LAMIVUDINE NORMON 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lamivudine Normon 150 mg Film-Coated Tablets EFG

Lamivudine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

1. What is Lamivudine Normon 150 mg and what is it used for
2. Before you take Lamivudine Normon 150 mg
3. How to take Lamivudine Normon 150 mg
4. Possible side effects
5. Storing Lamivudine Normon 150 mg
6. Package Contents and Further Information

1. What is Lamivudine Normon 150 mg and what is it used for

Lamivudine belongs to a group of antiviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), which are used to treat HIV infection.

Lamivudine Normon 150 mg is used in combination antiretroviral therapy for the treatment of HIV infection in adults and children. Lamivudine Normon reduces the amount of HIV in your body, keeping it at a low level. It also increases the number of CD4 cells in your blood. CD4 cells are a type of white blood cell that plays an important role in your immune system, helping to fight infection. The response to treatment with Lamivudine Normon 150 mg can vary from person to person. Your doctor will monitor the effectiveness of your treatment.

2. Before you take Lamivudine Normon 150 mg

• Do not take Lamivudine Normon 150 mg:

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

If you are not sure, ask your doctor.

• Take special care with Lamivudine Normon 150 mg:

Tell your doctor if you have kidney problems. You may need to take a lower dose of Lamivudine Normon.

The class of medicines to which lamivudine belongs (NRTIs) can cause a condition called lactic acidosis (a build-up of lactic acid in the body), as well as an increase in the size of the liver. Lactic acidosis, if it occurs, usually develops after a few months of treatment. Rapid breathing, deep and fast, drowsiness and non-specific symptoms such as nausea, vomiting and stomach pain may indicate the development of lactic acidosis. This rare but serious side effect has been fatal in some cases. Lactic acidosis occurs more often in women, particularly if they are overweight. If you have liver disease, you may also have a higher risk of developing this condition. While you are being treated with Lamivudine Normon, your doctor will regularly check for any signs 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 and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling it to fight infections that have been present without causing symptoms. If you notice any symptoms of infection, tell your doctor immediately.

Tell your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents have a higher risk of severe and potentially fatal liver reactions and may require blood tests to monitor liver function.

If you have chronic hepatitis B, you should not stop taking Lamivudine Normon without your doctor's advice, as you may experience a recurrence of hepatitis. This recurrence can be more severe if you have severe liver disease.

You will need to take Lamivudine Normon every day. This medicine helps control your condition, but it does not cure HIV infection. You may continue to develop other infections and illnesses related to HIV. You must keep regular contact with your doctor. Do not stop taking the medicine without talking to your doctor first.

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

Bone problems: some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to loss of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis are stiffness in the joints, pain and discomfort, especially in the hips, knees, and shoulders, and difficulty moving. If you notice any of these symptoms, tell your doctor.

• Using other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. These may affect the action of Lamivudine Normon or Lamivudine Normon may affect their action.

Lamivudine Normon should not be taken with zalcitabine, high doses of co-trimoxazole, or with ganciclovir or foscarnet infusions.

• Pregnancy and breastfeeding:

Ask your doctor or pharmacist for advice before taking any medicine. If you become pregnant or plan to become pregnant, you should contact your doctor to discuss the potential risks and benefits of your antiretroviral therapy for you and your child. Lamivudine Normon is not recommended during the first three months of pregnancy.

If you have taken Lamivudine Normon during your pregnancy, your doctor may require regular visits to monitor the development of your child. These visits may include blood tests and other diagnostic tests.

In children whose mothers took nucleoside and nucleotide analogues during pregnancy, the benefit of reducing the likelihood of being infected with HIV is greater than the risk of experiencing side effects.

As lamivudine and the virus pass into breast milk, it is recommended that mothers taking Lamivudine Normon do not breastfeed their children. It is recommended that HIV-infected women do not breastfeed their children under any circumstances to avoid transmitting HIV.

• Lamivudine Normon contains sodium

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

3. How to take Lamivudine Normon

Follow exactly the instructions for taking Lamivudine Normon 150 mg as indicated by your doctor. Ask your doctor or pharmacist if you have any doubts. Swallow the Lamivudine Normon 150 mg tablets with water or another drink. These tablets can be taken with or without food.

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

Children (under 12 years): for children who weigh at least 30 kg, the recommended oral dose of Lamivudine Normon is 1 tablet of 150 mg twice a day, approximately every 12 hours.

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

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

• If you take more Lamivudine Normon than you should,it is unlikely that accidentally taking too much Lamivudine Normon will cause serious problems. However, you should tell your doctor or pharmacist, or go to the nearest hospital emergency department for advice.

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

• If you forget to take Lamivudine Normon 150 mg tablets:If you forget to take a dose of Lamivudine Normon, take it as soon as you remember and then continue as before. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Lamivudine Normon 150 mg can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to say whether a side effect is caused by Lamivudine Normon, by other medicines you are taking at the same time, or by the HIV disease itself. For this reason, it is very important that you tell your doctor about any changes in your health.

The most frequently reported side effects (more than 1 in 100 patients treated) are nausea, vomiting, stomach pain, diarrhea, headache, joint pain, muscle problems, cough, nasal symptoms (irritation, runny nose), fever, tiredness, general feeling of being unwell, skin rash, hair loss, and difficulty sleeping.

The following side effects are not common (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 the number of platelets (blood cells important for blood clotting). If the number of red blood cells is reduced, you may experience symptoms of tiredness or difficulty breathing. A reduction in the white blood cell count can make you more prone to infection. If you have a low platelet count, you may notice that you bruise more easily. Increases in some liver enzymes have also been observed in blood samples from patients treated with lamivudine.

Rarely, the following side effects have been reported (between 1 in 10,000 and 1 in 1,000 patients treated): liver inflammation (hepatitis), pancreas inflammation (pancreatitis), muscle tissue breakdown.

Very rarely, the following side effects have been reported (less than 1 in 10,000 patients treated): numbness, tingling, or weakness in the limbs, severe anemia, and severe neutropenia.

In rare cases, a condition called lactic acidosis has been reported, which is an increase in the production of lactic acid in the body, which can cause dehydration and coma in patients taking NRTIs (for more information, see the section Take special care with Lamivudine Normon 150 mg tablets).

Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These can include loss of fat in the legs, arms, and face, an increase in fat in the abdomen (stomach) and other internal organs, enlargement of the breasts, and accumulation of fat in the back of the neck ("buffalo hump"). At present, the cause and long-term effects on health of these events are not known.

Treatment with a combination of antiretrovirals can also cause an increase in lactic acid and sugar in the blood, hyperlipemia (increase in fats in the blood), and insulin resistance.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storing Lamivudine Normon 150 mg tablets

Keep out of the sight and reach of children.

Do not store above 25°C.

Expiry date:Do not use Lamivudine Normon after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month shown.

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. Package Contents and Further Information

Composition of Lamivudine Normon 150 mg tablets:

The active substance is lamivudine. Each tablet contains 150 mg of lamivudine.

The other ingredients (excipients) are: microcrystalline cellulose, sodium starch glycolate (from potato), magnesium stearate, titanium dioxide (E-171), hypromellose, and macrogol 6000.

Appearance and packaging of the product:

Lamivudine Normon 150 mg is presented in the form of film-coated tablets. The tablets are white or almost white, elongated, and biconvex. Each pack contains 60 tablets.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Lamivudine Normon 300 mg film-coated tablets EFG

This leaflet was approved in May 2009