Aciclovir Tablets 200mg, 400mg, 800mg (Actavis UK Ltd)

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

Aciclovir 200mg and 400mg tablets are used to:

• treat or prevent herpes simplex infections of the skin and mucous membranes e.g. cold sores and genital herpes
• prevent herpes simplex infections in patients whose immune system is not working properly
• treat chicken pox (varicella infection).

Aciclovir 800mg tablets are used to:

• treat chicken pox (varicella infection)
• treat shingles (herpes zoster infection).

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.

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.

Sugar intolerance (200mg tablets only)

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

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

• Herpes zoster infection (shingles)
  Adults
  • treatment - 800mg 5 times a day at 4 hourly intervals for 7 days
  • treatment in patients with moderately impaired kidney function - 800mg 3 times a day at 6-8 hourly intervals
  • treatment in patients with severely impaired kidney function - 800mg twice a day at 12 hourly intervals

• 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.

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, pale or red irregular raised patches with severe itching (hives), tiredness.

Uncommon (occurs in less than 1 in 100 users): sensitivity to sunlight or artificial light (e.g. sunbeds), fever.

Rare (occurs in less than 1 in 1000 users): an increase in bilirubin and liver related enzymes, 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), hair loss, 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), 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.

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.

What Aciclovir tablets contain

• The active substance (the ingredient that makes the tablets work) is aciclovir PhEur. Each tablet contains either 200mg, 400mg or 800mg of the active substance.
• The other ingredients are:
  200mg tablets: lactose, magnesium stearate, polyvidone, sodium starch glycollate, E132, E460.
  400mg tablets: colloidal anhydrous silica, magnesium stearate, polyvidone, sodium starch glycollate, E172, E460.
  800mg tablets: colloidal anhydrous silica, magnesium stearate, polyvidone, sodium starch glycollate, E460.

What Aciclovir tablets look like and contents of the pack

200mg Aciclovir tablets are blue, circular, flat bevelled-edge, uncoated tablets. Pack size is 25.

400mg Aciclovir tablets are pink, circular, flat bevelled-edge, uncoated tablets. Pack size is 56.

800mg Aciclovir tablets are white, oval, biconvex, uncoated tablets. Pack size is 35.

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