Prospecto: Information for the User

Lamivudina Teva Pharma B.V. 150mg Film-Coated Tablets

Lamivudina

1.Lamivudina Teva Pharma B.V. and its use

2.What you need to know before starting to take Lamivudina Teva Pharma B.V.

3.How to take Lamivudina Teva Pharma B.V.

4.Adverse effects

5.Storage of Lamivudina Teva Pharma B.V.

6.Contents of the package and additional information

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

The active ingredient of Lamivudina Teva Pharma B.V. is lamivudine. Lamivudina Teva Pharma B.V. is a type of medication known as an antiretroviral. It belongs to a group of medications calledinhibitors of reverse transcriptase analogs of nucleosides (NRTIs).

Lamivudina Teva Pharma B.V. 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 cellsare a type of white blood cell that plays an important role in helping your body fight infection.

Not everyone responds to treatment with Lamivudina Teva Pharma B.V. in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take Lamivudina Teva Pharma B.V.

-if you areallergicto lamivudine or any of the other ingredients of this medicine (listed in section6).

Consult your doctorif you think this affects you.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeLamivudina Teva Pharma B.V.

Some people taking Lamivudina Teva Pharma B.V. or other combination treatment for HIV infections have a higher risk of severe 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 Lamivudina Teva Pharma B.V. without consulting your doctor, as you may experience hepatitis again)
• if you havesignificant overweight(especially if you are a woman)
• if you or your child has a kidney problem, your dose may be adjusted.

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

Be aware of important symptoms

Some people taking HIV medications develop other disorders, which can be serious. You need to know what signs and symptoms to be aware of while taking Lamivudina Teva Pharma B.V.

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

Protect others

HIV infection is transmitted by having sexual contact with someone who has the disease or by blood transfer (for example, by sharing injection needles). While taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces the risk.

Consult your doctor about what precautions are necessary to avoid infecting others.

Other medicines and Lamivudina Teva Pharma B.V.

Inform your doctor or pharmacist if you are taking,have taken recently or may need to take any other medicine.

Remember to inform your doctor or pharmacist if you start taking a new medicine while taking Lamivudina Teva Pharma B.V.

The following medicines should not be used with Lamivudina Teva Pharma B.V.:

• 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 antibiotic.
• cladribine (used to treat hairy cell leukemia).

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

Pregnancy and breastfeeding

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

Lamivudina Teva Pharma B.V. and similar medicines may cause side effects in babies during pregnancy. If you have been taking Lamivudina Teva Pharma B.V. during your pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took INTIs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Women infected with HIV should not breastfeed their babies, as HIV infection can be passed to the baby through breast milk.

A small amount of the components of Lamivudina Teva Pharma B.V. may also pass into breast milk.

If you are breastfeeding, or are planning to do so:consult your doctor immediately.

Driving and operating machinery

Lamivudina Teva Pharma B.V. is unlikely to affect your ability to drive or operate machinery.

Lamivudina Teva Pharma B.V. contains sodium

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

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

Swallow the Lamivudina Teva Pharma B.V. tablets with a little water. Lamivudina Teva Pharma B.V. 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; take the entire dose immediately.

Maintain regular contact with your doctor

Lamivudina Teva Pharma B.V. helps control your disease. You will need to take it every day to prevent your disease from worsening. You may continue to develop other infections and diseases associated with HIV infection.

Stay in contact with your doctor and do not stop taking Lamivudina Teva Pharma B.V.without first speaking with your doctor.

The recommended dose is

Adults, adolescents, and children weighing at least 25kg

The usual dose of Lamivudina Teva Pharma B.V. is 300mg per day.It can be taken as one 150mg tablet twice a day (leaving approximately 12hours between each dose), or as two 150mg tablets once a day, as indicated by your doctor.

Children weighing between at least 20kg and less than 25kg

The usual dose of Lamivudina Teva Pharma B.V.is 225mg per day. It can be given as 75mg (half of a 150mg tablet) in the morning and 150mg (one 150mg tablet) in the afternoon, or 225mg (one and a half 150mg tablets) once a day, as indicated by your doctor.

