Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
DOXAZOSIN AS MESYLATE
DEXCEL LTD, ISRAEL
C02CA04
TABLETS
DOXAZOSIN AS MESYLATE 1 MG
PER OS
Required
DEXCEL LTD, ISRAEL
DOXAZOSIN
DOXAZOSIN
Antihypertensive agent. For the treatment of benign prostatic hyperthropy.
2014-02-28
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold with a physician’s prescription only CADEX 1 MG, TABLETS / CADEX 2,4 MG, CAPLETS Each CADEX 1 mg tablet contains doxazosin as mesylate 1 mg Each CADEX 2 mg caplet contains doxazosin as mesylate 2 mg Each CADEX 4 mg caplet contains doxazosin as mesylate 4 mg Inactive ingredients and allergens in the medicine – see section 6 "Additional information" and in section 2 "Important information about some of the ingredients of this medicine". READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask the 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 you think that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of hypertension and the treatment of benign prostatic hyperplasia. THERAPEUTIC GROUP: Selective alpha-1 adrenoreceptor blockers. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are hypersensitive (allergic) to the active ingredient (doxazosin), to other types of quinazolines (such as prazosin or terazosin), or to any of the other ingredients this medicine contains (see section 6). This can manifest in itching, redness of the skin, or breathing difficulties. • You suffer from benign prostatic hyperplasia and low blood pressure. • You have a history of orthostatic hypotension, a type of low blood pressure that causes a feeling of dizziness when you stand up from sitting or lying down. • You suffer from an enlarged prostate gland with one of the following conditions: any type of congestion or blockage of the urinary tract, a longstanding urinary tract infection, or bladder stones. • You suffer from a certain type of incontinence due to bladder overflow (you do not feel the urge to urinate) or failure of the kidneys to Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cadex 1 mg, Cadex 2 mg, Cadex 4 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CADEX 1MG: each tablet contains Doxazosin 1mg (as mesylate). Excipient with known effect: Each tablet contains approximately 38mg Lactose. CADEX 2MG: each caplet contains Doxazosin 2mg (as mesylate). Excipient with known effect: Each caplet contains approximately 77mg Lactose. CADEX 4MG: each caplet contains Doxazosin 4mg (as mesylate). Excipient with known effect: Each caplet contains approximately 154mg Lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM CADEX 1 MG: White to off-white, round, biconvex tablets, scored on one side. CADEX 2 MG: White to off-white, biconvex caplets, scored on one side. CADEX 4 MG: White to off-white, biconvex caplets, scored on both sides and marked "D4" on one side. The tablets/caplets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antihypertensive agent. For the treatment of benign prostatic hypertrophy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY CADEX may be administered in the morning or the evening. _HYPERTENSION:_ CADEX is used in a once daily regimen: the initial dose is 1mg, to minimise the potential for postural hypotension and/or syncope (see section 4.4: Special warnings and precautions for use). Dosage may then be increased to 2mg after an additional one or two weeks of therapy and thereafter, if necessary to 4mg. The majority of patients who respond to CADEX will do so at a dose of 4mg or less. Dosage can be further increased if necessary to 8mg or the maximum recommended dose of 16mg. _BENIGN PROSTATIC HYPERPLASIA:_ The recommended initial dosage of CADEX is 1mg given once daily to minimise the potential for postural hypotension and/or syncope (see section 4.4). Depending on the individual patient's urodynamics and BPH symptomatology dosage may then be increased to 2mg and thereafter to 4mg and up to the maximum recommended dose of 8mg. The recommen Baca dokumen lengkap