KALETRA® Tablets and KALETRA™ Oral Solution
200mg lopinavir &
50mg ritonavir per tablet
80mg lopinavir &
20mg ritonavir per mL
PLEASE READ THIS INFORMATION CAREFULLY
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, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What Kaletra is used for
Kaletra is used in the treatment of HIV (Human Immunodeficiency Virus) infections. Kaletra belongs to a group of medicines called HIV protease inhibitors. It helps control the HIV infection by inhibiting or interfering with the protease enzyme that the HIV virus needs to multiply.
Kaletra is used by adults and children 2 years of age or older who are infected with HIV, the virus which causes AIDS. It may be given alone or with certain other anti-HIV medicines. Your doctor will determine which medicines are best for you.
Kaletra has not been shown to decrease the chance of transmitting HIV to a sexual partner. You must continue to use safe sexual practices (e.g. condoms) while taking Kaletra.
Kaletra is available only with a doctor's prescription.
Kaletra is not addictive.
Before you take Kaletra
Do not take Kaletra if
- you have an allergy to the active ingredients, lopinavir or ritonavir
- you are allergic to any of the ingredients listed at the end of this leaflet.
- the packaging is torn or shows signs of tampering
- the expiry date printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work.
If you are not sure whether you should start taking Kaletra, talk to your doctor.
Before you start to take Kaletra you must tell your doctor if:
- you are pregnant or plan to become pregnant.
Your doctor will discuss the risks and benefits of taking Kaletra when pregnant. - you are breastfeeding or plan to breastfeed.
Health experts recommend that HIV infected women should not breastfeed their infants because of the possibility your baby can be infected with HIV through your breast milk.
Your doctor will discuss the risks and benefits of taking Kaletra when breastfeeding. - you have, or have ever had, any other health problems or medical conditions, including liver problems.
People with liver disease or hepatitis who take Kaletra may need additional testing. Your doctor will decide if this is needed for you. - you are allergic to any other medicines, foods, dyes or preservatives.
- you suffer from diabetes mellitus or sugar diabetes
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given Kaletra.
Taking other medicines
It is important to tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
Tell your doctor if:
- You are currently taking any of the following medicines:
- dihydroergotamine, ergotamine (used to treat migrane headaches)
- midazolam, triazolam (used to relieve anxiety and/or trouble sleeping)
- pimozide (used to treat schizophrenia)
- cisapride (used to relieve certain stomach problems)
- flecainide (used for heart problems)
- rifampicin (used to treat certain infections)
- amiodarone (used to treat abnormal heart beat)
If you are currently taking any of these medicines, ask your doctor about switching to a different medicine while you are taking Kaletra.
Kaletra may interact with certain other medications with potential clinical consequences.
Kaletra should be taken with the following medicines only on your doctors advice.
- taking erectile dysfunction agents (e.g. sildenafil, tadalafil, vardenafil) and Kaletra together, may put you at risk of side effects such as low blood pressure, 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 permanant damage to your penis.
- medicines used to lower blood cholesterol (e.g. simvastatin)
- medicines affecting the immune system (e.g. cyclosporin, tacrolimus)
- various corticosteroids (e.g. dexamethasone, fluticasone, budesonide) administered orally, into the nose or inhaled through the mouth.
- other anti-HIV medication such as protease inhibitors, nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors
- certain heart medicines such as: calcium channel antagonists (e.g. felodipine, nifedipine) and drugs used to correct heart rhythm (e.g. digoxin, amiodarone, systemic lignocaine, quinidine)
- antifungals (e.g. ketoconazole, itraconazole, voriconazole)
- morphine-like medicines (e.g. methadone)
- anticonvulsants (e.g. carbamazepine, phenytoin, phenobarbitol)
- warfarin
- disulfiram
- certain antibiotics (e.g. metronidazole, rifabutin)
Other interactions
Kaletra affects the way oral or patch contraceptives work. Another form of contraception should be used whilst you are taking Kaletra.
Patients taking protease inhibitors/non-nucleoside reverse transcriptase inhibitors (NNRTIs) must not take products containing Hypericum perforatum (St John's Wort) as this may result in the loss of therapeutic effect and development of resistance.
Kaletra oral solution contains 42% 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, it should be taken one hour before or two hours after taking Kaletra with your meal.
How to take Kaletra
How much to take and when to take it
Take Kaletra only when 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.
The usual adult dose is 2 tablets or 5mL of the oral solution twice a day i.e. every 12 hours. For children, the doctor will decide the right dose based on the child's height and weight.
