TABLETS and ORAL SOLUTION
lopinavir and ritonavir
Consumer Medicine Information (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Kaletra.
It does not contain all of the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking
Kaletra against the benefits they expect it will have on you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT KALETRA IS USED FOR
Kaletra is used to help control Human Immunodeficiency Virus (HIV) infection in adults
and children 2 years of age and older. Kaletra does this by slowing down the spread
of the infection in the body.
Kaletra is an antiretroviral medicine. It belongs to a group of medicines called protease
Kaletra is prescribed for use in combination with other antiviral medicines. Your
doctor will determine which medicines are best for you.
Kaletra has not been shown to reduce the chance of transmitting HIV to a sexual partner.
Therefore, you must continue to use safe sexual practices (eg condoms) while taking
Kaletra is available only with a doctor's prescription.
Kaletra is not addictive.
BEFORE YOU TAKE KALETRA
When you must not take it
Do not take Kaletra if you have an allergy to:
any medicine containing lopinavir and/or ritonavir
any of the ingredients listed at the end of this leaflet
Some symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
hives, rash or itching of the skin.
Do not take Kaletra if you have severe liver problems.
Do not take Kaletra if you are pregnant.
If may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine.
The active ingredient in Kaletra passes into breast milk and there is a possibility
your baby may be affected.
Do not give Kaletra to a child under the age of 2 years.
Do not take Kaletra with any of the following medicines:
alfuzosin hydrochloride (treatment of Benign Prostatic Hyperplasia or BPH in men);
ranolazine to treat angina
dronedarone to correct heart rhythm
fusidic acid (an antibiotic);
colchicine (a treatment for gout) if you have liver or kidney problems
astemizole or terfenadine (these antihistamine medicines may be available without
blonanserin, lurasidone or pimozide (used to treat certain psychological and emotional
midazolam or triazolam (used to relieve anxiety and/or trouble sleeping);
ergotamine, dihydroergotamine, ergometrine or ethylergometrine (treatment for migraine
cisapride (used to relieve certain stomach problems);
elbasvir/grazoprevir (treatment for hepatitis C)
products that contain St John's Wort (Hypericum perforatum);
lovastatin or simvastatin (used to reduce blood cholesterol levels);
salmeterol (treatment for asthma);
sildenafil if you suffer from a lung disease called pulmonary arterial hypertension
(PAH) that makes breathing difficult. Patients without this disease may use sildenafil
for erectile dysfunction under their doctor's supervision
Additionally, do not take Kaletra Oral Solution with the following medicines:
disulfiram (used for alcohol dependency);
metronidazole (used to treat infections by certain parasites)
Read the list of medicines under 'Taking other medicines' for information on certain
other medicines which require special care.
If you are currently taking any of these medicines, ask your doctor about switching
to another medicine while you are taking Kaletra.
Do not take it after the expiry date printed on the bottle or if the packaging is
damaged or shows signs of tampering.
If it has expired or is damaged return it to your pharmacist for disposal.
Take special care to keep all of your doctor's appointments
Kaletra is not a cure for HIV infection or AIDS.
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.
Kaletra does not reduce the risk of passing HIV to others. Appropriate precautions
should be taken to prevent passing the disease through sexual contact (e.g. use of
a condom) or blood contamination.
Before you start to take it
Tell your doctor or pharmacist if you have any allergies to any other medicines, foods,
preservatives or dyes.
Tell your doctor or pharmacist if any of the ingredients listed at the end of the
leaflet concern you.
Tell your doctor or pharmacist if you have or have had any of the following medical
Haemophilia, as Kaletra might increase the risk of bleeding.
Diabetes, as increased blood sugars have been reported in patients receiving Kaletra.
A history of liver problems - regular blood tests may be required to check that your
liver is working properly.
Tell your doctor or pharmacist if you are pregnant, intend to become pregnant or are
Pregnant or breastfeeding mothers should not take Kaletra unless specifically directed
by their doctor.
It is recommended that HIV-infected women do not breastfeed their infants because
there is a possibility that the baby can be infected with HIV through breast milk.
Your doctor will discuss the risks and benefits involved.
