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

• Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection. Kaletra does this by slowing down the spread of the infection in your body.
• Kaletra is used by children 2 years of age or older and adults who are infected with HIV, the virus which causes AIDS. Kaletra should not be administered to children younger than 2 years of age unless specifically directed by their doctor.
• Kaletra is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors.
• Kaletra is prescribed for use in combination with other antiviral medicines. Your doctor will discuss with you and determine which medicines are best for you.

Do not take Kaletra:

• If you are allergic (hypersensitive) to lopinavir, ritonavir or any of the other ingredients of Kaletra.
• If you have severe liver problems.

Do not take Kaletra with any of the following medicines:

• Astemizole or terfenadine (commonly used to treat allergy symptoms ? these medicines may be available without prescription);
• Midazolam taken orally (taken by mouth), triazolam (used to relieve anxiety and/or trouble sleeping);
• Pimozide (used to treat schizophrenia);
• Cisapride (used to relieve certain stomach problems);
• Ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches);
• Amiodarone (used to treat abnormal heart beat);
• Lovastatin, simvastatin (used to lower blood cholesterol);
• Vardenafil (used to treat erectile dysfunction);
• Sildenafil (used to treat pulmonary arterial hypertension). Sildenafil used to treat erectile dysfunction may be taken under doctor?s supervision (see Take special care with Kaletra section);
• Products that contain St John?s wort ( Hypericum perforatum).

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 making necessary changes either in the treatment for your other condition(s) or in your antiretroviral treatment.

Take special care with Kaletra

Important information

• 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.
• There is still a risk of passing HIV to others when taking Kaletra. Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or contamination with blood.

Tell your doctor if you have/had:

• Haemophilia type A and B as Kaletra might increase the risk of bleeding.
• Diabetes as increased blood sugars has been reported in patients receiving Kaletra.
• A history of liver problems as patients with a history of liver disease, including chronic hepatitis B or C are at increased risk of severe and potentially fatal liver side effects.

Tell your doctor if you experience:

• Nausea, vomiting, abdominal pain, difficulty breathing and severe weakness of the muscles in the legs and arms as these symptoms may indicate raised lactic acid levels.
• Thirst, frequent urination, blurred vision or weight loss as this may indicate raised sugar levels in the blood.
• Nausea, vomiting, abdominal pain as large increases in the amount of triglycerides (fats in the blood) have been considered a risk factor for pancreatitis (inflammation of the pancreas) and these symptoms may suggest this condition.
• Changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (?buffalo hump?). The cause and long-term health effects of these conditions are not known at this time.
• In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body?s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately to seek necessary treatment.
• Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movementas some patients taking these medicines may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduction in the activity of the immune system), higher body mass index, among others, may be some of the many risk factors for developing this disease.
• Muscle pain, tenderness or weakness, particularly in combination with these medicines. On rare occasions these muscle disorders have been serious.
• Symptoms of dizziness, lightheadedness, fainting or sensation of abnormal heartbeats. Kaletra may cause changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an ECG (electrocardiogram).

Taking other medicines

Tell your doctor if you are taking any of the medicines listed below, as special care should then be taken:

• Antibiotics (e.g. rifabutin, rifampicin, clarithromycin);
• Anticancer medicines (e.g. most tyrosine kinases inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine);
• Antidepressants (e.g. trazodone, bupropion);
• Anti-epilepsy medicines (e.g. carbamazepine, phenytoin, phenobarbital);
• Antifungals (e.g. ketoconazole, itraconazole, voriconazole);
• Erectile dysfunction medicines (e.g. sildenafil and tadalafil);
• Heart medicines including:
• Digoxin;
• Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine);
• Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
• Medicines used to lower blood cholesterol (e.g. atorvastatin, lovastatin, rosuvastatin or simvastatin);
• Medicines affecting the immune system (e.g. cyclosporin, sirolimus (rapamycin), tacrolimus);
• Medicines used for smoking cessation (e.g. bupropion);
• Pain-relieving medicines (e.g. fentanyl);
• Morphine-like medicines (e.g. methadone);
• Oral contraceptive or using a patch contraceptive to prevent pregnancy (see section below titled Contraceptives);
• Protease inhibitors (e.g. amprenavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir);
• Sedatives (e.g. midazolam administered by injection);
• Steroids (e.g. dexamethasone, fluticasone propionate, ethinyl oestradiol);
• Warfarin.
• Medicines that cause a reaction with alcohol (e.g. disulfiram).

