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LAMIVUDINE 300 MG FILM-COATED TABLETS

Active substance(s): LAMIVUDINE

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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.
The active ingredient in Lamivudine is lamivudine. Lamivudine is a
type of medicine known as an anti-retroviral. It belongs to a group
of medicines 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 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 in the same
way. Your doctor will monitor 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 Lamivudine (listed in section 6).
Check with your doctor if you think this applies to you.

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Lamivudine 300 mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamivudine 300 mg

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Lamivudine and similar medicines may cause side effects in unborn
babies. If you become pregnant while you’re 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 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 you’re breast-feeding, or thinking about 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 or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablet, with some water. Lamivudine can be taken with
or without food.
If you cannot swallow the tablet whole, you may crush and combine
with a small amount of food or drink, and take all the dose
immediately.
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
The usual dose of Lamivudine for adults and children who weigh at
least 30 kg is:

one tablet once a day.
An oral solution is also available for the treatment of children over 3
months of age, or for people who need a lower dose than usual, or
who can’t take tablets.
If you have a kidney problem, your dose may be altered.
Talk to your doctor if this applies to you.

Warnings and precautions
Some people taking Lamivudine 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 without
your doctor’s advice, as your hepatitis may come back)

if you’re seriously overweight (especially if you’re a woman)

if you’re 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’re taking your
medicine. See Section 4 for more information.

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

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
Lamivudine.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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.

Don’t risk blood transfer — for example, don’t share needles.
Other medicines and Lamivudine
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’re taking Lamivudine.
These medicines should not be used with Lamivudine:

other medicines containing lamivudine, (used to treat HIV
infection or hepatitis B infection)

emtricitabine (used to treat HIV infection)

high doses of co-trimoxazole, an antibiotic.

cladribine (used to treat hairy cell leukaemia)
Tell your doctor if you’re being treated with any of these.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before
taking this medicine.
Pregnancy
If you are pregnant, if you become pregnant, or are planning to
become pregnant, talk to your doctor about the risks and benefits to
you and your baby of taking Lamivudine.

Black

If you forget to take Lamivudine
If you forget to take a dose, take it as soon as you remember. Then
continue your treatment 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

When you’re 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. 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, 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’.
Common side effects
These may affect up to 1 in 10 people:

headache

feeling sick (nausea)

being sick (vomiting)

diarrhoea

stomach pains

tiredness, lack of energy

fever (high temperature)

general feeling of being unwell

muscle pain and discomfort

joint pain

difficulty in sleeping (insomnia)

cough

irritated or runny nose

rash

hair loss (alopecia).
Uncommon side effects
These may affect up to 1 in 100 people:
Uncommon side effects that may show up in blood tests are:

a decrease in the number of cells involved in blood clotting
(thrombocytopenia)

a low red blood cell count (anaemia) or low white blood cell
count (neutropenia)

an increase in the level of liver enzymes.

Rare side effects
These may affect up to 1 in 1000 people:

serious allergic reaction causing swelling of the face, tongue or
throat which may cause difficulty in swallowing or breathing

lactic acidosis (see the next section, ‘Other possible side
effects of combination therapy for HIV’)

inflammation of the pancreas (pancreatitis)

breakdown of muscle tissue

liver disorders, such as jaundice, enlarged liver or fatty liver,
inflammation (hepatitis).
A rare side effect that may show up in blood tests is:

increase in an enzyme called amylase.
Very rare side effects
These may affect up to 1 in 10,000 people:

tingling or numbness of the arms, legs, hands or feet.
A very rare side effect that may show up in blood tests is:

a failure of the bone marrow to produce new red blood cells
(pure red cell aplasia).




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 you’re diabetic, you may have to
change your insulin dose to control your blood sugar).

If you get side effects
Tell your doctor or pharmacist if any of the side effects gets
severe or troublesome, or if you notice any side effects not listed in
this leaflet.

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 (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.

Other possible side effects of combination therapy for HIV
Combination therapy including Lamivudine may cause other
conditions to develop during HIV treatment.

The United Kingdom
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Website:www.mhra.gov.uk/yellowcard

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
Lamivudine:
Tell your doctor immediately. Don’t 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 (NRTIs),
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.

5. How to store Lamivudine
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 and carton after EXP. The expiry date refers to the last
day of that month.
Store below 300C.
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 contains
The active substance is lamivudine. Each film-coated tablet
contains 300 mg of lamivudine.
The other ingredients are:
Tablet core: Microcrystalline cellulose (E460), sodium starch
glycolate (Type A), magnesium stearate (E572)
Film-coat: Hypromellose (E464), macrogol 400, titanium dioxide
(E171), polysorbate 80 (E433) and iron oxide black (E172).
What Lamivudine looks like and contents of the pack
Film-coated tablet
Grey, film coated, diamond shaped tablets, debossed with ‘Z26’ on
one side and plain on the other side.
Lamivudine film-coated tablets are available in clear PVC/Aclar Aluminium blister packs and HDPE bottle packs with polypropylene
closure.
Blister pack: 1, 14, 30, 60, 120 and 500 tablets
Bottle pack: 30 and 500 tablets.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 11/2013.

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:





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

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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:

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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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