Abbott Confirms Long-Term Commitment to HIV Care with the Planned Development of New Formulations (2)

        
        - Nausea, vomiting, abdominal pain, difficulty breathing and
          severe weakness of the muscles in the legs and arms as these symptoms
          may indicate raised lactic acid levels.
        - Thirst, frequent urination, blurred vision or weight loss as
          this may indicate raised sugar levels in the blood.
        - Nausea, vomiting, abdominal pain as large increases in the
          amount of triglycerides (fats in the blood) have been considered a risk
          factor for pancreatitis (inflammation of the pancreas) and these
          symptoms may suggest this condition.
        - Changes in body shape due to changes in fat distribution. These
          may include loss of fat from legs, arms and face, increased fat in the
          abdomen (belly) and other internal organs, breast enlargement and fatty
          lumps on the back of the neck ('buffalo hump'). The cause and long-term
          health effects of these conditions are not known at this time.
        - In some people with advanced HIV infection and a history of
          opportunistic infection, signs and symptoms of inflammation from
          previous infections may occur soon after anti-HIV treatment is started.
          It is believed that these symptoms are due to an improvement in the
          body's immune response, enabling the body to fight infections that may
          have been present with no obvious symptoms. If people notice any
          symptoms of infection, their doctor should be informed immediately to
          seek necessary treatment.
        - Joint stiffness, aches and pains (especially of the hip, knee
          and shoulder) and difficulty in movement as some people taking these
          medicines may develop a bone disease called osteonecrosis (death of bone
          tissue caused by loss of blood supply to the bone). The length of
          combination antiretroviral therapy, corticosteroid use, alcohol
          consumption, severe immunosuppression (reduction in the activity of the
          immune system), higher body mass index, among others, may be some of the
          many risk factors for developing this disease.
        - Muscle pain, tenderness or weakness, particularly in combination
          with these medicines. On rare occasions these muscle disorders have been
          serious.
        - Symptoms of dizziness, lightheadedness, fainting or sensation of
          abnormal heartbeats. Kaletra may cause changes in heart rhythm and
          electrical activity of the heart. These changes may be seen on an ECG
          (electrocardiogram).

People taking sildenafil or tadalafil and Kaletra together may be at risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting more than 4 hours. If an erection lasts longer than 4 hours, they should get medical help immediately to avoid permanent damage to their penis. Their doctor can explain these symptoms.

Women taking oral contraceptive or using a patch to prevent pregnancy should use an additional or different type of contraception since Kaletra may reduce the effectiveness of oral and patch contraceptives.

Pregnant or nursing mothers should not take Kaletra unless specifically directed by their doctor.

Kaletra should not be given to children younger than 2 years of age unless specifically directed by their doctor. Kaletra once daily has not been evaluated in pediatrics.

Very common (meaning affects more than 1 user in 10) side effects of Kaletra include diarrhoea, nausea and upper respiratory tract infection. This is not a complete list of reported side effects.

For more information about Kaletra, the local Summary of Product Characteristics should be consulted.

Information about Norvir

Use

Norvir is a protease inhibitor used to control HIV infection. Norvir is used in combination with other anti-HIV medicines (antiretrovirals) to control HIV infection in adults and children of 2 years of age and older.

Norvir can be used at full dose on its own, or at lower doses (called booster doses) with other medicines.

Norvir is not a cure for HIV infection or AIDS and does not lower the risk of passing HIV to others. People taking Norvir may still develop infections or other illnesses associated with HIV infection or AIDS.

Important Safety Information

Norvir should not be taken by people who are allergic (hypersensitive) to ritonavir or any of the other ingredients of Norvir or people who have severe liver disesase.

Norvir should not be taken with the following medicines: astemizole, terfenadine, amiodarone, bepridil, encainide, flecainide, propafenone, quinidine, dihydroergotamine, ergotamine, ergonovine, methylergonovine, clorazepate, diazepam, estazolam, flurazepam, triazolam or oral (taken by mouth) midazolam, clozapine, pimozide, pethidine, piroxicam, propoxyphene, cisapride rifabutin, voriconazole, simvastatin, lovastatin, alfuzosin, fusidic acid, sildenafil used to treat a lung disease called pulmonary arterial hypertension, and products containing St John's wort (Hypericum perforatum).

People must tell their doctor or pharmacist if they are taking or have recently taken any other medicines, including medicines obtained without a prescription.

People must tell their doctor if they have/had:

        
        - A history of liver disease.
        - Hepatitis B or C and are being treated with a combination of
          antiretroviral agents, as they are at a greater risk of a severe and
          potentially life threatening reaction because of the effect on the
          liver. Regular blood tests may be required to check if the liver is
          working properly.
        - Haemophilia, as there have been reports of increased bleeding in
          patients with haemophilia who are taking this type of medicine (protease
          inhibitors). The reason for this is not known. Additional medicine maybe
          needed to help blood clot (factor VIII), in order to control any
          bleeding.
        - Erectile Dysfunction, as the medicines used to treat erectile
          dysfunction can cause hypotension and prolonged erection.
        - Diabetes, as there have been reports of worsening of or the
          development of diabetes (diabetes mellitus) in some patients taking
          protease inhibitors.
        - Kidney (renal) disease, since a doctor may need to check the
          dose of other medicines (such as protease inhibitors).

People must tell their doctor if they experience:

        
        - Changes in the distribution of the fat on their body, or a
          build up or loss of body fat
        - Diarrhoea or vomiting that is not improving (persistent), as
          this may reduce how well the medicines are working.
        - Feeling sick (nausea), vomiting or have stomach pain, because
          these may be signs of inflammation of the pancreas (pancreatitis). Some
          patients taking Norvir can develop serious problems with their pancreas.
        - Symptoms of infection - Some patients with advanced HIV
          infection (AIDS) who then start anti-HIV treatment may develop the
          symptoms of infections they have had in the past even if they didn't
          know they had them. It is believed that this happens because the body's
          immune response improves and helps the body to fight these infections.
        - Joint stiffness, aches and pains (especially of the hip, knee
          and shoulder) and difficulty moving, as this may be a sign of a problem
          that can destroy bone (osteonecrosis). Some patients taking a number of
          antiretroviral medicines may develop this disease.
        - Muscle pain, tenderness or weakness, particularly in combination
          with antiretroviral therapy including protease inhibitors and nucleoside
          analogues. On rare occasions these muscle disorders have been serious.
        - Dizziness, lightheadedness, fainting spells or abnormal
          heartbeat. Some patients taking Norvir may experiences changes in the
          electrocardiogram (ECG). People must tell their doctor if they have a
          heart defect or conduction defect.
        - If people have any other health concerns, they should discuss
          these with their doctor as soon as they can.

People must tell their doctor if they are taking any of the medicines listed below, as special care should be taken.

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