
Entumin-Eng-final-05.2020
•
The treatment must be stopped gradually.
!
CHILDREN AND ADOLESCENTS:
Entumin should not be administered

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entumin
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotiapine 40 mg
Excipient with known effect:
Entumin 40 mg tablets contain lactose.
This medicinal product is contraindicated in patients with rare
hereditary problems of
galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of severe mental and emotional disorders
(neuroleptic)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_INITIAL TREATMENT _
3 to 5 tablets daily in 2 or 3 divided doses may prove sufficient.
The daily oral dose may be increased to a maximum of 360 mg in divided
doses,
especially in cases of agitation/excitation.
The initial dosage may be given for periods of weeks or even months.
_MAINTENANCE AND LONG-TERM TREATMENT:_
20 to 160 mg daily per os in 2 to 3 divided
doses.
_SPECIFIC POPULATIONS _
In underweight patients, patients with liver or kidney disease and in
elderly patients,
lower initial doses and a gradual dosage increase are indicated.
_Paediatric population_
The safety and efficacy of Entumin in children aged less than 16 years
have not yet
been established.
Method of administration
Entumin 40 mg tablets are for oral use. Entumin 40 mg tablets should
not be chewed,
should be administered with a small amount of water.
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Entumin-SPC-final 04.2020
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
-
Comatose states, severe CNS depression and post-encephalitic syndrome.
-
Marked predisposition to convulsions: especially epilepsy.
-
Children under 16 years of age.
-
Contraindications due to the anticholinergic action:
-
absolute: angle-closure glaucoma.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be exercised:
-
in elderly patients, due to their high sensitivity (sedation and
hypotension);
-
in