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LAMIVUDINE SANDOZ 150 MG FILM COATED TABLETS

Active substance(s): LAMIVUDINE

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Package leaflet: Information for the user

SZ00000LT000

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.
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 youʼre allergic (hypersensitive) 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.
Take special care with Lamivudine

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, donʼt stop Lamivudine without your doctorʼs advice, as
your hepatitis may come back).
• if youʼre seriously overweight (especially if youʼre a woman).
• if youʼre diabetic and using insulin.
• 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 youʼre 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 youʼre taking Lamivudine.

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 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

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 youʼre 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 youʼre being treated with any of these.

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.

Lamivudine and similar medicines may cause side effects in unborn babies. If
you become pregnant while youʼre 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 youʼre 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.

Lamivudine contains Isomalt
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

3

How to take Lamivudine

Always take this medicine exactly as your doctor has told you to. 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.

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 donʼt stop taking Lamivudine without your
doctorʼs advice.

How much to take
Adults and children who weigh at least 30 kg:
The usual dose of Lamivudine is 300 mg a day to be taken as:
• Either one 150 mg tablet twice a day, approximately 12 hours apart, or
• one 300 mg tablet once a day.

Children weighing 21 – 30 kg
• one half (½) of an Lamivudine tablet (75 mg) in the morning, and
• one whole Lamivudine tablet (150 mg) in the evening.

Children weighing 14 – 21 kg
• one half (½) of an Lamivudine tablet (75 mg) in the morning, and
• one half (½) of an Lamivudine tablet (75 mg) in the evening.

Tablets containing less lamivudine and an oral solution are available for the
treatment of children over 3 months of age, or for people who need a lower dose
than usual, or who canʼt take tablets.

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 too much Lamivudine
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.

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. Donʼt take a double dose to make up for a missed
dose.

Continued on the next page >>

4

Possible side effects

Like all medicines, Lamivudine can cause side effects, although not everybody
gets them.
When youʼre 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 ʻOther possible
side effects of combination therapy for HIVʼ.

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 1,000 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, ʻOther possible side effects of
combination therapy for HIVʼ)
• 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:
• an 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 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.

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 bodyʼs immune system becoming stronger, so that the body starts
to fight these infections.
If you get any symptoms of infection while youʼre taking Lamivudine:
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, 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.

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 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

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 (month, year).
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
In use shelf life for bottle: After first opening: 3 months.

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 Lamivudine 150 mg Film-coated Tablet contains 150 mg of lamivudine.
Each Lamivudine 300 mg Film-coated Tablet contains 300 mg of lamivudine.

The other ingredients are:
isomalt (E953), crospovidone Type A, magnesium stearate (E572),
hypromellose 3cp (E464), hypromellose 6cp (E464), titanium dioxide (E171),
macrogol 400, polysorbate 80 (E433).

What Lamivudine looks like and the contents of the pack
Lamivudine 150 mg Film-coated Tablets:
White capsule shaped, biconvex scored film coated tablets with a dimension of
15 x 6.5 mm, debossed with J on one side and 16 on the other side, 1 and 6
separated by a score line.
The tablet can be divided into equal doses.
Lamivudine 300 mg Film-coated Tablets:
White capsule shaped, biconvex film coated tablets with a dimension of 19.1 x
8.9 mm, debossed with 17 on one side and J on the other side.

Alu-Alu blister pack: 14, 28, 30, 56, 60, 84, 90 and 120 film-coated tablets.
HDPE container with child resistant polypropylene cap: 30, 60, 90 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, 95-010 Strykow, 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 05/2013.

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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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