Patient Information Leaflet: Information for the User

Kaletra (80 mg + 20 mg)/mL oral solution

(lopinavir + ritonavir)
Please read this leaflet carefully before 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Kaletra is and what it is used for
What you need to know before you or your child take Kaletra
How to take Kaletra
Possible side effects
How to store Kaletra
Contents of the pack and other information

1. What Kaletra is and what it is used for

Your doctor has prescribed Kaletra to help you control Human Immunodeficiency Virus (HIV) infection. Kaletra works by slowing the spread of the infection in your body.
Kaletra is not a cure for HIV infection or AIDS.
Kaletra is used in children from 14 days of age, adolescents, and adults infected with HIV, the virus that causes AIDS.
Kaletra contains the active substances lopinavir and ritonavir. Kaletra is an antiretroviral medicine. It belongs to a group of medicines known as protease inhibitors.
Kaletra is prescribed to be used in combination with other antiviral medicines. Your doctor will discuss this with you and decide which medicines are most appropriate for your specific condition.

2. What you should know before you or the child takes Kaletra

Do not take Kaletra

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

Do not take Kaletra together with any of the following medicines:

astemizole or terfenadine (commonly used to treat allergic symptoms – these medicines may be available without a prescription);
midazolam administered orally (taken by mouth), triazolam (used to relieve anxiety and/or sleep disorders);
pimozide (used to treat schizophrenia);
quetiapine (used to treat schizophrenia, bipolar disorders, and major depressive disorder);
lurasidone (used to treat depression);
ranolazine (used to treat chronic chest pain [angina]);
cisapride (used to relieve certain digestive problems);
ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat migraine headaches);
amiodarone, dronedarone (used to treat heart rhythm disorders);
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 the bacterium Staphylococcus, such as impetigo and infected dermatitis. Fusidic acid used for long-term treatment of bone and joint infections must be taken under medical supervision (see section Other medicines and Kaletra);
colchicine (used to treat gout) if you have kidney or liver problems (see section Other medicines and Kaletra);
elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV] infection);
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 for erectile dysfunction may be taken under medical supervision (see section Other medicines and Kaletra);
products containing St. John’s wort (Hypericum perforatum).

Read the list of medicines below in the section “Other medicines and Kaletra”
for more specific information about other medicines that require special attention.
If you are currently taking any of these medicines, ask your doctor whether adjustments are needed
either to your treatment for other condition(s) or to your antiretroviral therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Kaletra.

Important information

Infections or other HIV- or AIDS-related illnesses may still occur in patients taking Kaletra. For this reason, it is important to have regular medical check-ups during treatment with Kaletra.

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

Haemophilia type A or B, as Kaletra may increase the risk of bleeding.
Diabetes, as increased blood sugar levels have been reported in patients taking Kaletra.
Liver problems, as patients with liver disease, including chronic hepatitis B or C, may have an increased risk of developing potentially life-threatening or serious liver-related side effects.

Tell your doctor if you or your child notice

Nausea, vomiting, abdominal pain, difficulty breathing, and severe muscle weakness in the arms and legs, as these symptoms may indicate elevated levels of lactic acid.
Thirst, frequent urination, blurred vision, or weight loss, as these may indicate high blood sugar levels.
Nausea, vomiting, abdominal pain, and marked increases in triglyceride levels (fats in the blood) are considered risk factors for pancreatitis (inflammation of the pancreas), and these symptoms may indicate this condition.
In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, enabling the body to fight latent infections that were previously asymptomatic.
In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting medicines for HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and spreading toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive appropriate treatment.
Joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders) and difficulty moving, as osteonecrosis (bone tissue death due to reduced blood supply) may occur in some patients taking these medicines. Factors such as duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduced immune system activity), higher body mass index, among others, may increase the risk of developing this condition.
Muscle pain, tenderness, or weakness, especially if associated with taking these medicines. In rare cases, these conditions have been severe.
Symptoms of dizziness, feeling faint, lightheadedness, or 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 is taking, has recently taken, or might take any other medicine.

