Lamivudine Normon 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lamivudine Normon 100 mg film-coated tablets EFG

Lamivudine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Leaflet contents:

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

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

Lamivudina Normon belongs to a group of medicines called antivirals. It is used to treat infection caused by the hepatitis B virus. The hepatitis B virus infects the liver and causes liver damage. Lamivudina Normon can be used in patients whose liver is damaged but still functions (compensated liver disease) and in patients whose liver is damaged and does not function normally (decompensated liver disease).

Lamivudina Normon is used to treat patients aged 18 years and older with long-term (chronic) hepatitis B.

Treatment with Lamivudina Normon may reduce the amount of hepatitis B virus in your body. This may lead to a reduction in liver damage and improvement in liver function.

2. What you need to know before taking Lamivudina Normon

• Do not take Lamivudina Normon

• If you are allergic (hypersensitive) to lamivudine or to any of the other components of Lamivudina Normon.

If you are unsure, consult your doctor.

• Warnings and precautions

Talk to your doctor or pharmacist before starting to take Lamivudina Normon.

Lamivudina Normon reduces the amount of hepatitis B virus in your body and keeps liver disease under control, thereby reducing future liver-related health problems. For treatment to be effective, you must take Lamivudina Normon every day. Patients respond differently to treatment, so it is not known how long you will need to take this medicine.

Your doctor will monitor your response to treatment by performing regular blood tests. The results of these tests will help determine when treatment with Lamivudina Normon should be stopped.

Before starting treatment with Lamivudina Normon, you must inform your doctor of any other medical conditions you may have. If you have kidney problems, your dose of this medicine may need to be reduced, as your kidneys are primarily responsible for eliminating the medicine from your body.

Do not stop taking Lamivudina Normon unless instructed by your doctor, as there is a small risk that your hepatitis may worsen. When you stop taking Lamivudina Normon, your doctor will monitor you for at least the following four months to check for any problems. This will involve taking blood samples to check for abnormalities in liver enzymes, which may indicate liver damage.

The active substance in this product is lamivudine. If you are already taking this medicine for HIV infection, your doctor will continue treating you with the higher dose, usually 150 mg twice daily, as the lower dose of 100 mg is not sufficient to treat HIV infection.

Since your medicine helps control your hepatitis B and it is not yet known whether it can cure it, there is a risk that you could transmit the virus to others through sexual contact or via blood, so you should take appropriate precautions to prevent this. An effective vaccine is available to protect those at risk of hepatitis B virus infection.

The class of medicines to which lamivudine belongs (NRTIs) can cause a condition called lactic acidosis (build-up of lactic acid in the body), along with enlargement of the liver. Lactic acidosis, if it occurs, usually develops after a few months of treatment. Deep and rapid breathing, drowsiness, and non-specific symptoms such as nausea, vomiting, and stomach pain may indicate the development of lactic acidosis. This rare but serious adverse reaction occurs more frequently in women, especially those who are overweight. If you have liver disease, you may also be at higher risk of developing this condition. While you are being treated with Lamivudina Normon, your doctor will closely monitor you for any signs that you may be developing lactic acidosis.

• Taking Lamivudina Normon with other medicines

Some medicines may affect the action of Lamivudina Normon. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Lamivudina Normon must not be taken together with:

• zalcitabine (used to treat HIV infection)

• emtricitabine (used to treat HIV infection or hepatitis B)

• Taking Lamivudina Normon with food and drinks

Lamivudina Normon may be taken with food or on an empty stomach.

• Pregnancy and breastfeeding

Use during pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will advise you whether you should continue taking Lamivudina Normon during pregnancy. Do not stop treatment with Lamivudina Normon without consulting your doctor.

Use during breastfeeding

Components of Lamivudina Normon may pass into breast milk. If you are breastfeeding, you must speak with your doctor before taking Lamivudina Normon.

• Driving and using machines

No studies have been conducted on the effect of Lamivudina Normon on the ability to drive and use machines.

• Lamivudina Normon contains sodium

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

3. How to take Lamivudina Normon

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Lamivudina Normon is one tablet (100 mg of lamivudine) once daily. The tablet should be swallowed whole with water. It may be taken with or without food.

Your doctor will tell you for how long you need to take your medicine.

Your doctor may need to reduce your dose of Lamivudina Normon if you have kidney problems. You may need to take an oral solution instead of tablets so that your dose can be reduced precisely.

• If you take more Lamivudina Normon than you should

Accidentally taking too much of this medicine is unlikely to cause serious problems. However, you should inform your doctor or pharmacist, or go to the nearest hospital emergency department for advice.

If you have taken more Lamivudina Normon than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

• If you forget to take Lamivudina Normon

If you forget to take your medicine, take it as soon as you remember and then continue taking it as before. Do not take a double dose to make up for forgotten doses.

• If you stop taking Lamivudina Normon

Do not stop taking Lamivudina Normon without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Lamivudina Normon may cause adverse effects, although not everyone experiences them. The adverse effects observed in clinical trials with Lamivudina Normon included fatigue, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting, and diarrhea, as well as increases in liver enzymes and in enzymes produced in the muscles (see below).

Some people may be allergic to medicines. If you experience any of the following symptoms shortly after taking Lamivudina Normon, STOP taking the medicine and contact your doctor immediately:

• Sudden wheezing and pain or tightness in the chest.
• Swelling of the eyelids, face, or lips.
• Skin rash or lumps ("bumps") anywhere on the body.

The following are adverse effects believed to be caused by lamivudina:

Very common adverse effects

May affect more than 1 in 10 people

• Increase in liver enzymes known as transaminases

Common adverse effects

May affect up to 1 in 10 people

• Increase in the enzyme called creatine phosphokinase produced in the muscles
• Muscle cramps and muscle pain

Other adverse effects

Other adverse effects have been reported in a very small number of people, but their exact frequency is unknown:

• Reduction in the number of platelets, which are important blood cells involved in blood clotting. If you have a low platelet count, you may notice that you bruise more easily.
• Muscle rupture.
• If resistance develops during treatment with lamivudina or upon discontinuation, there may be a marked worsening of liver disease, which may be fatal in some patients.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Lamivudine Normon

Keep out of the sight and reach of children.

Do not use Lamivudine Normon after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Punto Sigre collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lamivudina Normon

• The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
• The other components are: microcrystalline cellulose, sodium carboxymethylstarch (type A) (derived from potato starch), magnesium stearate, hypromellose, titanium dioxide (E-171), macrogol 6000, iron oxide red (E-172), and iron oxide yellow (E-172).

Appearance of the product and contents of the pack

Lamivudina Normon film-coated tablets are presented in blisters containing 28 tablets.

The tablets are orange-colored, elongated, and biconvex.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

This patient information leaflet was approved in October 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es