LAMIVUDINE NORMON 300 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lamivudina Normon 300 mg film-coated tablets EFG

Lamivudine

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Lamivudina Normon 300 mg tablets are and what they are used for
2. What you need to know before taking Lamivudina Normon 300 mg tablets
3. How to take Lamivudina Normon 300 mg tablets
4. Possible side effects
5. How to store Lamivudina Normon 300 mg tablets
6. Contents of the pack and other information

1. What Lamivudina Normon 300 mg tablets are and what they are used for

Lamivudine belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs). These are used in the treatment of Human Immunodeficiency Virus (HIV) infection.

Lamivudina Normon 300 mg is used in combination antiretroviral therapy for the treatment of HIV infection in adults and children. Lamivudina Normon reduces the HIV viral load in your body by maintaining it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cell that plays an important role in maintaining a healthy immune system to help fight infection. Response to treatment with Lamivudina Normon 300 mg varies among patients. Your doctor will monitor the effectiveness of your treatment.

2. What you should know before taking Lamivudina Normon 300 mg tablets

• Do not take Lamivudina Normon 300 mg tablets:

• If you are allergic to lamivudine or to any of the other ingredients of Lamivudina Normon tablets.

If you are unsure, please consult your doctor.

• Take special care with Lamivudina Normon 300 mg tablets:

Talk to your doctor about using Lamivudina Normon if you have kidney disease. The recommended standard dose of Lamivudina Normon may need to be reduced.

The class of medicines to which lamivudine belongs (NRTIs) may cause a condition known as lactic acidosis (build-up of lactic acid in the body), as well as enlargement of the liver. Lactic acidosis, if it occurs, usually develops after a few months of treatment. Rapid, deep 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 has been fatal in some cases. Lactic acidosis occurs more frequently in women, particularly those who are overweight. If you have liver disease, you may also be at increased risk of this reaction. While you are being treated with Lamivudina Normon, your doctor will regularly monitor you for any signs suggesting that you may be developing lactic acidosis.

Redistribution, accumulation, or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after initiating anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that were previously present without apparent symptoms. If you notice any signs of infection, please inform your doctor immediately.

Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C who are treated with antiretroviral drugs have an increased risk of serious and potentially fatal liver-related adverse reactions and may require blood tests to monitor liver function.

If you have chronic hepatitis B, you should not stop treatment with Lamivudina Normon without first consulting your doctor, as you may experience a recurrence of hepatitis. This recurrence may be more severe if you have severe liver disease.

You will need to take Lamivudina Normon every day. This medicine helps control your condition but does not cure HIV infection. You may continue to develop other infections and HIV-related illnesses. You should maintain regular contact with your doctor. Do not stop taking this medicine without first talking to your doctor.

Treatment with Lamivudina Normon has not been shown to reduce the risk of transmitting HIV infection to others through sexual contact or blood transfusion. You must continue to take appropriate precautions to prevent transmission.

Bone problems: Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Numerous risk factors for developing this condition include duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain, and discomfort, especially in the hip, knee, and shoulder, as well as difficulty moving. If you experience any of these symptoms, inform your doctor.

• Use of other medicines:

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription. These may affect the action of Lamivudina Normon, or Lamivudina Normon may affect their action.

Lamivudina Normon must not be administered with zalcitabine, high-dose cotrimoxazole, or intravenous ganciclovir or foscarnet.

• Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking any medicine. If you become pregnant or are planning to become pregnant, contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral treatment for both you and your child. Lamivudina Normon is not recommended during the first three months of pregnancy.

If you have taken Lamivudina Normon during pregnancy, your doctor may require regular visits to monitor your child's development. These visits may include blood tests and other diagnostic procedures.

In children whose mothers took nucleotide or nucleoside analogues during pregnancy, the benefit of reduced risk of HIV infection outweighs the risk of adverse effects.

Since lamivudine and the virus are excreted in breast milk, it is recommended that mothers taking Lamivudina Normon do not breastfeed their children. Women infected with HIV are advised not to breastfeed their children under any circumstances to avoid transmission of HIV.

• 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 administration instructions for Lamivudina Normon 300 mg given by your doctor. Consult your doctor or pharmacist if you have any doubts. Swallow the Lamivudina Normon 300 mg tablets with water or another beverage. These tablets may be taken with or without food.

The usual daily dose of Lamivudina Normon in adults and adolescents over 12 years of age is 300 mg. This dose can be taken either as one 150 mg tablet twice daily, approximately every 12 hours, or as 300 mg once daily (2 tablets of 150 mg or 1 tablet of 300 mg).

For children under 12 years of age and weighing less than 30 kg: this formulation is not suitable for achieving the optimal dose.

If you have renal problems, your dose may be adjusted. Follow your doctor's instructions.

• If you take more Lamivudina Normon than you should: Accidental ingestion of an excessive amount of Lamivudina Normon 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 or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

• If you forget to take Lamivudina Normon 300 mg tablets: If you miss a dose of Lamivudina Normon, take it as soon as you remember, and then continue as before. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, Lamivudine Normon 300 mg may cause adverse effects, although not everyone experiences them. When treating HIV infection, it is not always possible to determine whether any adverse reaction occurring is caused by Lamivudine Normon, by other medications being taken simultaneously, or by the HIV disease itself. For this reason, it is very important that you inform your doctor about any changes in your health.

The adverse effects most frequently reported (in more than 1 in 100 patients treated) are nausea, vomiting, stomach pain, diarrhea, headache, joint pain, muscle disorders, cough, nasal symptoms (irritation, runny nose), fever, fatigue, general malaise, skin rash, hair loss, and difficulty sleeping.

The following side effects are not common (occurring in between 1 in 1,000 and 1 in 100 patients treated): anemia (low red blood cell count), neutropenia (low white blood cell count), and reductions in platelet count (blood cells important for blood clotting). If your red blood cell count decreases, you may experience symptoms such as fatigue or shortness of breath. A reduction in white blood cell count may make you more susceptible to infections. If you have a low platelet count, you may notice that you bruise more easily. Increases in certain liver enzymes have also been observed in blood samples from patients treated with lamivudine.

Rarely reported (in between 1 in 10,000 and 1 in 1,000 patients treated) are inflammation of the liver (hepatitis), inflammation of the pancreas (pancreatitis), and muscle tissue rupture.

Very rarely reported (in fewer than 1 in 10,000 patients treated) are numbness, tingling, or weakness in the limbs, and severe anemia and neutropenia.

In rare cases, a condition called lactic acidosis has been reported, which is an increased production of lactic acid in the body and may lead to dehydration and coma in patients taking NRTIs (for further information, see section "Take special care with Lamivudine Normon 300 mg tablets").

Combination antiretroviral therapy may cause changes in body shape due to redistribution of body fat. These may include loss of fat in the legs, arms, and face; increased fat in the abdomen (belly) and other internal organs; breast enlargement; and accumulation of fat on the back of the neck ("buffalo hump"). At present, the cause and long-term health effects of these events are unknown.

Treatment with a combination of antiretrovirals may also lead to increased blood lactic acid and glucose levels, hyperlipidemia (increased blood fats), and insulin resistance.

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 300 mg Tablets

Keep out of the sight and reach of children.

Do not store above 25°C.

Expiry: 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a Sigre Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamivudina Normon 300 mg tablets:

The active substance is lamivudine. Each tablet contains 300 mg of lamivudine.

The other components (excipients) are: microcrystalline cellulose, sodium starch glycolate (from potato), magnesium stearate, titanium dioxide (E-171), hypromellose, macrogol 6000, red iron oxide (E-172) and black iron oxide (E-172).

Appearance of the product and pack contents:

Lamivudina Normon 300 mg is presented as film-coated tablets. The tablets are grey, elongated and biconvex. Each pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Lamivudina Normon 150 mg film-coated tablets EFG

This leaflet was approved in May 2009