antibiotics (e.g. rifabutin, rifampicin, clarithromycin);
anticancer medicines (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinase inhibitors such as dasatinib and nilotinib, vincristine, and vinblastine);
anticoagulants (e.g. dabigatran etexilate, edoxaban, rivaroxaban, vorapaxar, and warfarin);
antidepressants (e.g. trazodone, bupropion);
antiepileptics (e.g. carbamazepine, phenytoin, phenobarbital, lamotrigine, and valproate);
antifungals (e.g. ketoconazole, itraconazole, voriconazole);
medicines for gout (e.g. colchicine). Do not take Kaletra with colchicine if you have kidney or liver problems (see also ‘Do not take Kaletra’ above);
anti-tuberculosis medicines (bedaquiline, delamanid);
antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir, simeprevir, sofosbuvir/velpatasvir/voxilaprevir);
medicines used to treat erectile dysfunction (e.g. sildenafil and tadalafil);
fusidic acid used for long-term treatment of bone and joint infections (e.g. osteomyelitis);
medicines used to treat heart conditions:
- digoxin;
- calcium channel blockers (e.g. felodipine, nifedipine, nicardipine);
- medicines used to stabilize heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
HIV CCR5 antagonists (e.g. maraviroc);
HIV-1 integrase inhibitors (e.g. raltegravir);
medicines used to treat low platelet count (e.g. fostamatinib);
levothyroxine (used to treat thyroid problems);
medicines used to lower blood cholesterol (e.g. atorvastatin, lovastatin, rosuvastatin, and simvastatin);
medicines used to treat asthma and other lung conditions 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. ciclosporin, sirolimus [rapamycin], tacrolimus);
medicines used to stop smoking (e.g. bupropion);
painkillers (e.g. fentanyl);
opioid-like medicines (e.g. methadone);
oral contraceptives or contraceptive patches used to prevent pregnancy (see section titled “Contraceptives” below);
protease inhibitors (e.g. fosamprenavir, ritonavir, tipranavir);
sedatives (e.g. midazolam administered by injection);
steroid medicines (e.g. budesonide, dexamethasone, fluticasone propionate, ethinylestradiol, triamcinolone);
medicines that cause a reaction with alcohol (e.g. disulfiram).

Read the list of medicines above in the section “Do not take Kaletra together with any of the following medicines”
for information about medicines that must not be taken with Kaletra.
Inform your doctor or pharmacist if you or your child is taking, has recently taken, or might take any other medicine, including those available without a prescription.

Medicines for erectile dysfunction (avanafil, vardenafil, sildenafil, tadalafil)

Do not take Kaletra if you are taking avanafil or vardenafil.
Do not take Kaletra with sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also section above Do not take Kaletra).
If you are taking sildenafil or tadalafil together with Kaletra, you may be at risk of side effects such as low blood pressure, fainting, vision changes, and prolonged erection lasting more than 4 hours. If an erection lasts longer than 4 hours, you must immediately contact your doctor for intervention to prevent permanent damage to the penis. Your doctor can explain these symptoms to you.

Contraceptives

If you are using an oral contraceptive or a contraceptive patch to prevent pregnancy, you should use additional contraceptive methods or switch to different methods (e.g. condoms), as Kaletra may reduce the effectiveness of oral contraceptives or contraceptive patches.

Pregnancy and breastfeeding

Inform your doctor immediately if you are planning to have a baby, are pregnant, or suspect you may be pregnant.
If you are breastfeeding or considering breastfeeding, discuss this with your doctor as soon as possible.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine, as it contains propylene glycol and alcohol.
Women living with HIV are advised not to breastfeed because of the risk of transmitting HIV infection to the infant through breast milk.

Driving and using machines
Kaletra has not been specifically tested for its possible effects on the ability to drive or use machines. Do not drive or operate machinery if you experience side effects (e.g. nausea) that may impair your ability to perform these activities safely. In such cases, consult your doctor.
Kaletra contains 42% v/v alcohol. The amount of alcohol in the medicine may affect your ability to drive or use machines, as well as your judgment and reaction times.

