Lamivudine Aurovitas 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lamivudina 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Lamivudina Aurovitas is used to treat HIV (human immunodeficiency virus) infection in adults and children.

The active substance of Lamivudina Aurovitas is lamivudine. Lamivudine is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside 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 play an important role in helping the body fight infection.

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

2. What you need to know before starting to take Lamivudina Aurovitas

Do not take Lamivudina Aurovitas

• if you are allergic to lamivudina 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

Some people taking lamivudina or other combination treatments for HIV infection are at increased risk of developing serious adverse effects. You should be aware that the risk is higher:

• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B, do not stop taking lamivudina without medical advice, as your hepatitis may return).
• if you are significantly overweight (particularly if you are female).
• if you or your child has kidney disease, your dose may need to be adjusted.

Consult your doctor if any of these situations apply to you. You may need additional tests, including blood tests, while taking this medicine. For more information, see section 4.

Be alert to important symptoms

Some people taking medicines for HIV infection develop other disorders, which may be serious. You should know which important signs and symptoms to watch for while taking lamivudina.

Read the information on “Other possible adverse effects of combination HIV treatment” in section 4 of this leaflet.

Other medicines and Lamivudina Aurovitas

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

Remember to inform your doctor or pharmacist if you start taking a new medicine while on lamivudina.

The following medicines must not be used together with lamivudina:

• medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly.
• other medicines containing lamivudina (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 leukemia).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

If you are pregnant, become pregnant, or are planning to become pregnant, discuss with your doctor the risks and benefits of taking lamivudina for both you and your baby.

Lamivudina and similar medicines may cause adverse effects in babies during pregnancy. If you have taken lamivudina during pregnancy, your doctor may recommend periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects occurring.

Breastfeeding

Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.

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

If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

Lamivudina is unlikely to affect your ability to drive or operate machinery.

Lamivudina Aurovitas contains sodium

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

3. How to take Lamivudina Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Maintain regular contact with your doctor

Lamivudine helps control your condition. You will need to take it every day to prevent your condition from worsening. You may continue to develop other infections and illnesses associated with HIV infection.

Stay in contact with your doctor and do not stop taking lamivudine without first speaking to your doctor.

How much to take

Adults, adolescents, and children weighing at least 25 kg:

The recommended dose of lamivudine is 300 mg daily.

For treatment of children older than three months with a weight below 25 kg, 150 mg lamivudine tablets are also available.

An oral solution may also be available for treatment of children older than three months and for patients who cannot swallow tablets or who require a lower dose.

If you have kidney problems, your dose may need to be adjusted.

Consult your doctor if this applies to you.

If you take more Lamivudina Aurovitas than you should

If you take more lamivudine than you should, inform your doctor or pharmacist, or contact the nearest hospital emergency department for further advice. If possible, show them the Lamivudina Aurovitas packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lamivudina Aurovitas

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

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

4. Possible adverse effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health, lifestyle factors, and, in the case of blood lipids, sometimes to the anti-HIV medications themselves. Your doctor will monitor you for these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When receiving HIV treatment, it may be difficult to determine whether a symptom is an adverse effect of lamivudine, of other medicines you are taking, or due to the HIV-related illness itself. Therefore, it is very important that you inform your doctor of any changes in your health.

In addition to the adverse effects listed below for lamivudine, other disorders may develop during combination antiretroviral therapy.

It is important that you read the information under the section “Other possible adverse effects of combination HIV treatment”.

Common adverse effects

May affect up to 1 in 10 people:

• headache.
• discomfort (nausea).
• vomiting.
• diarrhea.
• stomach pain.
• tiredness, lack of energy.
• fever (elevated temperature).
• general feeling of being unwell.
• muscle aches and pains.
• joint pain.
• difficulty sleeping (insomnia).
• cough.
• irritated nose or excessive nasal discharge.
• skin rash.
• hair loss (alopecia).

Uncommon adverse effects

May affect up to 1 in 100 people:

Uncommon adverse effects that may appear in blood tests include:

• a decrease in the number of cells involved in blood clotting (thrombocytopenia).
• low red blood cell count (anemia) or low white blood cell count (neutropenia).
• increased levels of liver enzymes.

Rare adverse effects

May affect up to 1 in 1,000 people:

• severe allergic reaction causing swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing.
• inflammation of the pancreas (pancreatitis).
• breakdown of muscle tissue.
• inflammation (hepatitis).

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

• increased levels of an enzyme called amylase.

Very rare adverse 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 adverse effect that may appear in blood tests is:

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

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

Other possible adverse effects of combination HIV therapy

Combination treatments including Lamivudine Aurovitas may lead to the development of other disorders during HIV treatment.

Exacerbation of previous infections

People with advanced HIV infection (AIDS) have weakened immune systems and are more likely to suffer from serious infections (opportunistic infections). When these individuals start treatment, previously hidden infections may flare up, causing signs and symptoms of inflammation. These symptoms are likely due to an improvement in the body's immune response, enabling it to fight these infections.

In addition to these opportunistic infections, autoimmune disorders (conditions that occur when the immune system attacks healthy body tissue) may also occur after starting medications for the treatment of 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, ascending weakness in the hands and feet towards the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive appropriate treatment.

If you notice any symptoms of infection while taking lamivudine:

Inform your doctor immediately. Do not take any other medication for the infection without first consulting your doctor.

You may have bone problems

Some patients receiving combination HIV treatment may develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone. The risk of developing this disease is higher in people who:

• have been on combination treatment for a long time.
• are also taking anti-inflammatory medicines called corticosteroids.
• drink alcohol.
• have a severely weakened immune system.
• 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:

Inform your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the label and on the carton after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamivudina Aurovitas

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

Tablet core: microcrystalline cellulose (E460), sodium carboxymethyl starch (type A) (derived from potato starch), magnesium stearate (E572).

Tablet coating: hypromellose (E464), macrogol 400, titanium dioxide (E171), polysorbate 80 (E433) and black iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated grey diamond-shaped tablets, marked "Z26" on one side and smooth on the other.

Lamivudina 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. 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 medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Germany Lamivudin Aurobindo 300 mg Filmtabletten

Spain Lamivudina Aurovitas 300 mg film-coated tablets EFG

France Lamivudine Arrow 300 mg comprimé pelliculé sécable

Italy Lamivudina Aurobindo 300 mg compresse rivestite con film

Netherlands Lamivudine Aurobindo 300 mg filmomhulde tabletten

Portugal Lamivudina Aurobindo 300 mg

Date of the most recent review of this leaflet: December 2022

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