Lopinavir/Ritonavir 40 mg/10 mg Oral Suspension

Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan is indicated in combination with other antiretroviral medicines for the treatment of HIV - 1 infection in adults and children over 6 months old and weighing over 6 kg. It slows down the spread of infection in your child’s body. Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors. Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan is prescribed for use in combination with other antiviral medicines. Your health care provider will discuss with you which medicines are best for your child. This medicine is intended for use in children. Safety information on use in adults is also provided.

Do not give Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan:

• if he/she are allergic (hypersensitive) to lopinavir, ritonavir or any of the other ingredients of Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan (listed in section 6);
• if you if your child has severe liver problems;
• if your child is taking any of the following medicines:

o Amiodarone, dronedarone, bepridil, quinidine, propafenone, verapamil (medicines used to treat abnormal heartbeat)

o Pimozide, lurasidone (used to treat depression)

o Quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder);

o Astemizole, terfenadine (commonly used to treat allergy symptoms);

o Triazolam, diazepam, flurazepam (used to relieve anxiety or trouble sleeping);

o Midazolam taken by mouth and clorazepate (sedative, used to treat epilepsy);

o Ranolazine (used to treat chronic chest pain [angina]);

o Cisapride (used to relieve certain stomach problems);

o Ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat migraine headaches);

o Simvastatin and lovastatin (used to lower blood cholesterol);

o Colchicine (anti-gout medicine) – patients with renal or hepatic impairment. (See the section on Other Medicines and Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan);

o Fusidic acid (used to treat skin infections such as impetigo and infected dermatitis). (See the section on Taking Other Medicines);

o Elbasvir/grazoprevir, ombitasvir/paritaprevir/ritonavir with or without (used to treat chronic hepatitis C virus [HCV]);

o Sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery). Sildenafil used to treat erectile dysfunction may be taken under the health care provider’s supervision (see “Warnings and precautions” section);

o Avanafil or vardenafil (used to treat erectile dysfunction);

o Products that contain St John’s Wort (Hypericum perforatum).

Do not share medicines prescribed for you with any other person. Always take Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The recommended doses of Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan in infants and children is as follows:

Child’s weight Dose (twice daily)

• 6 – 9.9 kg 3 sachets in the morning 3 sachets in the evening
• 10 – 13.9 kg 4 sachets in the morning 4 sachets in the evening
• 14 – 19.9 kg 5 sachets in the morning 5 sachets in the evening
• 20 – 24.9 kg 6 sachets in the morning 6 sachets in the evening

Your child’s health care provider may adjust the dose in case your child is receiving certain other medicines. Your child should receive each dose of Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan about 12 hours apart.

Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan must be taken with a meal twice daily. Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan should be sprinkled/mixed with soft food such as applesauce or porridge, or mixed with liquid such as water, as described below. Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan should not be chewed or crushed.

Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan can have side effects. Not all side effects reported for Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to Lopinavir/Ritonavir 40 mg/10 mg granules for oral suspension Mylan. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequency not known

• yellowing of the skin or whites of eye (jaundice),
• severe or life-threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme).

These are all serious side effects. You may need urgent medical attention.

Store all medicines out of reach of children.

• Store at or below 30 °C in the original container.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).