Important information about some ingredients in Kaletra
Kaletra contains 42% v/v alcohol and 15% w/v propylene glycol. Each 1 mL of Kaletra oral solution contains 356.3 mg of alcohol and 152.7 mg of propylene glycol. Alcohol and propylene glycol may be harmful to individuals with liver disease, kidney disease, alcoholism, epilepsy, or brain injury, as well as to pregnant women and children. They may increase or alter the effects of other medicines.
At the recommended adult dose, the estimated blood alcohol concentration is approximately 0.002–0.01 g/dL, equivalent to about 4–22 mL of beer or 1–4 mL of wine consumed by an adult.
Alcohol may also be present in other medicines or may be consumed in food and drinks. Combined effects could lead to increased blood alcohol levels and enhance alcohol-related side effects.
This medicine contains up to 0.8 g of fructose per dose when taken at the recommended dosage. Not suitable for patients with hereditary fructose intolerance. Due to the possibility of undiagnosed fructose intolerance, this medicine should only be given to children and newborns after consulting a doctor.
Kaletra contains glycerol, which may be harmful in high doses and may cause headache, stomach disturbances, and diarrhea.
Kaletra contains polyoxyl 40 hydrogenated castor oil, which may cause nausea, vomiting, colic, and severe diarrhea at high doses. This should not be administered if intestinal obstruction is present.
Kaletra contains potassium as potassium acesulfame, which may be harmful in individuals on a low-potassium diet. High blood potassium levels may cause stomach disturbances and diarrhea.
Kaletra contains sodium as sodium saccharin, sodium chloride, and sodium citrate, which may be harmful in individuals on a low-sodium diet.
Kaletra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, i.e., essentially ‘sodium-free’.

3. How to take Kaletra

Kaletra is recommended for use in adults and children from 14 days of age who are infected with HIV.
Great care should be taken when determining the dosage for children. The dosage must not exceed 5 mL twice daily in children weighing less than 40 kg.
If you or your child is able to swallow tablets, Kaletra is also available as film-coated tablets containing 200 mg of lopinavir and 50 mg of ritonavir, and as film-coated tablets containing 100 mg of lopinavir and 25 mg of ritonavir.
Take this medicine exactly as prescribed by your doctor. If you have any doubts about how to take the medicine, consult your doctor or pharmacist.

What is the correct dose of Kaletra and when should it be taken?

For children from 14 days of age up to body weight of 15 kg

Your doctor will determine the most appropriate dose based on the child's height and weight.
It is important that all doses of Kaletra oral solution are taken with food.
To measure the dose, use the provided 2 mL oral syringe.

For children weighing more than 15 kg

Your doctor will determine the most appropriate dose based on the child's height and weight.
It is important that all doses of Kaletra oral solution are taken with food.
To measure the dose, use the provided 5 mL oral syringe.

Use in adults

The usual dosage of Kaletra for adult patients is 5 mL of oral solution twice daily (i.e., every 12 hours), in combination with other anti-HIV medicines. Your doctor will advise you on the exact dosage of Kaletra to take.
It is important that all doses of Kaletra oral solution are taken with food.
To measure the dose, use the provided 5 mL dosing syringe.

How do I measure the correct dose?

If the dose is up to 2 mL: prepare the dose using the 2 mL oral dosing syringe.
If the dose is between 2 mL and 5 mL: prepare the dose using the 5 mL oral dosing syringe.

Ask your pharmacist to confirm that you have the correctly sized syringe. If you are unsure how to use the oral dosing syringe, consult your doctor, pharmacist, or nurse, who will explain how to use it correctly.
Before using the dosing syringe for the first time, wash the plunger and cylinder with warm water and liquid detergent. Rinse thoroughly with tap water and allow to air dry.
Do not shake the bottle, as this may cause air bubbles to form, which can interfere with accurate dose measurement.
To open the child-resistant safety cap, press down firmly with the palm of your hand and turn counterclockwise or in the direction of the arrow on the cap. Consult your pharmacist if you have difficulty opening the bottle.

Two hands firmly hold a small medicine vial while an arrow indicates the point where to remove the top cap

Using the 2 mL oral dosing syringe for doses up to 2 mL

Technical drawing of two vertical syringes on a gray background, one with a graduated scale and the

The syringe consists of two main parts: a “plunger” and a “barrel”. In the illustration, the plunger is shown outside the barrel to clearly show each component.

