Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aciclovir
PLIVA Pharma Ltd
D06BB03
Aciclovir
50mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100300
ACICLOVIR CREAM 5% READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your doctor or pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve. • If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT IS ACICLOVIR CREAM IS AND WHAT IS IT USED FOR? 2. BEFORE YOU USE ACICLOVIR CREAM 3. HOW TO USE ACICLOVIR CREAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ACICLOVIR CREAM 6. FURTHER INFORMATION 1. WHAT IS ACICLOVIR CREAM AND WHAT IS IT USED FOR? Aciclovir cream is used in the treatment of genital herpes and cold sores. Once genital herpes or a cold sore has appeared, treatment with Aciclovir cream can accelerate the healing process. The active substance in Aciclovir cream is aciclovir. Aciclovir is an antiviral agent that has been shown to be effective in treating infections caused by the herpes simplex virus, such as genital herpes and cold sores. 2. BEFORE YOU USE ACICLOVIR CREAM DO NOT USE ACICLOVIR CREAM AND TELL YOUR DOCTOR: • If you are ALLERGIC (hypersensitive) TO ACICLOVIR, VALACICLOVIR or ANY OF THE OTHER INGREDIENTS OF ACICLOVIR CREAM (listed in section 6, Further Information). Cetyl alcohol, propylene glycol or sorbic acid may cause local skin reactions or irritation (e.g. contact dermatitis). • In the eyes, INSIDE the mouth or genitals. CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE USING ACICLOVIR CREAM IF: • Your IMMUNE SYSTEM is not working properly (for instance you have had a bone marrow transplant or you have AIDS). TAKING OTHER MEDICINES: Please TELL YOUR DOCTOR OR PHARMACIST if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking: • Probenecid (used for gout). PREGNANCY AND BREAST-FEEDING: As with all medicines, Aciclovir cream should not be used during pregnancy or brea Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ACICLOVIR CREAM 5% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Contains 5% w/w Aciclovir PhEur. 3. PHARMACEUTICAL FORM White to off-white cream. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 1) Treatment of herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Aciclovir Cream should be applied to the lesion or impending lesion as early as possible after the start of an infection. It is particularly important to start treatment of recurrent episodes during the prodromal period or when lesions first appear. _Adults_ (_including elderly_): Aciclovir Cream should be applied five times daily at approximately four hourly intervals, omitting the night time application. Treatment should be continued for five days. If, after five days, healing is not complete then treatment can be continued for up to an additional five days. 4.3 CONTRA-INDICATIONS Aciclovir cream is contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir, propylene glycol or any of the excipients of aciclovir cream. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In severely immunocompromised patients (_eg _AIDS patients or bone marrow transplant recipients) oral Aciclovir dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection. Aciclovir Cream is not recommended for application to mucous membranes such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into the eye. Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of Aciclovir greatly in excess of those employed therapeutically. There has been no experience of the effect of Aciclovir Cream on human fertility. Two generation studies in mice did not reveal any effect of (orally admi Read the complete document