LAMIVUDINE AUROVITAS 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lamivudine Aurovitas 300 mg Film-Coated Tablets EFG

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 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. What you need to know before you take Lamivudine Aurovitas
3. How to take Lamivudine Aurovitas
4. Possible side effects
5. Storage of Lamivudine Aurovitas
6. Contents of the pack and other information

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

Lamivudine Aurovitas is used in the treatment of HIV (Human Immunodeficiency Virus) infection in adults and children.

The active substance of Lamivudine Aurovitas is lamivudine. Lamivudine is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Lamivudine 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 the blood. CD4 cells are a type of white blood cell that plays an important role in helping your body fight infection.

Not everyone responds to treatment with lamivudine in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Lamivudine Aurovitas

Do not 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 this applies to you.

Warnings and precautions

Some people who take lamivudine or other combination treatments for HIV infection have a higher risk of serious side effects. You need to know that there is a higher risk:

• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B, do not stop taking lamivudine without your doctor's advice, as you may get hepatitis again).
• if you are significantly overweight (especially if you are a woman).
• if you or your child have kidney disease, your dose may be changed.

Consult your doctor if you have any of these conditions.You may need to have extra checks, including blood tests, while you are taking this medicine (see section 4 for more information).

Be aware of important symptoms

Some people who take medicines for HIV infection develop other conditions, which can be serious. You need to know what important signs and symptoms to look out for while you are taking lamivudine.

Read the information under the heading “Other possible side effects of combination therapy for HIV” in section 4 of this leaflet.

Other medicines and Lamivudine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, including herbal medicines.

Remember to tell your doctor or pharmacist if you start taking any new medicines while you are taking lamivudine.

The following medicines must not be used with lamivudine:

• medicines (usually liquids) that contain sorbitol and other polyalcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
• other medicines that contain lamivudine (used to treat HIV infection or hepatitis B virus infection).
• emtricitabine (used to treat HIV infection).
• high doses of cotrimoxazole (a combination of trimethoprim and sulfamethoxazole), an antibiotic.
• cladribine (used to treat hairy cell leukaemia).

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

If you are pregnant, if you become pregnant, or if you are planning to become pregnant, talk to your doctor about the risks and benefits of taking lamivudine, both for you and for your baby.

Lamivudine and similar medicines may cause side effects in babies during pregnancy. If you have been taking lamivudine during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

Breast-feeding

It is not recommendedthat women with HIV infection breast-feed their babies because HIV infection can be passed on to the baby through breast milk.

A small amount of the components of lamivudine may also pass into breast milk.

If you are breast-feeding or thinking of breast-feeding, you should consult your doctor as soon as possible.

Driving and using machines

Lamivudine is unlikely to affect your ability to drive or use machines.

Lamivudine Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Lamivudine Aurovitas

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Swallow the tablets whole with a little water. Lamivudine can be taken with or without food.

If you cannot swallow the tablets whole, you can break them and mix them with a small amount of food or drink, and take the whole dose immediately.

Stay in regular contact with your doctor

Lamivudine helps control your disease. You will need to take it every day to avoid your disease getting worse. You may still develop other infections and illnesses associated with HIV.

Stay in contact with your doctor and do not stop taking lamivudinewithout discussing it with your doctor first.

How much to take

Adults, adolescents and children weighing at least 25 kg:

The recommended dose of lamivudine is 300 mg once daily.

For the treatment of children over 3 months with a weight below 25 kg, 150 mg lamivudine tablets are also available.

An oral solution is also available for the treatment of children over 3 months and for patients who cannot take tablets or who require a lower dose.

If you have kidney problems, your dose may be changed.

Consult your doctorif this applies to you.

If you take more Lamivudine Aurovitas than you should

If you take more lamivudine than you should, tell your doctor or pharmacist, or contact the nearest hospital emergency department for more information. If possible, show them the Lamivudine Aurovitas pack.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Lamivudine Aurovitas

If you forget to take a dose, take it as soon as you remember and then continue with your normal treatment schedule. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

During HIV treatment, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly due to the recovery of your health and to your lifestyle and, in the case of blood lipids, to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When you are being treated for HIV, it can be difficult to tell whether a symptom is a side effect of lamivudine or another medicine you are taking, or a result of the HIV disease itself. It is very important that you tell your doctor about any changes in your health.

In addition to the side effects listed below for lamivudine, other conditions can develop during combination therapy for HIV.

It is important that you read the information under the heading “Other possible side effects of combination therapy for HIV”.

Common side effects

May affect up to 1 in 10people:

• headache.
• nausea.
• vomiting.
• diarrhoea.
• 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

May affect up to 1 in 100people:

The uncommon side effects that can appear in blood tests are:

• a decrease in the number of cells involved in blood clotting (thrombocytopenia).
• low red blood cell count (anaemia) or low white blood cell count (neutropenia).
• an increase in the level of liver enzymes.

Rare side effects

May affect up to 1 in 1,000people:

• severe allergic reaction that causes swelling of the face, tongue or throat that can cause difficulty in swallowing or breathing.
• inflammation of the pancreas (pancreatitis).
• muscle breakdown.
• inflammation (hepatitis).

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

• an increase in an enzyme called amylase.

Very rare side effects

May affect up to 1 in 10,000people:

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

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

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

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination treatments that include Lamivudine Aurovitas may cause other conditions to develop during treatment for HIV.

Worsening of old infections

People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably due to the improvement in the body's immune response, which enables it to fight off these infections.

In addition to these opportunistic infections, autoimmune disorders (diseases that occur when the immune system attacks healthy body tissue) may also occur after starting treatment with medicines for HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness in the hands and feet that spreads to the torso, palpitations, tremors or hyperactivity, tell your doctor immediately so that you can receive the necessary treatment.

If you notice any symptoms of infection while taking lamivudine:

Tell your doctor immediately. Do not take any other medicine for the infection without your doctor's advice.

You may have problems with your bones

Some patients who receive combination therapy for HIV may develop a bone disease called osteonecrosis. With this disease, part of the bone tissue dies due to a lack of blood supply to the bone. People are more likely to get this disease:

• 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 weakened.
• if they are overweight.

Signs of osteonecrosis include:

• stiffness in the joints.
• pain and discomfort (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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label and carton after EXP. The expiry date refers to the last day of that month.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamivudine Aurovitas

• The active substance is lamivudine. Each film-coated tablet contains 300 mg of lamivudine.
• The other ingredients are:

Core of the tablet:microcrystalline cellulose (E460), sodium carboxymethyl starch (type A) (derived from potato starch), magnesium stearate (E572).

Coating of the tablet:hypromellose (E464), macrogol 400, titanium dioxide (E171), polysorbate 80 (E433) and black iron oxide (E172).

Appearance of the product and pack contents

Film-coated tablets are grey, rhomboid in shape, engraved with “Z26” on one side and smooth on the other side.

Lamivudine Aurovitas film-coated tablets are available in blister packs and high-density polyethylene (HDPE) bottles.

Pack sizes:

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

Bottles:30 and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Germany Lamivudin Aurobindo 300 mg Filmtabletten

Spain Lamivudina Aurovitas 300 mg film-coated tablets EFG

France Lamivudine Arrow 300 mg scored film-coated tablet

Italy Lamivudina Aurobindo 300 mg film-coated tablets

Netherlands Lamivudine Aurobindo 300 mg film-coated tablets

Portugal Lamivudina Aurobindo 300 mg

Date of last revision of this leaflet:December 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (www.aemps.gob.es).