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LAMIVUDINE/ZIDOVUDINE MYLAN 150 MG/300 MG FILM-COATED TABLETS

Active substance(s): LAMIVUDINE / ZIDOVUDINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

4. POSSIBLE SIDE EFFECTS

Some medicines can make it more likely that you will
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 Pneumocystis pneumonia (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.

LAMIVUDINE/ZIDOVUDINE
150 mg/300 mg
FILM-COATED TABLETS
(lamivudine and zidovudine)

Read all of this leaflet carefully before you start taking
this medicine
• 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 personally.
Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Like all medicines, Lamivudine/Zidovudine can cause side
effects, although not everybody gets them. When you are
being treated for HIV, it can be hard to tell whether a
symptom is a side effect of Lamivudine/Zidovudine, or
other medicines you are taking or an effect of the HIV
disease itself. For this reason it is very important that you
inform 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 'Other possible side
effects of combination therapy for HIV'.
Stop taking Lamivudine/Zidovudine and contact your
doctor or go to your hospital emergency department
immediately if you experience any of the following
serious side effects:
• severe allergic reaction causing swelling of the face,
tongue or throat which may cause difficulty in
swallowing or breathing (angioedema)
• flu-like symptoms, such as high temperature, chills,
runny nose, sore throat (influenza like syndrome) or
mouth ulcers which may be a sign of infection or a lack
of white blood cells (neutropenia or leucopenia)
• increased bleeding or bruising due to a decrease in the
number of cells involved in blood clotting
(thrombocytopenia)
• chest pain with fatigue and palpitations which may be
due to a disease of the heart muscle (cardiomyopathy)
• inflammation of the liver with signs such as feeling sick
(nausea) or being sick (vomiting), loss of appetite,
feeling generally unwell, fever, itching, yellowing of the
skin and eyes, light coloured bowel motions and dark
coloured urine (hepatitis)
• inflammation of the pancreas which causes severe
upper stomach pain often with nausea and vomiting
(pancreatitis)
• weakness, bleeding and bruising more easily than
normal, frequent infections which may be a sign of a
severe reduction in blood cells (aplastic anaemia or
pancytopenia) or failure of the bone marrow to produce
new red blood cells (red cell aplasia).

Tell your doctor if you are taking any of these.

In this leaflet:
1. What Lamivudine/Zidovudine is and what it is used for.
2. Before you take Lamivudine/Zidovudine.
3. How to take Lamivudine/Zidovudine.
4. Possible side effects.
5. How to store Lamivudine/Zidovudine.
6. Further information.

Some medicines interact with Lamivudine/Zidovudine
These include:
• clarithromycin, an antibiotic. If you are 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 you are taking phenytoin. Your doctor
may need to monitor you while you are taking
Lamivudine/Zidovudine.

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 HIV 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
cell 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 be
monitoring the effectiveness of your treatment.

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 you are 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.

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.
If you get any symptoms of infection while you are taking
Lamivudine/Zidovudine:
Tell your doctor immediately. Do not take other
medicines for the infection without your doctor's advice.

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 are breast-feeding or thinking of
breast-feeding talk to your doctor immediately.

2. BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE
Do not take Lamivudine/Zidovudine:
• If you are allergic (hypersensitive) to lamivudine or
zidovudine or any of the other ingredients of
Lamivudine/Zidovudine tablets (see Section 6).
• If you have a very low red blood cell count (anaemia) or
a very low white blood cell count (neutropenia).

Driving and using machines
Lamivudine/Zidovudine can make you dizzy and have
other side effects that make you less alert.

Check with your doctor if you think any of these apply to
you.

3. HOW TO TAKE LAMIVUDINE/ZIDOVUDINE

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, don't stop
Lamivudine/Zidovudine without your doctor's 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 'Other possible side effects of
combination therapy for HIV' 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
• do not risk blood transfer - for example do not share
needles.
Other medicines and Lamivudine/Zidovudine

Always take Lamivudine/Zidovudine exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

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.

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

Signs of lactic acidosis include:
• deep, rapid, difficult breathing
• drowsiness
• numbness or weakness in the limbs
• feeling sick (nausea), being sick (vomiting)
• stomach pain.

If you cannot swallow the tablets whole, you may crush
and combine them with a small amount of food or drink,
and take all the 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, and don't stop taking
Lamivudine/Zidovudine without your doctor's advice.

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.

Children who weigh between 21 kg 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 kg 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.

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.

For children who weigh less than 14 kg, lamivudine and
zidovudine (the ingredients of Lamivudine/Zidovudine)
should be taken separately.

