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LAMIVUDINE MYLAN 300 MG FILM-COATED TABLETS

Active substance(s): LAMIVUDINE

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Package leaflet: Information for the patient

Lamivudine 150 mg
Film-coated Tablet
Lamivudine 300 mg
Film-coated Tablet
lamivudine

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 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 is and what it is used for
2. What you need to know before you
take Lamivudine
3. H
 ow to take Lamivudine
4. P
 ossible side effects
5. H
 ow to store Lamivudine
6. C
 ontents of the pack and other information

1. What Lamivudine is and what it is
used for
Lamivudine is used to treat HIV (human
immunodeficiency virus) infection in adults
and children.
Lamivudine belongs to a group of antiviral
medicines, also known as antiretrovirals, called
nucleoside analogue reverse transcriptase
inhibitors (NRTIs).
Lamivudine 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 CD4 cell count in your blood. CD4 cells
are a type of white blood cell that are important
in maintaining a healthy immune system to
help fight infection.
Response to treatment with lamivudine
varies between patients. Your doctor will be
monitoring the effectiveness of your treatment.

2. What you need to know before
you take Lamivudine
Do not take Lamivudine:

• if you are allergic to lamivudine or any of
the other ingredients of this medicine (listed
in section 6).
Check with your doctor if you think this applies
to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Lamivudine:
• if you are currently being treated for HIV
with tenofovir and abacavir or tenofovir and
didanosine (other NRTIs).
• if you have ever had liver disease, including
hepatitis B or C (if you have hepatitis B
infection, don’t stop taking Lamivudine
without your doctor’s advice, as your hepatitis
may come back).
• if you are seriously overweight (especially if
you are a woman).
• if you are diabetic and using insulin.
• if you have a kidney problem, your dose may
be altered.
Talk to your doctor if any of these apply to
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.
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 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

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, 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.

Tell your doctor if you are being treated with
any of these:
• other medicines containing lamivudine (used
to treat HIV infection or hepatitis B infection)
• a group of medicines called cytidine analogues
used to treat HIV such as emtricitabine
• co-trimoxazole (an antibiotic medicine used
to treat infections)
• cladribine (used to treat cancer of the
blood (leukemia)).

Pregnancy and breast-feeding

Pregnancy
If you are pregnant, think you may be pregnant,
or are planning to have a baby, ask your
doctor or pharmacist for advice before taking
this medicine.
Lamivudine and similar medicines may cause side
effects in unborn babies. If you become pregnant
while you are taking Lamivudine, 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) during pregnancy had a reduced
risk of being infected with HIV. This benefit is
greater than the risk of suffering from 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.
A small amount of the ingredients in this
medicine can also pass into your breast milk.
If you are breast-feeding or thinking of
breast-feeding talk to your doctor immediately.

Driving and using machines

Lamivudine is unlikely to affect your ability to
drive or use machines.

3. How to take Lamivudine
Always take this medicine exactly as your
doctor has told you to. You should check with
your doctor or pharmacist if you are not sure.
Swallow the tablets with some water.
Lamivudine 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 all the dose immediately.
Alternatively other forms of the medicine may be
available, ask your doctor or pharmacist
[For 150 mg] The tablet can be divided into
equal doses.
Stay in regular contact with your doctor
Lamivudine 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 without your doctor’s advice.

How much to take

[For 150 mg only]
Use in adults, adolescents and children who
weigh at least 25kg:
The recommended dose of Lamivudine is
300 mg a day. This may be taken as either:
• one 150 mg tablet twice a day, leaving
approximately 12 hours between each dose, or
• two 150 mg tablets once a day as advised by
your doctor.
Use in children weighing at least 20 kg and
less than 25 kg:
The recommended dose is 225 mg a day. This
can be given as either:
• 75 mg (half a Lamivudine 150 mg tablet in the
morning, and
• one whole Lamivudine tablet (150 mg) in the
evening, or
• 225 mg (one and a half 150 mg tablets) once a
day as advised by your doctor.
Use in children weighing 14-20 kg:
The recommended dose is 150 mg a day. This
can be given as either:
• 75 mg (half a Lamivudine 150 mg tablet
twice a day, leaving approximately 12 hours
between each dose, or
• 150 mg (one 150 mg tablet) once a day as
advised by your doctor.
[For 300 mg only]
The usual dose of Lamivudine Mylan for adults,
adolescents and children who weigh at least
25 kg is:
• One 300 mg tablet once a day.
Other forms of this medicine may be more
suitable for children or for people who need a
lower dose than normal, or those who cannot
take the tablets; ask your doctor or pharmacist.
If you have a kidney problem, your dose may be
altered. Talk to your doctor if this applies to you.

