Lopimune

LOPIMUNE 40/10 ORAL PELLETS is indicated in combination with other antiretroviral agents 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. LOPIMUNE 40/10 ORAL PELLETS is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors. LOPIMUNE 40/10 ORAL PELLETS 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 take / give LOPIMUNE 40/10 ORAL PELLETS if:

• You / he / she are allergic to lopinavir, ritonavir or to any of the other ingredients of LOPIMUNE 40/10 ORAL PELLETS.
• You / he / she have severe liver disease.
• You / he / she is currently taking any of the following medicines:
• Cholesterol (too much fat in your body) lowering medicines like simvastatin and lovastatin.
• Amiodarone, dronedarone, bepridil, quinidine, propafenone, verapamil (medicines used to treat abnormal heartbeat)
• Pimozide, lurasidone (used to treat depression)
• Quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder);
• Astemizole, terfenadine (commonly used to treat allergy symptoms);
• Triazolam, diazepam, flurazepam (used to relieve anxiety or trouble sleeping);
• Midazolam taken by mouth and clorazepate (sedative, used to treat epilepsy);
• Ranolazine (used to treat chronic chest pain [angina]);
• Cisapride (used to relieve certain stomach problems);
• Ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat migraine headaches);
• Simvastatin and lovastatin (used to lower blood cholesterol);
• Colchicine (anti-gout medicine) – patients with renal or hepatic impairment. (See the section on Other Medicines and LOPIMUNE 40/10 ORAL PELLETS);
• Fusidic acid (used to treat skin infections such as impetigo and infected dermatitis). (See the section on Taking Other Medicines);
• Elbasvir/grazoprevir, ombitasvir/paritaprevir/ritonavir with or without (used to treat chronic hepatitis C virus [HCV]);
• 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);
• Avanafil or vardenafil (used to treat erectile dysfunction);
• Products that contain St John’s Wort (Hypericum perforatum)).

Read the list of medicines under ‘Other medicines and LOPIMUNE 40/10 ORAL PELLETS’ for information on certain other medicines which require special care. If your child is taking any of these medicines, ask the health care provider about making changes either in the treatment for your child’s other condition(s) or in your child’s antiretroviral treatment.

Warnings and precautions

Take special care with LOPIMUNE 40/10 ORAL PELLETS: Check with your health care provider before giving LOPIMUNE 40/10 ORAL PELLETS to your child if your child has or had had liver disease- patients with chronic hepatitis B or C treated with antiretroviral medicines such as LOPIMUNE 40/10 ORAL PELLETS are at an increased risk for severe and potentially fatal liver adverse reactions, and may require blood tests to monitor liver function.

Do not share medicines prescribed for you with any other person. Always take LOPIMUNE 40/10 ORAL PELLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Caregivers, parents or guardians must also give LOPIMUNE 40/10 ORAL PELLETS according to the patient’s doctor’s instructions.

REMEMBER TO ALWAYS TAKE LOPIMUNE 40/10 ORAL PELLETS WITH FOOD.

Method of administration: Capsules containing the oral pellets should not be swallowed whole but should be administered with food as shown below (capsule contents should be emptied into ready-to-eat-porridge).

• Place soft food or porridge, which is at room temperature, in a small bowl.
• Obtain the prescribed number of capsules needed for a dose.
• Hold both ends of the capsule between your fingertips as depicted above.
• Twist the ends of the capsule in opposite direction and pull apart so that the entire contents of the capsule are sprinkled over the soft food or porridge.
• Repeat this step for the prescribed number of capsules per dose. Ensure that the entire content of each capsule is sprinkled over the porridge.
• This medicine-porridge mixture should be eaten immediately. The oral pellets should not be chewed or crushed. They should not be stored for future use.
• Administration of the required dose should be followed by drinking water, to ensure that no pellets are left behind in the mouth.
• Repeat above steps for next dose.

The recommended dose must be taken twice daily with food about 12 hours apart. You doctor will determine the correct dose for you. Dosage of LOPIMUNE 40/10 ORAL PELLETS in infants and children is as follows:

• Child’s weight Dose (twice daily)
• 6 – 9,9 kg 3 capsules in the morning 3 capsules in the evening
• 10 – 13.9 kg 4 capsules in the morning 4 capsules in the evening
• 14 – 19,9 kg 5 capsules in the morning 5 capsules in the evening
• 20 – 24,9 kg 6 capsules in the morning 6 capsules 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 LOPIMUNE 40/10 ORAL PELLETS about 12 hours apart.

LOPIMUNE 40/10 ORAL PELLETS must be taken with a meal twice daily. LOPIMUNE 40/10 ORAL PELLETS should be sprinkled/mixed with soft food such as applesauce or porridge, or mixed with liquid such as water, as described below. LOPIMUNE 40/10 ORAL PELLETS should not be chewed or crushed.

Not all side effects reported for LOPIMUNE 40/10 ORAL PELLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LOPIMUNE 40/10 ORAL PELLETS, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking LOPIMUNE 40/10 ORAL PELLETS 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 LOPIMUNE 40/10 ORAL PELLETS. 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:

• 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.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Diarrhoea,
• nausea,
• Upper respiratory tract infection,
• changes in body shape or face shape due to changes in fat distribution
• headache including migraine,
• dizziness, anxiety,
• feeling, tired, lack of strength and energy,
• vomiting, enlarged abdomen, abdominal pain, 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, increased triglycerides,
• high blood pressure,
• inflammation of the pancreas,
• 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,
• inflammation of the liver including increased liver enzymes,
• muscle disorders such as weakness and spasms, pain in the joints, muscles and back,
• night sweats,
• rash, eczema, accumulation of scales or greasy skin,
• itching, rash including raised bumps on the skin, infection of the skin, inflammation of skin or hair pores, accumulation of fluid in cells or tissues,

Further information about nausea, vomiting or abdominal pain Tell your health care provider if you have 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 health care provider 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. Tell your health care provider if you notice any changes in your body shape due to changes in fat distribution.

Store in the original container at or below 30 C. KEEP OUT OF REACH AND SIGHT OF CHILDREN. Do not use after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).