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.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Erectile dysfunction medicines (vardenafil, sildenafil, tadalafil)

• Do not take Kaletra if you are currently taking vardenafil.
• You must not take Kaletra with sildenafil used to treat pulmonary arterial hypertension (see also Do not take Kaletra section).
• If you take sildenafil or tadalafil 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.

Contraceptives

• 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 contact.

Pregnancy and breast-feeding

• Tell you doctor immediately if you are pregnant, think you may be pregnant or if you are breast-feeding.
• Pregnant or breast-feeding mothers should not take Kaletra unless specifically directed by the doctor.
• It is recommended that HIV-infected women do not breast-feed their infants because there is a possibility that the baby can be infected with HIV through your breast milk.

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.

Important information about some of the ingredients of Kaletra

Kaletra contains 42% v/v alcohol. Each dose contains up to 1.7 g of alcohol. Potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. May modify or increase the effect of other medicines.

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 physician.

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.

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 5 ml twice daily for children weighing less that 40 kg.

• Always take Kaletra exactly as your doctor has told you.
• You should 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?

Use in adults

• The usual adult dose is 5 ml of the oral solution twice a day i.e. every 12 hours, in combination with other anti-HIV medicines. Your doctor will advise on the amount of Kaletra to be taken.
• It is important that all doses of Kaletra oral solution are taken with food.

Use in children 2 years of age and above

• Your doctor will decide the right dose based on the child?s height and weight.
• It is important that all doses of Kaletra oral solution are taken with food.

If you are 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.

How do I measure the correct dose of the solution?

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 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.

If you take more Kaletra than you should

• If you realise you have taken more Kaletra than you were supposed to, contact you doctor right away.
• If you cannot contact your doctor, go to the hospital.

If you forget to take Kaletra

• If you miss a dose, take the missed dose as soon as possible together with some food, and then continue with your normal dose on the regular schedule as prescribed by your doctor.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Kaletra

• Do not stop or change the daily dose of Kaletra without first consulting with your doctor.
• Kaletra should always be taken twice 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 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.

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. You should tell your doctor promptly about these or any other symptoms. If the condition persists or worsens, seek medical attention.

VERY COMMON side effects (affects more than 1 user in 10):

• Diarrhoea;
• Nausea;
• Upper respiratory tract infection.

COMMON side effects (affects 1 to 10 users in 100):

• Inflammation of the pancreas;
• 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;
• Changes in body shape or face shape due to changes in fat distribution;
• 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.

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 (inflammation of the pancreas).

Further information about increased cholesterol and triglycerides

• The long-term risks for complications such as heart attacks or stroke due to increased triglycerides and cholesterol are not known at this time.
• Your doctor will monitor you and may prescribe other medicines if needed.
• Large increases in the amount of triglycerides (fats in the blood) have been considered a risk factor for pancreatitis (inflammation of the pancreas).

Changes in body shape due to changes in fat distribution

Combination antiretroviral therapy, which may include Kaletra, may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (?buffalo hump?). The cause and long-term health effects of these conditions are not known at this time.
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.

