Lamivudine Aurovitas

Package Leaflet: Information for the User

Lamivudine Aurovitas, 100 mg, Film-Coated Tablets

Lamivudine

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack:

• 1. What is Lamivudine Aurovitas and what is it used for
• 2. Before you take 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 is Lamivudine Aurovitas and what is it used for

The active substance of Lamivudine Aurovitas is lamivudine.

Lamivudine Aurovitas is used to treat long-term (chronic) hepatitis B virus infection in adults.

Lamivudine Aurovitas is an antiviral medicine that stops the hepatitis B virus from multiplying and belongs to a group of medicines called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). The hepatitis B virus can cause long-term (chronic) infection and may lead to liver damage. Lamivudine Aurovitas can be used in patients with liver damage but with normal liver function (compensated liver disease). Treatment with Lamivudine Aurovitas can reduce the amount of hepatitis B virus in the body. This may 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 your treatment and regularly order blood tests.

2. Before you take Lamivudine Aurovitas

Before and during treatment with lamivudine for hepatitis B, your doctor should offer you advice and testing for HIV. If you are infected with HIV or become infected with HIV, see section 3.

• 3.

When not to take Lamivudine Aurovitas

• if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in section 6). Consult your doctorif you think you may be affected by these conditions.

Warnings and precautions

Before taking Lamivudine Aurovitas, discuss this with your doctor or pharmacist.

Some patients taking Lamivudine Aurovitas or similar medicines are more likely to have serious side effects. You should be aware of this extra risk:

• if you have had other liver diseases, such as hepatitis C.
• if you are very overweight (especially women).

Tell your doctor if any of these conditions apply to you.

Your doctor may order additional monitoring tests, including blood tests. For more information about this risk, see section 4.
Do not stop taking Lamivudine Aurovitaswithout your doctor's advice, as there is a risk of your hepatitis getting worse. After stopping Lamivudine Aurovitas, your doctor will monitor your condition for at least 4 months to check for any problems, i.e., blood samples will be taken to check for abnormal liver enzyme activity, which may indicate liver damage. For more information on taking Lamivudine Aurovitas, see section 3.

Protecting others

Hepatitis B can be passed on through sexual contact with infected people or through infected blood (e.g., by sharing injection needles). Taking Lamivudine Aurovitas does not stop you from passing on hepatitis B to others. To protect others from hepatitis B:

• use a condomduring oral sex and penetration;
• do not risk passing on the infection through blood -e.g., do not share injection needles.

Lamivudine Aurovitas and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription, and herbal products.
If you start taking any new medicines while taking Lamivudine Aurovitas, remember to tell your doctor or pharmacist.
The following medicines must not be taken with Lamivudine Aurovitas:

• medicines (usually in liquid form) containing sorbitol or other sugar alcohols (such as xylitol, mannitol, lactitol, or maltitol) if taken long-term
• other medicines containing lamivudine used to treat HIV infection(sometimes called AIDS virus)
• emtricitabine used to treat HIV infectionor hepatitis B virus
• cladribine used to treat hairy cell leukemia.

Tell your doctorif you are taking any of these medicines.

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby:
Ask your doctorfor advice before taking Lamivudine Aurovitas, as the benefits and risks of taking this medicine during pregnancy will need to be discussed.

Breast-feeding

Lamivudine Aurovitas can pass into breast milk. If you are breast-feeding or thinking of breast-feeding:
Consult your doctorbefore taking Lamivudine Aurovitas.

Driving and using machines

Lamivudine Aurovitas can cause fatigue, which may affect your ability to drive or operate machinery. Do not drive or operate machinery unless you are sure that this medicine does not affect you in this way.

Lamivudine Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Lamivudine Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, check with your doctor or pharmacist.

You should stay in regular contact with your doctor

Lamivudine Aurovitas helps control hepatitis B virus infection. You should take it every day to keep the infection under control and stop it from getting worse.

Stay in regular contact with your doctor and do not stop taking Lamivudine Aurovitas

without your doctor's advice.

What dose to take

The usual dose of Lamivudine Aurovitas is one tablet(100 mg lamivudine) once a day.
Your doctor may prescribe a lower dose of Lamivudine Aurovitas if you have kidney problems. Lamivudine Aurovitas is also available as an oral solution for patients who need a lower dose than usual or who cannot take tablets.
Tell your doctorif any of these conditions apply to you.

Patients infected with HIV or patients who may become infected with HIV

If you are infected with HIV during treatment with lamivudine for hepatitis B, or if you become infected with HIV, and this infection is not being treated, HIV may develop resistance to some antiretroviral medicines, making treatment of your HIV infection more difficult. Lamivudine can also be used to treat HIV infection. Tell your doctorif you are infected with HIV. Your doctor may recommend that you continue treatment with a higher dose of lamivudine, usually 150 mg twice a day, because the dose of lamivudine in Lamivudine Aurovitas (100 mg) is not enough to treat HIV infection. If you plan to change your HIV treatment, you should discuss this with your doctor first.
Tell your doctorif any of these conditions apply to you.
Swallow the tablet whole with water. Lamivudine Aurovitas can be taken with or without food.

If you take more Lamivudine Aurovitas than you should

If you accidentally take too much Lamivudine Aurovitas, tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, show them the Lamivudine Aurovitas packaging.

If you forget to take Lamivudine Aurovitas

If you miss a dose, take it as soon as you can, and then continue with your treatment as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Lamivudine Aurovitas

Do not stop taking Lamivudine Aurovitas without consulting your doctor. There is a risk that your hepatitis may get worse (see section 2). If you stop taking Lamivudine Aurovitas, your doctor will monitor your condition for at least 4 months to check for any problems. This includes taking blood samples to check for abnormal liver enzyme activity, which may indicate liver damage. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects that were reported in clinical studies of lamivudine include tiredness, respiratory tract infections, discomfort in the throat, headache, discomfort and pain in the stomach, nausea, vomiting, and diarrhea, increased liver enzyme activity, and increased muscle enzyme activity (see below).

Allergic reactions

These occur rarely (may affect up to 1 in 1,000 people). Symptoms include:

• swelling of the eyelids, face, and lips
• difficulty swallowing or breathing. Contact your doctor immediatelyif 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) that may be found in blood tests:

• increased liver enzyme activity (aminotransferases), which may indicate liver inflammation or damage.

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

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

Common side effectsthat may be found in blood tests:

• increased muscle enzyme activity (creatine kinase), which may indicate muscle damage.

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

• lactic acidosis (excess of 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 breakdown
• worsening of liver disease after stopping Lamivudine Aurovitas or during treatment if the hepatitis B virus becomes resistant to Lamivudine Aurovitas. In some patients, this can be fatal.

Side effects that may be found in blood tests:

• decreased platelet count (thrombocytopenia).

If you get any side effects

Tell your doctor or pharmacist, including any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the national reporting system via the Medicines Information Department, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamivudine Aurovitas

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 carton and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Medicines should 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 lamivudine.
• The other ingredients are: Tablet core:microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), sodium carboxymethylcellulose (type A), magnesium stearate. Tablet coating:hypromellose 2910, macrogol 400, titanium dioxide (E 171), polysorbate 80, yellow iron oxide (E 172), red iron oxide (E 172).

What Lamivudine Aurovitas looks like and contents of the pack

Film-coated tablet.
The tablets are capsule-shaped, biconvex, yellowish in color, with "L100" engraved on one side and smooth on the other. The size is 11.1 mm x 5.6 mm.
Lamivudine Aurovitas tablets are available in blisters.
Pack sizes:
Blisters: 28 and 84 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: medicalinformation@aurovitas.pl

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 medicine is authorized in the Member States of the European Economic Area under the following names:

France:
Lamivudine Arrow 100 mg, film-coated tablet
Germany:
Lamivudine Aurobindo 100 mg film-coated tablets
Italy:
Lamivudine Aurobindo Italia
Poland:
Lamivudine Aurovitas
Portugal:
Lamivudine Aurobindo

Date of last revision of the leaflet: 09/2024