Technical drawing of a gray cylindrical medical device with two horizontal circular flanges on a white background

Push the plunger fully into the barrel.
Immerse the tip of the syringe into the liquid.
Pull back the plunger until the correct amount is reached, as indicated on the syringe. The “mL” mark should align with the top of the barrel collar.
Turn the syringe upside down so that the tip points upward, tap it gently, and push the plunger slightly to remove any air bubbles.
After removing air bubbles, check the dose indicator.
- If the “mL” mark on the collar exceeds the prescribed dose, push the plunger down to the prescribed dose.
- If the “mL” mark on the collar is below the prescribed dose, draw up more solution until the prescribed dose is reached.
Place the dosing syringe into the child’s mouth, aiming toward the cheek, and gently push the plunger to release the medicine.

After each administration, close the bottle with the cap.
Using the 5 mL dosing syringe for doses above 2 mL

Technical diagram of a syringe showing the barrel, plunger, graduated scale, and tip for

Finger grip
Plunger

(c-----))(
The syringe consists of two main parts: a "plunger" and a "barrel". In the figure, the plunger is shown outside the barrel so that each component can be clearly seen.

Push the plunger fully into the barrel.

Technical drawing of a vertical syringe with a graduated scale and a black line indicating a specific measurement on the barrel

Immerse the tip of the syringe into the liquid.
Pull back the plunger until the raised ring aligns with the correct dose marked in "mL" on the barrel.
Turn the syringe upside down so that the tip points upward, gently tap it, and push the plunger to remove any air bubbles.
Once air bubbles have been removed, check the dose indicator.
- If the "mL" mark on the raised ring is above the prescribed dose, push the plunger down until it reaches the prescribed dose.
- If the "mL" mark on the raised ring is below the prescribed dose, draw up more solution until the prescribed dose is reached.
Insert the dosing syringe into the child’s mouth toward the cheek and gently push the plunger to release the medication.

After each administration, close the bottle with the cap.
After using the Kaletra dosing syringe, separate the plunger from the barrel. As soon as possible, wash both the plunger and the barrel with liquid detergent and warm water; you may also soak both parts in soapy water for about 15 minutes. Rinse the barrel and plunger thoroughly under running water. Reinsert the plunger into the syringe barrel and push it back and forth several times to expel water and ensure proper rinsing of the syringe. Allow the syringe to dry completely before using it for dosing.

Do not use the dosing syringes provided with Kaletra oral solution to administer any other medication to yourself or your child.

If you or your child takes more Kaletra than you should

If you realize that you have taken more Kaletra than prescribed, contact your doctor immediately.
If you are unable to contact your doctor, go to the hospital.

If you or your child forgets to take Kaletra

If you realize you have missed a dose within 6 hours of your usual dosing time, take the missed dose as soon as possible, then continue treatment according to your doctor’s instructions.
If you realize you have missed a dose more than 6 hours after your usual dosing time, do not take the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you or your child stops taking Kaletra

Do not stop or change the daily dose of Kaletra without first consulting your doctor.
Kaletra must always be taken twice daily to maintain control of HIV infection. You must continue taking Kaletra even if you notice an improvement in your condition.
Taking Kaletra as prescribed by your doctor will help delay the development of drug resistance for as long as possible.
If a side effect prevents you from taking Kaletra as prescribed, inform your doctor immediately.
Make sure you always have an adequate supply of Kaletra available so that you do not run out. When traveling or during hospitalization, ensure you have enough Kaletra to cover the period, at least until you can obtain another supply.
Continue treatment with this medicine until your doctor gives you different instructions.

4. Possible side effects

Like all medicines, Kaletra can cause side effects, although not everybody gets them. It may be difficult to distinguish between side effects caused by Kaletra and those that could occur as a result of taking other medicines administered concomitantly with Kaletra, or effects due to complications arising from HIV infection.

During HIV therapy, an increase in weight and in blood lipid and glucose levels may occur. This is partly related to the improvement in health status and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

The following side effects have been reported by patients taking this medicine. Inform your doctor immediately if you experience any of these symptoms or any other symptoms. If the condition persists or worsens, do not hesitate to seek prompt medical attention.

