Aciclovir

• For infections with herpes viruses, such as genital herpes
• For shingles
• Tablet for oral use
• Finish the entire course

Aciclovir belongs to a group of medicines called antivirals. It works by stopping the growth of viruses, such as herpes viruses. Aciclovir inhibits the action of a certain enzyme that is found in the herpes virus. As a result, the viruses cannot replicate.

Aciclovir can be used to treat various herpes infections of the skin and mucous membranes caused by the herpes simplex virus or varicella zoster virus, including:

• Herpes genitalis (herpes simplex infection of the genitals). This STD is likely to cause itching, pain, and blisters with scabs on the genitals.
• Shingles (varicella zoster virus). The condition is characterised by pain and itching, typically on one side of the body, followed by redness of the skin and blisters (which disappear within a number of weeks).

Aciclovir works by stopping the virus from reproducing. Although the initial symptoms usually clear up after a few weeks, the virus remains dormant (inactive) in the body and may be reactivated from time to time, causing recurrent outbreaks. Acyclovir can also be used to prevent outbreaks in people who are infected with the virus.

Acyclovir tablets should be taken with a drink of water. They can be taken with or without food. Always finish the entire course, even if you feel better.

Dosage

Aciclovir is available in various strengths. Your doctor will recommend the right dose for you. The general guidelines for use are as follows:

Treatment of herpes simplex viruses

• Adults and children aged two years and above: The usual dose is 200 mg taken five times a day. You should space each dose by four hours (suggested times: 7 a.m., 11 a.m., 3 p.m., 7 p.m. and 11 p.m.).

A course of treatment lasts five days. Prolonged therapy may be necessary in the case of first-time, severe infections. You should start taking the first dose as soon as you notice symptoms of the infection.

Prevention of genital herpes simplex infections

• Adults: The usual dose is 400 mg taken twice a day. You should space each dose by 12 hours.

The duration of administration is determined by the duration of the period at risk.

Shingles (recurring varicella zoster infection)

• Adults: The usual dose is 800 mg taken five times a day. You should space each dose by four hours (suggested times: 7 a.m., 11 a.m., 3 p.m., 7 p.m. and 11 p.m.).

A course of treatment lasts seven days. You should start taking the first dose as soon as you notice symptoms of the infection. No specific data are available on dosage in children.

Talk to your doctor or pharmacist if Aciclovir Sandoz does not have the desired effect.

Alcohol/driving

This medicine does not interact with alcohol and will normally not affect your ability to drive or operate machinery. If you experience side effects such as tiredness or dizziness, you should avoid driving.

If you take more Aciclovir than you should or miss a dose

Talk to your doctor or pharmacist if you have taken more tablets than you should.

If you forget to take a dose of Aciclovir, you may take it as soon as you remember, unless it is almost time for your next scheduled dose. Never take a double dose to make up for the forgotten one.

Aciclovir is not suitable for everyone. Do not use Aciclovir if you are allergic to valaciclovir or any of the other ingredients of this medicine (see section 'What Aciclovir contains').

When should this medicine be used with caution?

Talk to your doctor before using Aciclovir if:

• You are over 65 years of age and have a decreased kidney function. Your doctor will need to adjust your dose. (A lower dose is usually prescribed.)
• You suffer from severely impaired kidney function. The doctor may prescribe a different (lower) dose.
• You are taking a high dose.
• You are taking other medicines that may cause kidney damage.

Note: it is important that you drink plenty of water while taking Aciclovir tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Other medicines and Aciclovir

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• Probenecid (used to treat gout).
• Cimetidine (stomach acid inhibitor).
• Mycophenolate mofetil (used to stop your body rejecting transplanted organs).
• Interferon (used to treat multiple sclerosis).
• Zidovudine, also known as azidothymidine (AZT) (used to treat AIDS).
• Theophylline (used to treat asthma and COPD).

Consult your doctor or pharmacist if you are taking any of these medicines.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that are known to be associated with Aciclovir include:

Common (may affect up to 1 in 10 people):

• Headache, dizziness.
• Nausea, vomiting, diarrhoea, stomach pain.
• Itching, skin rash, skin reaction after exposure to light (photosensitivity).
• Feeling tired, fever.

Uncommon (may affect up to 1 in 100 people):

• Itchy, hive-like rash, hair loss.

Rare (may affect up to 1 in 1,000 people):

• Severe, life-threatening allergic reaction to certain substances (anaphylactic reaction).
• Shortage of breath.
• Bilirubin elevations, increases in the enzymes that work in the liver.
• Sudden moisture accumulation underneath the skin and in mucous membranes (e.g., throat, tongue), breathing difficulties and/or itching and skin rash (angioedema).
• Increased levels of urea and creatinine in the blood.

Very rare (may affect up to 1 in 10,000 people):

• Reduced numbers of red blood cells (anaemia), blood disorder characterised by a heightened susceptibility to infection, reduced numbers of blood platelets (cells that help blood to clot).
• Feeling agitated or confused, shaking or tremors, coordination problems, difficulty speaking, hallucinations, psychotic symptoms, fits, sleepiness, brain disorder, unconsciousness (coma).
• Inflammation of the liver (hepatitis), jaundice.
• Acute kidney failure, kidney pain.

Consult a doctor if you experience these or other side effects.

Aciclovir is available in tablets of 200 mg, 400 mg and 800 mg. The active substance is aciclovir.

The other ingredients are: lactose monohydrate, cellulose microcrystalline (E460), sodium starch glycolate, copovidone, magnesium stearaat (E470b).

The manufacturers of Aciclovir Sandoz are:

Sandoz B.V. Postbus 10332
1301 AH Almere
The Netherlands

Salutas Pharma GmbH Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany

Read the package leaflet before use.