Israel - English - Ministry of Health
Treatment with Lamivudine/Zidovudine Teva often causes
loss of fat from the legs, hands and face (lipoatrophy).
This loss of body fat has proven to not be fully reversible
after discontinuation of zidovudine. Your doctor should
monitor for signs of lipoatrophy.
Tell your doctor if you notice any loss of fat from your legs,
hands, and face. When these signs occur, treatment with
Lamivudine/Zidovudine Teva should be stopped and your
HIV treatment will be changed.
As with any medicine, use of Lamivudine/Zidovudine Teva
may cause side effects in some users. Do not be alarmed
when reading the list of side effects. You may not suffer
from any of them.
When you are being treated for HIV infection, it may be
difficult to tell whether the symptom is a side effect of
Lamivudine/Zidovudine or of other medicines you are
taking, or the effect of the HIV infection itself. Therefore,
it is very important to talk to your doctor about any
change in your health.
In addition to the list of side effects below for
Lamivudine/Zidovudine Teva, other medical conditions
can develop during combination therapy for HIV
It is important to read the information appearing later
on in this section under the caption “Other possible side
effects of combination therapy for HIV infection”.
Very common side effects that may occur in more than
1 in every 10 people:
Common side effects that may occur in up to 1 in every
Loss of appetite
Tiredness, lack of energy
General unwell feeling
Difficulty in sleeping (insomnia)
Muscle pain and discomfort
Irritated or runny nose
Common side effects that might show up in blood
A low red blood cell count (anemia) or low white blood
cell count (neutropenia or leucopenia).
An increase in the level of liver enzymes.
An increased amount of bilirubin (a substance produced
in the liver) in the blood, which may cause yellowing of
Uncommon side effects that may occur in up to 1 in
every 100 people:
Shortness of breath
An uncommon side effect that may show up in a blood
A decrease in the number of blood cells involved in blood
clotting (thrombocytopenia) or decrease in all the kinds
of blood cells (pancytopenia).
Rare side effects that may occur in up to 1 in every
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 (excess lactic acid in the blood; see later
on in “Other possible side effects of combination therapy
for HIV infection”)
Inflammation of the pancreas (pancreatitis)
Feeling depressed or anxious, not being able to
concentrate, feeling drowsy
Indigestion, taste disturbance
Changes in the color of your nails, your skin or the skin
inside your mouth
A flu-like feeling – chills and sweating
Tingling sensation (like pins and needles) in the skin
Sensation of weakness in the limbs
Breakdown of muscle tissue
Passing urine more often
Enlarged breasts in men
Rare side effects that may show up in blood tests
An increase in the amylase enzyme.
Failure of the bone marrow to produce new red blood
cells (pure red cell aplasia).
Very rare side effects that may occur in up to 1 in every
A very rare side effect that may show up in blood tests
Failure of the bone marrow to produce new red or white
blood cells (aplastic anemia).
If a side effect occurs, if any of the side effects worsen,
or if you are suffering from a side effect not mentioned
in the leaflet, consult the doctor or pharmacist.
Other possible side effects of combination therapy
for HIV infection
Combination therapy such as Lamivudine/Zidovudine Teva
may cause other medical conditions to develop during
Old infections may flare up
People with advanced HIV infection (AIDS) have a weak
immune system, 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 infection. These
symptoms are probably caused by the body’s immune
system becoming stronger, so that the body starts to fight
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 have started taking medicines for the treatment of
your HIV. 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, rapid heart beat, tremor or
hyperactivity, please refer to your doctor immediately
to receive the necessary treatment.
If you suffer from symptoms of infection while you
are taking Lamivudine/Zidovudine Teva: refer to your
doctor immediately. Do not take other medicines against
the infection without consulting with your doctor.
Lactic acidosis is a rare but serious side effect.
Some people taking Lamivudine/Zidovudine Teva develop
a condition called lactic acidosis, together with an enlarged
Lactic acidosis is caused by a build-up of lactic acid in the
body. This is rare; if it happens, it usually develops after
a few months of treatment. It can be life-threatening, by
causing failure of internal organs. Lactic acidosis is more
likely to develop in people with liver disease, or in obese
(very overweight) people, especially women.
Signs of lactic acidosis:
Breathing difficulties, deep and rapid breathing
Numbness or weakness in the limbs
During your treatment, your doctor will monitor you to
diagnose signs of lactic acidosis. If you have any of the
symptoms mentioned above or any other symptom that
worries you: Refer to the doctor as soon as possible.
You may have bone problems
There are people taking combination therapy for HIV
infection who develop a condition called osteonecrosis.
In this condition, parts of the bone tissue die because of
reduced blood supply to the bone. Patients may be more
likely to develop this condition if:
They have been taking combination therapy for a long
They are also taking anti-inflammatory medicines called
They drink alcohol.
Their immune system is very weak.
They are overweight.
Signs of osteonecrosis include:
Stiffness in the joints.
Aches and pains (especially in the hip, knee or
If you notice any of these symptoms: Refer to your
Other effects that may show up in blood tests
Combination therapy for HIV infection can also cause:
Increased levels of lactic acid in the blood, which, on rare
occasions, can lead to lactic acidosis.
If a side effect occurs, if any of the side effects worsen,
or if you are suffering from a side effect not mentioned
in the leaflet, consult the doctor.
Reporting side effects
Side effects can be reported to the Ministry of Health
by clicking on the link “Report Side Effects of Drug
Treatment” found on the Ministry of Health homepage
(www.health.gov.il) that directs you to the online form for
reporting side effects, or by entering the link:
5. HOW SHOULD THE MEDICINE BE STORED?
Avoid poisoning! This medicine and any other medicine
must be kept in a safe place out of the reach and sight
of children and/or infants in order to avoid poisoning. Do
not induce vomiting without explicit instruction from the
Do not use the medicine after the expiry date (exp. Date)
that appears on the package. The expiry date refers to the
last day of that month.
Store in a dry place, below 25ºC.
6. FURTHER INFORMATION
In addition to the active ingredients, the medicine also
Microcrystalline cellulose, Sodium starch glycolate,
Sodium stearyl fumarate
The tablet coating contains:
Titanium dioxide, Hypromellose, Macrogol 400,
What the medicine looks like and the contents of the
Tablet shape: a white, oblong tablet.
The letters “Z”, “L” and a score line appear on one side
of the tablet, the numbers “300”, “150” and a score line
appear on the other side.
Package sizes – 60 tablets, 100 tablets. Not all package
sizes may be marketed.
License Holder: Abic Marketing Ltd., P.O.B. 8077,
Manufacturer: Teva Pharmaceutical Industries, Private
Limited Company, Hungary.
This leaflet was checked and approved by the Ministry of
Health in March 2013 and was updated in June 2018 in
accordance with the Ministry of Health guidelines.
Registration number of the medicine in the National Drug
Registry of the Ministry of Health: 149.62.33825
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a
doctor’s prescription only
150 mg/300 mg Tablets
Each tablet contains:
Lamivudine (as anhydrous) 150 mg
Zidovudine 300 mg
For information on the inactive ingredients, see section 2
“Important information about some of the ingredients of
this medicine” and section 6 – “Further Information”.
Read this leaflet carefully in its entirety before using
the medicine. This leaflet contains concise information
about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for the treatment
of your ailment. Do not pass it on to others. It may
harm them even if it seems to you that their ailment
1. WHAT IS THE MEDICINE INTENDED FOR?
Lamivudine/Zidovudine Teva is intended as a
combination antiviral therapy for the human
immunodeficiency virus (HIV) infection.
Therapeutic group: Lamivudine/Zidovudine Teva contains
two active ingredients used to treat HIV infection: lamivudine
and zidovudine. These two active ingredients belong to
a group of anti-retroviral medicines called: nucleoside
analogue reverse transcriptase inhibitors (NRTIs).
Lamivudine/Zidovudine Teva 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 assisting your body to fight infection.
Not everyone responds to Lamivudine/Zidovudine Teva
treatment in the same way. Your doctor will monitor the
effectiveness of your treatment.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
You are sensitive (allergic) to the active ingredients or
to any of the additional ingredients contained in the
medicine; see section 6 ”Further Information” in this
You have a very low red blood cell count (anemia)
or a very low white blood cell count (neutropenia).
Refer to your doctor if you think that one of these
applies to you.
Special warnings regarding use of this medicine
Some people taking Lamivudine/Zidovudine Teva or
other combination therapy for HIV are more at risk of
experiencing serious side effects.
You should be aware of the following risks:
If you have ever had liver disease, including hepatitis
B or C (if you have a hepatitis B infection, do no stop
treatment with Lamivudine/Zidovudine Teva without
consulting your doctor, as the hepatitis may come
If you have kidney disease
If you are seriously overweight (especially if you are a
Refer to your doctor if any of these apply to you. Your
doctor will decide if the active ingredients are suitable
for you. You may need extra tests, including blood tests,
while you are taking your medicine. For further information,
see section 4.
Pay attention to important symptoms
Some people taking medicines for treatment of HIV
infection develop other problems, which can be serious.
You need to know about important signs and symptoms
so that you can look out for them while you are taking
Read the information “Other possible side effects of
combination therapy for HIV infection” in section 4
of this leaflet.
Protect other people
HIV infection is spread by sexual contact with a person
who carries 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 anti-retroviral therapy.
Talk to your doctor regarding the precautions needed to
avoid infecting other people.
Other medicines and Lamivudine/Zidovudine Teva
If you are taking, or have recently taken, other
medicines, including non-prescription medicines and
nutritional supplements, tell the doctor or pharmacist.
Remember to tell your doctor or pharmacist if you start
taking a new medicine while taking Lamivudine/Zidovudine
Do not use the following medicines together with
Other medicinal preparations that contain lamivudine, for
the treatment of HIV infection or hepatitis B
Emtricitabine, to treat HIV infection
Stavudine, to treat HIV infection
Ribavirin or injections of ganciclovir, to treat viral
High dosages of co-trimoxazole, an antibiotic
Cladribine, used to treat hairy cell leukemia
Refer to your doctor if you are being treated with any
of these medicines.
There are medicines that can increase your likelihood
of getting side effects, or worsen side effects.
These medicines include:
Sodium valproate, to treat epilepsy
Interferon, to treat viral infections
Pyrimethamine, to treat malaria and other parasitic
Dapsone, to prevent pneumonia and treat skin
Fluconazole or flucytosine, to treat fungal infections
such as Candida
Pentamidine or atovaquone, to treat parasitic infections
Amphotericin or co-trimoxazole, to treat fungal and
Probenecid, to treat gout and similar conditions, and
given together with certain antibiotics to make them
Methadone, used as a heroin substitute
Vincristine, vinblastine or doxorubicin, to treat cancer
Tell your doctor if you are taking any of these
Some medicines interact with Lamivudine/Zidovudine
These medicines include:
Clarithromycin, an antibiotic -
If you are taking clarithromycin, take your dose at
least two hours before or after you take Lamivudine/
Phenytoin, to treat epilepsy -
Tell your doctor if you are taking phenytoin. Your doctor
may need to monitor your condition while you are taking
Medicines (usually liquids) that contain sorbitol and
other sugar alcohols (e.g., xylitol, mannitol, lactitol or
maltitol), if taken regularly.
Tell your doctor or pharmacist if you are taking any of
Pregnancy, breastfeeding and fertility
If you are pregnant, if you become pregnant or if you are
planning a pregnancy, consult your doctor about the risks
and benefits to you and your baby, of taking Lamivudine/
Lamivudine/Zidovudine Teva and similar medicines may
cause side effects in unborn babies. If you have taken
Lamivudine/Zidovudine Teva during your pregnancy, your
doctor may order 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.
Women who are HIV carriers must avoid breastfeeding,
because HIV infection can be passed on to the baby
through breast milk.
A small amount of the ingredients in Lamivudine/Zidovudine
Teva can also pass into your milk.
If you are breastfeeding or thinking about breastfeeding,
refer to your doctor immediately.
Driving and operating machinery
Lamivudine/Zidovudine Teva can make you dizzy and
cause other side effects that make you less alert. Do not
drive or operate machinery unless you are feeling well.
Important information about some of the ingredients
of this medicine
This medicine contains less than 23 mg sodium per tablet
and is therefore considered sodium-free.
3. HOW SHOULD YOU USE THE MEDICINE?
Always use the preparation according to the doctor’s
instructions. Check with the doctor or pharmacist if you are
uncertain about the preparation dosage and instructions
The dosage and treatment regimen will be determined
by the doctor only.
Swallow the Lamivudine/Zidovudine Teva tablets with a
little water. Lamivudine/Zidovudine Teva can be taken
with or without food.
If you cannot swallow the tablets whole, you can crush
them, mix them with a bit of food or drink and take the
whole dose immediately.
The tablet can be halved at the score line. There is no
information about chewing.
Stay in regular contact with your doctor.
Lamivudine/Zidovudine Teva helps control your condition.
Continue taking the medicine every day to avoid your
illness from getting worse. You may still develop infections
and illnesses linked to HIV infection.
Keep in touch with your doctor, and do not stop taking
Lamivudine/Zidovudine Teva without consulting with
The usual dosage is generally:
Adults and adolescents weighing 30 kg or more
The usual dosage is generally one tablet, twice a
Take the tablets at regular times, leaving approximately
12 hours between each tablet.
Children weighing 21-30 kg
The usual starting dose of Lamivudine/Zidovudine Teva
is half a tablet (1/2), taken in the morning, and one whole
tablet, taken in the evening.
Children weighing 14-21 kg
The usual starting dose of Lamivudine/Zidovudine Teva is
half a tablet (1/2), taken in the morning, and half a tablet
(1/2), taken in the evening.
For children weighing less than 14 kg, lamivudine and
zidovudine (the ingredients of Lamivudine/Zidovudine
Teva) should be taken separately.
Do not exceed the recommended dose
If you accidentally took a higher dosage or if a child has
accidentally swallowed the medicine, refer immediately
to a doctor or proceed to a hospital emergency room and
bring the package of the medicine with you.
If you forgot to take this medicine at the required time,
take it as soon as you remember. Continue treatment as
usual. Do not take a double dose instead of the forgotten
Adhere to the treatment regimen as recommended by
Even if there is an improvement in your health, do not
stop treatment with the medicine without consulting the
doctor or pharmacist.
Do not take medicines in the dark! Check the label and
the dose each time you take a medicine. Wear glasses
if you need them.
If you have further questions regarding use of the
medicine, consult the doctor or pharmacist.
4. SIDE EFFECTS
During HIV treatment, there may be an increase in weight
and in blood lipids and glucose levels. This is partly linked
to health and life style, and in the case of blood lipids,
sometimes to the HIV medicines themselves. Your doctor
will check these changes.
LAMI/ZIDO TAB PL SH 240518
LAMI/ZIDO TAB PL SH 240518