If you take more Lamivudine than you should
Accidentally taking too much Lamivudine
is unlikely to cause any serious problems.
However, you should tell your doctor or your
pharmacist, or contact your nearest hospital
emergency department for further advice.

If you forget to take Lamivudine

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

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

4. Possible side effects
Like all medicines, this medicine 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 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, 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’.

Contact your doctor or go to the nearest
hospital emergency department if you get
any of the following:

• an increase in the number of infections you
get which causes fever, severe chills, sore
throat or mouth ulcers. This may be signs you
have a low number of white blood cells in your
blood (neutropenia).
• unexplained bruising or bleeding for longer
than usual. These may be signs of a decrease
in the number of cells involved in blood
clotting (thrombocytopenia).
• swelling in the face, mouth, lips, tongue or throat
causing difficulty breathing or swallowing.
• severe stomach pain which may radiate to
your back. This may be signs of problems with
your pancreas.
• yellowing of your skin or whites of your eyes,
dark urine, pale stools, tiredness, fever, feeling
sick (nausea), weakness, drowsiness and
abdominal pain. These may be signs you have
serious problems with your liver.
• dark coloured urine with muscle weakness
or tiredness. These may be signs of muscle
breakdown (rhabdomyolysis).
• tiredness, weakness, pale coloured skin,
shortness of breath. These may be signs of
a disorder where you are not producing red
blood cells (pure red cell aplasia).
• numbness and tingling (commonly known
as pins and needles), burning, stabbing or
shooting pain in the feet or hands leading to
loss of balance and co-ordination. These may
be signs of nerve damage.

Other possible side effects include:

Common side effects (may affect up to 1 in
10 people):
• feeling sick (nausea)
• being sick (vomiting)
• stomach pains
• diarrhoea
• headache
• joint pain
• muscle pain and discomfort
• cough
• irritated or runny nose
• fever (high temperature)
• tiredness, lack of energy
• general feeling of being unwell
• skin rash
• hair loss (alopecia),
• difficulty in sleeping (insomnia).
Uncommon side effects (may affect up to 1 in
100 people):
• a low red blood cell count (anaemia)
• an increase in the level of liver enzymes.
Rare side effects (may affect up to 1 in
1,000 people):
• increase in an enzyme called amylase that can
be seen in a blood test

Other possible side effects of combination
therapy for HIV
Combination therapy including Lamivudine
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
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:
Tell your doctor immediately. Do not take
other medicines for the infection without your
doctor’s 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, or other
medicines like it (NRTI’s), 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 that 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 you are 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 Yellow Card
Scheme, Website: 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
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the bottle or blister or carton
after EXP. The expiry date refers to the last day
of that month.
This medicine does not require any special
storage conditions
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and
other information
What Lamivudine film-coated tablets contain
The active substance is lamivudine. Each
150 mg film-coated tablet contains 150 mg of
lamivudine. Each 300 mg film-coated tablet
contains 300 mg of lamivudine.

The other ingredients are:
Tablet core: microcrystalline cellulose, sodium
starch glycolate, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide,
propylene glycol

What Lamivudine film-coated tablets look
like and contents of the pack

Lamivudine 150 mg film-coated tablets are
white to off-white, capsule shaped with two
sides that curve out, marked with “M105” on
one side and a functional scoreline on the other.
Lamivudine 300 mg film-coated tablets are
white to off-white, oval shaped with two sides
that curve out, marked with “M300” on one side
and plain on the other.
Lamivudine is available in blisters of 30, 60, 90,
120 tablets and in bottles of 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
This leaflet was last revised in
August 2015.
655029

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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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