Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
CLOTIAPINE
TARO INTERNATIONAL LTD, ISRAEL
N05AX09
TABLETS
CLOTIAPINE 40 MG
PER OS
Required
DELPHARM L’AIGLE, FRANCE
CLOTIAPINE
CLOTIAPINE
For the treatment of severe mental and emotional disorders (Neuroleptic).
2017-07-31
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 Lue koko asiakirja
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. Page 1 of 7 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 Lue koko asiakirja