KALETRA 200 mg/50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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.

• 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.

Contents of the pack and other information

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

1. What is Kaletra and what is it used for

• Your doctor has prescribed Kaletra to help control your human immunodeficiency virus (HIV) infection. This is because Kaletra helps to stop the infection from spreading rapidly.
• Kaletra is not a cure for HIV infection or AIDS.
• Kaletra is used in children from 2 years of age, adolescents and adults who are infected with HIV, the virus that causes AIDS.
• Kaletra contains the active substances lopinavir and ritonavir. Kaletra is an antiretroviral medicine that belongs to a group of medicines called protease inhibitors.
• Kaletra is prescribed for use in combination with other antiviral medicines. Your doctor will inform you and decide which medicines are best for you.

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

Do not take Kaletra:

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

Do not take Kaletra with any of the following medicines:

• astemizole or terfenadine (normally used to treat allergy symptoms – these medicines may not require a prescription);
• oral midazolam, 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 pectoris]);
• cisapride (used to relieve certain stomach problems);
• ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headache);
• amiodarone, dronedarone (used to treat heart rhythm problems);
• lovastatin, simvastatin (used to lower blood cholesterol);
• lomitapide (used to lower blood cholesterol);
• alfuzosin (used in men to treat symptoms of enlarged prostate [benign prostatic hyperplasia (BPH)]);
• fusidic acid (used to treat skin infections caused by the bacteria Staphylococcus such as impetigo and infected dermatitis). Fusidic acid is also used to treat long-term bone and joint infections under medical supervision (see section Other medicines and Kaletra);
• colchicine (medicine used to treat gout). If you have liver or kidney problems (see section Other medicines and Kaletra);
• elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV] infection);
• ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus [HCV] infection);
• neratinib (used to treat breast cancer);
• avanafil or vardenafil (used to treat impotence);
• sildenafil used for the treatment of pulmonary hypertension (high blood pressure in the pulmonary artery). Sildenafil may be used for the treatment of erectile dysfunction under medical supervision (see section Other medicines and Kaletra);
• products containing St. John's Wort (Hypericum perforatum).

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

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 Kaletra.

Important information

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

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

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

• Diabetes, as increases in blood sugar have been reported in patients taking Kaletra.
• A history of liver 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 side effects.

Tell your doctor if you or your child are experiencing

• 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 significant increases in triglycerides (fats in the blood) are considered a risk factor for pancreatitis (inflammation of the pancreas), and the symptoms described may suggest this condition.
• In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation of previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to be due to an improvement in the body's immune response, allowing it to fight 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 moving up towards 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 hips, knees, and shoulders) 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 many risk factors for developing this disease are the duration of combined antiretroviral treatment, the use of corticosteroids, alcohol consumption, severe immunodepression, and high body mass index.
• Muscle pain, discomfort, or weakness, particularly in combination with these medicines. In rare cases, these muscle disorders have been severe.
• Symptoms of dizziness, dizziness sensation, fainting, or sensation of abnormal heartbeats. Kaletra may cause changes in heart rhythm and electrical activity of the heart. These changes can be seen on an ECG (electrocardiogram).

Other medicines and Kaletra

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

• antibiotics (e.g., rifampicin, rifabutin, clarithromycin);
• anticancer medicines (e.g., abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinase inhibitors such as dasatinib and nilotinib, and also vincristine and vinblastine);
• anticoagulant (e.g., warfarin, rivaroxaban, vorapaxar)
• antidepressants (e.g., trazodone, bupropion);
• antiepileptic medicines (e.g., carbamazepine, phenytoin, phenobarbital, lamotrigine, and valproate);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole, voriconazole);
• medicines used to treat gout (e.g., colchicine). You must 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 to treat chronic hepatitis C virus (HCV) infection in adults (e.g., glecaprevir/pibrentasvir, simeprevir, and sofosbuvir/velpatasvir/voxilaprevir);
• medicines for erectile dysfunction (e.g., sildenafil and tadalafil);
• fusidic acid used in the long-term treatment of 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, systemic lidocaine, quinidine);
• HIV CCR5 antagonist (e.g., maraviroc)
• HIV-1 integrase inhibitor (e.g., raltegravir)
• levothyroxine (used to treat thyroid problems);
• medicines used to lower blood cholesterol (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 help stop 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., injectable midazolam);
• corticosteroids (e.g., budesonide, dexamethasone, fluticasone propionate, ethinylestradiol, triamcinolone).

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

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, including 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 must not take Kaletra with sildenafil when used for the treatment of pulmonary hypertension (high blood pressure in the pulmonary artery) (see also the section above Do not take Kaletra).
• If you are taking sildenafil or tadalafil and Kaletra together, you may be at risk of adverse reactions such as decreased blood pressure, fainting, changes in vision, and an erection of the penis that lasts more than 4 hours. If the erection of the penis lasts more than 4 hours, you must go immediatelyto the doctor to avoid permanent damage to the penis. Your doctor can explain these symptoms to you.

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 transmitting HIV to others. You must use appropriate precautions (e.g., using a condom) to prevent the transmission of the disease through sexual contact.

