Aciclovir 400mg/5ml Oral Suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Aciclovir 400mg/5ml Oral Suspension but it will be referred to as Aciclovir throughout this leaflet.

1. What Aciclovir is and what it is used for
2. What you need to know before you take Aciclovir
3. How to take Aciclovir
4. Possible side effects
5. How to store Aciclovir
6. Contents of the pack and other information

• You are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in section 6).

Do not take Aciclovir if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir.

Talk to your doctor or pharmacist before taking Aciclovir if:

• You have kidney problems.
• You are over 65 years of age.
• You are thirsty. You must make sure you drink plenty of liquids such as water whilst taking this medicine.
• Your immune system is weak.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Aciclovir.

There is no data available to support the use of this medicine in stopping cold sores and genital herpes returning after having had them and treatment of shingles in children whose immune systems work well.

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 - used to treat stomach ulcers.
• Mycophenolate mofetil - used to stop your body rejecting transplanted organs.

Food and drink should not affect the absorption of your medicine.

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

The ingredients in Aciclovir can pass into breast milk. If you are breast-feeding, you must check with your doctor before you take Aciclovir.

Some side effects such as feeling drowsy or sleepy may impair your ability to concentrate and react. Make sure you are not affected before you drive or operate machinery.

Sorbitol (E420): This medicine contains 1575mg sorbitol in each 5ml which is equivalent to 315mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you(or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Methyl parahydroxybenzoate (E218): May cause an allergic reaction (possibly delayed).

Propylene glycol (E1520): This medicine contains 5mg propylene glycol in each 5 ml which is equivalent to 1mg/ml. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

Treatment of chickenpox and shingles

• The usual dose is two 5 ml spoonfuls five times a day.
• You should space each dose by 4 hours.
  Suggested times are: 7am, 11am, 3pm, 7pm and 11pm.
• You should take Aciclovir for seven days.

Treatment of cold sores and genital herpes

• The usual dose is one 2.5 ml spoonful five times a day.
• You should space each dose by 4 hours.
  Suggested times are: 7am, 11am, 3pm, 7pm and 11pm.
• You should take Aciclovir for five days, or longer if your doctor tells you to.

• The usual dose is one 2.5 ml spoonful four times a day.
• You should try to space each dose by 6 hours.
• You should take Aciclovir until your doctor tells you to stop.

• The usual dose is one 2.5 ml spoonful four times a day. Your doctor may decide to double the dose to two 5ml spoonfuls four times daily in people whose immune system are severely impaired.
• You should try to space each dose by 6 hours.
• You should take Aciclovir until your doctor tells you to stop.
• Your doctor may decide to increase the dose or give a different form of this medicine by intravenous infusion.

Your doctor may adjust the dose of Aciclovir if it is for a child.

There is no data available to support the use of this medicine in stopping cold sores and genital herpes returning after having had them and treatment of shingles in children whose immune systems work well.

Treatment of cold sores and genital herpes:

• 2 years and over: one 2.5 ml spoonful five times a day.
• Under 2 years: other forms of this medicine are more suitable for children under 2 years.

Preventing these problems in children whose immune systems work less:

• 2 years and over: one 2.5 ml spoonful four times a day.
• Under 2 years: other forms of this medicine are more suitable for children under 2 years.

Treatment of chicken pox

• 6 years and over: two 5 ml spoonfuls four times a day.
• 2-5 years: one 5 ml spoonfuls four times a day.
• Under 2 years: one 2.5 ml spoonful four times a day.
• You should try to space each dose by 5 hours.
  Suggested times are: 7am, 12noon,5pm and 10pm.
• Your child should take Aciclovir for five days.

• You are over 65 years of age.
• You have kidney problems.

It is very important while you are taking Aciclovir that you drink water regularly during the day. This will help to reduce side effects that can affect the kidney or nervous system. Your doctor will closely monitor you for signs of these. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.

Talk to your doctor before taking Aciclovir if any of the above apply.

• Take this medicine by mouth.
• Use the spoon provided to carefully measure the dose needed (see figure below).
• Start to take Aciclovir as soon as possible.
• Shake the bottle well before use.
• Swallow the suspension.
• Wash the spoon with clean water after taking every dose.

Aciclovir is not usually harmful, unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Aciclovir. Take the medicine pack with you.

• If you forget to take Aciclovir, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is aciclovir.

Each 5ml of oral suspension contains 400mg aciclovir.

The other ingredients are xanthan gum (E415), sorbitol liquid (non-crystallising) (E420), methyl parahydroxybenzoate (E218), orange flavour (containing propylene glycol (E1520)), vanilla flavour (containing propylene glycol (E1520)) and purified water.

A white to off-white uniform oral suspension with orange and vanilla odour. It comes in an amber glass bottle with a child-resistant plastic cap. The pack also contains a 2.5-5ml double ended measuring spoon.

This medicine is available in a bottle containing 100ml of oral suspension.

If this leaflet is hard to see or read, please call +44 (0) 208 515 3700 for help.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

IE and UK (NI): Aciclovir 400mg/5ml Oral suspension