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

inflammation of the pancreas;
vomiting, abdominal bloating, pain in the upper and lower stomach area, flatulence, indigestion, decreased appetite, gastroesophageal reflux that may cause pain;
Inform your doctor if you experience nausea, vomiting, or abdominal pain, as these may indicate pancreatitis (inflammation of the pancreas);
swelling or inflammation of the stomach, intestine, and colon;
increased blood cholesterol levels, increased blood triglyceride levels (a type of fat), increased blood pressure;
reduced ability of the body to metabolize sugar, including diabetes mellitus, weight loss;
low red blood cell count, low white blood cell count usually used to fight infections;
rash, eczema, accumulation of greasy skin scales;
dizziness, anxiety, difficulty sleeping;
feeling of tiredness, lack of strength and energy, headache including migraine;
haemorrhoids;
liver inflammation including increased liver enzymes;
allergic reactions including urticaria and mouth inflammation;
lower respiratory tract infection;
swollen lymph nodes;
impotence, heavy or prolonged menstrual flow or absence of menstruation;
muscle disorders such as weakness and spasms, joint, muscle and back pain;
damage to nerves of the peripheral nervous system;
night sweats, itching, rash including skin swellings, skin infections, skin or hair pore inflammation, fluid accumulation in cells or tissues.

Uncommon: may affect up to 1 in 100 people

abnormal dreams;
loss or change in taste sensation;
hair loss;
abnormality in electrocardiogram (ECG) called atrioventricular block;
formation of plaques inside arteries that may lead to heart attack and stroke;
inflammation of blood vessels and capillaries;
inflammation of the bile duct;
uncontrolled body tremor;
constipation;
deep vein thrombosis due to blood clot;
dry mouth;
inability to control bowel movements;
inflammation of the first part of the small intestine just after the stomach, wound or ulcer in the digestive tract, bleeding from the intestinal tract or rectum;
red blood cells in urine;
yellowing of the skin or whites of the eyes (jaundice);
fat deposits in the liver, enlarged liver;
testicular dysfunction;
a group of symptoms related to inactive infections in the body (immune reconstitution);
increased appetite;
abnormally high level of bilirubin (a pigment produced by red blood cell breakdown) in the blood;
decreased sexual desire;
kidney inflammation;
bone necrosis due to poor blood supply to the area;
mouth sores or ulcers, stomach and intestinal inflammation;
impaired kidney function;
breakdown of muscle fibers resulting in the release of muscle fiber contents (myoglobin) into the bloodstream;
a sound in one or both ears, such as ringing, buzzing, or whistling (tinnitus);
tremor;
abnormal closure of one of the heart valves (tricuspid valve);
vertigo (sensation of spinning);
eye disorders, abnormal vision;
weight gain.

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

severe or life-threatening skin rash and blisters (Stevens-Johnson syndrome and erythema multiforme).

Not known: frequency cannot be estimated from the available data

kidney stones.

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kaletra

Keep this medicine out of sight and reach of children.
Do not use Kaletra after the expiry date stated on the bottle.
Do not use this medicine if you notice that the solution has changed colour or contains particles.

How to store Kaletra and for how long?

Store in a refrigerator (2°C–8°C).
Storage during use: If the bottle is stored outside the refrigerator, do not keep it above 25°C and discard any unused content in the bottle after 42 days (6 weeks). It is recommended to write on the package the date when the bottle was removed from the refrigerator.
It is important to keep Kaletra in the bottle in which it was supplied and to close it with the cap after each administration. Do not transfer the contents to any other container.

How to dispose of unused Kaletra?
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kaletra contains
The active substances are lopinavir and ritonavir.
Each mL of Kaletra oral solution contains 80 mg of lopinavir and 20 mg of ritonavir.
The other components are:
Alcohol, high-fructose corn syrup, propylene glycol, purified water,
glycerol, povidone, magnasweet 110 flavour (a mixture of monoammonium glycyrrhizinate and glycerol),
vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid,
vanillin, heliotropine, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour
(containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame
potassium, sodium saccharin, sodium chloride, peppermint essential oil, sodium citrate,
citric acid, levomenthol.

Description of the appearance of Kaletra and contents of the pack
Kaletra oral solution is supplied in a 60 mL amber multidose bottle. Each mL of
Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Two pack sizes are available:

120 mL (2 bottles x 60 mL). The 2-bottle pack also contains two 2 mL graduated syringes, graduated in 0.1 mL increments. For volumes up to 2 mL. An alternative pack is available for larger volumes.
300 mL (5 bottles x 60 mL). The 5-bottle pack also contains five 5 mL graduated syringes, graduated in 0.1 mL increments. For volumes greater than 2 mL. An alternative pack is available for smaller volumes.