Take your Kaletra at regular twelve-hour intervals 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.
Follow all directions given to you by your doctor carefully. This may differ from the information contained in this leaflet.
If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.
How to take it
Tablets
Kaletra tablets can be taken with or without food. It is important that the tablets are swallowed whole and not chewed, broken or crushed.
The Oral solution:
Kaletra oral solution should preferably be taken with meals.
The oral solution dosage syringe has been specially designed to give you the right dose of Kaletra. This syringe is the only syringe you should use to measure your 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. Talk to your pharmacist if you have difficulty opening the bottle.
5 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 soap 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
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. Continue taking Kaletra for as long as your doctor prescribes.
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 with food, 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.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering to take your Kaletra, ask your pharmacist for some hints.
If you take too much Kaletra(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 handy.
While you are taking Kaletra
Things you must do
Use another or different type of contraception. If you are using oestrogen based hormonal contraceptives, Kaletra may reduce the effectiveness of oral contraceptives.
Tell your doctor if you become pregnant while taking Kaletra.
- You should not take medicines that cause a reaction with alcohol such as disulfiram while taking Kaletra oral solution.
Tell your doctor or pharmacist that you are taking Kaletra if you are about to be started on any new medicine.
Tell all the doctors, dentists, and pharmacists who are treating you that you are taking Kaletra.
Things you must not do
Do not stop taking Kaletra or change the dose without first checking with your doctor. Do not let yourself run out of medicine over weekends or on holidays.
Do not give this medicine to any one else, even if they have the same condition as you.
Things to be careful of
Kaletra has not been tested for its possible effects on the ability to drive a car or operate machines. Make sure you know how you react to Kaletra before you drive a car or operate machinery.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Kaletra.
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 taking Kaletra.
Ask your doctor or pharmacist to answer any questions you may have.
While you are taking Kaletra
Tell your doctor if you experience any of the following:
- abdominal pain
- abnormal stools
- nausea, vomiting
- diarrhoea
- feeling weak or tired
- headache
These are the more common side effects of Kaletra.
In some individuals, treatment with protease inhibitors may cause changes in body shape due to changes in fat distribution. These may include decreased fat under the skin, increased fat in the abdomen (belly), breast enlargement and fatty lumps on the back of the neck. Protease inhibitors may also cause hyperlipidaemia (increase fats in the blood) and raised blood sugar.
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor. Should this happen to you, seek immediate advice from your doctor. Cases of diabetes mellitus or increased blood sugars have been reported in patients receiving Kaletra or other protease inhibitors.
Some patients have had increases in triglycerides and cholesterol. There are no short-term risks that result from the increases observed. The long-term risks for complication such as heart attacks or stroke due to increases in triglycerides and cholesterol are not known at this time.
Abnormal liver function tests have been reported in patients taking Kaletra. People with pre-existing liver disease or hepatitis may have worsening of liver disease. Some patients had other illnesses or were taking other medicines. It is uncertain if Kaletra caused these liver problems.
There have been reports of muscle pain, tenderness or weakness, particularly in combination with antiretroviral therapy including protease inhibitors and nucleoside analogues. On rare occasions these muscle disorders have been serious (rhabdomyolysis).
Other side effects may occur with Kaletra. Ask your doctor or pharmacist for more information about side effects. Both have a more complete list of side effects. Inform your doctor promptly about these or any other symptoms. If the condition persists or worsens, seek medical attention.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
After using Kaletra
Storage
Tablets in bottle
Kaletra tablets should be stored below 30°C and should be used within the expiry date shown on the bottle/box.
Tablets in blister pack
Kaletra tablets should be stored below 25°C and should be used within the expiry date shown on the bottle/box.
Oral Solution
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 heat.
It is important to keep Kaletra in the bottle it came in. Do not transfer it to any other container.
Do not use after the expiry date stated on the pack.
PRODUCT DESCRIPTION
Kaletra comes in two dosage forms.
Tablets
Kaletra tablets come in bottles and blisters containing 120 tablets.
Oral Solution
Kaletra oral solution comes in a multiple-dose 60 mL amber bottle. Five bottles of 60 mL are provided in one package.
Ingredients
Tablets:
Each tablet of Kaletra contains 200 mg of lopinavir and 50 mg 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, hydroxypropylcellulose, talc, silica-colloidal anhydrous, macrogol 3350, iron oxide yellow CI 77492, and polysorbate 80
Oral Liquid:
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.