Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DAPOXETINE HYDROCHLORIDE
A. MENARINI SINGAPORE PTE. LTD.
DAPOXETINE HYDROCHLORIDE
3Tablet Tablets; 6Tablet Tablets
Menarini - Von Heyden Gmbh, Leipziger
_Consumer Medication_ _ _ _Information Leaflet (RiMUP)_ 1 PRILIGY 60MG AND 30MG FILM COATED TABLETS _Dapoxetine Hydrochloride (60mg & 30mg) _ _ _ WHAT IS IN THIS LEAFLET 1. What Priligy is used for 2. How Priligy works 3. Before you use Priligy 4. How to use Priligy 5. While you are using it 6. Side effects 7. Storage and Disposal of Priligy 8. Product Description 9. Manufacturer 10. Product Registration holder WHAT PRILIGY IS USED FOR PRILIGY is indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following: • An intravaginal ejaculatory latency time (IELT) of less than two minutes • Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes • Marked personal distress or interpersonal difficulty as a consequence of PE • Poor control over ejaculation HOW PRILIGY WORKS PRILIGY containing the active ingredients dapoxetine, is a type of drug called a selective serotonin reuptake inhibitor (SSRI) and belongs to a group of drugs known as other urologicals. PRILIGY increases your time to ejaculation and can improve your control over ejaculation and reduce your distress over how fast you ejaculate. This may improve your satisfaction with sexual intercourse. BEFORE YOU USE PRILIGY _WHEN YOU MUST NOT USE IT_ Do not take Priligy if you have an allergy to: • Any medicine containing dapoxetine • Any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include rash, itching, or hives on the skin, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body. DO NOT TAKE PRILIGY: • If you are taking a MAOI (monoamine oxidase inhibitor) used to treat depression, or have taken a MAOI within the last 14 days. • If you are taking thioridazine used to treat schizophrenia, or have taken thioridazine within the last 14 days. • If you are taking a selective serotonin reuptake inhibitor (SSRI), Đọc toàn bộ tài liệu
1 NAME OF THE MEDICINAL PRODUCT PRILIGY (dapoxetine hydrochloride) QUALITATIVE AND QUANTITATIVE COMPOSITION Each PRILIGY 30 mg film-coated tablet contains 30 mg of dapoxetine base (33.60 mg dapoxetine hydrochloride). Each PRILIGY 60 mg film-coated tablet contains 60 mg of dapoxetine base (67.20 mg dapoxetine hydrochloride). The chemical name is (+)-(S)-N, N-dimethyl-( α )-[2-(1-naphthalenyloxy) ethyl]- benzenemethanamine hydrochloride. For excipients, see List of Excipients. PHARMACEUTICAL FORM PRILIGY Tablets are round, convex, film-coated tablets. 30 mg: light grey tablets debossed with “30” inside a triangle on one side 60 mg: grey tablets debossed with “60” inside a triangle on one side CLINICAL PARTICULARS THERAPEUTIC INDICATIONS PRILIGY is indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following: • An intravaginal ejaculatory latency time (IELT) of less than two minutes; and • Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; and • Marked personal distress or interpersonal difficulty as a consequence of PE; and • Poor control over ejaculation. POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Tablets should be swallowed whole to avoid the bitter taste. It is recommended that tablets be taken with at least one full glass of water. Priligy may be taken with or without food (see Pharmacokinetic properties). _Precautions to be taken before handling or administering the medicinal product_ _ _ Before treatment is initiated, see Special Warnings and Precautions for Use regarding orthostatic hypotension. 2 _ADULT MEN (18 TO 64 YEARS OF AGE)_ The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment with Priligy should not be initiated with the 60 mg dose. Priligy is not intended for continuous daily use. Priligy should be taken only when sexual activity is anticipated. Pr Đọc toàn bộ tài liệu