Pregnancy and breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor immediatelybefore using this medicine.
• Mothers who are breast-feeding should not take Kaletra unless specifically recommended by their doctor.
• It is recommended that HIV-infected women do not breast-feed their babies, as there is a possibility that the baby may become infected with HIV through breast milk.

Driving and using machines

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

3. How to take Kaletra

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, 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 daily, e.g., every 12 hours, in combination with other anti-HIV medicines. Adult patients who have not previously been treated with another antiviral medicine may also take Kaletra once daily in a dose of 800 mg/200 mg. Your doctor will tell you how many tablets to take. If your doctor decides it is appropriate, adult patients who have been previously treated with other antiviral medicines may take Kaletra tablets once daily in a dose of 800 mg/200 mg.
• Kaletra must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital, and phenytoin.
• Kaletra tablets can be taken with or without food.

Use in children

• For children, your doctor will decide 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 as 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 you should, 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 the usual time, take it as soon as possible and then continue with your normal dosing schedule, taking the next dose at the usual time, as prescribed by your doctor.

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

If you are taking Kaletra once a day

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

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

If you or your child stop taking Kaletra

• Do not stop taking or change your daily dose of Kaletra without consulting your doctor first.
• Kaletra must be taken every day to help control HIV, regardless of how much better you feel.
• Taking Kaletra as recommended is the best way to delay the development of resistance to the medicine.
• If a side effect prevents you from taking Kaletra as directed, tell your doctor promptly.
• Always have enough Kaletra to last until you can get more. When traveling or in the hospital, make sure you have enough Kaletra.
• Continue taking this medicine until your doctor tells you to stop.

4. Possible Adverse Effects

Like all medicines, Kaletra can cause adverse effects, although not all people suffer from them. It is difficult to distinguish between the adverse effects caused by Kaletra and those caused by other medicines being taken at the same time or those derived from the complications of HIV infection.

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

The following adverse effects have been reported by patients taking this medication.You should inform your doctor promptly about these or any other symptoms. Consult 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;
• vomiting, abdominal distension, pain in the upper and lower abdomen, flatulence, indigestion, decreased appetite, reflux from the stomach to the esophagus that can cause pain;

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

• swelling or inflammation of the stomach, intestine, and colon;
• increased cholesterol levels in the blood, increased 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 is used to fight infections;
• rash, eczema, accumulation of scaly skin;
• dizziness, anxiety, difficulty sleeping;
• feeling of fatigue, loss of strength and energy, headache including migraine;
• hemorrhoids;
• liver inflammation and increased liver enzymes;
• allergic reactions including hives and inflammation in the mouth;
• lower respiratory tract infection;
• increased lymph nodes;
• impotence, abnormally heavy or prolonged menstrual flow or lack of menstruation,
• muscle problems such as muscle weakness and spasms, joint, muscle, and back pain;
• damage to the nerves of the peripheral nervous system;
• night sweats, itching, rash including elevated bumps on the skin, skin infection, skin inflammation or hair follicle inflammation, fluid accumulation in cells and tissues.

Uncommon:may affect up to 1 in 100 people

• abnormal dreams;
• loss or change of taste;
• hair loss;
• a change in your electrocardiogram (ECG) called atrioventricular block;
• platelet accumulation in the arteries that can lead to a heart attack and stroke;
• inflammation of blood vessels and capillaries;
• bile duct inflammation;
• uncontrollable body tremors;
• constipation;
• vein inflammation related to a blood clot;
• dry mouth;
• inability to control 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 the whites of the eyes (jaundice);
• fat deposits in the liver, increased liver size;
• testicular dysfunction;
• sudden onset of symptoms related to an inactive infection in the 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 sores or ulcers, stomach and intestine inflammation;
• kidney failure;
• rupture of muscle fibers that causes the release of their contents (myoglobin) into the bloodstream;
• a sound in one or both ears, such as ringing, buzzing, or whistling;
• tremors;
• abnormal closure of one of the valves (tricuspid valve of the heart);
• vertigo (feeling of spinning);
• eye disorder, abnormal vision;
• weight gain.

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

• severe skin rash and blisters (Stevens-Johnson syndrome and erythema multiforme).

If you consider any of the adverse effects you are experiencing to be serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Adverse Effect Reporting

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

5. Storage of Kaletra

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

How should I dispose of unused Kaletra?

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Kaletra Composition

The active ingredients are lopinavir and ritonavir.

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

The other ingredients are:

Tablet

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

Coating

Hypromellose, titanium dioxide, macrogol type 400 (polyethylene glycol 400), hydroxypropyl cellulose, talc, anhydrous colloidal silica, macrogol type 3350 (polyethylene glycol 3350), yellow iron oxide E-172, polysorbate 80.

Product Appearance and Package Contents

Kaletra film-coated tablets are yellow with an embossed logo (Abbott logo) and "KA".

Kaletra film-coated tablets are available in packs containing 120 tablets (1 plastic bottle of 120 tablets) and multipacks containing 3 plastic bottles of 120 tablets each (360 tablets). Also available are multipacks with blisters of 120 tablets (1 box of 120 tablets or 3 boxes containing 40 tablets each).

Not all pack sizes may be marketed.

Marketing Authorization Holder:

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

Manufacturer:

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

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

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu