ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION B.P.

Active substance: ACICLOVIR SODIUM

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PATIENT INFORMATION LEAFLET

Aciclovir Sodium for Intravenous Infusion 250mg / 500mg


This leaflet contains important information about your
medicine; read it carefully.
Keep this leaflet; you may want to read it again. For I.V
use only. If you have any questions or are not sure about
anything, ask your doctor.



The active substance is aciclovir sodium
The other ingredients are sodium hydroxide,
Nitrogen and Water for Injections. Sodium
hydroxide are used to adjust the pH of the
solution.

The marketing authorisation holder is:
ZeCare Ltd.
Unit 5 Blenheim Court,
Brownfields, Welwyn Garden City, Hertfordshire,
AL7 1AN
1.

What Aciclovir Sodium for Intravenous Infusion is
and what it is used for
Aciclovir Sodium for Intravenous Infusion is an antiviral
medicine. The medicine is presented in the form of a
white powder dispensed in vial for infusion (a
concentrated solution, which is reconstituted with water
for injection to make a solution, which can be given as a
slow injection via a drip).
Each vial of Aciclovir Sodium for Intravenous Infusion 250
mg of aciclovir as aciclovir sodium. It is available in packs
containing: 3/5 vials of 250 mg aciclovir, or 5 vials of 500
mg aciclovir.
Aciclovir Sodium for Intravenous Infusion is used to treat
and prevent certain virus infections.
It is used to treat:





Genital herpes
Shingles (which is caused by a virus called
Varicella zoster virus) in patients whose immune
system isn't working properly
First and repeat infections with Varicella zoster
(e.g. shingles or chicken pox) in patients whose
immune system is not working properly
Herpes encephalitis (inflammation of the brain
following infection with the Herpes simplex virus).

It is used to treat and prevent:


Herpes simplex infections (may appear as cold
sores around the lips or as blisters on any part of
the skin including the genitals) in patients whose
immune system isn't working properly, in very
young babies and infants up to 3 months of age.

you are taking or have recently taken any
medicines, including ones you have bought
yourself

Your doctor will be especially careful when giving you
this medicine if:
• you have any underlying nervous system disorder
such as convulsions, hallucinations
• you have had a nervous system reaction following
treatment with cytotoxic (cancer treatment) drugs
• you have serious problems with your liver
• you have any problems with your kidneys
• you are hypoxic i.e. have a low amount of oxygen
reaching your body tissues
• you have abnormal amounts of electrolytes in
your blood
• you are elderly
• you need to have this medicine over a long period
of time or repeated doses and you have a
severely low immune system
• you need to have this medicine over a long period
of time or repeated doses and you have a
severely low immune system
• you are taking or have recently taken any of the
following medicines:
· probenecid (a medicine used in the treatment of
gout)
· cimetidine (a medicine used to reduce stomach
acid)
· mycophenolate mofetil (a medicine used to
prevent transplant rejection)
· drugs which may affect the kidneys e.g.
cyclosporin, tacrolimus (medicines used to
prevent transplant rejection)
This medicine should only be given by intravenous
infusion (a slow injection into a vein).
Avoid contact with eyes and unprotected skin.
It is important that while you are being treated with Aciclovir
you do not become dehydrated. Before you are given this
medicine your doctor will check to make sure you are
passing urine and are not dehydrated. The doctor will also
check if you are taking any other medicine which could
harm your kidneys. These checks are particularly important
in patients whose kidneys may not be working properly.
Before driving or using machines:
This medicine may impair your ability to drive, if affected
do not drive or operate machinery.
3.

2.