If you have not told your doctor or pharmacist about any of the above, tell them before
you take Kaletra.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you buy without a prescription from your pharmacy, supermarket or health food
Some medicines and Kaletra may interfere with each other. These include:
medicines used to treat chronic pain (e.g. fentanyl);
antibiotics (e.g. rifabutin, rifampicin, bedaquiline, delamanid, clarithromycin, metronidazole);
medicines used to treat psychiatric disorders (e.g. quetiapine);
medicines used to treat cancer (e.g. dasatinib, nilotinib, venetoclax, vincristine,
medicines used to treat depression (e.g. trazodone, bupropion);
medicines used to treat epileptic seizures (e.g. carbamazepine, lamotrigine, phenytoin,
medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, voriconazole);
medicines used to treat gout (e.g. colchicine);
erectile dysfunction medicines (e.g. sildenafil, tadalafil and vardenafil);
medicines used to treat heart conditions (eg digoxin; calcium channel antagonists
including felodipine, nifedipine, nicardipine; and medicines used to correct heart
rhythm including amiodarone, bepridil, systemic lignocaine, quinidine);
antiretroviral medicines in the CCR5 class, used to treat HIV(e.g. maraviroc)
medicines used to lower blood cholesterol (e.g. atorvastatin or rosuvastatin);
medicines affecting the immune system (e.g. cyclosporin, sirolimus (rapamycin), tacrolimus);
medicines used for smoking cessation (e.g. bupropion);
morphine-like medicines (e.g. methadone);
medicines used in alcohol dependence (e.g. disulfiram);
antiretroviral medicines known as Non-nucleoside reverse transcriptase inhibitors
(NNRTIs) used to treat HIV (e.g. efavirenz, nevirapine, delavirdine, rilpivirine,
oral contraceptives or using a patch contraceptive to prevent pregnancy (see section
below titled Contraceptives);
antiretroviral medicines known as Protease inhibitors used to treat HIV (e.g. amprenavir,
fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir, tipranavir,
boceprevir, simeprevir, ombitasvir/paritaprevir/ritonavir and dasabuvir);
steroids (e.g. budesonide, dexamethasone, fluticasone propionate, triamcinolone, ethinyl
medicines used to open blood vessels to treat high blood pressure (e.g. bosentan)
blood thinning medicines (eg warfarin, rivaroxaban).
Read the list of medicines under 'Do not take Kaletra with any of the following medicines'
for information on medicines that you must not take with Kaletra.
Kaletra oral solution contains 42% v/v alcohol. While taking Kaletra oral solution
you should not take medicines that cause a reaction with alcohol such as disulfiram
If you are taking didanosine while taking Kaletra oral solution, it should be taken
one hour before or two hours after taking Kaletra oral solution, remembering that
Kaletra should be taken with food.
Erectile dysfunction medicines (vardenafil, sildenafil, tadalafil)
If you take sildenafil, tadalafil or vardenafil and Kaletra together, you may be at
risk of side effects such as low blood pressure, passing out, visual changes and penile
erection lasting more than 4 hours.
If an erection lasts longer than 4 hours, you should get medical help immediately
to avoid permanent damage to your penis. Your doctor can explain these symptoms to
You must not take Kaletra with sildenafil if you also suffer from pulmonary arterial
If you are currently using an oral contraceptive or using a patch contraceptive to
prevent pregnancy, you should use an additional or different type of contraception
(e.g. condom) as Kaletra may reduce the effectiveness of oral and patch contraceptives.
Kaletra does not reduce the risk of passing HIV to others. Appropriate precautions
(e.g. use of a condom) should be taken to prevent passing on the disease through sexual
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
HOW TO TAKE KALETRA
Take Kaletra only as prescribed by your doctor.
Kaletra may be prescribed in combination with other appropriate medicines. Your doctor
will tell you how much to take and when to take it.
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist
How much to take and when to take it
The usual adult dose is 400mg/100mg (two 200mg/50mg tablets) or 5mL of the oral solution
twice a day i.e. every 12 hours in combination with other anti-HIV medicines. Adult
patients can also take Kaletra tablets once daily as an 800mg/200mg dose (four 200mg/50mg
tablets) or 10mL of the oral solution once daily.
Kaletra should not be taken once daily with efavirenz, nevirapine, nelfinavir, amprenavir,
carbamazepine, phenobarbital and phenytoin.
Kaletra should not be given to children once daily on its own.
