LAMIVUDINE TEVA PHARMA B.V. 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lamivudine Teva Pharma B.V. 300 mg film-coated tablets EFG

Lamivudine

Contents of the pack:

1. What is Lamivudine Teva Pharma B.V. and what is it used for
2. What you need to know before you take Lamivudine Teva Pharma B.V.
3. How to take Lamivudine Teva Pharma B.V.
4. Possible side effects
5. Storage of Lamivudine Teva Pharma B.V.
6. Pack contents and further information

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

Lamivudine Teva Pharma B.V. is used in the treatment of HIV infection in adults and children.

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

Lamivudine 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 plays an important role in helping your body to fight infection.

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

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

Do not take Lamivudine Teva Pharma B.V.

• 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

Consult your doctor or pharmacist before you start taking Lamivudine Teva Pharma B.V.

Some people who take Lamivudine Teva Pharma B.V. 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 you must not stop taking Lamivudine Teva Pharma B.V. 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 problems, your dose may need to be adjusted.

Consult your doctorif you are affected by any of these conditions. You may need to have extra checks, such as blood tests, while you are taking this medicine For more information see section 4.

Be aware of important symptoms

Some people who take medicines for HIV infection develop other conditions that can be serious. You need to know about the signs and symptoms to look out for while you are taking Lamivudine Teva Pharma B.V.

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

Protect others

HIV infection is spread by having sex with someone who is infected or by transfer of infected blood (for example, by sharing injection needles). While you are taking this medicine you may still transmit HIV to others, even if you are taking antiviral effective treatment that reduces the amount of virus in your blood.

Consult your doctor about the precautions you need to take to avoid infecting others.

Other medicines and Lamivudine Teva Pharma B.V.

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines.

Remember to tell your doctor or pharmacist if you start taking any new medicines while you are taking Lamivudine Teva Pharma B.V.

The following medicines must not be taken with Lamivudine Teva Pharma B.V.:

• 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 co-trimoxazole, an antibiotic.
• cladribine (used to treat hairy cell leukaemia).

Tell your doctorif 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Lamivudine Teva Pharma B.V. and similar medicines may harm your unborn child. If you have taken Lamivudine Teva Pharma B.V. during your pregnancy, your doctor may request that you 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.

Women with HIV infection should not breastfeed their babiesbecause HIV infection can be passed on to the baby through breast milk.

A small amount of the ingredients of Lamivudine Teva Pharma B.V. can also pass into breast milk.

If you are breastfeeding, or think you might want to breastfeed: consult your doctor immediately.

Driving and using machines

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

Lamivudine Teva Pharma B.V. contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e., essentially “sodium-free”.

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

Always take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure.

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

If you are unable to swallow the tablets whole, you can break them and mix with a small amount of food or drink; take the whole dose immediately.

Keep in regular contact with your doctor

Lamivudine Teva Pharma B.V. helps to control your condition. You must take it every day to control your HIV infection. You may still develop other infections and illnesses associated with HIV infection.

Stay in touch with your doctor and do not stop taking Lamivudine Teva Pharma B.V.without discussing it with your doctor first.

The recommended dose is

Adults, adolescents and children weighing at least 25 kg

The usual dose is one 300 mg tablet once daily.

Lamivudine Teva Pharma B.V. is also available as 150 mg tablets for the treatment of children from 3 months of age and weighing less than 25 kg.

It is also available as an oral solution for the treatment of children over 3 months of age and for patients who are unable to take tablets or who require a dose adjustment.

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

Consult your doctorif this applies to you or your child.

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

If you take more Lamivudine Teva Pharma B.V. than you should, contact your doctor or pharmacist, or go to the nearest hospital emergency department for more information. If possible, show them the Lamivudine Teva Pharma B.V. pack.

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

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

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

4. Possible side effects

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

During HIV treatment, weight and levels of blood sugars and fats may increase. This is partly due to a return to better health and partly due to the treatment itself. Your doctor will monitor these changes.

When you are being treated for HIV, it can be difficult to tell whether a symptom is a side effect of Lamivudine Teva Pharma B.V. or other medicines you are taking, or a result of the HIV infection 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 Lamivudine Teva Pharma B.V., 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
• feeling sick (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:

Uncommon side effects that may show up 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)
• 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 may cause difficulty in swallowing or breathing.

• inflammation of the pancreas (pancreatitis)
• muscle breakdown
• liver disorders, such as jaundice, enlarged liver, fatty liver, inflammation of the liver (hepatitis).

A rare side effect that may show up in blood tests is:

• 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 may show up in blood tests is:

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

If you experience any side effects

Tell your doctor or pharmacistif you experience any side effects, even if they are not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination therapy for HIV, such as Lamivudine Teva Pharma B.V., can cause other conditions to develop during HIV treatment.

Worsening of previous problems

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 natural defence (immune) system, which enables the body to fight these infections.

In addition to opportunistic infections, autoimmune disorders (a condition where the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms such as muscle weakness, weakness in the hands and feet that gradually spreads to the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately for further evaluation and treatment.

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

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

You may have problems with your bones

Some patients taking combination therapy for HIV develop a condition called osteonecrosis. In this condition, parts of the bone tissue die because the bone is no longer receiving sufficient blood. People have a higher risk of getting this condition:

• 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:

• joint stiffness
• pain and discomfort (especially in the hip, knee and shoulder joints)
• difficulty moving.

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

Reporting of side effects

If you get 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 national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

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 no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Lamivudina Teva Pharma B.V.

• The active ingredient is lamivudine. Each film-coated tablet contains 300 mg.
• The other ingredients 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 and Packaging of the Product

Gray tablet, rhomboid in shape, biconvex, film-coated, engraved with "L 300" on one side and smooth 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 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

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 medicinal product, please contact the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet: January 2022

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