Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluconazole
FDC International Ltd
J02AC01
Fluconazole
50mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100
Follow the dose prescribed by your doctor (either adults or children posology). The maximum dose for children is 400 mg daily. The dose will be based on the child's weight in kilograms. Use in children of 3 to 4 weeks of age: The same dose as above but given once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours. Use in children less than 2 weeks old: The same dose as above but given once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours. The usual adult dose should be given unless you have kidney problems. Your doctor may modify your dose, depending on your kidney function. Taking too many capsules at once may make you unwell. Contact your doctor or your nearest hospital casualty department at once. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour). Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate. Do not take a double dose to make up for a forgotten dose. If you forgot to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the dose that you missed. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Like all medicines Fluconazole may sometimes cause side-effects, although not everybody gets them. A few people develop although serious allergic reactions are rare. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. If you get any of the following symptoms, l sudden wheeziness, difficulty breathing or tightness in the chest l swelling of the eyelids, face or lips l itching all over the body, reddening of the skin or itchy red spots l hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (Drug Reaction Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azocan 50mg Capsules Fluconazole 50mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluconazole 50mg. Excipient(s) of known effects: each hard capsule also contains 25 mg lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard capsule A hard gelatin size “4” capsule with a blue cap and white body containing a white free flowing powder. 4 CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Fluconazole is indicated for the treatment of the following fungal infections (see section 5.1): Fluconazole is indicated in adults for the treatment of: • Coccidioidomycosis (see section 4.4). • Invasive candidiasis. • Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate. • Candidal balanitis when local therapy is not appropriate. • Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis. • Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or tropical treatment are insufficient. • Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal _candida _infections when systemic therapy is indicated. • Cryptococcal meningitis (see section 4.4). •_ Tinea unguinium (onychomycosis)_ when other agents are not considered appropriate. Fluconazole is indicated in adults for the prophylaxis of: • Relapse of cryptococcal meningitis in patients with high risk of recurrence. • Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse. • To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year). • Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation (see section 5.1)). Fluconazole is indicated in term Прочитать полный документ