Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Aciclovir
Rowex Ltd
D06BB; D06BB03
Aciclovir
5 percent
Cream
Product not subject to medical prescription
Antivirals; aciclovir
Not marketed
2003-05-02
1 WHAT ACIC IS AND WHAT IT IS USED FOR The name of your medicine is Acic. This belongs to a group of medicines that treat viral infections. Acic is used to treat cold sores. These are caused by the herpes simplex virus. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE ACIC DO NOT USE ACIC: − if you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in Section 6). − on sores inside your mouth, on the eyes or on your genitals. Do not use Acic if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Acic. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Acic if you have any problems which might weaken your immune system or if you have severe cold sores. CHILDREN AND ADOLESCENTS As for adults OTHER MEDICINES AND ACIC Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. • Acic should not affect any other medicines you are taking by mouth. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine. DRIVING AND USING MACHINES This medicine is unlikely to affect you being able to drive or use any tools or machines. However, you should wait to see how Acic affects you before you try these activities. ACIC CONTAINS: • Cetyl alcohol: May cause skin reactions where you apply the cream such as dermatitis. • 300 mg of propylene glycol in each 2 g tube which is equivalent to 150 mg/g of cream. 3 HOW TO USE ACIC Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. ADULTS AND CHILDREN: • Start using the cream when you get the first signs of infection. You may see skin blisters or be able to recognise the tingle sensation that means that a blister will appear soon. • Spread a thin layer of cream onto the cold sore about Read the complete document
Health Products Regulatory Authority 25 November 2021 CRN00C6K4 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acic 5% Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 g of Acic 5% Cream contains 50 mg aciclovir. Excipients with known effect: Contains Propylene glycol 15% and Cetyl alcohol 1.5% For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A white to off-white creamy mass. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 2g and 5g tube: ACIC 5% Cream is indicated for the treatment of Herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis. 2g tube: For the treatment of Herpes simplex virus infections of the skin, lips and face (recurrent herpes labialis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: Cutaneous RECOMMENDED DOSAGE SCHEDULE: Adults and children: ACIC 5% Cream should be applied five times daily at approximately four-hourly intervals omitting the night time application. ACIC 5% Cream should be applied to the lesions or impending lesions as soon as possible, preferably during the earliest stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages. Treatment should be continued for at least 4 days of herpes labialis and for 5 days for genital herpes. If healing has not occurred treatment may be continued for up to 10 days. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, valaciclovir, propylene glycol or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Precautions: Acic 5% 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 contact with the eye. In severely immune-compromised patients (e.g. AIDS patients or bone marrow transplant recipients) oral dosing should be considered. Such patients should be encouraged to consult a physician concerning th Read the complete document