Label: information for the user

Kaletra 200 mg/50 mg film-coated tablets

lopinavir/ritonavir

Read this label carefully before starting to take this medicine,because it contains important information for you or your child.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you or your child and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

• Your doctor has prescribed Kaletra to help control your human immunodeficiency virus (HIV) infection. This is possible because Kaletra acts by preventing the infection from spreading rapidly.
• Kaletra is not a cure for HIV or AIDS infection.
• Kaletra is used in children 2 years of age or older, adolescents, and adults infected with HIV, the virus that causes AIDS.
• Kaletra contains the active ingredients lopinavir and ritonavir. Kaletra is an antiretroviral medication that belongs to the group of drugs known as protease inhibitors.
• Kaletra is prescribed for use in combination with other antiviral medications. Your doctor will inform and decide which medications are best for your case.

Do not take Kaletra:

• if you are allergic to lopinavir, ritonavir, or any of the other ingredients in this medicine (listed in section 6).
• if you have severe liver problems.

Do not take Kaletra with any of the following medicines:

• astemizol or terfenadine (usually used to treat allergy symptoms – these medicines may not require a prescription);
• midazolam oral (taken by mouth), triazolam (used to relieve anxiety and/or sleep problems);
• 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 irregular heart rhythms);
• lovastatin, simvastatin (used to lower cholesterol in the blood);
• lomitapide (used to lower cholesterol in the blood);
• alfuzosin (used in men to treat symptoms of an enlarged prostate (benign prostatic hyperplasia (BPH));
• acid fusidic (used to treat skin infections caused by the Staphylococcus bacteria such as impetigo and infected dermatitis). Acid fusidic is also used to treat long-term bone and joint infections under medical supervision (see sectionOther medicines and Kaletra);
• colchicine (medicine used to treat gout). If you have liver or kidney problems (see sectionOther medicines and Kaletra);
• elbasvir/grazoprevir (used to treat chronic hepatitis C [HCV] infection);
• ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C [HCV] infection);
• neratinib (used to treat breast cancer);
• avanafil or vardenafil (used to treat impotence);
• sildenafil used to treat pulmonary hypertension (high blood pressure in the pulmonary artery). Sildenafil may be used to treat erectile dysfunction under medical supervision (see sectionOther medicines and Kaletra);
• products containing St. John's Wort (Hypericum perforatum).

For more information on other medicines that require special precautionssee the list of medicines included in“Other medicines and Kaletra”below.

If you are currently taking any of these medicines, consult your doctor to see if you need to change your treatment for other conditions or your antiretroviral treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kaletra.

Important information

• People taking Kaletra may still develop infections or other diseases associated with HIV and AIDS. Therefore, it is essential to remain under your doctor's supervision while taking Kaletra.
• Despite effective antiretroviral treatment reducing the risk of transmission,you may still transmit HIV to others while taking this medicine.Consult your doctor about what precautions are necessary to avoid infecting others.

Inform your doctor if you or your child have or have had

• Hemophiliatype A and B, as Kaletra may increase the risk of bleeding.

• Diabetesas there have been reports of increased blood sugar levels in patients taking Kaletra.
• History ofliver problems, as patients with a history of liver disease, including chronic hepatitis B or C, have a higher risk of severe and potentially life-threatening liver adverse effects.

Inform your doctor if you or your child experience

• Nausea, vomiting, abdominal pain, difficulty breathing, and severe muscle weakness in the legs and arms, as these may be symptoms of increased lactic acid levels.
• Thirst, frequent urination, blurred vision, or weight loss, as this may indicate high blood sugar levels.
• Nausea, vomiting, abdominal pain, as large increases in triglyceride levels (fats in the blood) are considered a risk factor for pancreatitis (inflammation of the pancreas) and the described symptoms may suggest this condition.
• Signs and symptoms of inflammation of previous infections may appear shortly after starting antiretroviral treatment. 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.
• In addition to opportunistic infections, you may also experience autoimmune disorders (a problem that occurs when the immune system attacks healthy body tissue) after starting treatment for your HIV infection. Autoimmune disorders may appear several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and spreading to the trunk, palpitations, tremors, or hyperactivity, please inform your doctor immediately to seek necessary treatment.
• Stiffness in the joints, pain, and discomfort(especially in the hip, knee, and shoulder) and difficulty moving, 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). Among the numerous risk factors for developing this disease are the duration of combined antiretroviral treatment, the use of corticosteroids, alcohol consumption, severe immunodepression (decreased activity of the immune system), and high body mass index.
• Muscle pain, discomfort, or weakness, particularly in combination with these medicines. In rare cases, these muscle changes have been severe.
• Symptoms of dizziness, feeling dizzy, fainting, or abnormal heartbeats. Kaletra may cause changes in heart rhythm and cardiac electrical activity. These changes may be seen on an ECG (electrocardiogram).

