Kaletra / ml Oral 80 mg/20 mg Oral Solution

KALETRA SOLUTION  The active substance for KALETRA SOLUTION is a combination of two medicines: lopinavir and ritonavir. Each 1 mL solution contains 80 mg lopinavir and 20 mg ritonavir. KALETRA is a type of medicine called an HIV (human immunodeficiency virus) protease inhibitor. KALETRA is always used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. KALETRA is for adults and for children age 6-months and older. HIV infection destroys CD 4 (T) cells, which are important to the immune system. After a large number of T-cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. KALETRA blocks HIV protease, which is a chemical that is needed for HIV to multiply. KALETRA reduces the amount of HIV in your blood and increases the number of CD 4 (T) cells (cells in your immune system). Patients who took KALETRA in clinical studies had significant reduction in both death and AIDS defining diseases; however KALETRA may not have these effects in all patients.

Do not take KALETRA:  If you are allergic (hypersensitive) to lopinavir, ritonavir or to any of the other ingredients of KALETRA (see section 6).  Do not take the following medicines with KALETRA because they can cause serious problems or death if taken with KALETRA: - midazolam, triazolam (used to relieve anxiety and/or trouble sleeping) - ergotamine, dihydroergotamine (used to treat migraine headache) - egonovine, methylergonovine (used to treat post-partum bleeding) - cisapride (used to relieve certain stomach problems) - astemizole, terfenadine (commonly used to treat allergy symptoms) - salmeterol (commonly used to treat asthma) - Alfuzosin (used in men to treat symptoms of an enlarged prostate) - Amiodarone, dronedarone (used to treat abnormal heartbeat) - Fusidic acid (used to treat long-term infections of the bones and joints) - Colchicine if you have kidney and or liver problems (used to treat gout). - Ranolazine (used to treat chronic chest pain [angina]) - Blonanserin, Quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder) - Lurasidone, pimozide (used to treat abnormal thoughts or feelings) - Product that contains St John’s Wort (Hypericum perforatum) - lovastatin, simvastatin (used to lower blood cholesterol) - elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]) - lomitapide (used to lower blood cholesterol) - avanafil or vardenafil (used to treat erectile dysfunction) - sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery). Sildenafil used to treat erectile dysfunction may be taken under doctor’s supervision (see Other medicines and KALETRA section). - neratinib (used for breast cancer) - apalutamide (used for prostate cancer)  Do not take KALETRA with rifampin, because rifampin may lower the amount of KALETRA in your blood and make it less effective.  Do not take KALETRA with St. John’s wort (Hypericum perforatum) , an herbal product sold as a dietary supplement, or products containing St. John’s wort. Talk to your doctor if you are taking or planning to take St. John’s wort. Taking St. John’s wort may lower the amount of KALETRA and lead to increased viral load and possible resistance to KALETRA or cross-resistance to other anti-HIV medicines.  Do not take KALETRA with the cholesterol-lowering medicines lovastatin or simvastatin because of possible serious reactions. There is also an increased risk of medicine interactions between KALETRA and atorvastatin or rosuvastatin; talk to your doctor before you take any of these cholesterol-reducing medicines with KALETRA.  Do not take KALETRA with voriconazole as KALETRA may lower the amount of voriconazole in your blood.

Always take KALETRA exactly as your doctor has told you. Dosage:  The usual dose for adults is 400/100 mg (5,0 mL) twice daily taken with food, in combination with other HIV medicines.  The doctor may prescribe KALETRA as 10,0 mL of oral solution (800/200 mg) once-daily in combination with other anti-HIV medicines for some patients who have not taken anti-HIV medicines in the past. .  The dosing of KALETRA may be different for you than for other patients. Follow the directions from your doctor, exactly as written on the label.  Children from 6-months to 12-years of age can also take KALETRA. The child’s doctor will decide the right dose based on the child’s height and weight.  Take KALETRA with food if possible to help it work better.  Be sure to set up a schedule and follow it carefully.  When your KALETRA supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to KALETRA and become harder to treat.  Only take medicine that has been prescribed specifically for you. Do not give KALETRA to others or take medicine prescribed for someone else. If you or your child take more KALETRA than you should As with all medicines, KALETRA should be kept out of reach of young children. KALETRA SOLUTION contains a large amount of alcohol. If a toddler or young child accidentally drinks more than the recommended dose of KALETRA, it could make him/her sick from too much alcohol. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you or your child forget to take KALETRA It is important that you do not miss any doses. If you miss a dose of KALETRA, take it as soon as possible and then take your next scheduled dose at its regular time. If it is almost time for your next dose, wait and take the next dose at the regular time. Do not double the next dose. Call your doctor or pharmacist if you have any questions about how to take KALETRA. If you or your child stop taking KALETRA - Do not change your treatment or stop treatment without first talking with your doctor. If you are not sure, you should check with your doctor. - KALETRA should always be taken twice every day to help control your HIV infection, no matter how much better you feel. - Taking KALETRA as recommended should give you the best chance of delaying the development of resistance to the product. - If a side effect is preventing you from taking KALETRA as directed tell your doctor right away. - 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. - Continue to take this medicine until your doctor tells you otherwise.

KALETRA can have side-effects. Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.  The more frequent side-effects that are thought to be medicine-related are: diarrhoea, nausea and upper respiratory tract infections. Children taking KALETRA may sometimes get a skin rash.  Frequent:  inflammation of the pancreas (Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis);  vomiting, enlarged abdomen, pain in the lower and upper stomach area, passing wind,  indigestion, decreased appetite, reflux from your stomach to your oesophagus which may cause pain;  swelling or inflammation of the stomach, intestines and colon;  increased cholesterol levels in your blood, increased triglycerides (a form of fat) levels in your blood, high blood pressure;  decreased ability of the body to handle sugar including diabetes mellitus, weight loss;  low number of red blood cells, low number of white blood cells which are usually used to fight infection;  rash, eczema, accumulation of scales of greasy skin;  dizziness, anxiety, difficulty in sleeping;  feeling tired, lack of strength and energy, headache including migraine;  haemorrhoids;  inflammation of the liver including increased liver enzymes;  allergic reactions including hives and inflammation in the mouth;  lower respiratory tract infection;  enlargement of the lymph nodes;  impotence, abnormally heavy or extended menstrual flow or a lack of menstruation;  muscle disorders such as weakness and spasms, pain in the joints, muscles and back;  damage to nerves of the peripheral nervous system;  night sweats, itching, rash including raised bumps on the skin, infection of the skin, inflammation of skin or hair pores, accumulation of fluid in the cells or tissues.

Keep KALETRA and all other medicines out of reach of children. KALETRA SOLUTION  Refrigerated KALETRA SOLUTION remains stable until the expiration date printed on the label. If stored at room temperature up to 25 ºC, KALETRA SOLUTION should be used within 2- months.  Dosing syringes are included in each carton of KALETRA oral solution. After each dose of KALETRA separate the plunger and the syringe. Wash the plunger and the syringe with dish soap and warm water immediately after use. Rinse the syringe and the 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.  Use KALETRA SOLUTION by the expiration date on the bottle. Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).