Before Aciclovir Sodium for Intravenous Infusion
is used. Do not use Aciclovir Sodium for
Intravenous Infusion:
• If you are allergic to aciclovir, valaciclovir or any of
the other ingredients of this medicine

Tell your doctor if:



you are pregnant or planning to become pregnant
you are breast feeding

How Aciclovir Sodium for Intravenous Infusion is
used
How your medicine is given
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.
This medicine will be diluted with a solution such as
sodium chloride 0.9% before it is given to you.
It will be given to you by a slow injection via a drip into a
continued...
vein over a period of 1 hour.
ZC−Ver.3s

The dose of medicine given to you and how often you are
given it will be determined by your doctor and will depend
on

the type of infection you have

your weight

your age
Your doctor may adjust the dose of Aciclovir Sodium
for Intravenous Infusion if:

you have kidney problems. If you have kidney
problems, it is important you receive plenty of
fluids while you are being treated with Aciclovir
Sodium
If you are given too much of Aciclovir Sodium for
Intravenous Infusion:
If you think you have been given too much Aciclovir, talk
to your doctor straight away.
If you have been given too much Aciclovir you may
experience any of the following:
• Confusion, seeing or hearing things that are not
real (hallucinations), feeling agitated or fits. If you
experience any of these tell your doctor
immediately. Loss of consciousness/coma also
indicates that too much Aciclovir has been given
and should be reported to doctor at once.
4. Possible side effects
Like all medicines Aciclovir Sodium for Intravenous
Infusion can have side effects.
Common side effects could happen to more than 1 in 100
people:
• Feeling or being sick.
• Itching, mild skin reactions e.g. ‘hives’/’nettle rash’
or skin rashes (including skin reaction after
exposure to sunlight).
• Effects on some blood and urine tests. Let your
doctor know you are taking this medicine if you
are having a blood or urine test.
Uncommon side effects that could happen to between 1
in 100 and 1 in 1,000 people:
• Weakness, tiredness, feeling faint or shortness of
breath: these symptoms may mean you have
reduced numbers of red blood cells(anaemia)
• Although you may not notice symptoms: aciclovir
can cause a decrease in your white blood cells.
• Bruising or nosebleeds: these symptoms may
mean you have low numbers of platelets, a type
of blood cell.



pain in your lower back, the kidney area of your
back or just above your hip (kidney pain)

These symptoms may mean that you are allergic to
Aciclovir. Do not take any more of this medicine unless
your doctor tells you to do so














Difficulty breathing
Diarrhoea and stomach pains
Agitation
Confusion
Shakiness
Irregular body movements
Difficulty with speech
Hallucinations
Fits
Sleepiness during the day
Loss of consciousness
Loss of contact with reality
Liver problems or yellowing of the skin and whites
of the eyes, impaired kidney function or kidney
failure.

If you experience these or any other unwanted side
effects not mentioned in this leaflet, tell your doctor.
5. Storing Aciclovir Sodium for Intravenous Infusion
Keep out of the reach and sight of children. Do not use if
you notice any visible black particles. For single use.
Discard any unused contents. Do not store above 25°C.
Do not refrigerate.
This information applies only to
Aciclovir Sodium for Infusion B.P. PL 24581/0002 (250mg)
Aciclovir Sodium for Infusion B.P. PL 24581/0003 (500mg)

Date of last revision: November 2011.

Rare side effects that could happen to between 1 in 1,000
and 1 in 10,000 people. There are no rare side effects
documented for Aciclovir Sodium for Intravenous Infusion.
Very rare side effects that could happen to less than 1 in
10,000:
• Fatigue
• Headache
• Dizziness
• Fever
• Localised swelling and redness around the
injection.
• Severe allergic reaction symptoms; sudden
wheeziness, fluttering or tightness in the chest,
collapse, swelling of eyelids, face, lips or
elsewhere, skin rash or weals. Check with your
doctor immediately if you experience any of
these symptoms.

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

Aciclovir Intravenous Infusion
PIL
175 mm x 250 mm
Font SansSerif − Min. Text 8pt
ZC−Ver.3s
01/11/11
1 − Pantone Black CVC

ZeCare

L I M I T E D
ZC−ver.3s

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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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