Children weighing between at least14 kgand less than 20 kg

The usual dose of Lamivudina Teva Pharma B.V is 150mg per day. It can be taken as 75mg (half of a 150mg tablet) twice a day (leaving approximately 12hours between each dose), or 150mg (one 150mg tablet) once a day, as indicated by your doctor.

It is also available as an oral solution for the treatment of children over three months old and for patients who cannot take tablets or who need a lower dose.

If you or your child has a kidney problem, your dose may be modified.

Consult your doctorif this affects you or your child.

If you take more Lamivudina Teva Pharma B.V. than you should

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

If you forget to take Lamivudina Teva Pharma B.V.

If you forget to take a dose, take it as soon as you remember and then continue with your usual treatment.

Do not take a double dose to compensate for the missed doses.

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

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 the recovery of health and lifestyle, and in the case of lipids in the blood, sometimes with HIV medications themselves. Your doctor will monitor these changes.

When you are being treated for HIV, it may be difficult to distinguish whether a symptom is a side effect of Lamivudina Teva Pharma B.V. or of other medicines you are taking, or is due to an effect of the disease caused by HIV itself.Therefore, it is very important that you inform your doctor about any changes in your health.

In addition to the side effects listed below for Lamivudina Teva Pharma B.V., other disorders may develop during combination HIV treatment.

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

Common side effects

May affectup to 1 in 10people:

• headache
• unwellness(nausea)
• vomiting
• diarrhea
• stomach pain
• fatigue, lack of energy
• fever (elevated temperature)
• general feeling of unwellness
• muscle pain and discomfort
• joint pain
• difficulty falling asleep (insomnia)
• cough
• irritated or runny nose
• skin rash
• hair loss (alopecia).

Rare side effects

May affectup to 1 in 100people:

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

• a decrease in the number of cells involved in blood clotting (trombocytopenia)
• low red blood cell count(anemia)or low white blood cell count(neutropenia)
• increase in the level of enzymes produced by the liver.

Very 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 of the liver (hepatitis).

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

• increase in an enzyme called amylase.

Very rare side effects

May affectup to 1 in 10,000people:

• lactic acidosis (excess lactic acid in the blood).
• tingling or numbness in 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

Inform your doctor or pharmacistif you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet.

Other possible side effects of combination HIV therapy

Combination therapies, such as Lamivudina Teva Pharma B.V., may cause other disorders to develop during HIV treatment.

Exacerbation of old infections

People with advanced HIV infection (AIDS) have weakened immune systems and a higher risk of developing 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 develop after starting HIV treatment. Autoimmune disorders can occur many monthsafter starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness in the hands and feet that goes towards the trunk, palpitations, tremors, or hyperactivity, please inform your doctor immediately to receive the necessary treatment.

If you notice any symptoms of infection while taking Lamivudina Teva Pharma B.V.:

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

You may have problems with your bones

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 develop this disease:

• if they have been taking 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, and shoulder)
• difficulty moving.

If you notice any of these symptoms:inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging or the box and the blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe packaging and the medications that you no longerneed.This will help protect the environment.

Composition of Lamivudina Teva Pharma B.V.

• The active ingredient is lamivudine. Each film-coated tablet contains 150mg.
• The other components are:

Nucleus of the tablet: Microcrystalline cellulose, sodium glycolate starch, magnesium stearate. Film coating: Hypromellose, titanium dioxide (E171), macrogol, polisorbate80, yellow iron oxide (E172), black iron oxide (E172)

Appearance of the product and contents of the package

Light gray, biconvex, rectangular tablet, film-coated, engraved with “L150” and scored on one side and notched on the other.

Lamivudina Teva Pharma B.V. is available in aluminum blisters containing 20, 30, 60, 80, 90, 100, and 500 tablets or HDPE containers containing 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Responsible for manufacturing

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: January 2022

The detailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/.