ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION B.P.

Active substance: ACICLOVIR SODIUM

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PATIENT INFORMATION LEAFLET

Aciclovir 250mg / 500mg for Intravenous Infusion
(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.
• 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. What Aciclovir Sodium is and what it is used for
2. What you need to know before you take Aciclovir
Sodium
3. How to take Aciclovir Sodium
4. Possible side effects
5. How to store Aciclovir Sodium
6. Contents of the pack and other information
1. What Aciclovir Sodium is and what it is used for
Aciclovir Sodium for Intravenous Infusion is an antiviral
medicine which acts on infected cells by stopping the
virus growing.
Aciclovir Sodium is used to treat and prevent viral
infections:
• 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 who have a low
immune system
• First and repeat infections with Varicella Zoster (e.g.
Shingles or Chickenpox) in patients who have a low
immune system
• Genital herpes
• Herpes encephalitis (inflammation of the brain
following infection with the Herpes simplex virus)
2.

What you need to know before you take Aciclovir
Sodium
Do not use Aciclovir Sodium:
If you are allergic to aciclovir, valaciclovir, other antiviral
medicines or any of the other ingredients of this medicine
(see Section 6 "Contents of the pack and other
information").
Warnings and precautions
Talk to your doctor before taking Aciclovir Sodium:
• If you are taking other nephrotoxic medicines
(medicines that may cause kidney failure) such as
cyclosporin and tacrolimus (See "Medicines which
may interact with Aciclovir Sodium section")
• If you are elderly
• If you suffer from kidney problems (including if you
have dialysis therapy)
• 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 Sodium
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, even

those not prescribed for you. This includes herbal
medicines.
Medicines which may interact with Aciclovir Sodium:
• Probenecid (used to treat gout)
• Cimetidine (used to reduce stomach acid)
• Mycophenolate mofetil (used to prevent transplant
rejection)
• Lithium (used to treat mood disorders)
• Medicines which may affect the kidneys e.g.
cyclosporin, tacrolimus (nephrotoxic medicines)
• Theophylline (used to treat breathing problems, such
as asthma)
Aciclovir Sodium with food and drink
It is important that you drink/receive plenty of fluids whilst
you are being treated with Aciclovir Sodium to prevent you
becoming dehydrated, especially if you suffer from kidney
problems.
Before you are given this medicine your doctor will check
to make sure you are not dehydrated and are passing
urine sufficiently.
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.
Aciclovir Sodium should be used with caution during
breast-feeding.
Driving and using machines
Aciclovir Sodium may impair your ability to drive. If this is
experienced, it is necessary to avoid driving or operating
machinery.
3. How to take Aciclovir Sodium
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.








For single, intravenous use only. This medicine
should not be taken orally.
This medicine will be diluted with a solution before it
is given to you. Once diluted, Aciclovir Sodium must
be used immediately.
It will be given to you by a slow injection via a drip
into a vein over a period of 1 hour.
The course of treatment you are given may vary
between 5 and 21 days depending on:
o the type of infection you have
o your body weight
o your age
o your response to treatment
Your doctor may adjust the dose of Aciclovir Sodium if
you suffer from kidney problems.
Avoid contact with eyes and unprotected skin.

If you are given too much Aciclovir Sodium:
If you think you have been given too much Aciclovir
Sodium speak to your doctor immediately.
Symptoms of overdose include: confusion, seeing or
hearing things that are not real (hallucinations), feeling
agitated, fits, loss of consciousness/coma.
continued...
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If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Seek medical advice immediately if you develop the
following symptoms:
• Allergic reactions (anaphylaxis): skin rashes, itching,
swelling of the face, tongue or throat, breathlessness,
difficulty in breathing, dizziness
• Severe localised redness and swelling around the
injection site
Common side effects: (may affect up to 1 in 10
people)
• Headache
• Dizziness
• Inflammation of the veins (phlebitis)
• Feeling sick (nausea) or being sick (vomiting)
• Diarrhoea
• Stomach pains
• Severe itching (pruritus), red, raised, itchy skin rash
(urticaria), skin rashes
• Abnormal sensitivity of the skin to sunlight
(photosensitivity)
• Increases in blood urea & creatinine (waste products
usually passed out in urine). High blood levels of urea
& creatinine (detected in blood tests) indicate that the
kidneys may not be working properly
Uncommon side effects (may affect up to 1 in 100
people)
• 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)
Symptoms of leukopenia may include: feelings of
tiredness or weakness, dizziness or lightheadedness,
loss of appetite, headaches, increased risk of
infections.
Rare Side Effects (may affect up to 1 in 1,000 people)
• Shortness of breath (dyspnoea)
• Increases in bilirubin and liver-related enzymes
(reversible)
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
• Symptoms of an abnormal state of mind (psychosis)
such as delusions, confused/disturbed thoughts, lack
of insight and self-awareness (unable to recognise
own mental illness, need for treatment or
consequences of behaviour)
• Fits (convulsions)
• Sleepiness (somnolence)
• Disorder of the brain (encephalopathy)
• Coma
• Yellowing of the skin or whites of the eyes (jaundice)
• Inflammation of the liver (hepatitis)
• Swelling of the deeper layers of the skin caused by a
build-up of fluid (angioedema)

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






Kidney problems, kidney failure or pain in the kidneys
Tiredness (fatigue)
Fever
Mild localised redness and swelling around the
injection site

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.
5. How to store Aciclovir Sodium
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 carton after "EXP". The expiry date refers to
the last day of that month.
Store in original container in order to protect from light. Do
not store above 25°C. Do not refrigerate.
Discard any unused contents. Do not throw away any
medicines via wastewater or household waste. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Aciclovir Sodium contain:
• Each vial of Aciclovir Sodium for Intravenous Infusion
contains 250mg or 500mg of active ingredient
aciclovir sodium.
• The other ingredients are water for injection or
sodium chloride injection 9 mg/ml diluted with an
infusion fluid from a specified list.
What Aciclovir Sodium looks like and contents of the
pack:
A white powder dispensed in a clear, glass vial for infusion
(a concentrated powder, which is dissolved and diluted to
be given as a slow injection via a drip).
Aciclovir Sodium is available in:
Aciclovir Sodium is available in packs of:
• 250mg: 3, 5 vials.
• 500mg: 5 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder & Manufacturer:
ZeCare Ltd.
3 Howard Road
Eaton Socon
St. Neots
Cambridgeshire
PE19 8ET
UK
Product Licence Numbers:
Aciclovir Sodium for Infusion - PL 24581/0002 (250mg)
Aciclovir Sodium for Infusion - PL 24581/0003 (500mg)
Date of last revision: November 2013

Aciclovir Intravenous Infusion
PIL
175 mm x 250 mm
Font SansSerif − Min. Text 8pt
ZC−Ver.4.2s
04/12/2013
1 − Pantone Black CVC

ZeCare

L I M I T E D
ZC−ver.4.2s

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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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