(15ºC – 25ºC)
(2ºC – 8ºC)
Sodium Chloride Intravenous Infusion (0.9% w/v)
Sodium Chloride (0.18% w/v) and Glucose
Do not refrigerate
(4% w/v) Intravenous Infusion
Sodium Chloride (0.45% w/v) and Glucose
(2.5% w/v) Intravenous Infusion
Compound Sodium Lactate Intravenous Infusion
Do not store
(Hartmann's Solution) – after reconstituted with
Compound Sodium Lactate Intravenous Infusion
Do not store
(Hartmann's Solution) - after reconstituted with
Sodium Chloride (0.9% w/v)
1. What Aciclovir is and what it is
Aciclovir 250 mg powder for solution for
infusion contains a medicine called aciclovir.
This belongs to a group of medicines called
antivirals. It works by killing or stopping the
growth of viruses.
Aciclovir can be used to:
treat recurrent chickenpox and shingles in
people whose immune system works well
treat primary and recurrent chickenpox
and shingles in people whose immune
systems work less well, which means
their bodies are less able to fight
treat severe cases of genital herpes
treat and stop cold sores and genital
herpes in people whose immune systems
work less well, which means their bodies
are less able to fight infections
treat serious virus infections in children up
to 3 months of age. This can rarely be
caused by the virus responsible for cold
sore infection and genital herpes
treat inflammation of the brain. This can
rarely be caused by the virus responsible
for cold sore infection and genital herpes.
2. What you need to know before
you are given Aciclovir
Do not use Aciclovir
if you are allergic to aciclovir or
valaciclovir or any of the other ingredients
of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Aciclovir if:
you have kidney problems
you are over 65 years of age
your immune system is weak.
If you are not sure if the above apply to you,
talk to your doctor or pharmacist before
taking Aciclovir. It is important that you drink
plenty of water while taking Aciclovir.
Other medicines and Aciclovir
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
tacrolimus, ciclosporin or mycophenolate
mofetil, used to stop your body rejecting
lithium, used in the treatment of manic-
theophylline, used in the treatment of
certain respiratory diseases.
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 or pharmacist
for advice before taking this medicine.
Driving and using machines
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.
Aciclovir contains sodium
This medicine contains less than 1 mmol
sodium (23 mg) per dose, i.e. essentially
3. How to use Aciclovir
You will never be expected to give yourself
this medicine. It will always be given to you
by a person who is trained to do so.
Before the medicine is given to you it will be
Aciclovir will be given to you as a continuous
infusion into your vein. This is where the
drug is slowly given to you over a period of
The dose you will be given, the frequency
and the duration of the dose will depend on:
the type of infection you have
Your doctor may adjust the dose of Aciclovir
if you have kidney problems.
For people over 65 years of age or with
kidney problems, it is important you receive
plenty of fluids while you are being treated
with Aciclovir. This will help to reduce side
effects that can affect the kidneys 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 having
Aciclovir if any of the above applies.
If you are given too much Aciclovir
If you think you have been given too much
Aciclovir, talk to your doctor or nurse straight
If you have been given too much Aciclovir
feel confused or agitated
have hallucinations (seeing or hearing
things that aren’t there)
become unconscious (coma).
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aciclovir 250 mg
powder for solution for infusion
Read all of this leaflet carefully before you are given 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.
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.
What is in this leaflet:
What Aciclovir is and what it is used for
What you need to know before you are given Aciclovir
How to use Aciclovir
Possible side effects
How to store Aciclovir
Contents of the pack and other information
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them. The following side effects may
happen with this medicine.
Allergic reactions (may affect up to 1 in
If you have an allergic reaction, stop taking
Aciclovir 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
unexplained fever (high temperature) and
feeling faint, especially when standing up.
Other side effects include:
Common (may affect up to 1 in 10 people)
feeling or being sick
itchy, hive-like rash
skin reaction after exposure to light
swelling, redness and tenderness at the
site of injection
increase in liver enzymes
increases in blood urea and creatinine
(that can determine kidney function, which
may be detected through a blood test).
Uncommon (may affect up to 1 in 100
reduced numbers of red blood cells
reduced numbers of white blood cells
reduced numbers of blood platelets (cells
that help the blood to clot)
Very rare (may affect up to 1 in 10,000
headache or feeling dizzy
diarrhoea or stomach pains
effects on some blood urine tests
feeling agitated or confused
shaking or tremors
hallucinations (seeing or hearing things
that aren’t there)
feeling unusually sleepy or drowsy
unsteadiness when walking and lack of
inability to think or judge clearly
paralysis of part or all of your body
disturbances of behaviour, speech and
stiff neck and sensitivity to light
inflammation of the liver (hepatitis)
yellowing of your skin and whites of your
kidney problems where you pass little or
pain in your lower back, the kidney area
of your back or just above your hip (renal
damage or malfunction of the brain
(encephalopathy) which is evident by an
altered mental state.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via:
UK: the Yellow Card Scheme at:
Ireland: HPRA Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
By reporting side effects you can help
provide more information on the safety of
5. How to store Aciclovir
Keep this medicine out of the sight and
reach of children.
Store in the original package.
For reconstituted solutions, chemical and
physical in-use stability has been
demonstrated for 12 hours at 25°C or in a
refrigerator (2ºC – 8ºC).
From a microbiological point of view, once
opened, the product should be used
immediately. If not used immediately, in-use
storage times and conditions prior to use
are the responsibility of the user and would
normally not be longer than 12 hours at
2-8°C, unless reconstitution has taken place
in controlled and validated aseptic conditions.
When diluted in accordance with the
recommended schedules, Aciclovir is known
to be compatible with the following infusion
fluids (see table below).
Do not use this medicine after the expiry
date which is stated on the carton after Exp.
The expiry date refers to the last day of that
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
protect the environment.
6. Contents of the pack and other
What Aciclovir contains
The active substance is aciclovir. Each vial
contains 250 mg of aciclovir (as aciclovir
sodium). The other ingredient is sodium
What Aciclovir looks like and contents of
Aciclovir is available in vials containing a
white powder, sealed with a stopper made
of bromobutyl rubber, a cap made of
aluminium and a plastic polypropylene lid.
Aciclovir is available in packs containing 1, 5
or 10 units.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Laboratórios Azevedos –
Indústria Farmacêutica, S.A.
Estrada Nacional 117-2,
Indústria Química e Farmacêutica, S.A.
Av. das Indústrias,
Alto do Colaride
This leaflet was last revised in 08/2017.
article code here 000000.00
For single use only.
Prepare immediately prior to use.
Aciclovir should be reconstituted using the
following volumes of either Water for Injections or
Sodium Chloride Intravenous Injection (0.9% w/v)
to provide a solution containing 25 mg Aciclovir
Volume of fluid
250 mg vial 10 ml
10.1 – 10.2 ml
From the calculated dose, determine the
appropriate number and strength of vials to be
To reconstitute each vial add the recommended
volume of infusion fluid and shake gently until the
contents of the vial have dissolved completely.
The solution reconstituted with Water for
Injections or sodium chloride intravenous
injection (0.9% w/v) is stable for a period of 12
hours at temperature below 25ºC or in a
refrigerator (2ºC – 8ºC).
The required dose of Aciclovir should be
administered by slow intravenous infusion over a
After reconstitution, Aciclovir may be
administered by a controlled-rate infusion pump.
Alternatively, the reconstituted solution may be
further diluted to give an aciclovir concentration
of not greater than 5 mg/ml (0.5% w/v) for
administration by infusion.
Add the required volume of reconstituted solution
to the chosen infusion solution, as recommended
below, and shake well to ensure adequate
For children and neonates, where it is advisable
to keep the volume of infusion fluid to a
minimum, it is recommended that dilution is on
the basis of 4 ml reconstituted solution (100 mg
aciclovir) added to 20 ml of infusion fluid.
For adults, it is recommended that infusion bags
containing 100 ml of infusion fluid are used, even
when this would give an aciclovir concentration
substantially below 0.5% w/v. Thus one 100 ml
infusion bag may be used for any dose between
250 and 500 mg aciclovir (10 ml of reconstituted
solution) but a second bag must be used for
doses between 500 mg and 1000 mg.
Aciclovir when diluted in accordance with the
above schedule will give an aciclovir
concentration not greater than 0.5% w/v.
Since no antimicrobial preservative is included,
reconstitution and dilution must be carried out
under full aseptic conditions, immediately before
use, and any unused solution discarded.
Should any visible turbidity or crystallisation
appear in the solution before or during infusion,
the preparation should be discarded.
Discard any unused solution. Any unused
medicinal product or waste material should be
disposed of in accordance with local requirements.
The following information is intended for healthcare professionals only
When diluted in accordance with the recommended schedules, Aciclovir is known to be compatible
with the following infusion fluids:
AZEVENDOS Aciclovir 250 mg PIL
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