ACICLOVIR DISPERSIBLE TABLETS 400MG

Active substance: ACICLOVIR

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PATIENT INFORMATION LEAFLET

Aciclovir 200mg and 400mg Dispersible Tablets
(Aciclovir)
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.





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. This includes any possible side effects not listed in this leaflet.
(See Section 4).
What is in this leaflet:
1

4

Possible side effects

What you need to know before you take Aciclovir

5

How to store Aciclovir

3

1

What Aciclovir is and what it is used for

2

How to take Aciclovir

6

Contents of the pack and other information

What Aciclovir is and what it is used
for

Aciclovir 200mg and 400mg Dispersible Tablets (referred
to as Aciclovir throughout this leaflet) belongs to a group of
medicines called anti−virals.
Aciclovir can be used:
to treat herpes simplex infections of the skin and
mucous membranes 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)

2

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,
receiving Aciclovir via injection 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

Hard to Read?

symptoms, it may be necessary to avoid driving or
operating machinery or pursuing any activity in which full
attention is required

3

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, dissolved in at
least 50mls of water or swallowed whole with a glass of
water.
The score line (present only in 400mg dispersible
tablets) is not intended for breaking the tablet
The recommended doses are:
Adults
Treatment of Herpes Simplex infections
200mg five times a day for 5 days at approximately 4
hour intervals (leaving out the night time dose)
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 alternatively, dosing via
injection may be considered
For treatment of infections in patients with a low
immune system:
200mg four times a day at approximately 6 hour
intervals
This dose may be changed to 400mg twice a day at
approximately 12 hour intervals, 200 mg three times a
day at approximately 8 hour intervals or twice a day at
approximately 12 hour intervals
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 at
approximately 6 hour intervals or alternatively, dosing
via injection may be considered
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 prevention of infections in patients with a low
immune system:
200mg five times a day for 5 days at approximately 4
hour intervals (leaving out the night time dose)
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 alternatively, dosing via
injection may be considered
The length of treatment will depend on the infection and
its severity
Shingles (Herpes Zoster infection) and Chickenpox
(Varicella infection)
800mg five times a day for 7 days at approximately 4
hour intervals (leaving out the night time dose)
For patients with a severely low immune system (e.g.
after a bone marrow transplant) or those suffering from
gut absorption problems, dosing via injection may be
considered
Treatment of shingles should start as soon as possible
after the start of the rash

Phone

continued....

0800 970 6115

for help
Till−Ver.5.3s

Treatment of chickenpox in patients with a low immune
system should start within 24 hours after the start of the
rash

Elderly and patients suffering from kidney problems
Herpes Simplex Infections
200mg two times a day at approximately 12 hour
intervals is recommended

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 white blood cells (leukopenia)
A reduction in blood platelets, which increases risk of
bleeding or bruising (thrombocytophenia)
Inflammation of the liver (hepatitis)
Yellowing of the skin or whites of the eyes (jaundice)
Kidney problems, failure or pain

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

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.

Children
Treatment of Herpes Simplex infections and
prevention of Herpes Simplex infections in children
with a low immune system
2 years and over: adult dose
Under 2 years: half the adult dose
Chickenpox (Varicella infection)
6 years or over: 800mg four times a day for 5 day
2−5 years: 400mg four times a day for 5 days
Under 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

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.

5

Keep this medicine out of the sight and reach of
children.
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.
Store below 25°C.
Store in original package.
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.

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.

4

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

How to store Aciclovir

6

Contents of the pack and other
information

What Aciclovir contain:
Each tablet contains either 200mg or 400mg of active
ingredient aciclovir
The other ingredients are potato starch, gelatin,
microcrystalline cellulose, sodium starch glycollate,
sodium stearyl fumarate and colloidal anhydrous silica
What Aciclovir looks like and contents of the pack
Aciclovir 200mg Dispersible: white/almost
white, round, convex tablet of 9.5mm diameter, marked
" HF 200" on one side
Aciclovir 400mg Dispersible: white/almost
white, oval, convex, scored tablet of 8mm x 16mm,
marked " HD 400" on one side
Aciclovir is available in:
Aciclovir Dispersible is available in packs of:
200mg: 25 and 100
400mg: 25, 30, 56, 60, 70 and 100
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd.
3 Howard Road,
Eaton Socon, St. Neots,
Cambridgeshire
PE19 8ET
United Kingdom
Product Licence Numbers:
Aciclovir 200mg Dispersible Tablets PL 11311/0201
Aciclovir 400mg Dispersible Tablets PL 11311/0202

Date of last revision: December 2013

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

Hard to Read?

Phone

0800 970 6115

for help
Till−Ver.5.3s

Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Aciclovir dispersible 200mg & 400mg
Tabs
PIL
175 mm x 330 mm
Font SansSerif − Min. Text 8pt
Till−Ver.5.3s
03/01/2014
Pantone Black CVC

Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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