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RETROVIR 100MG/10ML ORAL SOLUTION

Active substance(s): ZIDOVUDINE

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1
zidovudine
Read all of this leaflet carefully before
you start using 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
seem to be the same as yours.
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
1 What Retrovir is and what it is
used for
2 What you need to know before
you take Retrovir
3 How to take Retrovir
4 Possible side effects
5 How to store Retrovir

What Retrovir is and
what it is used for

Retrovir is used to treat HIV (human
immunodeficiency virus) infection.
The active ingredient in
Retrovir is zidovudine. Retrovir
is a type of medicine known as
an anti-retroviral. It belongs
to a group of medicines called
nucleoside analogue reverse
transcriptase inhibitors (NRTIs).
Retrovir does not get rid of
HIV infection; it reduces the
amount of virus in your body,
and keeps it at a low level.
Retrovir also increases the
CD4 cell count in your blood.
CD4 cells are a type of white
blood cells that are important
in helping your body to fight
infection.
Retrovir is used, in combination with other
medicines (‘combination therapy’), to
treat HIV in adults and children. To control
your HIV infection, and to stop your illness
getting worse, you must keep taking all
your medicines.
If you’re pregnant, your doctor may want
you to take Retrovir, to help prevent you
passing HIV on to your unborn baby. After
the birth, your baby may be given Retrovir
to help prevent it from getting infected
with HIV.
HIV infection is spread by sexual contact
with someone who’s got the infection, or
by transfer of infected blood (for example,
by sharing injection needles).

2 What you need to know
before you take Retrovir
Don’t take Retrovir:
• if you’re allergic (hypersensitive)
to zidovudine or any of the other
ingredients of Retrovir (listed in
Section 6)
• if you have a very low white blood cell
count (neutropenia) or a very low red
blood cell count (anaemia).

Retrovir for new-born babies
Retrovir must not be given to some
new-born babies with liver problems,
including:
• some cases of hyperbilirubinaemia
(increased amounts in the blood of a
substance called bilirubin which may
make the skin appear yellow)
• other problems which cause high levels
of liver enzymes in the blood.

Take special care with Retrovir
Some people taking Retrovir or
combination therapy for HIV are more at
risk of serious side effects. You need to be
aware of the extra risks:
• if you have ever had liver disease
(including hepatitis B or C)
• if you’re seriously overweight (especially
if you’re a woman)
➔ Talk to your doctor if any of these
applies to you. You may need extra
check-ups, including blood tests, while
you’re taking your medication. See
Section 4 for more information.

Look out for important
symptoms

6 Contents of the pack and other
information

Some people taking medicines for HIV
infection develop other conditions, which
can be serious. You need to know about
important signs and symptoms to look out
for while you’re taking Retrovir.
Please read the information in Section 4 of
this leaflet. If you have any questions about
this information or the advice given:
➔ Talk to your doctor.

Other medicines and Retrovir
Tell your doctor or pharmacist if you’re
taking any other medicines, or if you’ve
taken any recently, including herbal
medicines or other medicines you bought
without a prescription.
Remember to tell your doctor or pharmacist
if you begin taking a new medicine while
you’re taking Retrovir.
Don’t take these medicines with Retrovir:
• stavudine, used to treat HIV infection
• ribavirin or injections of ganciclovir to
treat viral infections
• rifampicin, which is an antibiotic.
Some medicines can make it more likely
that you’ll have side effects, or make side
effects worse
These include:
• sodium valproate, used to treat epilepsy
• aciclovir, ganciclovir or interferon, used
to treat viral infections
• pyrimethamine, used to treat malaria
and other parasitic infections
• dapsone, used to prevent pneumonia
and treat skin infections
• fluconazole or flucytosine, used to treat
fungal infections such as candida
• pentamidine or atovaquone, used to
treat parasitic infections such as PCP

United Kingdom-GBR; ViiV Healthcare

10000000139580

GSK-CAN-Mississauga-CAMIS

Retrovir

N/A

N/A

Specification Number:

Some medicines interact with Retrovir
These include:
• clarithromycin, which is an antibiotic
• phenytoin, used for treating epilepsy.
➔ Tell your doctor if you’re taking
clarithromycin or phenytoin. Your doctor
may need to monitor you while you’re
taking Retrovir.

3 How to take Retrovir

Pregnancy

Adults and adolescents weighing at least
30 kg:
The usual dose of Retrovir is 25 ml
(250 mg) or 30 ml (300 mg) twice a day.
Take each dose 12 hours apart.

If you are pregnant, if you become pregnant,
or if you’re planning to become pregnant:
➔ Talk to your doctor about the risks and
benefits of taking Retrovir.
If pregnant women who are HIV-positive
take Retrovir, they are less likely to pass the
HIV infection on to their unborn babies.
Retrovir and similar medicines may cause
side effects in unborn babies; if it does,
these effects won’t show up until after the
baby has been born. Even so, the benefit
of protecting your baby from getting HIV is
greater than the risk of your baby getting
side effects.
If you’ve taken Retrovir while you were
pregnant, your baby may be given extra
check-ups (which may include blood tests),
to make sure it’s developing normally.

Breast-feeding
Women who are HIV-positive must not
breast-feed, because HIV infection can be
passed on to the baby in breast milk.
A small amount of the ingredients in
Retrovir can also pass into your breast milk.
If you are breast-feeding, or thinking about
breast-feeding:
➔ Talk to your doctor immediately.

Driving and using machines
Retrovir can make you dizzy and have
other side effects that make you less alert.
➔ Don’t drive or operate machinery unless
you’re feeling well.

Important information about
some ingredients of Retrovir
Retrovir oral solution contains maltitol, a
sugar. If you have an intolerance to some
sugars, contact your doctor before taking
Retrovir. Maltitol may have a mild laxative
effect. It contains 2.3 kilocalories per gram.

You will need regular blood tests
For as long as you’re taking Retrovir, your
doctor will arrange regular blood tests
to check for side effects. There’s more
information about these side effects in
Section 4 of this leaflet.

Stay in regular contact with your
doctor
Retrovir helps to control your condition, but
it is not a cure for HIV infection. You need to
keep taking it every day to stop your illness
getting worse. You may still develop other
infections and illnesses linked to HIV infection.
➔ Keep in touch with your doctor, and
don’t stop taking Retrovir without your
doctor’s advice.

HIV infection is spread by sexual contact
with someone who has the infection, or
by transfer of infected blood (for example,
by sharing injection needles). You can still
pass on HIV when taking this medicine,
although the risk is lowered by effective
antiretroviral therapy.
Discuss with your doctor the precautions
needed to avoid infecting other people.

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

How much Retrovir will you need
to take?

Children weighing at least 9 kg and less
than 30 kg:
Your doctor will decide on the correct dose
of Retrovir for your child, depending on the
size of the child. Your child can also take
Retrovir 100 mg capsules.
The usual dose is 9 mg for each kg of
bodyweight twice a day and will be no
more than 30 ml (300 mg) twice a day.
Children weighing at least 4 kg and less
than 9 kg:
Your doctor will decide on the correct dose
of Retrovir for your child, depending on the
size of the child.
The usual dose is 12 mg for each kg of
bodyweight twice a day. If your baby
cannot take medicines by mouth, your
doctor may decide to give your baby
Retrovir by injection instead.

7 Put the syringe into your mouth, placing
the tip of the syringe against the inside
of the cheek. Slowly push the plunger
in, allowing time to swallow. Don’t push
too hard and squirt the liquid into the
back of the throat or you may choke.
8 Repeat steps 3 to 7 in the same way until
you have taken the whole dose.
9 Do not leave the syringe in the bottle.
Take the syringe and the adaptor off and
wash them thoroughly in clean water.
Let them dry completely before you use
them again.
10 Close the bottle tightly with the cap

If you take too much Retrovir
If you accidentally take too much Retrovir,
it is unlikely to cause you serious problems.
The most common effects of taking too
much Retrovir are tiredness, headaches and
being sick (vomiting). If you feel unwell:
➔ Ask your doctor or pharmacist for
advice.

If you forget to take Retrovir
If you forget to take a dose, don’t worry.
You can take your next dose as soon as you
remember but not within two hours of your
next dose. If you remember within two
hours of your next dose, just skip the dose
you missed and take your next dose at the
usual time. Then continue your treatment
as before.
Don’t take a double dose to make up for a
missed dose.

Don’t stop taking Retrovir
without advice
Take Retrovir for as long as your doctor
recommends. Don’t stop unless your doctor
advises you to.

Pregnancy, childbirth and newborn babies:
You should not normally take Retrovir
during the first 14 weeks of your
pregnancy. After week 14, the usual
dose is 50 ml (500 mg) each day given as
10 ml (100 mg) five times per day until
you start to go into labour. During the
labour and birth, your doctor may give
you injections of Retrovir, until your baby’s
umbilical cord has been clamped. Your
new-born baby may also be given Retrovir
to help prevent it from getting infected
with HIV.
People with kidney or liver problems:
If you have severe kidney or liver problems,
you may be given a lower dose of Retrovir,
depending on how well your kidneys or
liver are working. Follow your doctor’s
advice.

Step by step instructions
Use the oral dosing syringe supplied with
the pack to measure your dose accurately.
1 Remove the bottle cap and keep it
safely.
2 Push the plastic adaptor into the neck
of the bottle, while holding the bottle
firmly.
3 Insert the syringe firmly into the
adaptor
4 Turn the bottle upside down.
5 Pull out the syringe plunger until
the first portion of your full dose is
withdrawn.
6 Turn the bottle the right way up and
remove the syringe from the adaptor.

GSLFLT042

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A133009

Component Basic Dimensions:

457 x 314

(in mm)

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Protect other people

Mississauga - Additional Artwork Information Panel
(Does NOT include Specification version number)

A457314L

• amphotericin or co-trimoxazole, used to
treat fungal and bacterial infections
• probenecid, used to treat gout and
similar conditions, and given with some
antibiotics to make them more effective
• methadone, used as a heroin substitute
• vincristine, vinblastine or doxorubicin,
used to treat cancer.
➔ Tell your doctor if you’re taking any of
these.

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4 Possible side effects
During HIV therapy there may be an
increase in weight and in levels of blood
lipids and glucose. This is partly linked to
restored health and life style, and in the
case of blood lipids sometimes to the HIV
medicines themselves. Your doctor will test
for these changes.
Treatment with zidovudine (Retrovir) often
causes a loss of fat from legs, arms and
face (lipoatrophy). This loss of body fat has
been shown to be not fully reversible after
discontinuation of zidovudine. Your doctor
should monitor for signs of lipoatrophy.
Tell your doctor if you notice any loss of fat
from your legs, arms, and face. When these
signs occur, Retrovir should be stopped and
your HIV treatment changed.
Like all medicines, this medicine can cause
side effects, but not everyone gets them.
Some side effects may show up in your
blood tests, and may not appear until 4 to
6 weeks after you start taking Retrovir. If
you get any of these effects, and if they are
severe, your doctor may advise you to stop
taking Retrovir.
As well as the effects listed below, other
conditions can develop during combination
therapy for HIV.
➔ It is important to read the information
in ‘Other possible side effects of
combination therapy for HIV’.

Very common side effects
These may affect more than 1 in 10 people
taking Retrovir:
• headaches
• feeling sick (nausea).

Common side effects
These may affect up to 1 in 10 people
taking Retrovir:
• being sick (vomiting)
• diarrhoea
• stomach pains
• feeling dizzy
• aching muscles
• generally feeling unwell.
Common side effects that may show up in
your blood tests are:
• a low red blood cell count (anaemia) or
low white blood cell count (neutropenia
or leucopenia)
• an increase in the level of liver enzymes
• an increased amount in the blood of
bilirubin (a substance produced in the
liver) which may make your skin appear
yellow.

Uncommon side effects
These may affect up to 1 in 100 people
taking Retrovir:
• skin rash (red, raised or itchy skin)
• feeling breathless
• fever (high temperature)
• general aches and pains
• wind (flatulence)
• weakness.
Uncommon side effects that may show up
in your blood tests are:
• a decrease in the number of cells involved
in blood clotting (thrombocytopenia), or
in all kinds of blood cells (pancytopenia).

Rare side effects
These may affect up to 1 in 1000 people
taking Retrovir:
• lactic acidosis (excess lactic acid in the
blood; see the next section, ‘Other
possible side effects of combination
therapy for HIV’)

United Kingdom-GBR; ViiV Healthcare

• liver disorders, such as jaundice, enlarged
liver or fatty liver
• inflammation of the pancreas
• chest pain; disease of the heart muscle
• fits (convulsions)
• feeling depressed or anxious; not being
able to sleep (insomnia); not being able
to concentrate; feeling drowsy
• indigestion; loss of appetite; taste
disturbance
• changes in the colour of your nails, your
skin, or the skin inside your mouth
• a flu-like feeling — chills, sweating and
cough
• tingly feelings in the skin (pins and
needles)
• passing urine more often
• enlarged breasts in men.
A rare side effect that may show up in your
blood tests is:
• a decrease in the number of a type of red
blood cell (pure red cell aplasia).

Very rare side effects
A very rare side effect that may affect up to
1 in 10,000 people taking Retrovir, and may
show up in blood tests is:
• a failure of the bone marrow to produce
new blood cells (aplastic anaemia).

If you get any side effects
➔ Talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.

Other possible side effects of
combination therapy for HIV
Some other conditions may develop during
HIV treatment.

Old infections may flare up
People with advanced HIV infection (AIDS)
have weak immune systems, and are
more likely to develop serious infections
(opportunistic infections). When these
people start treatment, they may find that
old, hidden infections flare up, causing
signs and symptoms of inflammation. These
symptoms are probably caused by the
body’s immune system becoming stronger,
so that the body starts to fight these
infections.
In addition to the opportunistic infections,
autoimmune disorders (a condition
that occurs when the immune system
attacks healthy body tissue) may also
occur after you start taking medicines
for the treatment of your HIV infection.
Autoimmune disorders may occur many
months after the start of treatment. If
you notice any symptoms of infection or
other symptoms such as muscle weakness,
weakness beginning in the hands and feet
and moving up towards the trunk of the
body, palpitations, tremor or hyperactivity,
please inform your doctor immediately to
seek necessary treatment.
If you get any symptoms of infection while
you’re taking Retrovir:
➔ Tell your doctor immediately. Don’t
take other medicines for the infection
without your doctor’s advice.

Lactic acidosis is more likely to develop
in people who have liver disease, or in
obese (very overweight) people, especially
women.

Signs of lactic acidosis include:





deep, rapid, difficult breathing
drowsiness
numbness or weakness in the limbs
feeling sick (nausea), being sick
(vomiting)
• stomach pain.
During your treatment, your doctor will
monitor you for signs of lactic acidosis. If
you have any of the symptoms listed above,
or any other symptoms that worry you:
➔ See your doctor as soon as possible.

You may have problems with
your bones
Some people taking combination therapy
for HIV develop a condition called
osteonecrosis. With this condition, parts
of the bone tissue die because of reduced
blood supply to the bone.
People may be more likely to get this
condition:
• if they have been taking combination
therapy for a long time
• if they are also taking anti-inflammatory
medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight.

Signs of osteonecrosis include:
• stiffness in the joints
• aches and pains (especially in the hip,
knee or shoulder)
• difficulty moving.
If you notice any of these symptoms:
➔ Tell your doctor.

Other effects may show up in
tests
Combination therapy for HIV can also
cause:
• increased levels of lactic acid in the
blood, which on rare occasions can lead
to lactic acidosis
This effect may show up in the blood tests
you’ll have while you’re taking Retrovir.

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 Yellow Card Scheme 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 Retrovir
Keep this medicine out of the sight and
reach of children.
Don’t take this medicine after the expiry
date shown on the carton. Don’t store
Retrovir above 30 °C (86 °F). Store it in its
original package.
Throw away the bottle 1 month after
first opening it. Don’t throw away any
medicines via waste water or household
rubbish. Ask your pharmacist how to throw
away medicines you no longer use. This will
help protect the environment.

6 Contents of the pack and
other information
What Retrovir contains
The active substance is zidovudine. The
other ingredients are: maltitol solution,
glycerol, citric acid, sodium benzoate E211,
saccharin sodium, strawberry flavouring,
white sugar flavouring and purified water.

What Retrovir looks like and
contents of the pack
Retrovir oral solution is a clear, pale yellow,
strawberry-flavoured, sugar-free oral
solution containing 100 mg of the active
ingredient zidovudine per 10 ml.
Retrovir oral solution comes in bottles
of 200 ml. A 1 ml or a 10 ml oral-dosing
syringe is included in the pack, with an
adaptor, which should be fitted to the
bottle before use.

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
ViiV Healthcare UK Ltd,
980 Great West Road,
Brentford, Middlesex TW8 9GS
Manufacturer
Glaxo Operations UK Ltd (trading as
GlaxoWellcome Operations), Harmire Road,
Barnard Castle, Co. Durham, DL12 8DT,
United Kingdom

Other formats:
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name
Retrovir Oral Solution
Reference number 35728/0004
This is a service provided by the Royal
National Institute of Blind People.
Leaflet date: December 2015.
Retrovir is a registered trade mark of the
ViiV Healthcare group of companies.
© 2015 ViiV Healthcare group of
companies. All rights reserved.

Lactic acidosis is a rare but
serious side effect
Some people taking Retrovir develop a
condition called lactic acidosis, together
with an enlarged liver. Lactic acidosis is
caused by a build-up of lactic acid in the
body. It is rare; if it happens, it usually
develops after a few months of treatment.
It can be life-threatening, causing failure of
internal organs.

10000000139580

GSK-CAN-Mississauga-CAMIS

Retrovir

N/A

Mississauga - Additional Artwork Information Panel
Specification Number:
(Does NOT include Specification version number)

A457314L

N/A

N/A

K

Replaces Item Code:

A133009

Component Basic Dimensions:

457 x 314

(in mm)

1

GSLFLT042

0

0

1
8 pt
9 pt
100%
8 pt
Yes

Page 2 of 2

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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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