Document: leaflet MAH GENERIC_PL 11311-0199 change

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• leaflet MAH GENERIC_PL 00289-0295
• leaflet MAH GENERIC_PL 11311-0199

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PATIENT INFORMATION LEAFLET

Aciclovir 200mg, 400mg and 800mg Tablets

(Aciclovir)

□ What Aciclovir is and what it is used for

Aciclovir Tablets belongs to a group of medicines called antivirals.

Aciclovir can be used:

■    to treat herpes simplex infections of the skin e.g. cold sores and genital herpes (excluding newborn babies and children with low immune systems and severe herpes simplex infections)

■    to prevent recurrent attacks of herpes simplex

■    to help prevent those who have low immune systems from getting herpes infections

■    to treat chicken pox (varicella infection) and shingles (herpes zoster infection)

□ What you need to know before you take Aciclovir

Do not take Aciclovir:

If you are allergic (hypersensitive) to aciclovir, valaciclovir or any of the other ingredients in these tablets (see Section 6 "Contents of the pack and other information").

Warnings and precautions

Talk to your doctor before taking Aciclovir:

■    If you are taking other nephrotoxic medicines (medicines that may cause kidney failure) such as cyclosporin and tacrolimus (See "Other medicines and Aciclovir" section)

■    If you suffer from kidney problems [including if you have dialysis therapy] (as you may need a lower dose of aciclovir - see Section 3 "How to take aciclovir")

■    If you are elderly (as you may need a lower dose of aciclovir - see Section 3 "How to take aciclovir")

■    If you have a severely low immune system and need to have this medicine over a long period of time or in repeated doses

Other medicines and Aciclovir

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

Medicines which may interact with Aciclovir:

■    Probenecid (used to treat gout)

■    Cimetidine (used to reduce stomach acid)

■    Mycophenolate mofetil (used to prevent transplant rejection)

■    Medicines which may affect the kidneys e.g. cyclosporin, tacrolimus (nephrotoxic medicines)

■    Theophylline (used to treat breathing problems, such as asthma)

Aciclovir with food and drink

It is important that you drink plenty of fluids while you are taking Aciclovir to prevent you becoming dehydrated, especially if you are elderly, suffer from kidney problems or are taking a high dose of Aciclovir.

Pregnancy and Breast-feeding

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

Driving and using machines

Aciclovir is not likely to affect you being able to drive or use machinery. However, if you experience any difficulty or symptoms, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

Aciclovir contains lactose:

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

How to take Aciclovir

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

■    These tablets are to be taken orally.

■    The score line (present only in 400mg and 800mg tablets) is only there to help you break the tablet if you have difficulty swallowing it whole.

The recommended doses are:

Adults

Herpes Simplex Infections

For treatment of infections (including first and repeat attacks of genital herpes):

■    200mg five times a day for 5 days

■    Patients with severe infections, may need to take this medicine for more than 5 days

■    For patients with a severely low immune system (e.g. after a bone marrow transplant or those suffering from gut absorption problems), a higher dose of 400mg five times a day may be given or dosing via injection may be considered

■    For patients suffering from kidney problems, a lower dose of 200mg two times a day for 5 days should be given

For prevention of repeat infections:

■    800mg divided into two or four daily doses. This dose may be reduced to 400-600mg a day.

■    The length of treatment will depend on the infection and its severity

■    Treatment should be interrupted at intervals of 6-12 months, in order to see if there are any possible changes in the natural history of the infection

■    For patients suffering from kidney problems, a lower dose of 200mg two times a day should be given

For prevention of infections in patients with a low immune system:

■    200mg four times a day

■    For patients with a severely low immune system or those suffering from gut absorption problems, a higher dose of 400mg four times a day may be given or alternatively, dosing via injection may be considered

■    The length of treatment will depend on the infection and its severity

■    For patients suffering from kidney problems, a lower dose of 200mg two times a day should be given

Shingles (Herpes Zoster infection)

■    800mg five times a day for 7 days.

■    Treatment should begin within the first 3 days of the first signs of shingles occurring

■    For patients with a low immune system or those suffering from gut absorption problems, dosing via injection may be considered

■    For patients suffering from kidney problems, a lower dose of 800mg two - four times a day should be given depending on your condition

Chickenpox (Varicella infection)

■    800mg five times a day for 7 days at approximately 4 hour intervals (leaving out the night time dose)

■    Treatment should begin within 24 hours of the first signs of a rash

■    For patients with a low immune system or those suffering from gut absorption problems, dosing via injection may be considered

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■    For patients suffering from kidney problems, a lower dose of 800mg two - four times a day should be given depending on your condition

Children

Herpes Simplex Infections

For treatment of infections (including first and repeat attacks of genital herpes):

■    2 years and over: adult dose (200mg five times a day for 5 days)

■    Under 2 years: half the adult dose (100mg five times a day for 5 days)

For prevention of repeat infections:

■    2-14 years: adult dose (800mg divided into two or four daily doses)

■    Under 2 years: half the adult dose (100mg four times a day)

For prevention of infections in patients with a low immune system:

■    2-14 years: adult dose (200mg four times a day)

■    Under 2 years: half the adult dose (100mg four times a day)

Chickenpox

■ 6 years and over: 800mg four times a day for 5 days

■ 2-5 years: 400mg four times a day for 5 days

■    3 months- 2 years: 200mg four times a day for 5 days

■    Different dosage may be prescribed based on 20mg per kg of body weight (max of 800mg) four times a day for 5 days.

■    For children with a low immune system dosing should be given via injection for at least 5 days before starting on oral tablets

Elderly and patients suffering from kidney problems Herpes Simplex Infections

For treatment of infections (including first and repeat attacks of genital herpes):

■    200mg two times a day at approximately 12 hour intervals is recommended

Shingles (Herpes Zoster infection)

■    800mg two times a day at approximately 12 hour intervals for patients suffering from severe kidney problems

■    800mg three times a day at approximately 8 hour intervals for patients suffering from moderate kidney problems

It is especially important if you are elderly, suffering from kidney problems or are taking a high dose of Aciclovir that you drink plenty of fluids.

If you take more Aciclovir than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of overdose include: feeling and/or being sick, headache, confusion, seeing or hearing things that are not real (hallucinations), feeling agitated, fits, loss of consciousness/coma.

If you forget to take Aciclovir

Take it as soon as you remember, unless it is time for your next dose.

If you miss a dose do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

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

Seek medical advice immediately if you develop the following symptoms:

■    Allergic reactions: skin rashes, itching, swelling of the face, tongue or throat, breathlessness, difficulty in breathing, dizziness

Common side effects (may affect up to 1 in 10 people)

■    Headache

■    Dizziness

■    Feeling sick (nausea) or being sick (vomiting)

■    Diarrhoea

■    Stomach pains

■    Severe itching (pruritus), skin rashes

■    Abnormal sensitivity of the skin to sunlight (photosensitivity)

■    Tiredness (fatigue)

■    Fever

Uncommon side effects (may affect up to 1 in 100 people)

■    Red, raised, itchy skin rash (urticaria)

■    Hair loss (alopecia)

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

■    Shortness of breath (dyspnoea)

■    Increases in bilirubin and liver-related enzymes (reversible)

■    Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)

■    Effects on blood and urine tests

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

■    Agitation

■    Confusion

■    Shakiness (tremors)

■    Lack of voluntary co-ordination of muscle movements (ataxia)

■    Difficulty with speech (dysarthria)

■    Hallucinations

■    Mental health problems

■    Fits

■    Sleepiness (somnolence)

■    Disorder of the brain (encephalopathy)

■    Coma

The side effects listed above are generally reversible and usually reported in patients with kidney problems or with other pre-existing factors (See Section 2, "Warnings and precautions").

■    Looking pale and feeling tired (anaemia)

■    A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytophenia)

■    A reduction in white blood cells (leukopenia)

■    Inflammation of the liver (hepatitis)

■    Yellowing of the skin or whites of the eyes (jaundice)

■    Kidney problems, failure or pain

Reporting of side effects

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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Aciclovir

■    Keep this medicine out of the sight and reach of children.

■    Do not store above 25°C.

■    Do not use this medicine after the expiry date which is stated on the blister/carton after "EXP". The expiry date refers to the last day of that month

■    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.

Contents of the pack and other information

What Aciclovir contain

■    Each tablet contains either 200mg, 400mg or 800mg of active ingredient aciclovir

■    The other ingredients are lactose monohydrate, potato starch, gelatin, microcrystalline cellulose, sodium starch glycollate (type A), sodium stearyl fumerate

What Aciclovir looks like and contents of the pack

■    Aciclovir 200mg: white/almost white, round, biconvex tablet of 9.5mm diameter, marked "ACY/200" on one side.

■    Aciclovir 400mg: white/almost white, oblong, biconvex, scored tablet of 8mm x16mm, marked "ACY/400" on one side.

■    Aciclovir 800mg: white/almost white, capsule-shaped, biconvex, scored tablet of 9mm x19mm marked, "ACY/800" on one side.

Aciclovir is available in:

Aciclovir is available in packs of:

■    200mg: 25 and 100

■    400mg: 25, 30, 56, 60, 70 and 100

■    800mg: 35

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Tillomed Laboratories Ltd 3 Howard Road, Eaton Socon,

St. Neots.

Cambridgeshire PE198ET

Product licence numbers:

Aciclovir 200mg Tablets: PL11311/0198 Aciclovir 400mg Tablets: PL11311/0199 Aciclovir 800mg Tablets: PL11311/0200

Date of last revision: December 2013

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