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RETROVIR CAPSULES 250MG

Active substance: ZIDOVUDINE

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P8434
GSK-ROM-Brasov-ROBRA

P8434

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
6 Contents of the pack and other information

1 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)
• if you’re diabetic and using insulin.
➜ 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
Some people taking medicines for HIV infection develop

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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
• 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.
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.
Pregnancy
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.
If you’re 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.

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.
Protect other people
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.

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3 How to take Retrovir
Always take this medicine exactly as your doctor has
told you to. Check with your doctor or pharmacist if
you’re not sure.
Swallow the capsules whole, with some water.
How much Retrovir will you need to take?
Adults and adolescents weighing at least 30 kg:
The usual dose of Retrovir is 250 mg twice a day. Take
each dose 12 hours apart.
Children:
Your child can take Retrovir in liquid form or as 100 mg
capsules.
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 500 mg each day given as 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

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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.
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.

4 Possible side effects
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:
• 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.

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Your body shape may change
People taking combination therapy for HIV may find
that their body shape changes, because of changes in fat
distribution:
• Fat may be lost from the legs, arms or face.
• Extra fat may build up around the tummy
(abdomen), or on the breasts or internal organs.
• Fatty lumps (sometimes called buffalo hump) may
appear on the back of the neck.
It is not yet known what causes these changes, or
whether they have any long-term effects on your health.
If you notice changes in your body shape:
➜ Tell your doctor.
Lactic acidosis is a rare but serious side effect
Some people taking Retrovir, or other medicines like it
(NRTIs), 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.
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
• increased levels of sugar, fatty acids (triglycerides)
and cholesterol in the blood
• resistance to insulin (so if you’re diabetic, you may
have to change your insulin dose to control your
blood sugar).
These effects 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.
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

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What Retrovir contains
The active substance is zidovudine.
The other ingredients are: maize starches, microcrystalline
cellulose, sodium starch glycollate, magnesium stearate,
titanium dioxide E171, gelatin, indigo carmine E132, black
inks opacode 10A1 or 10A2 (shellac, black iron oxide
E172, propylene glycol, ammonium hydroxide, 28% (in
black ink opacode 10A1 only), strong ammonium solution
(in black ink opacode 10A2 only), potassium hydroxide (in
black ink opacode 10A2 only)).
What Retrovir looks like and contents of the pack
Retrovir 250 mg capsules are marked ‘GSJV2’. They are
white and blue, and supplied in foil blister packs of
40 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ViiV Healthcare UK Ltd, 980 Great West Road, Brentford,
Middlesex TW8 9GS
Manufacturer
S.C. Europharm S.A., 2 Panselelor St., Brasov, County of
Brasov, 500419 Romania
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:

GSK-ROM-Brasov-ROBRA
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0800 198 5000 (UK Only)

Please be ready to give the following information:
Retrovir 250 mg Capsules
Product name
Reference number 35728/0002
This is a service provided by the Royal National Institute
of Blind People.
Leaflet date: October 2014
Retrovir is a registered trade mark of the
ViiV Healthcare group of companies.
© 2014 ViiV Healthcare group of companies.
All rights reserved.

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Brasov – Additional Artwork Information Panel
Leaflet / dimensions after folding

420x150 mm / 210x150 mm

Carton dimensions

N/A

Foil / Laminates width

N/A

Label dimensions

N/A

Replacement No.:

P8137

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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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