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LAMIVUDINE/ZIDOVUDINE SANDOZ 150MG/300MG FILM-COATED TABLET

Active substance(s): LAMIVUDINE / ZIDOVUDINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Lamivudine/Zidovudine 150 mg/300 mg film-coated tablets

lamivudine/zidovudine

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 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 are the same as yours.
• If you get any of the 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 Lamivudine/Zidovudine is and what it is
used for
2. What you need to know before you take
Lamivudine/Zidovudine
3. How to take Lamivudine/Zidovudine
4. Possible side effects
5. How to store Lamivudine/Zidovudine
6. Contents of the pack and other information

1

What Lamivudine/Zidovudine is
and what it is used for

Lamivudine/Zidovudine is used to treat HIV
(human immunodeficiency virus) infection in
adults and children.

Lamivudine/Zidovudine contains two active
ingredients that are used to treat HIV infection:
lamivudine and zidovudine. Both of these belong to a
group of anti-retroviral medicines called nucleoside
analogue reverse transcriptase inhibitors (NRTIs).
Lamivudine/Zidovudine does not completely cure
HIV infection: it reduces the amount of virus in your
body, and keeps it at a low level. It 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.

Not everyone responds to treatment with
Lamivudine/Zidovudine in the same way. Your doctor
will monitor the effectiveness of your treatment.

2

What you need to know before you
take Lamivudine/Zidovudine

Do not take Lamivudine/Zidovudine:

• if youʼre allergic (hypersensitive) to lamivudine or
zidovudine, or any of the other ingredients of this
medicine (listed in Section 6).
• if you have a very low red blood cell count
(anaemia) or a very low white blood cell count
(neutropenia).
Check with your doctor if you think any of these
apply to you.

Take special care with Lamivudine/
Zidovudine

Some people taking Lamivudine/Zidovudine or other
combination treatments 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 have hepatitis B infection,
do not stop Lamivudine/Zidovudine without your
doctorʼs advice, as your hepatitis may come back).
• if you have kidney disease.
• if you are seriously overweight (especially if you
are a woman).
• if you are diabetic and using insulin.
Talk to your doctor if any of these apply to you.
Your doctor will decide if the active substances are
suitable for you. You may need extra check-ups,
including blood tests, while you are taking your
medicine. 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 are taking Lamivudine/
Zidovudine.
Read the information ʻOther possible side
effects of combination therapy for HIVʼ in
Section 4 of this leaflet.

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). Lamivudine/Zidovudine will not stop you
passing HIV infection on to other people. To protect
other people from becoming infected with HIV:
• Use a condom when you have oral or penetrative
sex
• Donʼt risk blood transfer – for example, donʼt
share needles.

Other medicines and Lamivudine/
Zidovudine

Tell your doctor or pharmacist if youʼre taking
any other medicines, or if youʼve 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 are taking
Lamivudine/Zidovudine.

These medicines should not be used with
Lamivudine/Zidovudine:
• other medicinal products containing lamivudine, to
treat HIV infection or hepatitis B infection
• emtricitabine, to treat HIV infection
• stavudine or zalcitabine, to treat HIV infection
• ribavirin or injections of ganciclovir to treat viral
infections
• high doses of co-trimoxazole, an antibiotic
• cladribine, used to treat hairy cell leukaemia.
Tell your doctor if you are being treated with any
of these.
Some medicines can make it more likely that
youʼll have side effects, or make side effects
worse.
These include:
• sodium valproate, to treat epilepsy
• interferon, to treat viral infections
• pyrimethamine, to treat malaria and other
parasitic infections
• dapsone, to prevent pneumonia and treat skin
infections
• fluconazole or flucytosine, to treat fungal
infections such as candida
• pentamidine or atovaquone to treat parasitic
infections such as PCP
• amphotericin or co-trimoxazole, to treat fungal
and bacterial infections
• probenecid, 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, to treat
cancer.
Tell your doctor if you are taking any of these.