You may experience any of the following less serious
side effects listed below:

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

Tell your doctor or pharmacist if you are taking any
other medicines, or if you have 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.
The following 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.
Tell your doctor if you are being treated with any of these.

Other possible side effects of combination therapy for HIV
Combination therapy such as Lamivudine/Zidovudine
may cause other conditions to develop during HIV
treatment.
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.
Other effects that may show up in blood tests
Combination therapy for HIV can also cause:
• increased levels of sugar and fats (triglycerides and
cholesterol) in the blood
• resistance to insulin (so if you are diabetic, you may have
to change your insulin dose to control your blood
sugar).
5. HOW TO STORE LAMIVUDINE/ZIDOVUDINE
Keep out of the reach and sight of children. Do not use
Lamivudine/Zidovudine after the expiry date, which is
stated on the carton, bottle or blister after 'EXP'. The
expiry date refers to the last day of that month. This
medicinal product does not require any special storage
conditions. Bottle packs ONLY: Use within 60 days of
opening. Medicines should not be disposed of via
wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help to protect the environment.

What Lamivudine/Zidovudine contains
The active substances are lamivudine and zidovudine.
One tablet contains 150 mg of lamivudine and 300 mg of
zidovudine.
The other ingredients are:
Core:
Cellulose microcrystalline (E460), silica, colloidal
anhydrous (E551), sodium starch glycolate (type A),
magnesium stearate (E572).
Film-coating (Opadry white 03H58736):
Hypromellose (E464), titanium dioxide (E171), propylene
glycol (E1520).
What Lamivudine/Zidovudine looks like and contents of
the pack
Lamivudine/Zidovudine 150 mg/300 mg film-coated
tablets are white to off-white, capsule shaped, biconvex
film coated tablets, debossed with 'M' on the left of the
scoreline and '103' on the right, on one side of the tablet,
and scored on the other side.
Lamivudine/Zidovudine is available in blisters of 30, 60,
60 x 1 (unit dose blister), 100, 200 tablets and in bottles of
60 tablets.

Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Mylan Hungary Kft. H-2900 Komárom, Mylan utca 1,
Hungary.

This leaflet was last revised in: January 2013

18-JAN-2013

Job No. 37006976v1

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.A.S, 117 Allée des parcs, 69 800 Saint Priest,
France.

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

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Rare side effects that may show up in blood tests are:
• an increase in an enzyme called amylase.

Not all pack sizes may be marketed.

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

If you forget to take Lamivudine/Zidovudine
If you forget to take a dose of Lamivudine/Zidovudine,
take it as soon as you remember and then continue your
treatment as before. Do not take a double dose to make
up for a missed dose.

Rare side effects
These may affect up to 1 in 1000 people:
• breakdown of muscle tissue (rhabdomyolysis)
• tingly feelings in the skin (pins and needles)
• sensation of weakness in the limbs
• liver disorders such as, enlarged liver or fatty liver
• changes in the colour of your nails, your skin or the skin
inside your mouth
• passing urine more often
• enlarged breasts in men
• indigestion, taste disturbance
• fits (convulsions)
• numbness
• feeling depressed or anxious, not being able to
concentrate, feeling drowsy.

6. FURTHER INFORMATION

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.

How much to take
Adults and adolescents who weigh 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.

Uncommon side effects
These may affect up to 1 in 100 people:
• wind (flatulence)
• feeling breathless
• itching
• muscle weakness.

DD-MMM-20YY

product category LAMIVUDINE_ZIDOVUDINE
market UK 2013
packing site Sanfarm

Black

product Lamivudine Zidovudine 150.300mg FCTab x60
component type Leaflet

artwork code 10004734
superseded code 10004676

Dimensions Cutter
MA no. 33302/0022
new/revised Revised

change control ref. Marketing
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Date

Pro
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Date

Braille (if applicable)
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barcode N/A
dimensions

Customer (if applicable)
Sign
Date

font & point size Myriad Pro Regular 9pt
Myriad Pro Bold 17pt

pharma code N/A

Registration Officer
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175 mm x 500 mm
Technical
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Quality Assurance
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10004734

500 mm

Lactic acidosis
Some people taking Lamivudine/Zidovudine, or other
medicines like it (NRTIs), develop a condition called lactic
acidosis, together with an enlarged liver.

Do not drive or operate machines if you are feeling unwell.

Common side effects that might show up in blood tests are:
• a low red blood cell count (anaemia)
• an increase in the level of liver enzymes
• an increased amount of bilirubin (a substance produced
by the liver) in the blood, which may make your skin
appear yellow.

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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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