Prospecto: information for the user

Lamivudina Aurovitas 300 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to knowbefore starting to take Lamivudina Aurovitas

3.How to take Lamivudina Aurovitas

4.Adverse effects

5.Storage of Lamivudina Aurovitas

6.Contents of the package and additional information

Lamivudina Aurovitas is used in the treatment of the infection caused by the HIV (human immunodeficiency virus) in adults and children.

The active ingredient of Lamivudina Aurovitas is lamivudine. Lamivudine is a type of medication known as an antiretroviral. It belongs to a group of medications calledinhibitors of reverse transcriptase analogs of nucleosides(INTIs).

Lamivudine does not completely cure the 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 the body to fight infection.

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

Do not takeLamivudina Aurovitas

-if you areallergicto lamivudine or any of the other ingredients of this medicine (listed in section 6).

Consult your doctorif you think you are affected.

Warnings and precautions

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

-if you have ever hadliver disease, including hepatitis B or C (if you have hepatitis B do not stop taking lamivudine without consulting your doctor, as you may develop hepatitis again).

-if you have asignificant overweight(especially if you are a woman).

-if you or your child has kidney disease, your dose may be adjusted.

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

Be aware of important symptoms

Some people taking HIV medicines develop other disorders, which can be serious. You need to know what signs and symptoms to look out for while takinglamivudine.

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

Other medicines andLamivudina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including herbal medicines and those bought without a prescription.

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

The following medicines should not be taken withlamivudine:

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

-other medicines containing lamivudine (used to treatHIV infectionorhepatitis B infection).

-emtricitabine (used to treatHIV infection).

-high doses ofco-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic.

-cladribine (used to treatacute lymphoblastic leukaemia).

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using 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 your baby.

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

Breastfeeding

Do not breastfeedif you have HIV, as the infection can be passed to the baby through breast milk.

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

If you are breastfeeding or plan to breastfeed,you must consult your doctor as soon as possible.

Driving and operating machines

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

Lamivudina Aurovitas contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Swallow the tablets whole with a little water. Lamivudina 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 entire dose immediately.

Maintain regular contact with your doctor

Lamivudina helps control your disease. You will need to take it every day to prevent your disease from getting worse. You may continue to develop other infections and diseases associated with HIV infection.

Stay in contact with your doctor and do not stop taking lamivudinawithout first talking to your doctor.

How much to take

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

The recommended dose of lamivudina is 300 mg per day.

For the treatment of children over three months weighing less than 25 kg, there are also available tablets of 150 mg of lamivudina.

There may also be available an oral solution for the treatment of children over three months and for patients who cannot take tablets or who need a lower dose.

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

Consult your doctorif this affects you.

If you take moreLamivudina Aurovitasthan you should

If you take more lamivudina than you should, inform your doctor or pharmacist, or contact the nearest hospital emergency service for more information. If possible, show them the Lamivudina Aurovitas packaging.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeLamivudina Aurovitas

If you forget to take a dose, take it as soon as you remember and then continue with your regular treatment. Do not take a double dose to compensate for the missed doses.

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

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

Like all medications, this medication may produce side effects, although not everyone will experience them.

When you are on treatment for HIV, it may be difficult to distinguish whether a symptom is a side effect of lamivudine or of other medications you are taking, or if it is due to an effect of the disease caused by HIV itself.Therefore, it is very important that you inform your doctor about any change in your health.

In addition to the side effects listed below for lamivudine, other disorders may develop during HIV combination treatment.

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

Common side effects

May affectup to 1 in 10people:

-headache.

-unpleasantness(nausea).

-vomiting.

-diarrhea.

-stomach pain.

-fatigue, lack of energy.

-fever (elevated temperature).

-general feeling of discomfort.

-muscle pain and discomfort.

-joint pain.

-difficulty falling asleep (insomnia).

-cough.

-irritated or runny nose.

-skin rash.

-hair loss (alopecia).

Uncommon side effects

May affectup to 1 in 100people:

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

-decrease in the number of cells involved in blood clotting (thrombocytopenia).

-low count of red blood cells(anemia)or low count of white blood cells(neutropenia).

-increase in the level of enzymes produced by the liver.

Rare side effects

May affectup to 1 in 1,000people:

-severe allergic reaction that causes swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing.

-inflammation of the pancreas(pancreatitis).

-muscle rupture.

-inflammation (hepatitis).

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

-increase in an enzyme calledamylase.

Very rare side effects

May affectup 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 may appear in blood tests is:

-failure of the bone marrow to produce new red blood cells (aplastic anemia).

If you experience side effects,consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Other possible side effects of combination HIV therapy

Combination treatmentsthat include Lamivudine Aurovitas,may cause other disorders to develop during HIV treatment.

Exacerbation of old infections

People with advanced HIV infection (AIDS) have weakened immune systems and are more likely to suffer from severe infections (opportunistic infections). When these people start treatment, they may find that old infections, which were previously hidden, flare up, causing signs and symptoms of inflammation. These symptoms are probably due to an improvement in the body's immune response, which allows it to fight these infections.

In addition to these opportunistic infections, autoimmune disorders (diseases that occur when the immune system attacks healthy body tissue) may also appear after starting HIV treatment medications. 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 thatascendsto the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

If you notice any symptoms of infection while takinglamivudine:

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

You may have bone problems

Some patients receiving combination HIV treatment may develop a bone disease calledosteonecrosis. With this disease, part of the bone tissue dies due to a reduction in blood supply to the bone. People are more likely to suffer from this disease:

-if they have been taking a combination treatment for a long time.

-if they also take anti-inflammatory medications called corticosteroids.

-if they drink alcohol.

-if their immune system is severely weakened.

-if they are overweight.

The 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 side effects

If you experienceany type ofside effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Vigilance of Medications for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

Composition of Lamivudine Aurovitas

-The active ingredient is lamivudine. Each film-coated tablet contains 300 mg of lamivudine.

-The other components 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 iron oxide black (E172).

Appearance of the product and contents of the package

Film-coated tablets of gray color, in the shape of a rhombus, engraved with “Z26” on one side and smooth on the other side.

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

Package sizes:

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

Bottles::30 and 500 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible 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 with the following names:

GermanyLamivudin Aurobindo 300 mg Filmtabletten

SpainLamivudine Aurovitas 300 mg film-coated tablets EFG

FranceLamivudine Arrow 300 mg coated tablet

ItalyLamivudine Aurobindo 300 mg film-coated tablets

NetherlandsLamivudine Aurobindo 300 mg film-coated tablets

PortugalLamivudine Aurobindo 300 mg

Last review date of this leaflet:December 2022

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (www.aemps.gob.es).