LAMIVUDINE ZIDOVUDINE TEVA 150 MG 300 MG

Israel - English - Ministry of Health

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Active ingredient:
LAMIVUDINE AS ANHYDROUS; ZIDOVUDINE
Available from:
ABIC MARKETING LTD, ISRAEL
ATC code:
J05AF01
Pharmaceutical form:
TABLETS
Composition:
ZIDOVUDINE 300 MG; LAMIVUDINE AS ANHYDROUS 150 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY, HUNGARY
Therapeutic group:
ZIDOVUDINE
Therapeutic area:
ZIDOVUDINE
Therapeutic indications:
Antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.
Authorization number:
149 62 33825 00
Authorization date:
2018-03-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

16-10-2018

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

infection.

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:

Headache

Feeling nauseated

Common side effects that may occur in up to 1 in every

10 people:

Vomiting

Diarrhea

Stomach pains

Loss of appetite

Feeling dizzy

Tiredness, lack of energy

Fever

General unwell feeling

Difficulty in sleeping (insomnia)

Muscle pain and discomfort

Joint pain

Cough

Irritated or runny nose

Skin rash

Hair loss

Common side effects that might show up in blood

tests are:

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

the skin.

Uncommon side effects that may occur in up to 1 in

every 100 people:

Shortness of breath

Wind (flatulence)

Itching

Muscle weakness

An uncommon side effect that may show up in a blood

test is:

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

1,000 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 (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)

Chest

pain,

disease

heart

muscle

(cardiomyopathy)

Fits (convulsions)

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

Numbness

Passing urine more often

Enlarged breasts in men

Rare side effects that may show up in blood tests

are:

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

10,000 people:

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

HIV treatment.

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

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 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

liver.

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

Drowsiness

Numbness or weakness in the limbs

Nausea, vomiting

Stomach pain

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

time.

They are also taking anti-inflammatory medicines called

corticosteroids.

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

shoulder).

Difficulty moving.

If you notice any of these symptoms: Refer to your

doctor.

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:

https://forms.gov.il/globaldata/getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

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

doctor.

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

contains –

Microcrystalline cellulose, Sodium starch glycolate,

Sodium stearyl fumarate

The tablet coating contains:

Titanium dioxide, Hypromellose, Macrogol 400,

Polysorbate 80.

What the medicine looks like and the contents of the

package –

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,

Netanya.

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

Lamivudine/Zidovudine Teva

150 mg/300 mg Tablets

Composition

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

is similar.

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

leaflet.

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

back)

If you have kidney disease

If you are seriously overweight (especially if you are a

woman)

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

Lamivudine/Zidovudine Teva.

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

Teva.

Do not use the following medicines together with

Lamivudine/Zidovudine Teva:

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

infections

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

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

Pneumocystis jirovecii

pneumonia (usually

called PCP)

Amphotericin or co-trimoxazole, to treat fungal and

bacterial infections

Probenecid, to treat gout and similar conditions, and

given together with certain antibiotics to make them

more effective

Methadone, used as a heroin substitute

Vincristine, vinblastine or doxorubicin, to treat cancer

Tell your doctor if you are taking any of these

medicines.

Some medicines interact with Lamivudine/Zidovudine

Teva

These medicines include:

Clarithromycin, an antibiotic -

If you are taking clarithromycin, take your dose at

least two hours before or after you take Lamivudine/

Zidovudine Teva.

Phenytoin, to treat epilepsy -

Tell your doctor if you are taking phenytoin. Your doctor

may need to monitor your condition while you are taking

Lamivudine/Zidovudine Teva.

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

these.

Pregnancy, breastfeeding and fertility

Pregnancy

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/

Zidovudine Teva.

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.

Breastfeeding

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

for use.

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

your doctor.

The usual dosage is generally:

Adults and adolescents weighing 30 kg or more

The usual dosage is generally one tablet, twice a

day.

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

dose.

Adhere to the treatment regimen as recommended by

the doctor.

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

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