Lamivudine Teva Pharma B.V.: detailed information

Package leaflet: Information for the user

Lamivudina Teva Pharma B.V. 150 mg film-coated tablets

lamivudine
Read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Lamivudina Teva Pharma B.V. is and what it is used for
What you need to know before taking Lamivudina Teva Pharma B.V.
How to take Lamivudina Teva Pharma B.V.
Possible side effects
How to store Lamivudina Teva Pharma B.V.
Contents of the pack and other information

1. What Lamivudine Teva Pharma B.V. is and what it is used for

Lamivudine Teva Pharma B.V. is used to treat HIV infection (Human Immunodeficiency Virus) in adults and children.
The active substance in Lamivudine Teva Pharma B.V. is lamivudina. Lamivudina Teva
Pharma B.V. is a type of medicine known as an antiretroviral. It belongs to a group of
medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Lamivudina Teva Pharma B.V. does not completely cure HIV infection; it reduces the amount of
virus in the body and keeps it at low levels. It also increases the number of CD4 cells in the blood.
CD4 cells are a type of white blood cell important in helping the body fight infection.
Not all people respond to treatment with Lamivudina Teva Pharma B.V. in the same
way. Your doctor will monitor how well the treatment is working.

2. What you should know before taking Lamivudina Teva Pharma B.V.

Do not take Lamivudina Teva Pharma B.V.

if you are allergic to lamivudine or to any of the other ingredients of this medicine (listed in section 6).

Consult your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lamivudina Teva Pharma B.V.
Some people who take Lamivudina Teva Pharma B.V., or other combination therapies for the
treatment of HIV, are at higher risk of serious side effects. You should be aware of these additional risks:

if you have had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Lamivudina Teva Pharma B.V. without consulting your doctor, as hepatitis may flare up)
if you are severely overweight (especially if you are a woman)
if you or your child has kidney problems, the dose may need to be adjusted. Inform your doctor if any of these situations apply to you. You may require additional monitoring, including blood tests, while taking this medicine. See section 4 for further information.

Be alert to important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. You should be informed about important signs and symptoms so that you can remain vigilant while taking Lamivudina Teva Pharma B.V.
Read the information under 'Other possible side effects of combination therapy for HIV' in section 4 of this leaflet.
Other medicines and Lamivudina Teva Pharma B.V.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Remember to inform your doctor or pharmacist if you start taking a new medicine while being treated with Lamivudina Teva Pharma B.V.
The following medicines must not be taken with Lamivudina Teva Pharma B.V.:

medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
other medicines containing lamivudine (used to treat HIV infection or hepatitis B virus infection).
emtricitabine (used to treat HIV infection).
high doses of co-trimoxazole, an antibiotic.
cladribine (used to treat hairy cell leukemia). Inform your doctor if you are being treated with any of these medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Lamivudina Teva Pharma B.V. and similar medicines may cause side effects in unborn children. If you have already taken Lamivudina Teva Pharma B.V. during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor your baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the child through breast milk.
A small amount of the components of Lamivudina Teva Pharma B.V. may also pass into breast milk.
If you are breastfeeding or considering breastfeeding, you should discuss this with your doctor as soon as possible.
Driving and using machines
It is unlikely that Lamivudina Teva Pharma B.V. will affect your ability to drive vehicles or operate machinery.
Lamivudina Teva Pharma B.V. contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially "sodium-free".

3. How to take Lamivudina Teva Pharma B.V.

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablets with water. Lamivudina Teva Pharma B.V. may be taken with or without food.
If you are unable to swallow the tablets whole, you may break them and mix them with a small amount of food or liquid, and take the entire dose immediately.

Stay in regular contact with your doctor.
Lamivudina Teva Pharma B.V. helps control your condition. You must take it every day to prevent your illness from worsening. You may still develop other infections and illnesses related to HIV infection.

Keep in contact with your doctor, and do not stop taking Lamivudina Teva Pharma B.V. without your doctor's advice.

The recommended dose is:

Adults, adolescents, and children weighing at least 25 kg:
The recommended dose of Lamivudina Teva Pharma B.V. is 300 mg daily. This may be taken either as one 150 mg tablet twice daily (approximately 12 hours apart), or as two 150 mg tablets once daily, according to your doctor’s instructions.

Children weighing at least 20 kg but less than 25 kg:
The recommended dose of Lamivudina Teva Pharma B.V. is 225 mg daily. This may be taken either as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one full 150 mg tablet) in the evening, or as 225 mg (one and a half 150 mg tablets) once daily, according to your doctor’s instructions.

Children weighing at least 14 kg but less than 20 kg:
The recommended dose of Lamivudina Teva Pharma B.V. is 150 mg daily. This may be taken either as 75 mg (half a 150 mg tablet) twice daily (approximately 12 hours apart), or as 150 mg (one 150 mg tablet) once daily, according to your doctor’s instructions.

An oral solution is also available for the treatment of children older than 3 months or for patients who require a lower dose than usual, or who are unable to swallow tablets.

If you or your child has kidney problems, the dose may need to be adjusted.
Talk to your doctor if this applies to you or your child.

If you take more Lamivudina Teva Pharma B.V. than you should
If you take too much Lamivudina Teva Pharma B.V., inform your doctor or pharmacist, or contact the nearest hospital emergency department for further advice. If possible, show them the Lamivudina Teva Pharma B.V. packaging.

If you forget to take Lamivudina Teva Pharma B.V.
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 the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
During HIV treatment, an increase in weight and in blood levels of lipids and glucose may occur. This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.
During HIV treatment, it may be difficult to determine whether a symptom is an unwanted effect of Lamivudina Teva Pharma B.V. or of other medicines you are taking, or an effect of HIV disease itself. For this reason, it is very important to inform your doctor about any changes in your health status.
During combination therapy for HIV, both the side effects listed below for Lamivudina Teva Pharma B.V. and other conditions may occur.
It is important to read the information elsewhere in this leaflet under the heading 'Other possible side effects of combination therapy for HIV'.

Common side effects
These may affect up to 1 in 10 patients:

headache
feeling unwell (nausea)
vomiting
diarrhoea
stomach pain
fatigue, lack of energy
fever (high temperature)
general feeling of illness
muscle discomfort and pain
joint pain
difficulty sleeping (insomnia)
cough
nasal irritation or runny nose
rash
hair loss (alopecia)

Uncommon side effects
These may affect up to 1 in 100 patients:
Uncommon side effects that may be detected by blood tests include:

reduced number of cells involved in blood clotting (thrombocytopenia)
low number of red blood cells (anaemia) or low number of white blood cells (neutropenia)
increased levels of liver enzymes

Rare side effects
These may affect up to 1 in 1,000 patients:

severe allergic reaction causing swelling of the face, tongue or throat, which may cause difficulty in swallowing or breathing
inflammation of the pancreas (pancreatitis)
breakdown of muscle tissue
inflammation of the liver (hepatitis)

A rare side effect that may be detected by blood tests is:

increased levels of an enzyme called amylase

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

lactic acidosis (excess lactic acid in the blood)
tingling or numbness in arms, legs, hands or feet

A very rare side effect that may be detected by blood tests is:

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

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

Other possible side effects of combination therapy for HIV
Combination therapy including Lamivudina Teva Pharma B.V. may lead to the development of other conditions during HIV treatment.

Old infections may flare up again
People with advanced HIV infection (Acquired Immunodeficiency Syndrome - AIDS) have a weakened immune system and are more likely to develop serious (opportunistic) infections. When such people start treatment, previously hidden old infections may flare up again, causing signs and symptoms of inflammation. These symptoms are likely due to immune reconstitution, whereby the body starts fighting these infections.
In addition to opportunistic infections, autoimmune diseases (a condition occurring when the immune system attacks healthy body tissue) may also occur after you start taking medicines for HIV infection. Autoimmune diseases may occur many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving towards the trunk, palpitations, tremor or hyperactivity, inform your doctor immediately to receive the necessary treatment.
If you notice any signs of infection while taking Lamivudina Teva Pharma B.V.: inform your doctor immediately. Do not take any other medicines for infection without medical advice.

You may have bone problems
Some people receiving combination antiretroviral therapy for HIV infection develop a condition called osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood supply to the bone. People may be more likely to develop this condition if they:

have been on combination therapy for a long time
are also taking anti-inflammatory medicines called corticosteroids
consume alcoholic beverages
have a very weak immune system
are overweight

Signs of osteonecrosis include:

joint stiffness
pain (especially in the knee, hip or shoulder)
difficulty moving

If you notice any of these symptoms: inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamivudine Teva Pharma B.V.

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 container, on the box, and on the
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lamivudina Teva Pharma B.V. contains

The active substance is lamivudine. Each film-coated tablet contains 150 mg of lamivudine.
The other components are: Tablet core: microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate. Film coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Lamivudina Teva Pharma B.V. and contents of the pack
Film-coated, light grey, rhomboid-shaped, biconvex tablets, marked with "L 150" and a breakline on one side and a breakline on the other side.
Lamivudina Teva Pharma B.V. is available in aluminum blisters containing 20, 30, 60, 80, 90, 100 and 500 tablets or in HDPE containers containing 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagiút 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Teл: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos,
Tél: +33 155917800 Lda.
Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

Package leaflet: Information for the user

Lamivudina Teva Pharma B.V. 300 mg film-coated tablets

lamivudine
Please read this entire leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Lamivudina Teva Pharma B.V. is and what it is used for
What you need to know before taking Lamivudina Teva Pharma B.V.
How to take Lamivudina Teva Pharma B.V.
Possible side effects
How to store Lamivudina Teva Pharma B.V.
Package contents and other information

1. What is Lamivudine Teva Pharma B.V. and what is it used for?

Lamivudine Teva Pharma is used to treat HIV (Human Immunodeficiency Virus) infection in adults and children.
The active substance in Lamivudine Teva Pharma B.V. is lamivudine. Lamivudine Teva
Pharma B.V. is a type of medicine known as an antiretroviral. It belongs to a group of
drugs called nucleoside reverse transcriptase inhibitors (NRTIs).
Lamivudine Teva Pharma B.V. does not completely cure HIV infection, but reduces the amount of
virus in the body and keeps it at low levels. It also increases the number of CD4 cells in the blood.
CD4 cells are a type of white blood cell important in helping the body fight infection.
Not all people respond to treatment with Lamivudine Teva Pharma B.V. in the same
way. Your doctor will monitor how well the treatment is working.

2. What you need to know before taking Lamivudina Teva Pharma B.V.

Do not take Lamivudina Teva Pharma B.V.

if you are allergic to lamivudine or to any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lamivudina Teva Pharma B.V.
Some people taking Lamivudina Teva Pharma B.V. or other combination therapies for the treatment of HIV are at higher risk of serious side effects. You should be aware of these additional risks:

if you have had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Lamivudina Teva Pharma B.V. without consulting your doctor, as hepatitis may worsen)
if you are severely overweight (especially if you are a woman)
if you or your child have kidney problems, the dose may need to be adjusted. Inform your doctor if any of these situations apply to you. You may require additional monitoring, including blood tests, while taking this medicine. See section 4 for further information.

Be alert to important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. You should be aware of important signs and symptoms so that you can pay attention while taking Lamivudina Teva Pharma B.V.
Read the information on ‘Other possible side effects of combination therapy for HIV’ in section 4 of this leaflet.
Other medicines and Lamivudina Teva Pharma B.V.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Remember to inform your doctor or pharmacist if you start taking a new medicine while being treated with Lamivudina Teva Pharma B.V.
The following medicines must not be taken with Lamivudina Teva Pharma B.V.:

medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
other medicines containing lamivudine (used to treat HIV infection or hepatitis B virus infection).
emtricitabine (used to treat HIV infection).
high doses of co-trimoxazole, an antibiotic.
cladribine (used to treat hairy cell leukemia). Inform your doctor if you are being treated with any of these medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Lamivudina Teva Pharma B.V. and similar medicines may cause side effects in unborn children. If you have already taken Lamivudina Teva Pharma B.V. during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor your baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the baby through breast milk.
A small amount of the components of Lamivudina Teva Pharma B.V. may also pass into breast milk.
If you are breastfeeding or considering breastfeeding, you should discuss this with your doctor as soon as possible.
Driving and using machines
It is unlikely that Lamivudina Teva Pharma B.V. will affect your ability to drive or use machinery.
Lamivudina Teva Pharma B.V. contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially "sodium-free".

3. How to take Lamivudine Teva Pharma B.V.

Take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
Swallow the tablets with water. Lamivudine Teva Pharma B.V. may be taken with or without food.
If you are unable to swallow the tablets whole, you may crush them and mix with a small amount
of food or liquid, then take the entire dose immediately.
Stay in regular contact with your doctor.
Lamivudine Teva Pharma B.V. helps control your condition. It is important to take it every
day to prevent your disease from worsening. You may still develop other infections and illnesses related
to HIV infection.
Keep in touch with your doctor and do not stop taking Lamivudine Teva Pharma B.V. without
your doctor's advice.
The recommended dose is
Adults, adolescents, and children weighing at least 25 kg
The recommended dose is one 300 mg tablet once daily.
A 150 mg tablet of Lamivudine Teva Pharma B.V. is also available for the treatment of children aged 3 months and older who weigh less than 25 kg.
An oral solution is also available for the treatment of children over 3 months of age or for patients who require a lower than usual dose, or who are unable to swallow tablets.
If you or your child have kidney problems, the dose may need to be adjusted.
Talk to your doctor if this applies to you or your child.
If you take more Lamivudine Teva Pharma B.V. than you should
If you take too much Lamivudine Teva Pharma B.V., inform your doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, show them the Lamivudine Teva Pharma B.V. packaging.
If you forget to take Lamivudine Teva Pharma B.V.
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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During HIV treatment, weight gain and increases in blood lipid and glucose levels may occur. This is
partly related to recovery of health status and lifestyle, and in the case of blood lipids, sometimes to
the HIV medicines themselves. Your doctor will monitor these changes.
During HIV treatment, it may be difficult to determine whether a symptom is an unwanted effect of
Lamivudina Teva Pharma B.V. or of other medicines you are taking, or an effect of HIV disease itself.
For this reason, it is very important to inform your doctor about any change in your health status.
During combination therapy for HIV, both the side effects listed below for Lamivudina Teva Pharma B.V.
and other conditions may occur.
It is important to read the information elsewhere in this leaflet under the heading ‘Other possible
side effects of combination therapy for HIV’.

Common side effects
These may affect up to 1 in 10 patients:

headache
feeling unwell ( nausea )
vomiting
diarrhoea
stomach pain
tiredness, lack of energy
fever (high temperature)
general feeling of being unwell
muscle discomfort and pain
joint pain
difficulty sleeping ( insomnia )
cough
nasal irritation or runny nose
skin rash
hair loss ( alopecia )

Uncommon side effects
These may affect up to 1 in 100 patients:
Uncommon side effects that may be detected by blood tests include:

reduced number of cells involved in blood clotting ( thrombocytopenia )
low number of red blood cells ( anaemia ) or low number of white blood cells ( neutropenia )
increased levels of liver enzymes.

Rare side effects
These may affect up to 1 in 1,000 patients:

severe allergic reaction causing swelling of the face, tongue or throat, which may cause difficulty in swallowing or breathing
inflammation of the pancreas ( pancreatitis )
breakdown of muscle tissue
inflammation of the liver ( hepatitis )

A rare side effect that may be detected by blood tests is:

increased levels of an enzyme called amylase.

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

lactic acidosis (excess lactic acid in the blood)
tingling or numbness in arms, legs, hands or feet.

A very rare side effect that may be detected by blood tests is:

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

If you experience side effects
Tell your doctor or pharmacist if any of the side effects become severe or bothersome, or if you notice
any side effect not listed in this leaflet.

Other possible side effects of combination therapy for HIV
Combination therapy including Lamivudina Teva Pharma B.V. may lead to the development of other
conditions during HIV treatment.

Old infections may flare up
People with advanced HIV infection (Acquired Immune Deficiency Syndrome - AIDS) have a weakened
immune system and are more likely to develop serious (opportunistic) infections. When these people
start treatment, previously hidden old infections may flare up, causing signs and symptoms of
inflammation. These symptoms are likely due to immune reconstitution, whereby the body begins to
fight these infections.

In addition to opportunistic infections, autoimmune diseases (a condition in which the immune system
attacks healthy body tissue) may also occur after you start taking medicines for HIV infection. Autoimmune
diseases may occur many months after starting treatment. If you notice any symptoms of infection or
other symptoms such as muscle weakness, weakness starting in the hands and feet and moving
upwards towards the trunk, palpitations, tremor or hyperactivity, inform your doctor immediately to
receive the necessary treatment.

If you notice any symptoms of infection while taking Lamivudina Teva Pharma B.V.:
inform your doctor immediately . Do not take any other medicines for infection without medical
advice.

You may have bone problems
Some people receiving combination antiretroviral therapy for HIV infection develop a condition called
osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood supply to
the bone. People may be more likely to develop this condition if they:

have been on combination therapy for a long time
are also taking anti-inflammatory medicines called corticosteroids
consume alcohol
have a very weak immune system
are overweight.

Signs of osteonecrosis include:

stiffness in the joints
pain (especially in the knee, hip or shoulder)
difficulty in movement

If you notice any of these symptoms: inform your doctor .

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You
can also report side effects directly via the national reporting system listed in Annex V. By reporting
side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamivudine Teva Pharma B.V.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container, on the box, and on the
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lamivudina Teva Pharma B.V. contains

The active substance is lamivudine. Each film-coated tablet contains 300 mg of lamivudine.
The other components are: Tablet core: microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate. Film coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Lamivudina Teva Pharma B.V. and pack contents
Grey, rhomboid-shaped, biconvex film-coated tablets, imprinted with "L 300" on one side and smooth on the other.
Lamivudina Teva Pharma B.V. is available in aluminum blisters containing 20, 30, 60, 80, 90, 100 and 500 tablets or in HDPE containers containing 30 tablets.
Not all pack sizes may be marketed.