Lamivudine Aurobindo Italia

Package leaflet: Information for the user

Lamivudina Aurobindo Italia 100 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of this leaflet

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

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

The active substance in Lamivudina Aurobindo Italia is lamivudine.
Lamivudina Aurobindo Italia is used for the long-term (chronic) treatment of hepatitis B infection in adults.
Lamivudina Aurobindo Italia is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).
Hepatitis B is caused by a virus that infects the liver, causes a long-lasting (chronic) infection, and can damage the liver. Lamivudina Aurobindo Italia can be used in people whose liver is damaged but still functions normally (compensated liver disease) and in combination with other medicines in people whose liver is damaged and does not function properly (decompensated liver disease).
Treatment with Lamivudina Aurobindo Italia can reduce the amount of hepatitis B virus in the body. This should lead to a reduction in liver damage and an improvement in liver function. Not all people respond to treatment with Lamivudina Aurobindo Italia in the same way. Your doctor will monitor the effectiveness of treatment with regular blood tests.

2. What you need to know before taking Lamivudine Aurobindo Italia

Your doctor should provide counselling and perform testing for HIV infection before starting treatment with lamivudine for hepatitis B infection, and during treatment. If you have or may have HIV infection, see section 3.

Do not take Lamivudine Aurobindo Italia

• 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 Lamivudine Aurobindo Italia.
Some people taking Lamivudine Aurobindo Italia or similar medicines are at increased risk of serious side effects. You should be aware of these additional risks:

• if you have had other types of liver disease, such as hepatitis C;
• if you are severely overweight (especially if you are a woman). 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 on the risks.

Do not stop taking Lamivudine Aurobindo Italia without medical advice, as there is a risk of worsening hepatitis. If you stop taking Lamivudine Aurobindo Italia, your doctor will monitor you for at least four months to check for any problems. This will include blood tests to monitor for any increases in liver enzyme levels, which may indicate liver damage. See section 3 for further information on how to take Lamivudine Aurobindo Italia.

Protecting other people
Hepatitis B infection spreads through sexual contact with infected individuals or through exposure to infected blood (for example, by sharing injecting needles). Lamivudine Aurobindo Italia will not prevent transmission of hepatitis B infection to others. To protect others from hepatitis B infection:

• use a condom during oral or penetrative sex;
• avoid contact with blood – for example, do not share needles.

Other medicines and Lamivudine Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other non-prescription medicines.
Remember to inform your doctor or pharmacist if you start taking a new medicine during treatment with Lamivudine Aurobindo Italia.
The following medicines must not be taken with Lamivudine Aurobindo Italia:

• 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 (sometimes called AIDS virus);
• emtricitabine, used to treat HIV infection or hepatitis B virus infection;
• cladribine, used to treat hairy cell leukaemia.

Inform your doctor if you are being treated with any of these medicines.

Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant:
Discuss with your doctor the risks and benefits of taking Lamivudine Aurobindo Italia during pregnancy. Do not stop treatment with Lamivudine Aurobindo Italia without consulting your doctor.

Breastfeeding
Lamivudine Aurobindo Italia may pass into breast milk. If you are breastfeeding or considering breastfeeding:
Talk to your doctor before taking Lamivudine Aurobindo Italia.

Driving and using machines
Lamivudine Aurobindo Italia may make you feel tired, which could affect your ability to drive or operate machinery. Do not drive or use machines unless you are sure you are not affected.

Lamivudine Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take Lamivudina Aurobindo Italia

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Stay in regular contact with your doctor.
Lamivudina Aurobindo Italia helps control hepatitis B infection. You must take it every day to keep the infection under control and to prevent the disease from worsening.
Stay in contact with your doctor and do not stop taking Lamivudina Aurobindo Italia without first consulting your doctor.

Dosage
The usual dose of Lamivudina Aurobindo Italia is one tablet (100 mg of lamivudine) once daily.
Your doctor may prescribe a lower dose if you have kidney problems. An oral solution of lamivudine is available for patients who require a lower dose than recommended or who cannot take tablets.
Talk to your doctor if this applies to you.

Patients who have or may contract HIV infection
If you have or develop HIV infection that is not being treated with antiretroviral medicines while taking lamivudine for hepatitis B infection, the HIV virus may develop resistance to certain HIV medicines, making the infection harder to treat. Lamivudine may also be used to treat HIV infection. Talk to your doctor if you have HIV infection. Your doctor may treat you with another medicine containing a higher dose of lamivudine, usually 150 mg twice daily, because the lower 100 mg dose of lamivudine is not sufficient to treat HIV infection. If you are planning to change your HIV treatment, talk to your doctor first about this change.
Talk to your doctor if this applies to you.

Swallow the tablet whole with a glass of water. Lamivudina Aurobindo Italia may be taken with or without food.

If you take more Lamivudina Aurobindo Italia than you should
If you accidentally take too much Lamivudina Aurobindo Italia, inform your doctor or pharmacist, or contact the emergency department of your nearest hospital for further advice. If possible, show them the Lamivudina Aurobindo Italia packaging.

If you forget to take Lamivudina Aurobindo Italia
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.

If you stop taking Lamivudina Aurobindo Italia
Do not stop taking Lamivudina Aurobindo Italia without consulting your doctor. There is a risk that hepatitis may worsen (see section 2). When you stop taking Lamivudina Aurobindo Italia, your doctor will monitor you for at least four months to check for any problems. This will involve blood tests to monitor any increases in liver enzyme levels, which may indicate liver damage.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects commonly reported in clinical studies of lamivudine include fatigue, respiratory tract infections, headache, stomach pain, nausea, vomiting and diarrhoea, and increases in liver enzymes and in enzymes produced in the muscles (see below).

Allergic reaction
These are rare (may affect up to 1 in 1,000 people). Signs include:

• swelling of the eyelids, face or lips;
• difficulty swallowing or breathing.
  Contact your doctor immediately if you experience these symptoms. Stop taking Lamivudina Aurobindo Italia.

Side effects believed to be caused by Lamivudina Aurobindo Italia
A very common side effect (may affect more than 1 in 10 people), which may be detected by blood tests, is:

• an increase in levels of certain liver enzymes (transaminases), which may be a sign of liver inflammation or damage.

A common side effect (may affect up to 1 in 10 people) is:

• muscle cramps and muscle pain;
• skin rash or hives anywhere on the body.

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

• an increase in levels of an enzyme produced in the muscles (creatine phosphokinase), which may be a sign of tissue damage.

A very rare side effect (may affect up to 1 in 10,000 people) is:

• lactic acidosis (excess lactic acid in the blood).

Other side effects
Other side effects have occurred in a very small number of people, but their exact frequency is unknown:

• breakdown of muscle tissue;
• worsening of liver disease after stopping Lamivudina Aurobindo Italia, or during treatment if the hepatitis B virus becomes resistant to Lamivudina Aurobindo Italia. This may be fatal in some people.

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

• a reduction in the number of cells involved in blood clotting (thrombocytopenia).

If you experience any side effects
Tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects
If you experience 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 at 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 Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton 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 Aurobindo Italia contains

• The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
• The other components are: Tablet core: microcrystalline cellulose (grades 101 and 102), sodium starch glycolate (type A), magnesium stearate. Tablet coating: hypromellose 2910, macrogol 400, titanium dioxide (E171), polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Lamivudina Aurobindo Italia and contents of the pack
Film-coated tablets.
Film-coated, caramel-coloured, capsule-shaped, biconvex tablets, with 'L100' engraved on one side and smooth on the other side. The size is 11.1 mm x 5.6 mm.
Lamivudina Aurobindo Italia tablets are available in blister packs.
Pack sizes:
Blister packs: 28 and 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102 – 21047 Saronno (VA) - Italy
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua João de Deus, 19, 2700-487 Amadora
Portugal
Arrow Génériques
26 avenue Tony Garnier, Lyon, 69007
France

This medicinal product is authorised in the European Economic Area countries under the
following names:
France: Lamivudine Arrow 100 mg, comprimé pelliculé
Germany: Lamivudin Aurobindo 100 mg Filmtabletten
Italy: Lamivudina Aurobindo Italia
Poland: Lamivudine Aurovitas
Portugal: Lamivudina Aurobindo