Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
TAMSULOSIN HYDROCHLORIDE
CTS LTD
G04CA
MODIFIED RELEASE CAPSULES HARD
TAMSULOSIN HYDROCHLORIDE 0.4 MG
PER OS
Required
ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS
Treatment of functional symptoms of benign prostatic hyperplasia (BPH).
2023-08-31
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only OMNIC 0.4 MODIFIED-RELEASE CAPSULES The active ingredient and its quantity per dosage unit: Tamsulosin Hydrochloride 0.4 mg/cap For a list of the inactive and allergenic ingredients in the preparation - see Section 6. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. The medicine is not intended for children or adolescents under the age of 18. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of functional symptoms caused by benign prostatic hyperplasia (BPH). THERAPEUTIC GROUP: Selective alpha 1A,1D -adrenoreceptor antagonist. 2. BEFORE USING THE MEDICINE: X XX DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to tamsulosin or to any of the other ingredients contained in the medicine. Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g., the throat or tongue), difficulty breathing and/or itching and rash (angioedema). • you suffer from severe liver failure. • you suffer from dizziness or faint due to decreased blood pressure when changing posture (transitioning to a sitting or standing position). ! ! SPECIAL WARNINGS REGARDING USE OF THE MEDICINE • Periodic medical examinations are necessary to monitor the progression of the condition you are being treated for. • In rare instances, this medicine can cause fainting. At the first signs of dizziness or weakness, the patient should sit or lie down until the signs pass. • BEFORE TREATMENT WITH OMNIC 0.4, INFORM THE DOCTOR IF: o you suffer or have suffered in the past from severe kidney problems. o you are about to under Lestu allt skjalið
1 SUMMARY OF PRODUCT CHARACTERISTIC 1. NAME OF THE MEDICINAL PRODUCT Omnic 0.4 mg, modified release capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains as active ingredient tamsulosin hydrochloride 0.4 mg. Excipient(s): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified release capsule, hard Orange/olive-green coded 0.4 and logo and 701 4. CLINICAL PARTICULARS _4.1 THERAPEUTIC INDICATIONS _ Treatment of functional symptoms of benign prostatic hyperplasia (BPH). _4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ Oral use One capsule daily, to be taken after breakfast or the first meal of the day. The capsule should be swallowed whole with a drink of water (about 150ml). The capsule must be swallowed whole and must not be crunched or chewed, as this interferes with the modified release of the active ingredient. No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3 Contraindications). Pediatrics population There is no relevant indication for use of Omnic in children. The safety and efficacy of tamsulosin in children <18 years have not been established. Currently available data are described in section 5.1. _4.3 CONTRAINDICATIONS _ Hypersensitivity to tamsulosin hydrochloride or to any of the excipients. A history of orthostatic hypotension. Severe hepatic insufficiency. _4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _ As with other α 1 -adrenoceptors antagonists, a reduction in blood pressure can occur in individual cases during treatment with Omnic 0.4, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared. Before therapy with Omnic 0.4 is initiated, the patient should be examined in order to exclude the presence of other conditions, which can cause the same symptoms as benign prostatic hyperplasia. Digital rectal examination and, w Lestu allt skjalið