Lamivudine Teva Pharma B.V. 150 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lamivudine Teva Pharma B.V. 150 mg film-coated tablets EFG

Lamivudine

Package leaflet

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

1. What is Lamivudina Teva Pharma B.V. and what is it used for?

Lamivudina Teva Pharma B.V. is used to treat HIV (human immunodeficiency virus) infection in adults and children.

The active substance in Lamivudina Teva Pharma B.V. is lamivudine. Lamivudina Teva Pharma B.V. is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside reverse transcriptase inhibitors (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 cells are a type of white blood cell that play an important role in helping the body fight infection.

Not everyone responds to treatment with Lamivudina Teva Pharma B.V. in the same way. Your doctor will monitor how well your treatment is working.

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

Do not take Lamivudina Teva Pharma B.V.

• if you are allergic to lamivudine 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

Talk to your doctor or pharmacist before taking Lamivudina Teva Pharma B.V.

Some people taking Lamivudina Teva Pharma B.V. or other combination treatments for HIV infection have a higher risk of developing serious side effects. You should be aware that the risk is greater:

• if you have ever had liver 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 your hepatitis may return)
• if you are significantly overweight (especially if you are female)
• if you or your child has a kidney problem, your dose may need to be adjusted.

Consult your doctor if any of these situations apply to you. You may require additional tests, such as 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 need to know which important signs and symptoms to watch for 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 through sexual contact with an infected person or through transfer of infected blood (for example, by sharing injecting needles). While you are taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces this risk.

Talk to your doctor about the precautions needed to avoid infecting others.

Other medicines and Lamivudina Teva Pharma B.V.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

• medicines (usually liquids) containing sorbitol and other polyalcohols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly.
• other medicines containing lamivudine (used to treat HIV infection or hepatitis B virus infection).
• emtricitabine (used to treat HIV infection).
• high doses of co-trimoxazole, an antibiotic.
• cladribine (used to treat hairy cell leukemia).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become 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 taken Lamivudina Teva Pharma B.V. during pregnancy, your doctor may recommend regular 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 side effects occurring.

Women infected with HIV must not breastfeed their children, because 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 considering doing so: consult your doctor immediately.

Driving and using machines

Lamivudina Teva Pharma B.V. is unlikely to affect your ability to drive or use machines.

Lamivudina Teva Pharma B.V. contains sodium

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

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

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

Swallow the Lamivudina Teva Pharma B.V. tablets with a little water. Lamivudina Teva Pharma B.V. may be taken with or without food.

If you cannot swallow the tablets whole, you may break them up 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 condition. You will need to take it every day to prevent your condition from worsening. You may still develop other infections and illnesses associated with HIV infection.

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

The recommended dose is

Adults, adolescents and children weighing at least 25 kg

The usual dose of Lamivudina Teva Pharma B.V. is 300 mg daily. This may be taken as one 150 mg tablet twice daily (approximately 12 hours apart), or as two 150 mg tablets once daily, as directed by your doctor.

Children weighing at least 20 kg and less than 25 kg

The usual dose of Lamivudina Teva Pharma B.V. is 225 mg daily. This may be given as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening, or as 225 mg (one and a half 150 mg tablets) once daily, as directed by your doctor.

Children weighing at least 14 kg and less than 20 kg

The usual dose of Lamivudina Teva Pharma B.V. is 150 mg daily. This may be taken as 75 mg (half a 150 mg tablet) twice daily (approximately 12 hours apart), or as 150 mg (one 150 mg tablet) once daily, as directed by your doctor.

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

If you or your child has kidney problems, your dose may need to be adjusted.

Consult your doctor if this applies to 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 department for advice. 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 regular dosing schedule.

Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

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

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, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

When undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of Lamivudina Teva Pharma B.V. or of other medicines you are taking, or is due to the HIV disease 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 Lamivudina Teva Pharma B.V., other disorders may develop during combination HIV treatment.

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

Frequent adverse effects

May affect up to 1 in 10 people:

• headache
• discomfort (nausea)
• vomiting
• diarrhea
• 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 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:

• decreased 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-produced 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 lead to difficulty swallowing or breathing.

• inflammation of the pancreas (pancreatitis)

• muscle tissue breakdown

• liver inflammation (hepatitis).

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

• increase in 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 adverse effects

Inform your doctor or pharmacist if you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not mentioned in this leaflet.

Other possible adverse 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 previous infections

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

In addition to these opportunistic infections, autoimmune disorders (conditions occurring when the immune system attacks healthy body tissue) may also develop after starting HIV treatment. Autoimmune disorders may occur many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness in the hands and feet spreading toward the trunk, palpitations, tremors, or hyperactivity, please inform your doctor immediately to receive appropriate treatment.

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

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

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:

• joint stiffness
• pain and discomfort (especially in the hip, knee, and 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 possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamivudine Teva Pharma B.V.

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

Do not use this medicine after the expiry date stated on the container, carton, or blister pack following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and their packaging when they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamivudine Teva Pharma B.V.

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

Tablet core: Microcrystalline cellulose, sodium starch glycolate, magnesium stearate.
Film coating: Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172), black iron oxide (E172)

Appearance of the product and contents of the pack

Light grey, diamond-shaped, biconvex, film-coated tablet, marked with "L 150" and a score line on one side and scored on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary

Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.