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

Manufacturer
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел.: +359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel: +420 233 098 111 Tel.: +36 1 455 8600

Danmark Malta
AbbVie A/S V.J.Salomone Pharma Limited
Tlf: +45 72 30-20-28 Tel: +356 21220174

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel: +372 623 1011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 9 1 384 0910 Tel.: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0)1 45 60 13 00 Tel: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: +385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor AbbVie s.r.o.
Tel: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0) 10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.
To listen to or request a copy of this package leaflet in , or , please contact the local representative of the Marketing Authorization Holder.

Package leaflet: Information for the user

Kaletra 200 mg/50 mg film-coated tablets

lopinavir/ritonavir
Please read this leaflet carefully before 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, because it may be dangerous.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Kaletra is and what it is used for
What you need to know before you or your child take Kaletra
How to take Kaletra
Possible side effects
How to store Kaletra
Contents of the pack and other information

1. What Kaletra is and what it is used for

Your doctor has prescribed Kaletra to help you control infection with the Human Immunodeficiency Virus (HIV). Kaletra works by slowing down the spread of the infection in your body.
Kaletra is not a cure for HIV infection or AIDS.
Kaletra is used in children aged 2 years and older, adolescents, and adults infected with HIV, the virus that causes AIDS.
Kaletra contains the active substances lopinavir and ritonavir. Kaletra is an antiretroviral medicine. It belongs to a group of medicines known as protease inhibitors.
Kaletra is prescribed to be used in combination with other antiviral medicines. Your doctor will discuss this with you and decide which medicines are most appropriate for your specific condition.

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

Do not take Kaletra

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

Do not take Kaletra together with any of the following medicines:

astemizole or terfenadine (commonly used to treat allergic symptoms – these medicines may be available without a prescription);
oral midazolam (taken by mouth), triazolam (used to relieve anxiety and/or sleep disorders);
pimozide (used to treat schizophrenia);
quetiapine (used to treat schizophrenia, bipolar disorders, and major depressive disorder);
lurasidone (used to treat depression);
ranolazine (used to treat chronic chest pain [angina]);
cisapride (used to relieve certain digestive problems);
ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat migraine headaches);
amiodarone, dronedarone (used to treat heart rhythm disorders);
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 the bacterium Staphylococcus, such as impetigo and infected dermatitis. Fusidic acid used for long-term treatment of bone and joint infections should be taken under medical supervision (see section Other medicines and Kaletra);
colchicine (used to treat gout) if you have kidney or liver problems (see section Other medicines and Kaletra);
elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV] infection);
neratinib (used to treat breast cancer);
avanafil or vardenafil (used to treat erectile dysfunction);
sildenafil used for the treatment of pulmonary arterial hypertension (high blood pressure in the pulmonary artery). Sildenafil used for erectile dysfunction may be taken under medical supervision (see section Other medicines and Kaletra);
products containing St. John’s wort (Hypericum perforatum).

Read the list of medicines below in the section “Other medicines and Kaletra”
for more specific information about other medicines that require special attention.
If you are currently taking any of these medicines, ask your doctor whether adjustments are needed either to the treatment for another condition(s) or to your antiretroviral therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Kaletra.

Important information

In patients taking Kaletra, infections or other HIV- or AIDS-related diseases may still occur. Therefore, it is important to have regular medical check-ups during treatment with Kaletra.

Inform your doctor if you or your child has ever had

Haemophilia type A or B, as Kaletra may increase the risk of bleeding.
Diabetes, as increased blood sugar levels have been reported in patients taking Kaletra.
Liver problems, as patients with liver disease, including chronic hepatitis B or C, may have an increased risk of potentially life-threatening or serious liver-related side effects.

Inform your doctor if you or your child experiences

nausea, vomiting, abdominal pain, difficulty breathing, and severe muscle weakness in the arms and legs, as these symptoms may indicate elevated lactate levels.
thirst, frequent urination, blurred vision, or weight loss, as these may indicate high blood sugar levels.
nausea, vomiting, abdominal pain, and marked increases in triglyceride levels (fats in the blood) have been considered risk factors for pancreatitis (inflammation of the pancreas), and these symptoms may indicate this condition.
In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, allowing the body to fight latent infections that were previously asymptomatic.
In addition to opportunistic infections, autoimmune diseases (a condition where the immune system attacks healthy body tissue) may also occur after starting HIV treatment. Autoimmune diseases may appear many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and spreading toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive appropriate treatment.
Joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders) and difficulty moving, as some patients on such medicines may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bones). Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduced immune system activity), higher body mass index, among others, may be some of the many risk factors for developing this condition.
Muscle pain, tenderness, or weakness, especially if associated with taking these medicines. In rare cases, these conditions have been serious.
symptoms of dizziness, feeling of emptiness in the head, fainting, or sensation of irregular heartbeat. 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 is taking, has recently taken, or might take any other medicine.