Some medicines interact with Lamivudine/
Zidovudine
These include:
• clarithromycin, an antibiotic
If youʼre taking clarithromycin, take your dose at
least 2 hours before or after you take your
Lamivudine/Zidovudine.
• phenytoin, for treating epilepsy.
Tell your doctor if youʼre taking phenytoin. Your
doctor may need to monitor you while youʼre
taking Lamivudine/Zidovudine.

Pregnancy

If you are pregnant, if you become pregnant or if you
are planning to become pregnant talk to your doctor
about the risks and benefits to you and your baby of
taking Lamivudine/Zidovudine.

Lamivudine/Zidovudine and similar medicines may
cause side effects in unborn babies. If you become
pregnant while youʼre taking Lamivudine/Zidovudine,
your baby may be given extra check-ups (including
blood tests) to make sure it is developing normally.
Children whose mothers took NRTIs (medicines like
Lamivudine/Zidovudine) during pregnancy had a
reduced risk of being infected with HIV. This benefit
is greater than the risk of having side effects.

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 youʼre breast-feeding or thinking about
breast-feeding:
Talk to your doctor immediately.

Driving and using machines

Lamivudine/Zidovudine can make you dizzy and
have other side effects that make you less alert.
Donʼt drive or operate machines unless youʼre
feeling well.

3

How to take Lamivudine/Zidovudine

Always take Lamivudine/Zidovudine exactly as
your doctor has told you. Check with your doctor
or pharmacist if youʼre not sure.

Swallow Lamivudine/Zidovudine tablets, with some
water. Lamivudine/Zidovudine can be taken with or
without food.

If you cannot swallow the tablets whole, you may
crush and combine them with a small amount of food
or drink, and take the full dose immediately.
Stay in regular contact with your doctor
Lamivudine/Zidovudine helps to control your
condition. 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.
Donʼt stop taking Lamivudine/Zidovudine
without your doctorʼs advice.
How much to take

Adults and adolescents 30 kg or more
• The usual dose of Lamivudine/Zidovudine is
one tablet twice a day.
• Take the tablets at regular times, leaving
approximately 12 hours between each tablet.

Children who weigh between 21 and 30 kg
• The usual starting dose of Lamivudine/Zidovudine
is one half tablet (½) taken in the morning and one
whole tablet taken in the evening.
Children who weigh between 14 and 21 kg
• The usual starting dose of Lamivudine/Zidovudine
is one half tablet (½) taken in the morning and one
half tablet (½) taken in the evening.
For children who weigh less than 14 kg lamivudine
and zidovudine (the ingredients of Lamivudine/
Zidovudine) should be taken separately.

If you take more Lamivudine/Zidovudine
than you should

If you accidentally take too much Lamivudine/
Zidovudine, tell your doctor or your pharmacist, or
contact your nearest hospital emergency department
for further advice.

If you forget to take Lamivudine/Zidovudine
If you forget to take a dose, take it as soon as you
remember. Then continue your treatment as before.
Donʼt take a double dose to make up for a missed
dose.

4

Possible side effects

Like all medicines, Lamivudine/Zidovudine can
cause side effects, but not everyone gets them.

When youʼre being treated for HIV, it can be hard to
tell whether a symptom is a side effect of
Lamivudine/Zidovudine or other medicines youʼre
taking, or an effect of the HIV disease itself. So it is
very important to talk to your doctor about any
changes in your health.
As well as the side effects listed below for
Lamivudine/Zidovudine, other conditions can
develop during combination therapy for HIV.

It is important to read the information later in this
section under ʻOther possible side effects of
combination therapy for HIVʼ.

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

Continued on the next page >>

Common side effects
These may affect up to 1 in 10 people:
• being sick (vomiting)
• diarrhoea
• stomach pains
• loss of appetite
• feeling dizzy
• tiredness, lack of energy
• fever (high temperature)
• general feeling of being unwell
• difficulty in sleeping (insomnia)
• muscle pain and discomfort
• joint pain
• cough
• irritated or runny nose
• skin rash
• hair loss (alopecia).

