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LAMIVUDINE MYLAN 150 MG FILM-COATED TABLETS

Active substance(s): LAMIVUDINE / LAMIVUDINE

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Transcript
(lamivudine)

TBC

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. How to take Lamivudine
4. Possible side effects
5. How to store Lamivudine
6. Contents 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:

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 have taken
Lamivudine during your pregnancy, your doctor may
request regular blood tests and other diagnostic
tests to monitor the development of your child.
In children whose mothers took NRTIs during
pregnancy, the benefit from the protection against
HIV outweighed the risk of 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 breastfeeding 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.

• if you are allergic to lamivudine or any of the other
ingredients of this medicine (listed in section 6)

Keep in touch with your doctor, and do not stop
taking Lamivudine without your doctor’s advice.

Check with your doctor if you think this applies to
you.

How much to take

Warnings and precautions

Use in adults, adolescents and children who
weigh at least 25 kg:

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,
do not 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 or your child has 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). 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.

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.

TBC

TBC

Lamivudine 150 mg
Film-coated Tablets
Lamivudine 300 mg
Film-coated Tablets

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
(leukaemia))

[For 150 mg only]

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 at least 14 kg and
less than 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 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 or your child has a kidney problem, your dose
may be altered. Talk to your doctor if this applies to
you or your child.

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.

TBC

Package leaflet: Information for the patient

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
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.
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’.

If you notice any of the following serious side
effects contact your doctor immediately:
Uncommon (may affect up to 1 in 100 people):
• 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).

Rare (may affect up to 1 in 1,000 people):
• swelling in the face, mouth, lips, tongue or
throat causing difficulty breathing or swallowing
(angioedema).
• severe stomach pain which may radiate to your
back. This may be signs of problems with your
pancreas (pancreatitis).
• 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 (hepatitis).
• dark coloured urine with muscle weakness
or tiredness. These may be signs of muscle
breakdown (rhabdomyolysis).
Very rare (may affect up to 1 in 10,000 people):
• 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 (peripheral neuropathy).
• deep, rapid, difficult breathing, drowsiness,
numbness or weakness in the limbs, feeling sick
(nausea), being sick (vomiting) and stomach pain.
These may be signs of excess lactic acid in the
blood (lactic acidosis).
Other possible side effects include:
Common (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 (may affect up to 1 in 100 people):
• a low red blood cell count (anaemia)
• an increase in the level of liver enzymes
Rare (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.

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 are
taking Lamivudine:
Tell your doctor immediately. Do not take other
medicines for the infection 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
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.

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

Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.

This leaflet was last revised in August 2016.

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).

CODE No.: MH/DRUGS/25/NKD/89

1161194

Package leaflet: Information for the patient

Lamivudine 150 mg
Film-coated Tablets
Lamivudine 300 mg
Film-coated Tablets
(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. How to take Lamivudine
4. Possible side effects
5. How to store Lamivudine
6. Contents 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.

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
(leukaemia))

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 have
taken Lamivudine during your pregnancy,
your doctor may request regular blood tests
and other diagnostic tests to monitor the
development of your child. In children whose
mothers took NRTIs during pregnancy, the
benefit from the protection against HIV
outweighed the risk of 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 breastfeeding 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

Response to treatment with lamivudine varies [For 150 mg] The tablet can be divided into
between patients. Your doctor will be
equal doses.
monitoring the effectiveness of your treatment.
Stay in regular contact with your doctor.

2. What you need to know before
you take Lamivudine

Lamivudine helps to control your condition.
You need to keep taking it every day to stop
Do not take Lamivudine:
your illness getting worse. You may still
• if you are allergic to lamivudine or any of
develop other infections and illnesses linked
the other ingredients of this medicine (listed to HIV infection.
in section 6)
Keep in touch with your doctor, and do
Check with your doctor if you think this
not stop taking Lamivudine without your
applies to you.
doctor’s advice.

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, do not 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 or your child has 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). You can still pass on HIV
when taking this medicine, although the risk is
lowered by effective antiretroviral therapy.

