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

Active substance(s): LAMIVUDINE / ZIDOVUDINE

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Lamivudine/Zidovudine 150 mg/300 mg film-coated tablets
lamivudine/zidovudine
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/Zidovudine is and what it is used for
2. What you need to know before you take Lamivudine/Zidovudine
3. How to take Lamivudine/Zidovudine
4. Possible side effects
5. How to store Lamivudine/Zidovudine
6. Contents of the pack and other information
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 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/Zidovudine in
the same way. Your doctor will monitor the effectiveness of your
treatment.
2. What you need to know before you take
Lamivudine/Zidovudine
Do not take Lamivudine/Zidovudine:
• if you are allergic to lamivudine or zidovudine, or any of the
other ingredients of this medicine (listed in section 6).
• if you have a very low red blood cell count (anaemia) or a
very low white blood cell count (neutropenia).
Check with your doctor if you think any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking
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’re a woman)
if you’re 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’re 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’re 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
Don’t risk blood transfer – for example, don’t share needles.

Other medicines and Lamivudine/Zidovudine
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/Zidovudine.
These 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.
• cladribine, used to treat hairy cell leukaemia
Tell your doctor if you’re being treated with any of these.
Some medicines can make it more likely that you’ll 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
PCP
• amphotericin or co-trimoxazole, to treat fungal and bacterial
infections

Black

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Lamivudine/Zidovudine

Package leaflet: Information for the user



Lamivudine/Zidovudine

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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
Tell your doctor if you’re taking any of these.
Some medicines interact with Lamivudine/Zidovudine
These include:
• clarithromycin, an antibiotic
if you’re 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’re taking phenytoin. Your doctor may need
to monitor you while you’re taking Lamivudine/Zidovudine.
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 or pharmacist for
advice before taking this medicine.
Pregnancy
Lamivudine/Zidovudine and similar medicines may cause side
effects in unborn babies. If you become pregnant while you’re
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.
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/Zidovudine can make you dizzy and have other side
effects that make you less alert.
Don’t drive or operate machines unless you’re feeling well.
3. How to take Lamivudine/Zidovudine
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 Lamivudine/Zidovudine tablets, with some water.
Lamivudine/Zidovudine 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/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.
How much to take
Adults and adolescents 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.
Children who weigh between 21 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 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.
For children who weigh less than 14 kg lamivudine and zidovudine
(the ingredients of Lamivudine/Zidovudine) should be taken
separately.
If you take more Lamivudine/Zidovudine than you should
If you accidentally take too much Lamivudine/Zidovudine, tell your
doctor or your pharmacist, or contact your nearest hospital
emergency department for further advice.
If you forget to take Lamivudine/Zidovudine
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
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
When you’re being treated for HIV, it can be hard to tell whether a
symptom is a side effect of Lamivudine/Zidovudine or other
medicines you’re 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/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’.
Very common side effects
These may affect more than than 1 in 10 people:
• headache
• feeling sick (nausea)
Common side effects
These may affect up to 1 in 10 people:
• being sick (vomiting)
• diarrhoea
• stomach pains
• loss of appetite
• feeling dizzy
• tiredness, lack of energy
• fever (high temperature)










general feeling of being unwell
difficulty in sleeping (insomnia)
muscle pain and discomfort
joint pain
cough
irritated or runny nose
skin rash
hair loss (alopecia)

Common side effects that might show up in blood tests are:
• a low red blood cell count (anaemia) or low white blood cell
count (neutropenia or leucopenia)
• an increase in the level of liver enzymes
• an increased amount in the blood of bilirubin (a substance
produced in the liver) which may make your skin appear yellow.
Uncommon side effects
These may affect up to 1 in 100 people:
• feeling breathless
• wind (flatulence)
• itching
• muscle weakness
An uncommon side effect that may show up in blood test is:
• a decrease in the number of cells involved in blood clotting
(thrombocytopenia) or in all kinds of blood cells (pancytopenia).
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
• liver disorders, such as jaundice, enlarged liver or fatty liver,
inflammation (hepatitis)
• lactic acidosis (see the next section, ‘Other possible side effects
of combination therapy for HIV’)
• inflammation of the pancreas (pancreatitis)
• chest pain; disease of the heart muscle (cardiomyopathy)
• fits (convulsions)
• feeling depressed or anxious, not being able to concentrate,
feeling drowsy
• indigestion, taste disturbance
• changes in the colour of your nails, your skin or the skin inside
your mouth
• a flu-like feeling – chills and sweating
• tingly feelings in the skin (pins and needles)
• sensation of weakness in the limbs
• breakdown of muscle tissue
• numbness
• passing urine more often
• enlarged breasts in men
Rare side effects that may show up in blood tests are:
• an increase in an enzyme called amylase
• a failure of the bone marrow to produce new red blood cells
(pure red cell aplasia).

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 you’re 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 (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.
The United Kingdom
Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard
5. How to store Lamivudine/Zidovudine
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.

Very rare side effects
These may affect up to 1 in 10,000 people:

Do not use this medicine after the expiry date which is stated on
the label, carton, and blister after EXP. The expiry date refers to the
last day of that month.

A very rare side effect that may show up in blood tests is:
• a failure of the bone marrow to produce new red or white blood
cells (aplastic anaemia).

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.

Other possible side effects of combination therapy for HIV
Combination therapy such as Lamivudine/Zidovudine 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.
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/Zidovudine:
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/Zidovudine, 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.

6. Contents of the pack and other information
What Lamivudine/Zidovudine contains
- The active substances are lamivudine and zidovudine. Each
film-coated tablet contains lamivudine 150 mg and zidovudine
300 mg.
-

The other ingredients are
Tablet core: Cellulose microcrystalline, sodium starch glycolate
(Type A), silica colloidal anhydrous, magnesium Stearate
Tablet film-coat: Hypromellose (E464), titanium dioxide (E171),
macrogol 400, polysorbate 80.

What Lamivudine/Zidovudine looks like and contents of the
pack
Film-coated tablet.
White to off-white modified capsule-shaped, biconvex film-coated
tablets with deep break line in between ‘J’ and ’59 on one side and
break line on other side. The tablet can be divided into equal
doses.
Lamivudine/Zidovudine film-coated tablets are available in
PVC/PVdC- Aluminium foil blisters and HDPE bottle with
polypropylene closures. Each pack type contains 60 film-coated
tablets.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
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 Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 11/2013.

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

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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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