Common side effects that might show up in 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:
• feeling breathless
• wind (flatulence)
• itching
• muscle weakness.

An uncommon side effect that may show up in blood
test is:
• 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 1,000 people:
• serious allergic reaction causing swelling of the
face, tongue or throat which may cause difficulty in
swallowing or breathing
• liver disorders, such as jaundice, enlarged liver or
fatty liver, inflammation (hepatitis)
• lactic acidosis (see the next section, ʻOther
possible side effects of combination therapy for
HIVʼ)
• inflammation of the pancreas (pancreatitis)
• chest pain; disease of the heart muscle
(cardiomyopathy)
• fits (convulsions)
• feeling depressed or anxious, not being able to
concentrate, feeling drowsy
• indigestion, taste disturbance
• changes in the colour of your nails, your skin or
the skin inside your mouth
• a flu-like feeling – chills and sweating
• tingly feelings in the skin (pins and needles)
• sensation of weakness in the limbs
• breakdown of muscle tissue
• numbness
• passing urine more often
• enlarged breasts in men.
Rare side effects that may show up in blood tests
are:
• an increase in an enzyme called amylase
• a failure of the bone marrow to produce new red
blood cells (pure red cell aplasia).
Very rare side effects
These may affect up to 1 in 10,000 people:

A very rare side effect that may show up in blood
tests is:
• a failure of the bone marrow to produce new red or
white blood cells (aplastic anaemia).
If you get side effects
Tell your doctor or pharmacist if any of the side
effects get severe or troublesome, or if you notice
any side effects not listed in this leaflet.

Other possible side effects of combination
therapy for HIV
Combination therapy such as Lamivudine/
Zidovudine may cause other conditions to 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 bodyʼs 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,
weakenss 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 youʼre
taking Lamivudine/Zidovudine:
Tell your doctor immediately. Donʼt take other
medicines for the infection without your doctorʼs
advice.
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 Lamivudine/Zidovudine, or other
medicines like it (NRTIs), develop a condition called
lactic acidosis, together with an enlarged liver.

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 blood 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 and fats (triglycerides
and cholesterol) in the blood
• resistance to insulin (so if youʼre diabetic, you
may have to change your insulin dose to control
your blood sugar).
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 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 Lamivudine/
Zidovudine

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 label after EXP. The expiry date
refers to the last day of that month.
Do not store above 30°C.

Do not use this medicine if you notice the visible
signs of deterioration.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines no longer use. These measures will
help protect the environment.

6

Contents of the pack and other
information

What Lamivudine/Zidovudine contains

• The active substances are lamivudine 150 mg and
zidovudine 300 mg.
• The other ingredients are:
Core:
Cellulose, Microcrystalline
Sodium Starch Glycolate (Type A)
Silica, Colloidal Anhydrous
Magnesium Stearate
Coating:
Hypromellose (E464)
Titanium dioxide (E171)
Macrogol
Polysorbate 80 (E433)

What Lamivudine/Zidovudine looks like and
contents of the pack
White coloured, capsule shaped, biconvex film
coated tablets with break line on both the sides.
The tablet can be divided into equal halves.

PVC/Alu blister
Pack sizes (Blister): 10, 20, 28, 30, 60, 90, 120 or
200 film-coated tablets.
HDPE bottle
Pack size (bottle): 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia
or

LEK S.A.,
ul. Podlipie 16. 96-010 Stryków,
Poland
or

LEK S.A.,
ul. Domaniewska 50 C, 02-672 Warszawa,
Poland
or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany
or

S.C. Sandoz, S.R.L.,
Str. Livezeni nr. 7A, RO-540472 Targu-Mures,
Romania.
This leaflet was last revised in 08/2013.

Lactic acidosis is caused by a buildup 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.

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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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