Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
lymecycline
Primegen Limited
J01AA04
lymecycline
408mg
Capsule, hard
Oral use
28 or 56 capsules
Product subject to prescription which may not be renewed (A)
Tetracyclines
It is indicated for the treatment of moderate to severe acne vulgaris
Authorised
2015-07-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rimicorim 300mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 408 mg of lymecycline equivalent to 300mg tetracycline’ For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, Hard Hard gelatin capsule with yellow body and red cap imprinted with “NM”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Lymecycline is indicated for the treatment of moderate to severe acne vulgaris (please see section 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Moderate to severe acne vulgaris: Adults: The usual dosage for the long-term treatment of moderate to severe acne is 1 capsule daily taken with at least half a glass of water whilst in an upright position. It should be taken with a light meal without dairy products. Treatment should be continued for at least 8 weeks to 12 weeks, however it is important to limit the use of antibiotics to the shortest possible period and discontinue their use when further improvement is unlikely. The treatment should not exceed a duration of 6 months. Elderly: As for other tetracyclines, no specific dose adjustment is required. Children: Not recommended for children under the age of 12 years. For children over the age of 12 years the adult dosage may be given. Renal Insufficiency: The excretion rate for tetracycline is reduced in case of renal insufficiency and thus normal dosage may lead to accumulation. In patients with renal impairment it is recommended to lower the dose. 4.3 CONTRAINDICATIONS Hypersensitivity to lymecycline or any other tetracycline or to any of the excipients. Its use is contraindicated in patie Olvassa el a teljes dokumentumot