UNCOMMON side effects (affects 1 to 10 users in 1,000):

• Abnormal dreams;
• Loss or changed sense of taste;
• Hair loss;
• An abnormality in your electrocardiogram called atrioventricular block;
• Plaque building up inside your arteries which could lead to heart attack and stroke;
• Inflammation of blood vessels and capillaries;
• Inflammation of the bile duct;
• Uncontrolled shaking of the body;
• Constipation;
• Deep vein inflammation related to a blood clot;
• Dry mouth;
• Inability to control your bowels;
• Inflammation of the first section 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 the urine;
• Fatty deposits in the liver, enlarged liver;
• Lack of functioning of the testes;
• A flare-up of symptoms related to an inactive infection in your body (immune reconstitution);
• Increased appetite;
• Abnormally high level of bilirubin (a pigment produced from the breakdown of red blood cells) in the blood
• Decreased sexual desire;
• Inflammation of the kidney;
• Bone death caused by poor blood supply to the area;
• Mouth sores or ulcerations, inflammation of the stomach and intestine;
• Kidney failure;
• Breakdown of muscle fibers resulting in the release of muscle fiber contents (myoglobin) into the bloodstream;
• A sound in one ear or both ears, such as buzzing, ringing or whistling;
• Tremor;
• Abnormal closure of one of the valves (tricuspid valve in your heart);
• Vertigo (spinning feeling);
• Eye disorder, abnormal vision;
• Weight gain.

Other side effects that have been reported with Kaletra: yellowing of the skin or whites of eyes (jaundice), severe or life threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme). It is not known how frequently these effects may occur.

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.

• Keep out of the reach and sight of children.
• Do not use Kaletra after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

How should I store Kaletra and for how long?

• Store in a refrigerator (2°C - 8°C).
• In use storage: If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks). It is advised to write the date of removal from the refrigerator on the package.
• 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.

How should I dispose of any unused Kaletra?

• Medicines should not be disposed of via wastewater or household waste.
• Ask your pharmacist how to dispose of medicines not longer required. These measures will help protect the environment.

What Kaletra contains

The active substances are lopinavir and ritonavir.
Each ml of Kaletra 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, heliotrope, 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, menthol.

What Kaletra look 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.

Five bottles containing 60 ml of oral solution (300 ml) are provided in one pack.

Marketing Authorisation Holder: Abbott Laboratories Limited, Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

Manufacturers:
Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Abbott SA TélTel 32 10 475311 LuxembourgLuxemburg Abbott SA BelgiqueBelgien TélTel 32 10 475311

Te. 359 2 44 55 400 Magyarország Abbott Laboratories Magyarország Kft. Tel. 36 1 465 2100

eská republika Abbott Laboratories s. r. o. Tel 420 267 292 111 Malta V.J.Salomone Pharma Limited Tel 356 22983201

Danmark Abbott Laboratories AS Tlf 45 39 77-00-00 Nederland Abbott B.V. Tel 31 0 88 8222 688

Deutschland Abbott GmbH Co. KG Tel 49 0 6122 58-0 Norge Abbott Norge AS Tlf 47 81 55 99 20

Österreich Abbott Ges.m.b.H. Tel 43 1 891-22 Eesti Abbott Laboratories Baltics Läti Tel 371 67605580

Abbott Laboratories .... 30 21 0 9985-222 Polska Abbott Laboratories Poland Sp. z o.o. Tel. 48 22 319 12 00

España Abbott Laboratories, S.A. Tel 34 9 1 337-5200 Portugal Abbott Laboratórios, Lda. Tel 351 0 21 472 7100

France Abbott France Tél 33 0 1 45 60 25 00 România S.C. Abbott Products Romania S.R.L. Tel 40 21 529 30 00

Ireland Abbott Laboratories, Ireland, Ltd Tel 353 0 1 469-1500 Slovenija Abbott Laboratories d.o.o. Tel 386 1 23 631 60

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Abbott Laboratories Slovakia s.r.o. Tel 421 0 2 4445 4176

Italia Abbott S.r.l. Tel 39 06 928921 SuomiFinland Abbott OY PuhTel 358 0 9 7518 4120

Lifepharma Z.A.M. Ltd . 357 22 34 74 40 Sverige Abbott Scandinavia AB Tel 46 0 8 5465 67 00

Latvija Abbott Laboratories Baltics Tel 371 67605580 United Kingdom Abbott Laboratories Ltd Tel 44 0 1628 773355

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Abbott Laboratories Baltics
Latvija
Tel: + 371 67605580

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