For children, your doctor will decide the right dose of oral solution or 100mg/25mg
tablets based on the child's height and weight.
Kaletra oral solution can also be used for patients who cannot take tablets.
Take Kaletra at about the same time each day.
This will have the best effect on the HIV infection. It will also help you remember
when to take your medicine.
How to take it
Swallow the tablets whole with a full glass of water.
It is important that Kaletra tablets are swallowed whole and not chewed, broken or
Kaletra tablets can be taken with or without food.
Kaletra is recommended for use in adults and children 2 years of age or older who
are infected with HIV.
Take care when dosing children. Dosing should be less than 5mL twice daily for children
weighing less than 40kg.
Kaletra oral solution should preferably be taken with meals.
This syringe is the only syringe you should use to measure your dose.
The oral solution dosage syringe has been specially designed to give you the right
dose of Kaletra.
Open the childproof cap by pushing down on it with your palm and twisting it counter
clockwise, i.e. in the direction of the arrow. Talk to your pharmacist if you have
difficulty opening the bottle.
Five dosing syringes are included in each carton of Kaletra oral solution. Ask your
pharmacist for instructions on how to use the syringe correctly.
After each dose of Kaletra separate the plunger and the syringe. Wash the plunger
and the syringe with dish washing liquid and warm water as soon as you can; you may
soak both in soapy water for up to 15 minutes. Rinse the syringe and plunger with
clean water. Put the syringes back together and draw up and expel tap water a few
times to rinse. Let the syringe dry completely before you use that syringe for dosing.
How long to take it for
Continue taking your medicine for as long as your doctor or pharmacist tells you.
Kaletra helps control your HIV infection but does not cure it. You may continue to
develop infections or other illnesses associated with HIV disease while you are taking
Kaletra. Therefore, Kaletra must be taken every day.
Do not stop or change the daily dose of Kaletra without first consulting with your
Kaletra should always be taken every day to help control your HIV infection, no matter
how much better you feel.
Using Kaletra as recommended should give you the best chance of delaying the development
of resistance to this medicine.
If a side effect is preventing you from taking Kaletra as directed tell your doctor
Always keep enough Kaletra on hand so you don't run out. When you travel or need to
stay in the hospital make sure you will have enough Kaletra to last until you can
get a new supply.
If you forget to take it
If it is almost time for you to take your next dose, skip the dose you missed and
take your next dose when you are meant to. Otherwise, take it as soon as you remember,
and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
If you take too much (overdose)
Immediately telephone your doctor, pharmacist or Poisons Information Centre (Australia:
Telephone - 13 11 26; New Zealand: Telephone - 0800 POISON or 0800 764 766) for advice,
or go to Accident and Emergency at your nearest hospital if you think that you or
anyone else may have taken too much Kaletra. Do this even if there are no signs of
discomfort or poisoning.
You may need urgent medical attention. Keep telephone numbers for these places/services
WHILE YOU ARE TAKING KALETRA
Things you must do
If you become pregnant while you are taking this medicine, tell your doctor or pharmacist
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Kaletra.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
If you are going to have surgery, tell the surgeon that you are taking this medicine.
If you are about to have any blood tests, tell your doctor that you are taking this
It may interfere with the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Things you must not do
Do not use this medicine to treat any other complaints unless your doctor tells you
Do not give this medicine to anyone else, even if they have the same condition as
Do not let yourself run out of medicine over weekends or on holidays.
Things to be careful of
Be careful driving or operating machinery until you know how Kaletra affects you.
Kaletra generally does not cause problems with your ability to drive a car or operate
machinery. However, as with many medicines, Kaletra may cause dizziness, sleepiness
and nausea in some people. Make sure you know how you react to Kaletra before you
drive a car or operate machinery.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Kaletra.
Do not be alarmed by this list of possible side effects. You may not experience any
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Frequently, it is difficult to tell whether side effects are the result of taking
Kaletra, effects of the HIV disease or side effects of other medicines you may be
taking. For this reason, it is very important to inform your doctor of any change
in your condition. Your doctor may want to change your dose or advise you to stop
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
laboratory test results: changes in blood test results (such as blood chemistry and
blood count, as well as increased levels of cholesterol, glucose, liver enzymes and
difficulty in sleeping;
lack of strength and energy;
nausea, vomiting, abdominal pain, abnormal stools, indigestion, wind, problems with
your digestive system;
tingling, prickling or numbness of the skin.
