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Kaletra is a combination of Ritonavir 50 mg and Lopinavir 200 mg, both of which belong to the category of anti-viral medicines.

Product Description:

General information
Kaletra 200 mg/50 mg film-coated tablets

lopinavir/ritonavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you or your child.

  • 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 or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Kaletra is and what it is used for
2. What you need to know before you or your child takes Kaletra
3. How to take Kaletra
4. Possible side effects
5. How to store Kaletra
6. Contents of the pack and other information

1. What Kaletra is and what it is used for

  • Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection. Kaletra does this by slowing down the spread of the infection in your body.
  • Kaletra is not a cure for HIV infection or AIDS.
  • Kaletra is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
  • Kaletra contains the active substances lopinavir and ritonavir. Kaletra is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors.
  • Kaletra is prescribed for use in combination with other antiviral medicines. Your doctor will discuss with you and determine which medicines are best for you.

2. What you need to know before you or your child takes Kaletra

Do not take Kaletra:

  • if you are allergic to lopinavir, ritonavir or any of the other ingredients of Kaletra (see section 6);
  • if you have severe liver problems.

Do not take Kaletra with any of the following medicines:

  • astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription);
  • midazolam taken orally (taken by mouth), triazolam (used to relieve anxiety and/or trouble sleeping);
  • pimozide (used to treat schizophrenia);
  • quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder);
  • lurasidone (used to treat depression);
  • ranolazine (used to treat chronic chest pain [angina]);
  • cisapride (used to relieve certain stomach problems);
  • ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches);
  • amiodarone, dronedarone (used to treat abnormal heart beat);
  • lovastatin, simvastatin (used to lower blood cholesterol);
  • lomitapide (used to lower blood cholesterol);
  • alfuzosin (used in men to treat symptoms of an enlarged prostate (benign prostatic hyperplasia (BPH));
  • fusidic acid (used to treat skin infections caused by Staphylococcus bacteria such as impetigo and infected dermatitis). Fusidic acid used to treat long-term infections of the bones and joints may be taken under doctor’s supervision (see Other medicines and Kaletra section);
  • colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on Other medicines and Kaletra);
  • elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]);
  • ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus [HCV]);
  • neratinib (used to treat breast cancer);
  • avanafil or vardenafil (used to treat erectile dysfunction);
  • sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery). Sildenafil used to treat erectile dysfunction may be taken under doctor’s supervision (see Other medicines and Kaletra section);
  • products that contain St John’s wort (Hypericum perforatum).

Read the list of medicines below under ‘Other medicines and Kaletra’ for information on certain other medicines which require special care.

If you are currently taking any of these medicines, ask your doctor about making necessary changes either in the treatment for your other condition(s) or in your antiretroviral treatment.

Warnings and precautions

Talk to your doctor or pharmacist before taking Kaletra.

Important information

  • People taking Kaletra may still develop infections or other illnesses associated with HIV disease and AIDS. It is therefore important that you remain under the supervision of your doctor while taking Kaletra.
  • You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

Tell your doctor if you or your child have/had

  • Haemophilia type A and B as Kaletra might increase the risk of bleeding.
  • Diabetes as increased blood sugars has been reported in patients receiving Kaletra.
  • A history of liver problems as patients with a history of liver disease, including chronic hepatitis B or C are at increased risk of severe and potentially fatal liver side effects.

Tell your doctor if you or your child experience

  • 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.
  • In some patients 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.
  • In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
  • Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement as some patients 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 your heart rhythm and the electrical activity of your heart. These changes may be seen on an ECG (electrocardiogram).

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