Aciclovir 400 mg Tablets - Patient Information Leaflet (PIL) (2024)

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Aciclovir 400 mg Tablets are and what they are used for
2. What you need to know before you take Aciclovir 400 mg Tablets
3. How to take Aciclovir 400 mg Tablets
4. Possible side effects
5. How to store Aciclovir 400 mg Tablets
6. Contents of the pack and other information.

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

Do not take Aciclovir 400 mg Tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir 400 mg Tablets.

Talk to your doctor, pharmacist or nurse before taking Aciclovir 400 mg Tablets

• if you have kidney problems
• if you are over 65 years of age

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Aciclovir 400 mg Tablets.

It is important that you drink plenty of water while taking Aciclovir 400 mg Tablets

Aciclovir tablets can be used mainly for the treatment of non-severe skin and mucous membranes herpes simplex virus (HSV) infections. Your child’s doctor will recommend IV aciclovir for the treatment of neonatal HSV and severe HSV infection, if your child’s immune system is not working properly.

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

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.

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.

• Take this medicine by mouth
• Dissolve the tablet in a glass of water and stir before drinking
• If you prefer, the tablet can also be swallowed whole with a little water.
• Start to take Aciclovir 400 mg Tablets as soon as possible.

The dose that you should take will depend on what you have been given Aciclovir 400 mg Tablets for. Your doctor will discuss this with you. A 200 mg tablet is also available.

• The usual dose is two 400 mg tablet taken five times a day
• You should space your dose by at least four hours
• Suggested times are: 7am, 11am, 3pm, 7pm and 11pm
• You should take Aciclovir 400 mg Tablets for seven days.

• The usual dose is one 200 mg tablet taken five times a day
• You should space your dose by at least four hours
• Suggested times are: 7am, 11am, 3pm, 7pm and 11pm
• You should take Aciclovir 400 mg Tablets for five days, or longer if your doctor tells you to.

• The usual dose is one 200 mg tablet taken four times a day
• You should try to space each dose by 6 hours
• You should take Aciclovir 400 mg Tablets until your doctor tells you to stop.

• The usual dose is one 200 mg tablet taken four times a day
• You should try to space each dose by 6 hours
• You should take Aciclovir 400 mg Tablets until your doctor tells you to stop.

• it is for a child
• you are over 65 years of age
• you have kidney problems. If you have kidney problems, it is important to drink plenty of water while you are being treated with Aciclovir 400 mg Tablets

Talk to your doctor before taking Aciclovir 400 mg Tablets if any of the above apply.

Aciclovir 400 mg Tablets are not usually harmful, unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Aciclovir 400 mg Tablets. Take the medicine pack with you.

• .If you forget to take Aciclovir 400 mg Tablets, 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 any of the following happen, stop taking Aciclovir 400 mg Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital.

Allergic reactions (may affect up to 1 in 1,000 people)

If you have an allergic reaction, stop taking Aciclovir 400 mg Tablets and see a doctor straight away. The signs may include:

• rash, itching or hives on your skin
• swelling of your face, lips, tongue or other parts of your body
• shortness of breath, wheezing or trouble breathing
• collapse

Common (may affect up to 1 in 10 people)

• headache
• feeling dizzy
• feeling or being sick
• diarrhoea
• stomach pains
• rash
• skin reaction after exposure to light (photosensitivity)
• itching
• feeling tired
• unexplained fever (high temperature) and feeling faint, especially when standing up.

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)

• effects on some blood and urine tests
• increases in the enzymes that work in the liver.

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

• reduced numbers of red blood cells (anaemia)
• reduced numbers of white blood cells
  (leukopenia)
• reduced numbers of blood platelets (cells that help blood to clot) (thrombocytopenia)
• feeling weak
• feeling agitated or confused
• shaking or tremors
• hallucinations (seeing or hearing things that aren’t there)
• fits
• feeling unusually sleepy or drowsy
• unsteadiness when walking and lack of coordination
• difficulty speaking
• inability to think or judge clearly
• unconsciousness (coma)
• paralysis of part or all of your body
• disturbances of behaviour, speech and eye movements
• stiff neck and sensitivity to light
• inflammation of the liver (hepatitis)
• yellowing of your skin and whites of your eyes (jaundice)
• kidney problems where you pass little or no urine
• pain in your lower back, the kidney area of your back or just above your hip (renal pain).

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 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 tablet contains 400 mg of Aciclovir.

The other ingredients are:

Magnesium stearate, microcrystalline cellulose, sodium starch glycollate, pregelatinised starch and colloidal anhydrous silica.

Aciclovir 400 mg tablets are capsule shaped biconvex uncoated white to off-white tablets with “400” debossed on one side and “ACV” on the other side.

Aciclovir Tablets are available in packs of 56, 60, 70 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

SUN PHARMA UK LIMITED
6-9 The Square
Stockley Park
Uxbridge
UB11 1FW
United Kingdom

Manufacturers:

Terapia S.A.
124 Fabricii Street
400632 Cluj-Napoca
Cluj Romania

Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands