Lamivudine aurovitas

Package leaflet: Information for the user

Lamivudine Aurovitas, 100 mg, film-coated tablets
Lamivudinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Lamivudine Aurovitas is and what it is used for
2. Important information before taking Lamivudine Aurovitas
3. How to take Lamivudine Aurovitas
4. Possible side effects
5. How to store Lamivudine Aurovitas
6. Contents of the pack and other information

1. What Lamivudine Aurovitas is and what it is used for

The active substance in Lamivudine Aurovitas is lamivudine.
Lamivudine Aurovitas is used to treat chronic (long-term) hepatitis B virus infection in adults.
Lamivudine Aurovitas is an antiviral medicine that inhibits the replication of the hepatitis B virus and belongs to a group of medicines known as nucleoside analogue reverse transcriptase inhibitors (NRTIs).
The hepatitis B virus causes long-term (chronic) infection and may lead to liver damage. Lamivudine Aurovitas may be used in patients with liver damage but with preserved normal liver function (compensated liver disease).
Treatment with Lamivudine Aurovitas may reduce the amount of hepatitis B virus in the body. This may help reduce liver damage and improve liver function. Not everyone responds to treatment with Lamivudine Aurovitas in the same way. Your doctor will monitor the effectiveness of treatment and regularly order blood tests.

2. Important information before using Lamivudine Aurovitas

Before starting and during treatment for hepatitis B virus infection with lamivudine, the treating physician should offer the patient counselling and testing for HIV. If the patient is infected with HIV or becomes infected with HIV, see section 3.

When not to take Lamivudine Aurovitas

• if the patient is allergic to lamivudine or to any of the other ingredients of this medicine (listed in section 6). The patient should consult their doctor if they suspect any of these circumstances apply.

Warnings and precautions

Before taking Lamivudine Aurovitas, the patient should discuss this with their doctor or
pharmacist.

Some patients taking Lamivudine Aurovitas or similar medicines are at higher risk of developing severe side effects. The patient should be aware of this additional risk:

• if the patient has previously had other liver diseases, such as hepatitis C.
• if the patient is significantly overweight (particularly in women). The patient should inform their doctor if any of the above circumstances apply. The doctor may recommend additional monitoring tests during treatment, including blood tests. For more information about this risk, see section 4.

Do not stop taking Lamivudine Aurovitas without medical advice, as there is a risk of worsening hepatitis. After stopping Lamivudine Aurovitas, the doctor will monitor the patient’s condition for at least four months to detect any problems, including blood tests to check for abnormal liver enzyme activity, which may indicate liver damage. For more information on the use of Lamivudine Aurovitas, see section 3.

Protecting other people

Hepatitis B virus infection can be transmitted through sexual contact with infected individuals or through infected blood (e.g. by sharing contaminated injection needles). Treatment with Lamivudine Aurovitas does not prevent transmission of hepatitis B virus to others. To protect others from hepatitis B virus infection:

• condoms should be used during oral and penetrative sex;
• do not risk transmitting the infection through blood – for example, do not share needles.

Lamivudine Aurovitas and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, including herbal medicines and other medicines purchased without a prescription.

If the patient starts taking a new medicine while on Lamivudine Aurovitas, they should remember to inform their doctor or pharmacist.

The following medicines should not be used with Lamivudine Aurovitas:

• medicines (usually in liquid form) containing sorbitol or other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if used long-term;
• other medicines containing lamivudine used in the treatment of HIV infection (sometimes referred to as AIDS virus);
• emtricitabine used in the treatment of HIV infection or hepatitis B virus infection;
• cladribine used in the treatment of hairy cell leukaemia.

The patient should inform their doctor if they are being treated with any of these medicines.

Pregnancy

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant:

She should contact her doctor to discuss the benefits and risks of using Lamivudine Aurovitas during pregnancy.

Do not stop treatment with Lamivudine Aurovitas without consulting a doctor.

Breast-feeding

Lamivudine Aurovitas may pass into breast milk. If the patient is breast-feeding or intends to breast-feed:

She should consult her doctor before starting Lamivudine Aurovitas.

Driving and using machines

Lamivudine Aurovitas may cause fatigue, which could affect the ability to drive or operate machinery. Do not drive or operate machinery unless the patient is certain that the medicine does not affect them in this way.

Lamivudine Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Lamivudine Aurovitas

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
You should remain in regular contact with your doctor
Lamivudine Aurovitas helps control hepatitis B virus infection. It must be taken daily to keep the
infection under control and to prevent disease progression.
You must remain in regular contact with your doctor and must not stop taking
Lamivudine Aurovitas without your doctor's advice.
What dose should be taken
The usual dose of Lamivudine Aurovitas is one tablet (100 mg lamivudine)
once daily.
Your doctor may prescribe a lower dose of Lamivudine Aurovitas if you have kidney problems.
Lamivudine Aurovitas is available as an oral solution for patients who require a dose lower than
the standard dose or who cannot take tablets.
You should inform your doctor if either of these situations applies to you.
Patients infected with HIV or patients who may become infected with HIV
If, during treatment for hepatitis B virus infection with lamivudine, you are infected with HIV or
become infected with HIV and this infection is not treated, HIV may develop resistance to certain
antiretroviral drugs, making HIV treatment more difficult. Lamivudine can also be used in the
treatment of HIV infection. You should inform your doctor if you are infected with HIV. Your doctor
may recommend continuing treatment with a higher dose of lamivudine, usually 150 mg twice
daily, because the lamivudine dose in Lamivudine Aurovitas (100 mg) is not sufficient for treating
HIV infection. If you are planning to change your HIV treatment, you should discuss this with your
doctor first.
You should inform your doctor if either of these situations applies to you.
The tablet should be swallowed whole with water. Lamivudine Aurovitas may be taken with or
without food.
Taking more Lamivudine Aurovitas than prescribed
If you accidentally take too much Lamivudine Aurovitas, tell your doctor or pharmacist or go to the
nearest hospital emergency department for advice. If possible, show the medicine package of
Lamivudine Aurovitas.
Missing a dose of Lamivudine Aurovitas
If you miss a dose, take it as soon as possible and then continue taking the medicine as
prescribed. Do not take a double dose to make up for a missed dose.
Do not stop taking Lamivudine Aurovitas
Do not stop taking Lamivudine Aurovitas without consulting your doctor. There is a risk of
worsening liver inflammation (see section 2). If you stop taking Lamivudine Aurovitas, your doctor
will monitor your condition for at least four months to detect any problems. This includes blood
tests to check for increased liver enzyme activity, which may indicate liver damage.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects that were commonly reported in clinical trials of lamivudine include
fatigue, respiratory tract infections, sore throat, headache, stomach discomfort and pain,
nausea, vomiting and diarrhoea, increased activity of liver enzymes and enzymes
produced in muscles ( see below ).

Allergic reactions
These are rare (may affect no more than 1 in 1,000 people). Symptoms include:

• swelling of the eyelids, face and lips
• difficulty swallowing or breathing. You should contact your doctor immediately if you experience these symptoms. Stop taking Lamivudine Aurovitas.

Side effects that may be caused by Lamivudine Aurovitas
Very common side effects (may affect more than 1 in 10 people), which may be revealed in blood test results:

• increased activity of liver enzymes known as aminotransferases, which may indicate inflammation or damage to the liver.

Common side effects (may affect no more than 1 in 10 people):

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

Common side effects that may be revealed in blood test results:

• increased activity of an enzyme produced in muscles ( creatine kinase ), which may indicate damage to muscle tissue.

Very rare side effects (may affect no more than 1 in 10,000 people):

• 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:

• muscle tissue breakdown
• worsening of liver disease after stopping Lamivudine Aurovitas or during treatment, if hepatitis B virus becomes resistant to Lamivudine Aurovitas. In some patients, this may be fatal.

Adverse effects that may appear in blood tests:

• reduced number of blood cells involved in blood clotting (thrombocytopenia).

If the patient experiences any adverse effects
Tell your doctor or pharmacist , including any possible side effects not listed in this leaflet.
Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Lamivudine Aurovitas

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Lamivudine Aurovitas contains

• The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
• The other ingredients are: Tablet core: microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), sodium carboxymethyl starch (type A), magnesium stearate. Tablet coating: hypromellose 2910, macrogol 400, titanium dioxide (E 171), polysorbate 80, iron oxide yellow (E 172), iron oxide red (E 172).

What Lamivudine Aurovitas looks like and contents of the pack
Film-coated tablet.
Capsule-shaped, biconvex, toffee-coloured film-coated tablets, printed with "L100" on one side and plain on the other side. Size: 11.1 mm x 5.6 mm.
Lamivudine Aurovitas tablets are available in blisters.
Pack sizes:
Blister packs: 28 and 84 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised for marketing in the European Economic Area 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