Package Leaflet: Information for the User

Lamivudine Normon 100 mg Film-Coated Tablets

Lamivudine

Read this leaflet carefully before you start taking this medicine because 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 side effects, ask your doctor or pharmacist, even if they are not listed in this leaflet.

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

Lamivudina Normon is used to treat patients aged 18 years or older with chronic hepatitis B.

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

• 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

Consult 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, thus reducing future health problems related to your liver. For the treatment to be effective, you must take Lamivudina Normon every day. Patients respond to treatment differently, so it is not known for how long you will have to take this medication.

Your doctor will monitor your response to treatment by performing regular blood tests. The results of these tests will help your doctor decide when to stop your treatment with Lamivudina Normon.

Before starting treatment with Lamivudina Normon, you must inform your doctor of any additional medical conditions you have. If you have kidney problems, your doctor may need to reduce the dose of this medication, as your kidneys are mainly responsible for eliminating the medication from your body.

Do not stop taking Lamivudina Normon unless your doctor tells you to, as there is a small risk that your hepatitis will worsen. When you stop taking Lamivudina Normon, your doctor will monitor you for at least the next four months to check if there are any problems. This will involve taking blood samples to check for any abnormalities in liver enzymes indicative of liver damage.

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

Since your medication helps control your hepatitis B and it is still unknown whether it can cure it, there is a risk that you may transmit this virus to others through sexual contact or through blood, so you must take the necessary precautions to avoid it. There is an effective vaccine available to protect those at risk of infection with the hepatitis B virus.

The class of medications to which lamivudine belongs (NRTIs) may cause a condition called lactic acidosis (creation of lactic acid in the body), along with liver enlargement. 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 if they are overweight. If you have liver disease, you may also be at a higher risk of developing this state. While you are taking Lamivudina Normon, your doctor will closely monitor any signs that may indicate you are developing lactic acidosis.

• Taking Lamivudina Normon with other medications

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

Lamivudina Normon should not be taken 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 can be taken with food or on an empty stomach.

• Pregnancy and breastfeeding

Use in pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will tell you if you should continue taking Lamivudina Normon while pregnant. Do not stop taking Lamivudina Normon without consulting your doctor.

Use in breastfeeding

The components of Lamivudina Normon may pass into breast milk.If you are breastfeeding, you must speak with your doctorbefore taking Lamivudina Normon.

• Driving and operating machinery

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

• Lamivudina Normon contains sodium

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

Follow exactly the administration instructions for this medication as indicated 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 lamivudina) once a day. The tablet should be swallowed whole with water. It can be taken with food or on an empty stomach.

Your doctor will tell you 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 the tablets so that your medication dose can be reduced exactly.

• If you take more Lamivudina Normon than you should

It is unlikely that accidental ingestion of an excessive amount of your medication will cause serious problems. However, you should inform your doctor or pharmacist, or go to the nearest hospital emergency service for advice.

If you have taken more Lamivudina Normon than you should, consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

• If you forget to take Lamivudina Normon

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

• If you interrupt treatment with Lamivudina Normon

Do not stop taking Lamivudina Normon without consulting your doctor.

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

Like all medications, Lamivudina Normon can produce adverse effects, although not all people will experience them. The adverse effects recorded in clinical trials with Lamivudina Normon were fatigue, respiratory tract infections, throat discomfort, headache, abdominal discomfort and pain, nausea, vomiting, and diarrhea, increased liver enzymes, and increased enzymes produced in the muscles (see below).

Some people may be allergic to medications. If you experience any of the following symptoms shortly after taking Lamivudina NormonSTOPtaking the medication and inform your doctor immediately:

• “Wheezing” and chest pain or tightness.
• Swelling of the eyelids, face, or lips.
• Skin rash or “bumps” anywhere on the body.

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

Very Common Adverse Effects

May affectmore than 1 in 10people

• Increased liver enzymes called transaminases

Common Adverse Effects

May affectup to 1 in 10people

• Increased muscle enzyme called creatine phosphokinase
• 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, important cells in blood coagulation. If you have a low platelet count, you may notice that bruises appear more easily.
• Muscle rupture.
• If resistance develops during treatment with lamivudina or upon discontinuation, there may be a marked worsening of liver disease, which can be fatal in some patients.

If you consider that some of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of sight and reach of children.

Do not use Lamivudina Normon after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lamivudina Normon

• The active ingredient is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
• The other components are: microcrystalline cellulose, carboxymethylstarch sodium (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 content of the packaging

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

The tablets are orange in color, elongated, and biconvex.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

This leaflet was approved in October 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es