Further information about nausea, vomiting or abdominal pain
Tell your doctor if you experience nausea, vomiting or abdominal pain as these may
be suggestive of pancreatitis. The above list includes the more common side effects
of your medicine. They are usually mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
nausea, vomiting, abdominal pain, difficulty breathing and severe weakness of the
muscles in the legs and arms;
thirst, frequent urination, blurred vision or weight loss;
signs and symptoms of inflammation from previous infections soon after anti-HIV treatment
joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty
muscle pain, tenderness or weakness, particularly in combination with these medicines.
The above list includes serious side effects that may require medical attention. Serious
side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
severe or life threatening skin reaction including blisters (Stevens Johnson syndrome
and Toxic Epidermal Necrolysis)
serious allergic reaction (anaphylaxis)
high levels of sugar in the blood
The above list includes very serious side effects. You may need urgent medical attention.
These side effects are rare.
Tell your doctor if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some patients. Ask your doctor
or pharmacist for more information about side effects, as they have a more complete
list of side effects. Inform your doctor promptly about these or any other symptoms.
Some of these side effects can only be found when your doctor does tests from time
to time to check your progress.
AFTER USING KALETRA
Keep your tablets and solution in the bottle until it is time to take them.
If you take the tablets or oral solution out of the bottle they may not keep well.
Keep it where children cannot reach it
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Tablets in bottle
Kaletra tablets should be stored in a cool, dry place below 30°C and should be used
within the expiry date shown on the bottle.
Oral Solution in bottle
Store at 2°C - 8°C (in a refrigerator). Use within the expiry date. Refrigeration
of Kaletra oral solution by the patient is not required if used within 42 days after
dispensing and if the oral solution is not stored above 25°C. Avoid exposure to excessive
It is important to keep Kaletra in the bottle it came in. Do not transfer it to any
Do not use after the expiry date stated on the pack.
Do not store it or any other medicine in the bathroom, near a sink, or on a windowsill.
Do not leave it in the car.
Heat and dampness can destroy some medicines.
If your doctor or pharmacist tells you to stop taking this medicine, or the medicine
has passed its expiry date, ask your pharmacist what to do with any that are left
Kaletra comes in two dosage forms.
Kaletra 200mg/50 mg tablets come in bottles containing 120 tablets.
Kaletra 100mg/25 mg tablets come in bottles containing 60 tablets.
Kaletra oral solution comes in a multiple-dose 60 mL amber bottle. Five bottles of
60 mL are provided in one package.
Each tablet of Kaletra contains 200 mg of lopinavir and 50mg of ritonavir.
The other ingredients are: copovidone, sorbitan monolaurate, silica-colloidal anhydrous,
and sodium stearylfumarate.
The film coating components are: hypromellose, titanium dioxide, macrogol 400, hyprolose,
talc, silica-colloidal anhydrous, macrogol 3350, iron oxide yellow CI 77492, and polysorbate
100/25 mg Tablets:
Each tablet of Kaletra contains 100 mg of lopinavir and 25 mg of ritonavir.
The other ingredients are: copovidone, sorbitan monolaurate, silica-colloidal anhydrous,
and sodium stearylfumarate.
The film coating components are: polyvinyl alcohol, titanium dioxide, talc, macrogol
3350 and iron oxide yellow CI 77492.
Each mL of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
The other ingredients are: ethanol, high fructose corn syrup, propylene glycol, purified
water, glycerol, povidone, Magnasweet-110 flavour (mixture of monoammonium glycyrrhizinate
and glycerol), vanilla flavour, PEG 40 hydrogenated castor oil, cotton candy flavour,
acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate,
citric acid, menthol.
Kaletra is distributed by:
AbbVie Pty Ltd
241 O'Riordan Street
Mascot NSW 2020
Phone: 1800 225 311
(ABN 48 156 384 262)
6th Floor, 156-158 Victoria St
Australian registration numbers
Kaletra 200mg/50mg Tablets bottle - AUST R 121055
Kaletra 100mg/25mg Tablets bottle - AUST R 140509
Kaletra Oral Solution -
AUST R 78627
Date of Preparation: