国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
lidocaine, prilocaine
Recordati Ireland Ltd.
N01BB20
lidocaine, prilocaine
Anesthetics
Sexual Dysfunction, Physiological
Treatment of primary premature ejaculation in adult men.
Revision: 12
Authorised
2013-11-15
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER FORTACIN 150 MG/ML + 50 MG/ML CUTANEOUS SPRAY, SOLUTION lidocaine/prilocaine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Fortacin is and what it is used for 2. What you need to know before you use Fortacin 3. How to use Fortacin 4. Possible side effects 5. How to store Fortacin 6. Contents of the pack and other information 1. WHAT FORTACIN IS AND WHAT IT IS USED FOR Fortacin is a combination of two medicines: lidocaine and prilocaine. These belong to a group of medicines called local anaesthetics. Fortacin is indicated for the treatment of premature ejaculation occurring in adult men (aged 18 years and over) from first sexual intercourse. This is when you always, or nearly always, have ejaculated within one minute of sexual intercourse and this causes you negative emotional effects. Fortacin works by decreasing the sensitivity of the head of the penis to increase time before ejaculation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FORTACIN DO NOT USE FORTACIN • if you or your partner are allergic to lidocaine or prilocaine or any of the other ingredients of this medicine (listed in section 6); • if you or your partner have a history of allergy or sensitivity to other local anaesthetics with a similar structure (known as amide-type local anaesthetics). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Fortacin • if you, or your partner, have been diagnosed with a genetic disea 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine. Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine. 1 dose is equal to 3 actuations. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous spray, solution Colourless to light yellow solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fortacin is indicated for the treatment of primary premature ejaculation in adult men. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 3 actuations applied to cover the glans penis. Each dose consists of a total of 22.5 mg lidocaine and 7.5 mg prilocaine per application (1 dose is equal to 3 actuations). A maximum of 3 doses can be used within 24 hours with at least 4 hours between doses. Special populations _Elderly _ Dose adjustments are not required in the elderly (see section 5.1). _Renal impairment _ Clinical studies have not been performed in patients with impaired renal function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required. _Hepatic impairment _ Clinical studies have not been performed in patients with impaired hepatic function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required. Caution is advised in case of severe hepatic impairment (see section 4.4). _Paediatric population _ There is no relevant use of Fortacin in the paediatric population for the indication of treatment of primary premature ejaculation. Method of administration Cutaneous use. 3 Fortacin is only indicated for application to the glans penis. Before initial use, the spray container should be briefly shaken and then primed by spraying it into the air three times. Before each subsequent use, it should be briefly shaken and then the spray 完全なドキュメントを読む