Other medicines and Kaletra

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take any other medicine.

• antibiotics (e.g. rifampicin, rifabutin, clarithromycin);
• antineoplastic medicines (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax,most tyrosine kinase inhibitors such asdasatinib and nilotinib,and alsovincristine and vinblastine);
• anticoagulants (e.g. warfarin, rivaroxaban, vorapaxar)
• antidepressants (e.g. trazodone, bupropion);
• antiepileptic medicines (e.g. carbamazepine, phenytoin, phenobarbital, lamotrigine, and valproate);
• medicines for treating fungal infections (e.g. ketoconazole, itraconazole, voriconazole);
• medicines for treating gout (e.g. colchicine). You should not take Kaletra with colchicine if you have liver or kidney problems (see also “Do not take Kaletra” above);
• antitubercular medicines (e.g. bedaquiline, delamanid);
• antiviral medicines used in the treatment of chronic hepatitis C (HCV) infection in adults (e.g. glecaprevir/pibrentasvir, simeprevir and sofosbuvir/velpatasvir/voxilaprevir);
• medicines for erectile dysfunction (e.g. sildenafil and tadalafil);
• acid fusidic used in the treatment of long-term bone and joint infections (e.g. osteomyelitis);
• medicines for the heart including:
• • digoxin;
  • calcium channel blockers (e.g. felodipine, nifedipine, nicardipine);
  • medicines used to correct heart rhythm (e.g.bepridil, lidocaine systemic, quinidine);
• CCR5 HIV antagonist (e.g. maraviroc)
• integrase inhibitor HIV-1 (e.g. raltegravir)
• levothyroxine (used to treat thyroid problems);
• medicines used to lower cholesterol in the blood (e.g. atorvastatin, lovastatin, rosuvastatin or simvastatin);
• medicines used to treat asthma and other lung problems, such as chronic obstructive pulmonary disease (COPD) (e.g. salmeterol);
• medicines used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (e.g. bosentan, riociguat, sildenafil, tadalafil);
• medicines that affect the immune system (e.g. cyclosporine, sirolimus (rapamycin), tacrolimus);
• medicines used to quit smoking (e.g. bupropion);
• analgesics (e.g. fentanyl);
• medicines similar to morphine (e.g. methadone);
• non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g. efavirenz, nevirapine);
• oral contraceptives or contraceptive patches to prevent pregnancy (see section “Contraceptives” below);
• protease inhibitors (e.g. fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir);
• sedatives (e.g. midazolam injectable);
• steroids (e.g. budesonide, dexamethasone, fluticasone propionate, ethinylestradiol, triamcinolone).

For more information on other medicines that you should not take if you are taking Kaletrasee the list of medicines included in“Do not take Kaletra with any of the following medicines”above.

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take other medicines, even those obtained without a prescription.

Medicines for erectile dysfunction (e.g. avanafil, vardenafil, sildenafil, and tadalafil)

• Do not take Kaletraif you are currently taking avanafil or vardenafil
• You should not take Kaletra with sildenafil when it is used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also the section aboveDo not take Kaletra).
• If you are taking sildenafil or tadalafil and Kaletra together, you may have an increased risk of adverse reactions such as decreased blood pressure, fainting, changes in vision, and prolonged erection of the penis. If the erection of the penis lasts more than 4 hours, you should seek medical attentionimmediatelyto avoid permanent damage to the penis. Your doctor may explain these symptoms.

