Skip to Content

RETROVIR CAPSULES 100MG

Active substance(s): ZIDOVUDINE

View full screen / Print PDF » Download PDF ⇩
Transcript
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).

122250

GSK-POL-Poznan-PLPZN

United Kingdom-GBR; ViiV Healthcare

Retrovir

N/A

DRW_L_020_01_FD

N/A

N/A

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
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
• 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.

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.
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.

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.
Retrovir is also available in liquid form.
How much Retrovir will you need to take?
Adults and adolescents weighing at least 30 kg:
The usual dose of Retrovir is 300 mg twice a day. Take each dose
12 hours apart.
Children weighing more than 21 kg and less than 30 kg:
The usual dose of Retrovir is two 100 mg capsules twice daily.

Children weighing at least 14 kg and less than or equal to 21 kg:
The usual dose of Retrovir is one 100 mg capsule taken in the morning
and two 100 mg capsules taken in the evening
Children weighing at least 8 kg and less than 14 kg:
The usual dose of Retrovir is one 100 mg capsule twice daily.
Capsules are not suitable for children weighing less than 8 kg. Your
doctor may decide to give your child liquid Retrovir, or to give Retrovir
by injection instead.
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 one 100 mg capsule 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.
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.

122250

K

1

0

0

Poznan – Additional Artwork Information Panel

3

Leaflet / dimensions after folding

148 x 608 mm

Carton dimensions

N/A

Foil / Laminates width

N/A

Label dimensions

N/A

100%

Tube dimensions

N/A

8pt

Replacement No.:

N/A

Point of sale code No.:

N/A

8pt
8.5 pt

No

Page 1 of 2

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’)
• 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.

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.

122250

GSK-POL-Poznan-PLPZN

United Kingdom-GBR; ViiV Healthcare

Retrovir

N/A

DRW_L_020_01_FD

N/A

N/A

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 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.
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.
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: maize starches, microcrystalline cellulose,
sodium starch glycollate, magnesium stearate, titanium dioxide E171,
gelatin, 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 100 mg capsules are marked ‘GSYJU’. They are white, and
supplied in bottles of 100 capsules or foil blister packs of 100 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ViiV Healthcare UK Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS
Manufacturer
GlaxoSmithKline Pharmaceuticals S.A.
ul. Grunwaldzka 189
60-322 Poznan
Poland
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 100 mg Capsules
Reference number
35728/0001
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.

122250

K

1

0

0

Poznan – Additional Artwork Information Panel

3

Leaflet / dimensions after folding

148 x 608 mm

Carton dimensions

N/A

Foil / Laminates width

N/A

Label dimensions

N/A

100%

Tube dimensions

N/A

8pt

Replacement No.:

N/A

Point of sale code No.:

N/A

8pt
8.5 pt

No

Page 2 of 2

Expand view ⇕

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.

Hide