Aciclovir 200mg Tablets
^actavis
Aciclovir 200mg tablets
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Aciclovir is and what it is 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 Aciclovir is and what it is used for
Aciclovir is an antiviral medicine, which acts on infected cells by stopping the virus growing.
Aciclovir tablets are used to:
• treat or prevent herpes simplex infections of the skin and mucous membranes e.g. cold sores and genital herpes (except in children whose immune system work less well and they are unable to fight infections)
• prevent herpes simplex infections in patients whose immune system is not working properly
• treat chicken pox (varicella infection).
2. Before you take Aciclovir tablets
Do not take Aciclovir tablets
• if you are allergic (hypersensitive) to aciclovir, any of the ingredients in Aciclovir tablets or valaciclovir (see section 6).
Take special care with Aciclovir tablets
• if you have nervous system abnormalities, please tell your doctor before you start treatment with Aciclovir tablets.
• to avoid dehydration, it is important to drink plenty of water whilst taking Aciclovir tablets, especially if you are elderly or taking doses of 4g a day or higher.
• If you have kidney problems.
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. Especially:
• cimetidine (used to treat peptic ulcers) and probenecid (used to treat gout), as these increase the concentration of aciclovir.
• mycophenolate mofetil (medicine used in transplant patients). Care should be taken if you are taking high doses of Aciclovir, as blood levels of both drugs may increase.
• ciclosporin (an immunosuppressant drug). Your doctor may monitor your kidney function.
• theophylline (used in asthma and other breathing problems).
• zidovudine (used in HIV infection).
Pregnancy and breast-feeding
There is limited information on the use of Aciclovir tablets in pregnancy or breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some side effects such as drowsiness and sleepiness may impair your ability to concentrate and react. Make sure you are not affected before you drive or operate machinery.
3. How to take Aciclovir tablets
Always take Aciclovir tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
It is important to start treatment as soon as possible. Swallow the tablets with water, with or without food. If you experience difficulty in swallowing the tablets they may be dispersed in a glass of water (at least 50ml) which should be stirred before drinking.
Usual doses:
• Herpes simplex infection (e.g. cold sores, genital herpes)
Adults
- treatment - 200mg 5 times a day at 4 hourly intervals for 5 days
- prevention - 200mg 4 times a day at 6 hourly intervals for 6-12 months
- prevention in patients whose immune system is not working properly - 200mg 4 times a day at 6 hourly intervals for the period that the patient is at risk
- patients with severely impaired kidney function -200mg twice a day at 12 hourly intervals
If your immune system is severely impaired or you have impaired absorption from the gut, the dose may be increased or you may be given an injection (into a vein).
• Herpes simplex infection (e.g. cold sores, genital herpes)
Children
- treatment -
• 2 years and over - adult dose
• under 2 years - half the adult dose
- prevention in patients whose immune system is not working properly -
• 2 years and over - adult dose
• under 2 years - half the adult dose
5
6
• Varicella infection (chicken pox)
Children
- treatment - for 5 days
• 6 years and over - 800mg 4 times a day
• 2-5 years - 400mg 4 times a day
• under 2 years - 200mg 4 times a day
A liquid formulation might be more suitable for small children.
Elderly
Dosage may be reduced in the elderly, especially in those whose kidneys are not working properly.
To avoid dehydration, it is important to drink plenty of water whilst taking Aciclovir tablets, especially if you are elderly or taking doses of 4g a day or higher.
If you take more Aciclovir tablets than you should
If you take too many Aciclovir tablets, contact your doctor immediately. Signs of an overdose include effects on the stomach and intestines such as feeling or being sick and effects on the nervous system such as confusion.
If you forget to take Aciclovir tablets
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time.
4. Possible side effects
Like all medicines, Aciclovir tablets can cause side effects, although not everybody gets them.
Contact your doctor at once if you have a severe allergic reaction (anaphylaxis) such as swelling of the face, lips, tongue or throat (angioedema), difficulty breathing or swallowing.
Tell your doctor or pharmacist if you notice any of the
following effects or any not listed.
Common (occurs in less than 1 in 10 users): dizziness, headache, feeling or being sick, diarrhoea, stomach pain, skin rashes, itching, tiredness, sensitivity to sunlight or artificial light (e.g. sunbeds), fever.
Uncommon (occurs in less than 1 in 100 users): pale or red irregular raised patches with severe itching (hives), hair loss.
Rare (occurs in less than 1 in 1000 users): an increase in bilirubin and liver related enzymes, an increase in the blood levels of urea and creatinine, impaired kidney function which may progress to kidney failure (usually during treatment by injection into a vein), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis).
Very rare (occurs in less than one in 10,000 users): inflammation of the liver (hepatitis), yellowing of the skin or whites of the eyes (jaundice), changes in the numbers and types of your blood cells (anaemia, leucopenia, thrombocytopenia). If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test, kidney pain (felt in the back), kidney failure, nervous system reactions including drowsiness, confusion, seeing, hearing or feeling things that are not there (hallucinations), sleepiness, convulsions (fits), coma and a feeling of general discomfort and illness, agitation, involuntary shaking, difficulty controlling movements, difficulty speaking.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Aciclovir tablets
Keep out of the reach and sight of children.
Store below 25°C. Keep the blister in the outer carton to protect from light.
Do not use Aciclovir tablets after the expiry date stated on the label, carton or bottle. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Aciclovir tablets contain
• The active substance (the ingredient that makes the tablets work) is aciclovir PhEur. Each tablet contains 200mg of the active substance.
• The other ingredients are:
200mg tablets: colloidal anhydrous silica, magnesium stearate, povidone, sodium starch glycollate, indigo carmine lake (E132), microcrystalline cellulose (E460).
What Aciclovir tablets look like and contents of the pack
200mg Aciclovir tablets are pale blue, circular, flat bevelled-edge, uncoated tablets. Pack sizes are 25, 28, 30, 35, 56, 60 and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Manufacturer
Actavis
Barnstaple
EX32 8NS UK
This leaflet was last revised in August 2015.
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factavis
Actavis, Barnstaple, EX32 8NS, UK