How much to take
[For 150 mg only]

Use in adults, adolescents and children
who weigh at least 25 kg:
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 at least 14 kg
and less than 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 for adults,
adolescents and children who weigh at least
25 kg is:
• one 300 mg tablet once a day

Discuss with your doctor the precautions
needed to avoid infecting other people.

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
Other medicines and Lamivudine
Tell your doctor or pharmacist if you are taking, take the tablets; ask your doctor or pharmacist.
have recently taken or might take any other
If you or your child has a kidney problem, your
medicines, including herbal medicines or other dose may be altered. Talk to your doctor if this
medicines you bought without a prescription. applies to you or your child.
Remember to tell your doctor or pharmacist
if you begin taking a new medicine while you
are taking Lamivudine.

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.

(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
If you have any further questions on the use of occurs when the immune system attacks
this medicine, ask your doctor or pharmacist.
healthy body tissue) may also occur after you
start taking medicines for the treatment of
4. Possible side effects
your HIV infection. Autoimmune disorders
During HIV therapy there may be an increase
may occur many months after the start of
in weight and in levels of blood lipids and
treatment. If you notice any symptoms of
glucose. This is partly linked to restored health infection or other symptoms such as muscle
and life style, and in the case of blood lipids
weakness, weakness beginning in the hands
sometimes to the HIV medicines themselves.
and feet and moving up towards the trunk of
Your doctor will test for these changes.
the body, palpitations, tremor or hyperactivity,
please inform your doctor immediately to seek
Like all medicines, this medicine can cause
side effects, although not everybody gets them. necessary treatment.
If you get any symptoms of infection while
When you are being treated for HIV, it can be
hard to tell whether a symptom is a side effect you are taking Lamivudine:
Tell your doctor immediately. Do not take
of lamivudine or other medicines you are
taking, or an effect of the HIV disease itself. For other medicines for the infection without your
this reason it is very important that you inform doctor’s advice.
your doctor about any changes in your health. You may have problems with your bones
Some people taking combination therapy for
As well as the side effects listed below for
HIV develop a condition called osteonecrosis.
Lamivudine, other conditions can develop
With this condition, parts of the bone tissue
during combination therapy for HIV.
die because of reduced blood supply to the
It is important to read the information later
bone. People may be more likely to get this
in this section under ‘Other possible side
condition:
effects of combination therapy for HIV’.
• if they have been taking combination
therapy for a long time
If you notice any of the following

if they are also taking anti-inflammatory
serious side effects contact your doctor
medicines called corticosteroids
immediately:
• if they drink alcohol
Uncommon (may affect up to 1 in 100 people): • if their immune systems are very weak
• an increase in the number of infections you • if they are overweight
get which causes fever, severe chills, sore
Signs of osteonecrosis include:
throat or mouth ulcers. This may be signs
you have a low number of white blood cells • stiffness in the joints
• aches and pains (especially in the hip, knee
in your blood (neutropenia).
or shoulder)
• unexplained bruising or bleeding for longer

difficulty moving
than usual. These may be signs of a decrease
in the number of cells involved in blood
If you notice any of these symptoms tell your
clotting (thrombocytopenia).
doctor.
Rare (may affect up to 1 in 1,000 people):
• swelling in the face, mouth, lips, tongue
or throat causing difficulty breathing or
swallowing (angioedema).
• severe stomach pain which may radiate to
your back. This may be signs of problems
with your pancreas (pancreatitis).
• 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 (hepatitis).
• dark coloured urine with muscle weakness
or tiredness. These may be signs of muscle
breakdown (rhabdomyolysis).
Very rare (may affect up to 1 in
10,000 people):
• 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 (peripheral
neuropathy).
• deep, rapid, difficult breathing, drowsiness,
numbness or weakness in the limbs, feeling
sick (nausea), being sick (vomiting) and
stomach pain. These may be signs of excess
lactic acid in the blood (lactic acidosis).
Other possible side effects include:
Common (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 (may affect up to 1 in
100 people):
• a low red blood cell count (anaemia)
• an increase in the level of liver enzymes
Rare (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

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

Generics [UK] Limited, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last revised in August
2016.
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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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