Contraceptives

• If you are taking oral contraceptives or a contraceptive patch to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom), as Kaletra may reduce the effectiveness of oral contraceptives and patches.
• Kaletra does not reduce the risk of HIV transmission to others. You should use appropriate precautions (e.g. using a condom) to prevent the transmission of the disease through sexual contact.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctorimmediatelybefore using this medicine.
• Mothers who are breastfeeding should not take Kaletra unless specifically recommended by your doctor.
• Women infected with HIV should not breastfeed their children as there is a possibility that the child may become infected with HIV through breast milk.

Driving and operating machinery

No specific studies have been conducted on the possible effects of Kaletra on the ability to drive and operate machinery. Do not drive or operate machinery if you experience any adverse effects (e.g. nausea) that may affect your ability to do so safely. Consult your doctor.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How and when to take Kaletra

Use in adults

• The usual dose in adults is 400 mg/100 mg twice a day, for example, every 12 hours, in combination with other HIV medications. Adult patients who have not been previously treated with another antiviral medication may also take Kaletra once a day at a dose of 800 mg/200 mg. Your doctor will tell you how many tablets you should take. If your doctor decides it is appropriate, adult patients who have been previously treated with other antiviral medications may take Kaletra tablets once a day at a dose of 800 mg/200 mg.
• Kaletra should not be taken once a day with efavirenz, nevirapina, carbamazepina, phenobarbital, and phenytoin.
• Kaletra tablets can be taken with or without food.

Use in children

• Your doctor will decide on the correct dose (number of tablets) based on the child's weight and height.
• Kaletra tablets can be taken with or without food.

Kaletra is also available in 100 mg/25 mg film-coated tablets. Kaletra oral solution is available for patients who cannot take tablets.

If you or your child take more Kaletra than you should

• If you realize you have taken more Kaletra than indicated, inform your doctor immediately.
• If you cannot contact your doctor, go to the hospital.

If you or your child forget to take Kaletra

If you are taking Kaletra twice a day

• If you realize you have forgotten to take a dose within 6 hours of your usual time, take it as soon as possible and then continue with your normal dosing, taking the next dose at the time it is due, as prescribed by your doctor.

• If more than 6 hours have passed since your usual time for taking the dose, do not take the missed dose. Take the next dose at your usual time. Do not take a double dose to make up for the missed doses.

If you are taking Kaletra once a day

• If you realize you have forgotten to take a dose within 12 hours of your usual time, take it as soon as possible and then continue with your normal dosing at the time it is due, as prescribed by your doctor.

• If more than 12 hours have passed since your usual time for taking the dose, do not take the missed dose. Take the next dose at your usual time. Do not take a double dose to make up for the missed doses.

If you or your child stop taking Kaletra

• Do not stop taking or change your daily dose of Kaletra without first consulting your doctor.
• Kaletra must be taken every day to help control HIV, regardless of any improvement you may feel.
• Taking Kaletra as recommended is the best way to delay the development of drug resistance.
• If an adverse reaction prevents you from taking Kaletra as instructed, tell your doctor quickly.
• Always have a sufficient amount of Kaletra so you do not run out of medication. When traveling or needing to be in the hospital, ensure you have enough until you can get more.
• Continue taking this medicationuntil your doctor tells you to.

Like all medicines, Kaletra may cause side effects, although not everyone will experience them. It is difficult to distinguish between side effects caused by Kaletra and those of other medicines you are taking at the same time or those resulting from complications of HIV infection.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medicines themselves. Your doctor will monitor these changes.

The following side effects have been reported by patients who took this medicine.You should inform your doctor quickly about these or any other symptoms. See your doctor if they persist or worsen.

Very common:may affect more than 1 in 10 people

• diarrhea;
• nausea;
• upper respiratory tract infection;

Common:may affect up to 1 in 10 people

• pancreatitis inflammation;
• vomiting, abdominal enlargement, upper and lower abdominal pain, temporary flatulence, indigestion, decreased appetite, reflux from the stomach to the esophagus that may cause pain;

• Inform your doctorif you experience nausea, vomiting, or abdominal pain, as they may be symptoms of pancreatitis (pancreatitis inflammation).

