国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aciclovir
Almus Pharmaceuticals Ltd
J05AB01
Aciclovir
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030201; GTIN: 05060057404119
PATIENT INFORMATION LEAFLET ACICLOVIR 200MG, 400MG AND 800MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What are Aciclovir Tablets and what are they used for 2. Before you take Aciclovir Tablets 3. How to take Aciclovir Tablets 4. Possible side effects 5. How to store Aciclovir Tablets 6. Further information 1. WHAT ARE ACICLOVIR TABLETS AND WHAT ARE THEY USED FOR The name of your medicine is Aciclovir Tablets. This belongs to a group of medicines called antivirals. Aciclovir Tablets can be used: • to treat herpes and other viral infections caused by the herpes virus (varicella zoster), such as shingles • to prevent recurrent attacks of herpes simplex • to help prevent those who have low immune systems from getting herpes infections. Aciclovir Tablets should not be used to treat herpes simplex virus (HSV) infections in newborns and babies up to 3 months old or severe HSV infections in children with low resistance to disease. 2. BEFORE YOU TAKE ACICLOVIR TABLETS DO NOT TAKE ACICLOVIR TABLETS AND TELL YOUR DOCTOR IF: • you are allergic (hypersensitive) to aciclovir, valaciclovir or any other ingredients in this medicine (see section 6: Further Information). An allergic reaction can include a rash, itching or shortness of breath. Do not take this medicine if any of the above apply to you, talk to your doctor or pharmacist before taking Aciclovir Tablets. TAKE SPECIAL CARE WITH ACICLOVIR TABLETS Before you take Aciclovir Tablets tell your doctor if: • you are elderly • you have kidney problems • you are thirsty. You must make sure y 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aciclovir 400 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 400 mg tablet contains 400 mg aciclovir. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to off-white, round (diameter: 11.8 mm), biconvex, uncoated tablets debossed with ‘AR and 400’ separated with breakline on one side and plain on the other side. The tablet can be divided into equal doses 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aciclovir Tablets are indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children). Aciclovir Tablets are indicated for the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients. Aciclovir Tablets are indicated for the prophylaxis of herpes simplex infections in immunocompromised patients. Aciclovir Tablets are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Dosage in adults _ _ _ Treatment of herpes simplex infections: 200 mg Aciclovir should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for 5 days, but in severe initial infections this may have to be extended. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400 mg Aciclovir, or alternatively, intravenous dosing could be considered. Dosing should begin as early as possible after the start of an infection; for recurrent episodes this should preferably be during the prodromal period or when lesions first appear. Suppression of herpes simplex infections in immunocompetent patients: 200 mg Aciclovir should be taken four times daily at approximately six-hourly intervals. 完全なドキュメントを読む