antibiotics (e.g. rifabutin, rifampicin, clarithromycin);
anticancer medicines (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinase inhibitors such as dasatinib and nilotinib, vincristine, and vinblastine);
anticoagulants (e.g. dabigatran etexilate, edoxaban, rivaroxaban, and warfarin);
antidepressants (e.g. trazodone, bupropion);
antiepileptics (e.g. carbamazepine, phenytoin, phenobarbital, lamotrigine, and valproate);
antifungal medicines (e.g. ketoconazole, itraconazole, voriconazole);
medicines for gout (e.g. colchicine). You must not take Kaletra with colchicine if you have kidney or liver problems (see also ‘Do not take Kaletra’ above);
anti-tuberculosis medicines (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 used to treat erectile dysfunction (e.g. sildenafil and tadalafil);
fusidic acid used for long-term treatment of bone and joint infections (e.g. osteomyelitis);
medicines used to treat heart conditions:
digoxin;
calcium channel blockers (e.g. felodipine, nifedipine, nicardipine);
medicines used to stabilize heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
HIV CCR5 antagonists (e.g. maraviroc);
HIV-1 integrase inhibitors (e.g. raltegravir);
medicines used to treat low platelet counts (e.g. fostamatinib);
levothyroxine (used to treat thyroid problems);
medicines used to lower blood cholesterol (e.g. atorvastatin, lovastatin, rosuvastatin, and simvastatin);
medicines used to treat asthma and other lung conditions 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 stop smoking (e.g. bupropion);
painkillers (e.g. fentanyl);
opioid-like medicines (e.g. methadone);
non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g. efavirenz, nevirapine);
oral contraceptives or contraceptive patches used to prevent pregnancy (see the section titled “Contraceptives” below);
protease inhibitors (e.g. fosamprenavir, ritonavir, tipranavir);
sedatives (e.g. midazolam administered by injection);
steroid medicines (e.g. budesonide, dexamethasone, fluticasone propionate, ethinylestradiol, triamcinolone).

Read the list of medicines above in the section “Do not take Kaletra together with any of the following medicines”
for information about medicines that must not be taken with Kaletra.
Tell your doctor or pharmacist if you or your child is taking, has recently taken, or might take any other medicine, including medicines that can be obtained without a prescription.

Medicines for the treatment of erectile dysfunction (avanafil, vardenafil, sildenafil, tadalafil)

Do not take Kaletra if you are taking avanafil or vardenafil.
You must not take Kaletra with sildenafil used for the treatment of pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also the section above Do not take Kaletra).
If you are taking sildenafil or tadalafil together with Kaletra, you may be at risk of side effects such as low blood pressure, fainting, vision changes, and prolonged erection lasting more than 4 hours. If an erection lasts longer than 4 hours, you must immediately contact your doctor and seek medical help to prevent permanent damage to the penis. Your doctor can explain these symptoms to you.

Contraceptives

If you are using an oral contraceptive or a contraceptive patch to prevent pregnancy, you should use additional contraceptive methods or different contraceptive methods (e.g. condoms), as Kaletra may reduce the effectiveness of oral contraceptives or contraceptive patches.

Pregnancy and breastfeeding

Inform your doctor immediately if you are planning to become pregnant, are pregnant, or think you may be pregnant.
If you are breastfeeding or considering breastfeeding, discuss this with your doctor as soon as possible.
Women living with HIV are advised not to breastfeed because there is a risk that HIV infection could be transmitted to the baby through breast milk.

Driving and using machines
Kaletra has not been specifically tested for its possible effects on the ability to drive vehicles or operate machinery. Do not drive or operate machinery if you experience any side effects (e.g. nausea) that could negatively affect your ability to perform these activities safely. In such a case, consult your doctor.

Kaletra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.