Package Insert: Information for the User

Lamivudine Normon 300 mg Film-Coated Tablets

Lamivudine

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

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

• Do not take Lamivudina Normon 300 mg tablets:

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

If you are unsure, please ask your doctor.

• Be especially careful with Lamivudina Normon 300 mg tablets:

Speak with your doctor about using Lamivudina Normon if you have kidney disease. You may need to reduce the usual recommended dose of Lamivudina Normon.

Lamivudine, the class of medication to which it belongs (NRTI), may lead to a condition called lactic acidosis (accumulation of lactic acid in the body), as well as an increase in liver size. 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 severe adverse reaction has been fatal in some cases. Lactic acidosis occurs more frequently in women, particularly if they are overweight. If you have liver disease, you may also be at higher risk of this reaction. While you are being treated with Lamivudina Normon, your doctor will regularly monitor any signs that may indicate you are 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 previous infections may appear shortly after starting antiretroviral therapy. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight off infections that were present without apparent symptoms. If you notice any symptoms 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 and treated with antiretroviral drugs are at 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 Lamivudina Normon without 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 medication helps control your condition, but it does not cure HIV infection. You may continue to develop other infections and other diseases related to HIV infection. You should maintain regular contact with your doctor. Do not stop taking the medication without first speaking with your doctor.

Combination antiretroviral therapy with Lamivudina Normon has not been shown to reduce the risk of HIV transmission to others through sexual contact or blood transfusion. You should continue to take the necessary precautions to avoid transmission.

Bone problems: Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Factors that increase the risk of developing this disease include the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include stiffness in the joints, pain, and discomfort, especially in the hip, knee, and shoulder, and difficulty moving. If you notice any of these symptoms, inform your doctor.

• Use of other medications:

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

Lamivudina Normon should not be administered with zalcitabine, high doses of cotrimoxazole, or infusions of ganciclovir or foscarnet.

• Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication. If you become pregnant or are planning to become pregnant, you should contact your doctor to discuss the potential adverse effects and benefits and risks of your antiretroviral treatment for 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 the development of your child. These visits may include blood tests and other diagnostic tests.

In children whose mothers took nucleoside and nucleotide analogs during pregnancy, the benefit of reducing the likelihood of HIV infection is greater than the risk of adverse effects.

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

• 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 Lamivudina Normon 300 mg as indicated 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 can 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 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).

This formulation is not suitable for children under 12 years of age and weighing less than 30 kg.

If you have a kidney problem, your dose may be modified. Follow your doctor's instructions.

• If you take more Lamivudina Normon than you should,it is unlikely that accidental ingestion of an excessive amount of Lamivudina Normon will cause serious problems. However, you should inform your doctor or pharmacist, or visit the nearest hospital emergency department for advice.

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

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

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

Like all medicines, Lamivudina Normon 300 mg may cause side effects, although not everyone will experience them. When treating an HIV infection, it is not always possible to determine if any of the adverse reactions that occur are caused by Lamivudina Normon, other medicines you are taking at the same time, or the HIV disease. For this reason, it is very important that you inform your doctor about any changes in your health.

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

The following side effects are not very 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 (important blood cells for blood clotting). If your red blood cell count is reduced, you may experience symptoms of fatigue or difficulty breathing. A low white blood cell count may make you more susceptible 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 reported (between 1 in 10,000 and 1 in 1,000 patients treated) are liver inflammation (hepatitis), pancreatitis (inflammation of the pancreas), and muscle tissue rupture.

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

In rare cases, cases of a condition called lactic acidosis have 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 Be careful with Lamivudina Normon 300 mg tablets).

Combination antiretroviral therapy can cause a change in body shape due to changes in fat distribution. These may include loss of fat in the legs, arms, and face, an increase in abdominal fat (belly) and other internal organs, breast enlargement, and the appearance of fat deposits in the back of the neck ("buffalo hump"). At this time, the cause and long-term health effects of these events are unknown.

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

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

Keep out of the sight and reach of children.

Do not store at a temperature above 25°C.

Expiration Date: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.

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

Composition of Lamivudina Normon 300 mg tablets:

The active ingredient is lamivudina. Each tablet contains 300 mg of lamivudina.

The other components (excipients) are: microcrystalline cellulose, sodium glycolate starch (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 contents of the packaging:

Lamivudina Normon 300 mg is presented in the form of film-coated tablets. The tablets are grey, elongated and biconvex. Each package contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing:

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