Zovirax 200 mg/5 ml Suspension

Aci clovir (the active ingredient of ZOVIRAX SUSPENSION) belongs to a group of medicines called antivirals. ZOVIRAX SUSPENSION works by stopping the production of the virus. This reduces the length and severity of an outbreak of infection. ZOVIRAX SUSPENSION does not get rid of the virus from your body. ZOVIRAX SUSPENSION can be used to:

• treat chickenpox and shingles
• treat cold sores, genital herpes and other herpes simplex infections
• stop cold sores, genital herpes and other herpes virus infections from coming back after you have had them
• prevent herpes virus infections in people whose immune systems work less well, which means their bodies are less able to fight infections.

You should not take ZOVIRAX SUSPENSION:

• if you have an allergy to, or if you have previously experienced an allergic reaction to acyclovir, or valaciclovir, or to any of the ingredients of ZOVIRAX SUSPENSION (listed in section 6).

Warnings and precautions:

Take special care with ZOVIRAX SUSPENSION:

Before you start taking ZOVIRAX SUSPENSION, tell your doctor if:

• you are pregnant or intend to become pregnant
• you are breastfeeding or planning to breastfeed
• you have a kidney or liver condition
• if you are elderly.

If any of the above applies to you, or if you are unsure if they apply to you, and if you have not already discussed with your doctor, tell your doctor or pharmacist before you start taking ZOVIRAX SUSPENSION.

Drug reaction with eosinophilia and systemic symptoms (DRESS) appears initially as flu like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

If you develop a rash associated with fever and enlarged lymph nodes, stop taking ZOVIRAX SUSPENSION and contact your doctor or seek medical attention immediately.

Other medicines and ZOVIRAX SUSPENSION:

Always tell your health care professional if you are taking any other medicine. (This includes complementary or traditional medicines.)

Take special care with ZOVIRAX SUSPENSION if you are taking any of the following medicines: theophyllin, probenecid, cimetidine or mycophenolate mofetil (immunosuppressant agent used in kidney transplants).

Pregnancy and breastfeeding and fertility:

You should not breastfeed your infant if you are on treatment with ZOVIRAX SUSPENSION. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before you take ZOVIRAX SUSPENSION.

Do not share medicines prescribed for you with any other person. Always take ZOVIRAX SUSPENSION exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will decide on the correct dose to take, how often and for how long, depending on:

• the type of infection you have
• whether it is to treat the infection or to stop it coming back.

Your doctor will be monitoring you closely as there is a risk of you experiencing nervous system side effects (see section 4). It is important that you drink adequate fluids whilst you are having treatment.

If you have the impression that the effect of ZOVIRAX SUSPENSION is too strong or too weak, tell your doctor of pharmacist.

If you take more ZOVIRAX SUSPENSION that you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you missed a dose of ZOVIRAX SUSPENSION:

Take one dose as soon as you remember and then take the next dose at the correct time. Do not take a double dose to make up for forgotten individual doses.

ZOVIRAX SUSPENSION can have side effects. Not all side effects reported for ZOVIRAX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ZOVIRAX SUSPENSION, please consult your doctor, pharmacist of other healthcare professional for advice.

If any of the following happens, stop taking ZOVIRAX SUSPENSION and tell your doctor immediately or go to the casualty department at your nearest hospital.

• severe allergic reaction symptoms which include, sudden wheeziness, fluttering or tightness in the chest, collapse, swelling of eyelids, face, lips or elsewhere, skin rash or weals.
• Drug Reaction with Eosinophilia and Systemic Symptoms also known as DRESS or drug hypersensitivity syndrome, which is characterised by widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and possibly other body organs involvement. See also section 2.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ZOVIRAX SUSPENSION. You may need urgent medical attention or hospitalisation.

Tell your doctor if you experience any of the following side effects:

• Frequent side effects include:
• headache, dizziness
• feeling or being sick (nausea, vomiting), diarrhoea and stomach cramps
• itching, skin rashes (including a skin reaction after exposure to sunlight)
• fever and feeling tired.

Less frequent side effects include:

• mild skin reactions e.g. hives/nettle rash
• hair loss
• severe allergic reaction symptoms which include, sudden wheeziness, fluttering or tightness in the chest, collapse, swelling of eyelids, face, lips or elsewhere, skin rash or weals. Check with your doctor immediately if you or your child experiences any of these severe symptoms. These symptoms may mean that you or your child, are allergic to ZOVIRAX SUSPENSION. Do NOT take any more of this medicine unless your doctor has advised you to do so
• difficulty breathing
• effects on some blood and urine tests. Let the doctor know that you are taking ZOVIRAX SUSPENSION if you are having a blood or urine test
• liver problems, or yellowing of the skin and the whites of the eyes
• impaired kidney function or kidney failure
• weakness, tiredness, feeling faint or shortness of breath. These symptoms may mean you have reduced number of red blood cells (anaemia) although you may not notice any symptoms, this medicine may cause a decrease in your white blood cells
• bruising or nose bleeds. These symptoms mean you have a low number of platelets, a type of white blood cell
• agitation, confusion, shakiness, irregular body movements, difficulties with speech, hallucinations, fits, drowsiness, sleepiness during the day, loss of contact with reality
• pain in the flank/kidney area of your back.

Side effects with unknown frequency:

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ZOVIRAX SUSPENSION.

Store all medicines out of reach of children. Protect from light. ZOVIRAX SUSPENSION: Store at or below 25 °C.

Do not use if the expiry date on the packaging has passed. If you take ZOVIRAX SUSPENSION after the expiry date has passed, it may not work as well. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).