ACICLOVIR TABLETS BP 200MG

Active substance: ACICLOVIR

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Patient Information Leaflet Fyris 200 and 400mg Tablets

Please read this leaflet carefully before you take these tablets. It briefly outlines the most important things you need to know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or your pharmacist. The name of your medicine is Fyris 200 or 400mg Tablets WHAT ARE FYRIS TABLETS? Each Fyris Tablet contains 200 mg or 400 mg of the active ingredient aciclovir. The other ingredients are lactose, microcrystalline cellulose, sodium starch glycollate, povidone, magnesium stearate and the dye E132 (dispersed blue) in the 200 mg tablet, and E122 (dispersed red) in the 400 mg tablet. The product is available in pack sizes of 25, 28, 35, 56 or 100 tablets. Contents: See outer packaging or the pharmacy label for contents i.e. the number of tablets. Fyris is an antiviral agent effective against infections caused by viruses. The product licence holder and company responsible for manufacture is Teva UK Limited, Brampton Rd, Hampden Park, Eastbourne, E. Sussex, BN22 9AG England. WHAT ARE FYRIS TABLETS USED FOR? Fyris Tablets are used to treat and prevent recurrence of infections due to the herpes simplex virus including cold sores and genital herpes. Fyris Tablets may also be used to treat chickenpox and shingles. BEFORE YOU TAKE FYRIS TABLETS Are you sensitive to valaciclovir (another antiviral drug) or to any of the ingredients in the medicine (listed above)? E122 can cause and allergic-type reaction, including asthma. This reaction is more common in those people who are allergic to aspirin. Are you pregnant or breast-feeding your baby? Are you taking probenecid? Are you taking cimetidine? Are you taking myocophenolate mofetil, a drug used following an organ transplant? Are you taking any other medicines? Do you have kidney problems? If the answer to any of these questions is YES, do not take Fyris Tablets before talking to your doctor of pharmacist. TAKING FYRIS TABLETS The tablets should be swallowed with a drink of water.

The usual dosage instructions are given below. It is helpful to maintain your regular fluid intake. Treatment should begin as early as possible. Adults FOR THE TREATMENT OF HERPES SIMPLEX INFECTIONS 200 mg five times a day every 4 hours omitting the night time dose. This dose should be taken for as long as your doctor has stated. KIDNEY PROBLEMS 200 mg two times a day every 12 hours. TREATMENT OF CHICKENPOX OR SHINGLES 800 mg five times a day every 4 hours omitting the night time dose for seven days. SUPRESSION OR PREVENTION OF HERPES SIMPLEX INFECTIONS 200 mg four times a day every 6 hours. This dose may be adjusted, follow your doctors instructions. Children FOR THE TREATMENT OR PREVENTION OF HERPES SIMPLEX INFECTIONS FOR CHILDREN WITH REDUCED IMMUNITY 2 years and above: the adult dose is appropriate Under 2 years: half the adult dose TREATMENT OF CHICKENPOX 6 years and above: 800 mg four times a day 2 to 5 years: 400 mg four times a day Under 2 years: 200 mg four times a day Treatment should continue for five days. The Elderly If you suffer from kidney problems, discuss this with your doctor and the appropriate dosage will be set for your needs. Your doctor has decided the dose which is suited to you. Always follow your doctors instructions and those which are on the pharmacy label. If you do not understand these instructions, or you are in any doubt, ask your doctor or pharmacist.

You should continue to take these tablets for as long as your doctor tells you to. If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time. If you see another doctor or go into hospital, let him or the staff know what medicines you are taking. If you (or someone else) swallow a lot of tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. AFTER TAKING FYRIS TABLETS Fyris Tablets are taken by many patients without any problems. However, like many other medicines they may occasionally cause side effects in some people. These may include: Nausea, vomiting, diarrhoea and stomach pains. In patients with kidney problems reversible nervous reactions such as dizziness, confusion, hallucinations, tiredness, drowsiness and convulsions may be experienced. Other side effects: allergic reactions including skin rashes, itching, sensitivity to light, shortness of breath, difficult breathing and swelling of the lips, face and neck. Rarely, kidney and liver problems have been reported. Hair loss, headaches and problems with the blood have also been reported. If you have these or any other effects whilst taking Fyris Tablets tell your doctor immediately. STORING FYRIS TABLETS Do not use this medicine after the expiry date shown on the outside of the carton and on the blister foil. Do not store above 25C. Do not transfer them to another container. Keep them in a secure place where children cannot get at them. This medicine is for you ONLY, do not give it to anyone else. Unless your doctor tells you to, do not keep these tablets for longer than you need. Return all unused medicines to your pharmacist for safe disposal. FURTHER INFORMATION This leaflet only gives a brief outline of some of the more important points about Fyris Tablets. If you want to know more about these tablets or their effects, please ask your doctor or pharmacist. Revised: February 2002

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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