Active ingredient
- ritonavir
- lopinavir
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/01/172/003.
Kaletra 80mg/20mg Oral Solution
Package leaflet: Information for the user
Kaletra (80 mg + 20 mg) / ml oral solution
(lopinavir + ritonavir)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you or your child.
What is in this leaflet:
1. What Kaletra is and what it is used for
2. What you need to know before you or your child takes Kaletra
3. How to take Kaletra
4. Possible side effects
5. How to store Kaletra
6. Contents of the pack and other information
1. What Kaletra is and what it is used for
2. What you need to know before you or your child takes Kaletra
Do not take Kaletra
Do not take Kaletra with any of the following medicines:
Read the list of medicines below under ‘Other medicines and Kaletra’ for information on certain other medicines which require special care.
If you are currently taking any of these medicines, ask your doctor about making necessary changes either in the treatment for your other condition(s) or in your antiretroviral treatment.
Warnings and precautions
Talk to your doctor or pharmacist before taking Kaletra.
Important information
Tell your doctor if you or your child have/had
Tell your doctor if you or your child experience
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.
Read the list of medicines above ‘Do not take Kaletra with any of the following medicines’ for information on medicines that you must not take with Kaletra.
Please tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.
Erectile dysfunction medicines (avanafil, vardenafil, sildenafil, tadalafil)
Contraceptives
Pregnancy and breast-feeding
Driving or using machines
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines. Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safely. Instead, contact your doctor.
Kaletra contains 42% v/v alcohol. The amount of alcohol in this medicine may affect your ability to drive or use machines and may affect your judgement and reaction times.
Important information about some of the ingredients of Kaletra
Kaletra contains 42% v/v alcohol and 15% propylene glycol w/v. Each 1 ml of Kaletra oral solution contains 356.3 mg of alcohol and 152.7 mg of propylene glycol. Alcohol and propylene glycol are potentially harmful for those suffering from liver disease, kidney disease, alcoholism, epilepsy, brain injury or disease, as well as for pregnant women and children. They may modify or increase the effect of other medicines.
At the recommended adult dose(s) of this medicine, the estimated blood alcohol concentration in your body is about 0.002 - 0.01 g/dL. This is similar to an adult drinking 4-22 ml of beer or 1-4 ml of wine.
Other medicines may also contain alcohol and alcohol may be consumed in food and drinks. The combined effects may lead to increased blood alcohol levels and increase the side effects of alcohol.
This medicinal product contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations. Unsuitable in hereditary fructose intolerance. Due to the possibility of undetected fructose intolerance, this medicinal product should only be given to babies and infants after consultation with a doctor.
Kaletra contains glycerol which is harmful in high doses. Can cause headache and stomach upset and diarrhoea.
Kaletra contains polyoxyl 40 hydrogenated castor oil. This may cause nausea, vomiting, colic, severe purgation at high doses. It should not be given when intestinal obstruction is present.
Kaletra contains potassium as acesulfame potassium, which may be harmful to people on a low potassium diet. High potassium in the blood can cause stomach upset and diarrhoea.
Kaletra contains sodium as saccharin sodium, sodium chloride and sodium citrate, which may be harmful to people on a low sodium diet.
3. How to take Kaletra
Kaletra is recommended for use in adults and children 14 days of age and older who are infected with HIV.
Take care when dosing children. Dosing should be less than 5 ml twice daily for children weighing less than 40 kg.
If you or your child is able to swallow tablets, Kaletra is also supplied as film-coated tablets containing 200 mg of lopinavir and 50 mg of ritonavir and film-coated tablets containing 100 mg of lopinavir and 25 mg of ritonavir.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how you should take your medicine.
How much Kaletra should be taken and when?
For children 14 days and older and weighing up to 15 kg
For children weighing more than 15 kg
Use in adults
How do I measure the correct dose?
Check with your pharmacist that you have the correct size of syringe. If you are not sure how to use the oral dosing syringe ask your doctor, pharmacist or nurse. They will tell you how to use the syringe correctly.
Do not shake the bottle – this is because air bubbles can form which will affect how well you can measure the dose.
Open the child-proof cap by pushing down on it with your palm and twisting it counter clockwise, or in the direction of the arrow on the top of the cap. Talk to your pharmacist if you have difficulty opening the bottle.
Using the 2 ml oral dosing syringe for doses up to 2 ml
The syringe has two main parts, a ‘plunger’ and a ‘barrel’. In this picture we have pulled out the plunger so that you can see each part clearly.
1. Push the plunger all of the way into the barrel.
2. Place the tip of the syringe into the liquid.
3. Pull up the plunger until the correct dose amount is shown on the plunger. You should see the ‘ml’ marking aligned to the top of the collar of the barrel.
4. Turn the syringe so that the tip is pointing up, gently tap it and push plunger to remove any air bubbles.
5. After removing the air bubbles, look at the dose mark.
6. Place the dosing syringe in your child’s mouth towards the cheek and gently push the plunger down to release the medicine.
Replace the bottle cap after each dose.
Using the 5 ml oral dosing syringe for doses more than 2 ml
The syringe has two main parts, a ‘plunger’ and a ‘barrel’. In this picture we have pulled out the plunger so that you can see each part clearly.
1. Push the plunger all of the way into the barrel.
2. Place the tip of the syringe into the liquid.
3. Pull up the plunger until the black ‘O’ ring is on the correct dose ‘ml’ mark on the barrel.
4. Turn the syringe so that the tip is pointing up, gently tap it and push plunger to remove any air bubbles.
5. After removing the air bubbles, look at the dose mark.
6. Place the dosing syringe in your child’s mouth towards the cheek and gently push the plunger down to release the medicine.
Replace the bottle cap after each dose.
After each dose of Kaletra separate the plunger and the syringe. Wash the plunger and the syringe with washing up 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 syringe 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.
Do not use the dosing syringes supplied with Kaletra oral solution to administer any other medicines you or your child may be taking.
If you or your child take more Kaletra than you should
If you or your child forget to take Kaletra
If you or your child stop taking Kaletra
4. Possible side effects
Like all medicines, Kaletra can cause side effects, although not everybody gets them. It may be difficult to tell which side effects have been caused by Kaletra and which may occur due to other medicines you take at the same time or by the complications of the HIV infection.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
The following side effects have been reported by patients who took this medicine. You should tell your doctor promptly about these or any other symptoms. If the condition persists or worsens, seek medical attention.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Kaletra
How should I store Kaletra and for how long?
How should I dispose of any unused Kaletra?
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack 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 ingredients are:
Alcohol, high fructose corn syrup, propylene glycol, purified water, glycerol, povidone, magnasweet-110 flavour (mixture of monoammonium glycyrrhizinate and glycerol), vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, levomenthol.
What Kaletra looks like and contents of the pack
Kaletra oral solution comes in a multiple-dose 60 ml amber bottle. Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Two pack sizes are available:
Marketing Authorisation Holder:
Manufacturer:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in: 07/2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK
+44 (0)1628 561 092
+44 (0)1628 561 092