LAMIVUDINA 150 mg Film-Coated Tablets

Зміст інструкції

1. Lamivudina Aurobindo 150 mg film-coated tablets
   1. What is Lamivudina Aurobindo and what is it used for
   2. What you need to know before taking Lamivudina Aurobindo
   3. How to take Lamivudina Aurobindo
   4. Possible side effects
   5. How to store Lamivudina Aurobindo
   6. Contents of the pack and other information
2. Lamivudina Aurobindo 300 mg film-coated tablets
   1. What is Lamivudina Aurobindo and what is it used for
   2. What you need to know before taking Lamivudina Aurobindo
   3. How to take Lamivudina Aurobindo
   4. Possible side effects
   5. How to store Lamivudina Aurobindo
   6. Package contents and other information

Lamivudina Aurobindo 150 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lamivudina Aurobindo is and what it is used for
• 2. What you need to know before you take Lamivudina Aurobindo
• 3. How to take Lamivudina Aurobindo
• 4. Possible side effects
• 5. How to store Lamivudina Aurobindo
• 6. Contents of the pack and other information

1. What is Lamivudina Aurobindo and what is it used for

Lamivudina Aurobindo is used for the treatment of HIV (human immunodeficiency virus) infection in adults and children.
The active substance of Lamivudina Aurobindo is lamivudine. Lamivudina Aurobindo is a type of medicine
known as an antiretroviral. It belongs to a group of medicines called nucleoside reverse transcriptase inhibitors (NRTIs)

.
Lamivudina Aurobindo does not completely cure HIV infection; it reduces the amount of virus
in the body and keeps it at a low level. It also increases the number of CD4 cells in your blood.
CD4 cells are a type of white blood cell that are important in helping your body fight
infections.
Not all people respond to treatment with Lamivudina Aurobindo in the same way. The doctor
will check the effectiveness of the treatment.

2. What you need to know before taking Lamivudina Aurobindo

Do not take Lamivudina Aurobindo

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

Consult your doctorif you think this applies to you.

Warnings and precautions
Some people taking Lamivudina Aurobindo or other combination treatments for HIV are at higher risk of serious side effects. You should be informed of the additional risks:

• if you have previously had liver disease, including hepatitis B or C (if you have had hepatitis B infection, do not stop taking Lamivudina Aurobindo without consulting your doctor, as the hepatitis may return);
• 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.

Talk to your doctor if any of these situations apply to you. You may need further tests, including blood tests, while taking the medicine. See section 4 for more
information.
Be aware of important symptoms
Some people taking medicines for HIV infection develop other conditions that can be serious. You need to know the signs and symptoms to watch out for while taking
Lamivudina Aurobindo.

Read the information “Other possible side effects of combination therapy for HIV” in the
Protecting others
HIV infection spreads through sexual contact with someone who has the infection or through the passage of infected blood
(e.g. through sharing injection needles). You can still transmit HIV while taking
this medicine, although the risk is reduced by the effect of antiretroviral therapy.
Discuss with your doctor the precautions necessary to avoid transmitting the infection to others.

Other medicines and Lamivudina Aurobindo
Tell your doctor or pharmacist if you are taking any other medicines, or have recently
taken, or might take any other medicines, including herbal remedies or other non-prescription medicines.
Remember to tell your doctor or pharmacist if you start taking a new medicine while taking Lamivudina Aurobindo.

These medicines must not be used with Lamivudina Aurobindo:
lactitol or maltitol), if taken regularly;

• other medicines that contain lamivudine (used for the treatment of HIV infectionor hepatitis B);
• emtricitabine (used for the treatment of HIV infection);
• high doses of co-trimoxazole, an antibiotic;
• cladribine (used to treat hairy cell leukemia).

Tell your doctorif you are being treated with any of these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, discuss the risks and benefits of taking Lamivudina Aurobindo with your doctor for you and your baby.
Lamivudina Aurobindo and similar medicines can cause unwanted effects in unborn babies.
If you have taken Lamivudina Aurobindo during pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of the baby. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of
side effects.

Breastfeeding
Women who are HIV positive should not breastfeedas HIV infection can pass to the
baby through breast milk.
A small amount of lamivudine components may also pass into breast milk.
If you are breastfeeding or planning to breastfeed:

Consult your doctor immediately.
Driving and using machines
It is unlikely that Lamivudina Aurobindo will affect your ability to drive or operate
machinery.

3. How to take Lamivudina Aurobindo

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Swallow the tablets with a little water. Lamivudina Aurobindo can be taken with or without food.
If you are unable to swallow the tablet, you can break it and add it to a small amount of food or
drink, and take the entire dose immediately.

Stay in regular contact with your doctor
Lamivudina Aurobindo helps to control your condition. It is necessary to continue taking it every
day to prevent your illness from worsening. You may still develop other infections and diseases related
to HIV infection.

Stay in contact with your doctor and do not stop taking Lamivudina Aurobindo without your
doctor's advice.
How much medicine to take
Adults, adolescents and children weighing at least 25 kg:
The recommended dose of Lamivudina Aurobindo is 300 mg per day.This can be taken either
as one 150 mg tablet twice a day (leaving approximately 12 hours between each dose), or 2 tablets
of 150 mg once a day as recommended by your doctor.

Children weighing at least 20 kg and less than 25 kg:
The recommended dose of Lamivudina Aurobindo is 225 mg per day.This can be given either
as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening
or as 225 mg (one and a half 150 mg tablet) once a day as recommended by your doctor.

Children weighing at least 14 kg and less than 20 kg:
The recommended dose of Lamivudina Aurobindo is 150 mg per day.This can be given as 75
mg (half a 150 mg tablet) twice a day (leaving approximately 12 hours between each dose) or
150 mg (one 150 mg tablet) once a day as recommended by your doctor.
An oral solution may also be available for the treatment of children over 3 months of age
or for people who need lower doses or who are unable to take the tablets.

If you or your child have kidney problems, the dose may be adjusted.

Talk to your doctorif any of these situations apply to you or your child.

If you take more Lamivudina Aurobindo than you should
It is unlikely that accidentally taking an overdose of Lamivudina Aurobindo will cause serious
problems.
If you take an overdose, tell your doctor or pharmacist, or contact the nearest hospital emergency room for further advice.

If you forget to take Lamivudina Aurobindo
If you forget to take your dose, take it as soon as you remember. Then continue your treatment
as usual.
Do not take a double dose to make up for a missed tablet.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in body weight and levels of lipids and glucose in the blood may occur. This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check for these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
When you are being treated for HIV, it can be difficult to tell if a symptom is a side effect of Lamivudina Aurobindo or other medicines you are taking, or an effect of the HIV disease itself.

For this reason, it is important to inform your doctor about any changes in your state of health.

In addition to the side effects listed below for Lamivudina Aurobindo, other conditions may develop during combination therapy for HIV.
It is important to read the information further on in this paragraph under “Other possible side effects of combination therapy for HIV”.

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

• headache;
• feeling unwell (nausea);
• feeling sick (vomiting);
• diarrhea;
• stomach pain;
• fatigue, lack of energy;
• fever (high temperature);
• general feeling of being unwell;
• muscle pain and discomfort;
• joint pain;
• difficulty sleeping (insomnia);
• cough;
• irritated or runny nose;
• skin rash;
• hair loss (alopecia).

Uncommon side effects
These effects may affect up to 1 in 100 people:
Uncommon side effects that may show up in blood tests:

• reduction in the number of cells involved in blood clotting (thrombocytopenia);
• low number of red blood cells (anemia) or low number of white blood cells (neutropenia);
• increased levels of liver enzymes.

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

• severe allergic reaction causing swelling of the face, tongue or throat which can cause difficulty swallowing or breathing;
• inflammation of the pancreas (pancreatitis);
• muscle tissue breakdown;
• liver disorders such as jaundice, enlargement of the liver or fat in the liver, inflammation (hepatitis).

A rare side effect that may show up in blood tests is:

• increased levels of an enzyme called amylase.

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

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

A very rare side effect that may show up in blood tests is:

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

If you develop side effects
If any of these side effects get worse or become troublesome, or if you notice any

Other possible side effects of combination therapy for HIV
Combination therapy including Lamivudina Aurobindo can cause the development of other conditions during treatment for HIV.

Old infections can reappear
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old infections that were hidden can reappear, causing signs and symptoms of inflammation. These symptoms are likely caused by the body’s immune system, which, as it gets stronger, begins to fight these infections.
After starting treatment for HIV infection, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissues in the body) can also occur, in addition to opportunistic infections. Autoimmune disorders can 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 rising to the trunk, palpitations, tremors and hyperactivity, tell your doctor immediately for necessary treatment.
If you experience any symptoms of infection while taking Lamivudina Aurobindo:

Tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

You may have bone problems
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, part of the bone tissue dies due to a reduced blood supply to the bone. People are more likely to develop 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 system is very weak;
• if they are overweight.

The signs of osteonecrosis include:

• joint stiffness;
• pain (especially in the hip, knee or shoulder);
• difficulty moving. If you notice any of these symptoms: Tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lamivudina Aurobindo

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 on the packaging after SCAD.
The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lamivudina Aurobindo contains

• The active ingredient is lamivudine. Each film-coated tablet contains 150 mg of lamivudine.
• Other ingredients are: Tablet core:Microcrystalline cellulose (E460), Sodium starch glycolate (Type A), Magnesium stearate (E572). Tablet coating:Hypromellose (E464), Macrogol (400), Titanium dioxide (E171) and Polysorbate 80 (E433)

Description of Lamivudina Aurobindo and contents of the pack
Film-coated tablet.
Tablets of white to off-white color, film-coated, rhomboid in shape, imprinted with “Z” and
“25” separated by a score line on one side and smooth with a score line on the other side. The tablet
can be divided into two equal doses.
Lamivudina Aurobindo film-coated tablets are available in blisters and in HDPE bottles.

Pack size:

Blister pack:1, 14, 30, 60, 120 and 500 tablets.

Bottle pack:60 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
France Lamivudine Arrow 150 mg film-coated tablet, divisible
Germany Lamivudin Aurobindo 150 mg film tablets
Italy Lamivudina Aurobindo
Netherlands Lamivudine Aurobindo 150 mg film-coated tablets
Portugal Lamivudina Aurobindo 150 mg
Romania Lamivudine Aurobindo 150 mg film-coated tablets
United Kingdom Lamivudine Aurobindo 150 mg film-coated tablets

Lamivudina Aurobindo 300 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Lamivudina Aurobindo is and what it is used for
• 2. What you need to know before you take Lamivudina Aurobindo
• 3. How to take Lamivudina Aurobindo
• 4. Possible side effects
• 5. How to store Lamivudina Aurobindo
• 6. Contents of the pack and other information

1. What is Lamivudina Aurobindo and what is it used for

Lamivudina Aurobindo is used for the treatment of HIV (human immunodeficiency virus) infection in adults and children.
The active substance of Lamivudina Aurobindo is lamivudine. Lamivudina Aurobindo is a type of medicine
known as an antiretroviral and belongs to a group of medicines called nucleoside reverse transcriptase inhibitors

(NRTIs).
Lamivudina Aurobindo does not completely cure HIV infection; it reduces the amount of virus
in the body and keeps it at a low level. It also increases the count of CD4 cells in your blood.
CD4 cells are a type of white blood cells that are important in helping your body fight
infections.
Not all people respond to treatment with Lamivudina Aurobindo in the same way. Your doctor
will monitor the effectiveness of the treatment.

2. What you need to know before taking Lamivudina Aurobindo

Do not take Lamivudina Aurobindo

• if you are allergicto lamivudine or any of the other ingredients of this medicine (listed in section 6). See your doctorif you think this applies to you. Warnings and precautionsSome people taking Lamivudina Aurobindo or other combination treatments for HIV are at a higher risk of serious side effects. You should be informed of the additional risks:
• if you have had liver diseasein the past, including hepatitis B or C (if you have had hepatitis B infection, do not stop taking Lamivudina Aurobindo without consulting your doctor, as hepatitis may return);
• if you are severely overweight(especially if you are a woman);
• if you have kidney problems, the dose may be changed.

Talk to your doctor if any of these situations apply to you.
You may need further checks, including blood tests, while taking the medicine.

See section 4 for more information.
Pay attention to important symptoms
Some people taking medicines for HIV infection develop other conditions that can
be serious. You need to know the signs and symptoms to watch out for while taking
Lamivudina Aurobindo.

Read the information “Other possible side effects of combination therapy for HIV” in the
Protecting others
HIV infection spreads through sexual contact with someone who has the infection or through the passage of infected blood
(e.g. through sharing injection needles). You can still transmit HIV while taking
this medicine, although the risk is reduced by the effect of antiretroviral therapy.
Discuss with your doctor the precautions necessary to avoid transmitting the infection to others.

Other medicines and Lamivudina Aurobindo
Tell your doctor or pharmacist if you are taking any other medicines, or have recently
taken, or might take any other medicines, including herbal medicines or other non-prescription medicines.
Remember to tell your doctor or pharmacist if you start taking a new medicine while taking Lamivudina Aurobindo.

These medicines must not be used with Lamivudina Aurobindo:

• medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol,
• other medicines that contain lamivudine (used for the treatment of HIV infectionor hepatitis B);
• emtricitabine (used for the treatment of HIV infection);
• high doses of co-trimoxazole, an antibiotic;
• cladribine (used to treat hairy cell leukemia).

Tell your doctorif you are being treated with any of these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, discuss the risks and
benefits of taking Lamivudina Aurobindo with your doctor for you and your baby.
Lamivudina Aurobindo and similar medicines can cause unwanted effects in unborn babies.
If you have taken Lamivudina Aurobindo during pregnancy, your doctor may require regular blood tests and other diagnostic tests to monitor the development of the baby. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of
side effects.

Breastfeeding
Women who are HIV positive should not breastfeedas HIV infection can pass to the
baby through breast milk.
A small amount of the components of Lamivudina Aurobindo can also pass into breast milk.
If you are breastfeeding or thinking about breastfeeding:

Contact your doctor immediately.
Driving and using machines
It is unlikely that Lamivudina Aurobindo will affect your ability to drive or operate
machinery.

3. How to take Lamivudina Aurobindo

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Swallow the tablets with a little water. Lamivudina Aurobindo can be taken with or without food.
If you are unable to swallow the tablet, you can break it and add it to a small amount of food or
drink, and take the entire dose immediately.

Stay in regular contact with your doctor
Lamivudina Aurobindo helps to control your condition. It is necessary to continue taking it every
day to prevent your illness from worsening. You may still develop other infections and diseases related
to HIV infection.

Stay in contact with your doctor and do not stop taking Lamivudina Aurobindowithout your
doctor's advice.

How much medicine you should take
Children weighing at least 25 kg:
The recommended dose of Lamivudina Aurobindo is 300 mg once a day.
A 150 mg Lamivudina Aurobindo tablet is also available for the treatment of children from 3
months of age who weigh less than 25 kg.
An oral solution may also be available for the treatment of children over 3 months of age
or for people who need lower doses or who are unable to take the tablets.

If you have kidney problems, the dose may be adjusted.

Talk to your doctorif any of these situations apply to you.

If you take more Lamivudina Aurobindo than you should
It is unlikely that accidentally taking an excessive dose of Lamivudina Aurobindo will cause serious
problems.
If you take an excessive dose, inform your doctor or pharmacist, or contact the nearest hospital's Emergency
Room for further advice.

If you forget to take Lamivudina Aurobindo
If you forget to take your dose, take it as soon as you remember. Then continue treatment as usual. Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

During treatment for HIV, an increase in body weight and lipid and blood glucose levels may occur. This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check for these changes.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
When being treated for HIV, it can be difficult to tell if a symptom is a side effect of Lamivudina Aurobindo or other medicines you are taking, or an effect of the HIV disease itself.

For this reason, it is important to inform your doctor about any changes in your health
In addition to the side effects listed below for Lamivudina Aurobindo, other conditions may develop during combination therapy for HIV.
It is important to read the information provided later in this paragraph under “Other possible side effects of combination therapy for HIV”.

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

• headache;
• feeling unwell (nausea);
• illness (vomiting);
• diarrhea;
• stomach pain;
• fatigue, lack of energy;
• fever (high temperature);
• general feeling of being unwell;
• muscle pain and discomfort;
• joint pain;
• difficulty sleeping (insomnia);
• cough;
• irritated or runny nose;
• skin rash;
• hair loss (alopecia).

Uncommon side effects
These effects may affect up to 1 in 100 people:
Uncommon side effects that may appear in blood tests:

• reduction in the number of cells involved in blood clotting (thrombocytopenia);
• low number of red blood cells (anemia) or low number of white blood cells (neutropenia);
• increased levels of liver enzymes.

Rare side effects
These effects may affect up to 1 in 1000 people:

• severe allergic reaction causing swelling of the face, tongue or throat which can cause difficulty swallowing or breathing;
• inflammation of the pancreas (pancreatitis);
• muscle tissue breakdown;
• liver disorders such as jaundice, enlarged liver or fat in the liver, inflammation (hepatitis).

A rare side effect that may appear in blood tests is:

• increased levels of an enzyme called amylase.

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

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

A very rare side effect that may appear in blood tests is:

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

If you develop side effects
If any of these side effects get worse or become troublesome, or if you notice any not listed here

Other possible side effects of combination therapy for HIV
Combination therapy including Lamivudina Aurobindo can cause the development of other conditions during treatment for HIV.

Old infections can reappear
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old infections that were hidden can reappear, causing signs and symptoms of inflammation. These symptoms are likely caused by the body’s immune system, which, as it gets stronger, begins to fight these infections.
After starting treatment for HIV infection, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissues in the body) can also occur, in addition to opportunistic infections. Autoimmune disorders can 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 rising to the trunk, palpitations, tremors and hyperactivity, tell your doctor immediately for necessary treatment.
If you experience any symptoms of infection while taking Lamivudina Aurobindo:

Tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

You may have bone problems
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, part of the bone tissue dies due to reduced blood supply to the bone. People are more likely to develop this condition:

• if they have been taking combination therapy for a long time;
• if they are also taking anti-inflammatory drugs called corticosteroids;
• if they drink alcohol;
• if their immune system is very weak;
• if they are overweight.

The signs of osteonecrosis include:

• joint stiffness;
• pain (especially in the hip, knee or shoulder);
• difficulty moving. If you notice any of these symptoms: Tell your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lamivudina Aurobindo

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 on the packaging after SCAD.
The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Do not dispose of any medicine in waste water 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 Aurobindo contains

• The active ingredient is lamivudine. Each film-coated tablet contains 300 mg of lamivudine.
• The other ingredients are: Tablet core:Microcrystalline cellulose (E460), Sodium starch glycolate (Type A), Magnesium stearate (E572). Tablet coating:Hypromellose (E424), Macrogol 400, Titanium dioxide (E171), Polysorbate 80 (E433) and Black iron oxide (E172).

Description of Lamivudina Aurobindo and package contents
Film-coated tablet.
Grey-colored, film-coated tablets, rhomboid in shape, with “Z26” imprinted on one side and smooth
on the other side.
Lamivudina Aurobindo film-coated tablets are available in blisters and in HDPE bottles.

Pack size:

Blister pack:1, 14, 30, 60, 120 and 500 tablets.

Bottle pack:30 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
France Lamivudine Arrow 300 mg coated tablet
Germany Lamivudin Aurobindo 300 mg film tablets
Italy Lamivudina Aurobindo
Netherlands Lamivudine Aurobindo 300 mg film-coated tablets
Portugal Lamivudina Aurobindo 300 mg
Spain Lamivudina Aurovitas 300 mg film-coated tablets EFG
United Kingdom Lamivudine Aurobindo 300 mg film-coated tablets