• swelling or inflammation of the stomach, intestines, and colon;
• increase in blood cholesterol levels, increase in triglyceride levels (a type of fat) in the blood, high blood pressure;
• decreased ability of the body to metabolize sugar, such as diabetes mellitus, weight loss;
• low red blood cell count, low white blood cell count that are usually used to fight infections;
• eruption, eczema, accumulation of greasy skin scales;
• dizziness, anxiety, difficulty sleeping;
• feeling of fatigue, loss of strength and energy, headache including migraine;
• hemorrhoids;
• inflammation of the liver and increased liver enzymes;
• allergic reactions including urticaria and inflammation in the mouth;
• lower respiratory tract infection;
• enlargement of lymph nodes;
• impotence, abnormally heavy or prolonged menstrual flow or amenorrhea,
• muscle problems such as muscle weakness and spasms, joint, muscle, and back pain;
• damage to the peripheral nervous system nerves;
• nocturnal sweating, itching, hives including raised skin bumps, skin infection, inflammation of the skin or capillaries, accumulation of fluid in cells and tissues.

Uncommon:may affect up to 1 in 100 people

• abnormal dreams;
• loss or change of taste;
• hair loss;
• an alteration of your electrocardiogram (ECG) called atrioventricular block;
• accumulation of platelets in the arteries that may lead to heart attack and stroke;
• inflammation of blood vessels and capillaries;
• inflammation of the bile duct;
• involuntary body shaking;
• constipation;
• inflammation of the veins related to a blood clot;
• dry mouth;
• inability to control the sphincters;
• inflammation of the first section of the small intestine just after the stomach, wound or ulcer in the digestive tract, intestinal or rectal bleeding;
• red blood cells in the urine;
• yellowing of the skin or white of the eyes (jaundice);
• fat deposits in the liver, liver enlargement;
• testicular dysfunction;
• sudden reappearance of symptoms related to an inactive infection in your body (immune reconstitution);
• increased appetite;
• abnormal increase in bilirubin levels (a pigment produced by the breakdown of red blood cells) in the blood;
• decreased sexual desire;
• kidney inflammation;
• bone death caused by poor blood supply to the area;
• mouth or esophageal ulcers, stomach and intestinal inflammation;
• renal failure;
• rupture of muscle fibers that causes the release of their contents (myoglobin) into the bloodstream;
• a sound in one ear or both ears, such as buzzing, ringing, or hissing;
• trembling;
• abnormal closure of one of the valves (tricuspid valve of the heart);
• dizziness (sensation of spinning);
• eye disorder, abnormal vision;
• weight gain.

Rare:may affect up to 1 in 1,000 people

• severe skin eruptions and blisters that are potentially life-threatening (Stevens-Johnson syndrome and erythema multiforme).

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.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.

How should I dispose of unused Kaletra?

Unused medications should not be flushed down the drain or thrown away.

Ask your pharmacist how to dispose of the containers and unused medications. This will help protect the environment.

Composition of Kaletra

The active ingredients are lopinavir and ritonavir.

Each Kaletra tablet contains 200 mg of lopinavir and 50 mg of ritonavir.

The other components are:

Tablet

Copovidone, sorbitan laurate, anhydrous colloidal silica, sodium stearyl fumarate.

Capsule coating

Hydroxypropyl cellulose, titanium dioxide, macrogol 400 (polyethylene glycol 400), talc, anhydrous colloidal silica, macrogol 3350 (polyethylene glycol 3350), iron oxide yellow E-172, poloxamer 80.

Appearance of the product and contents of the package

Kaletra coated tablets are yellow in color with a raised impression of (Abbott logo) and “KA”.

Kaletra coated tablets are presented in containers containing 120 tablets (1 plastic bottle with 120 tablets) and multi-containers containing 3 plastic bottles each containing 120 tablets (360 tablets). Multi-containers with blisters of 120 tablets (1 box of 120 tablets or 3 boxes each containing 40 tablets) are also available.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Responsible for manufacturing:

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Ireland

For more information about this medication, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu