Aluvia Film-Coated Tablets

ALUVIA 100/25 film-coated tablets contain 100 mg of lopinavir and 25 mg of ritonavir. ALUVIA 100/25 is an inhibitor of the human immunodeficiency virus (HIV) protease enzyme. It helps control HIV infection by inhibiting or interfering with the protease enzyme that HIV needs to multiply. ALUVIA 100/25 is used by adults and children with a body surface area of 1.3 m2 or greater who are infected with HIV, the virus which causes AIDS. Your doctor has prescribed ALUVIA 100/25 to help control your HIV infection. ALUVIA 100/25 is prescribed for use in combination with other antiviral medicines. Your doctor will determine which medicines are best for you.

Do not take Aluvia 100/25:

• If you are allergic (hypersensitive) to lopinavir, ritonavir or to any of the other ingredients of Aluvia 100/25 (listed in section 6).
• If you have severe liver problems.
• If you are currently taking any of the following medicines:
• Alfuzosin (used in men to treat symptoms of enlarged prostate)
• Apalutamide (used for prostate cancer)
• Astemizole (used to treat allergy symptoms – this medicine may be available without prescription).
• Blonanserin (used to treat psychosis).
• Cisapride (used to relieve certain stomach problems)
• Colchicine (medicine used to treat gout) - if you have kidney and/or liver problems
• Amiodarone, dronedarone (used to correct irregular heartbeat)
• Ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches)
• Elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV])
• Fusidic acid (used to treat bacterial infection)
• HMG – CoA Reductase Inhibitors: Lovastatin, simvastatin, rosuvastatin, atorvastatin (used to treat high blood cholesterol)
• Lomitapide- (used to lower blood cholesterol)
• lurasidone (used to treat depression)
• Midazolam, triazolam (used to relieve anxiety and/or trouble sleeping)
• Neratinib (used to treat breast cancer)
• Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus)
• Pimozide (used to treat schizophrenia)
• Quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder)
• Salmeterol (used to treat asthma)
• Ranolazine (used to treat chronic chest pain [angina])
• PDE5 inhibitors: sildenafil, tadalafil and vardenafil (for the treatment of pulmonary arterial hypertension)
• Avanafil or vardenafil (used to treat erectile dysfunction)

Patients taking ALUVIA 100/25 must not take products containing St John’s Wort (Hypericum perforatum) as this may stop ALUVIA 100/25 from working properly.

Do not share medicines prescribed for you with any other person. Always take ALUVIA 100/25 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is important that you take ALUVIA 100/25 every day exactly as your doctor prescribed it. Even if you feel better, do not stop taking ALUVIA 100/25 without talking to your doctor. Using ALUVIA 100/25 as recommended should give you the best chance to delay the development of resistance to the product. Your doctor or pharmacist will advise on the number of tablets to be taken. The recommended oral dose of ALUVIA 100/25 film-coated tablets are as follows:

Use in adults

• ALUVIA 100/25 film-coated tablets adult usual dose is 400/100 mg twice daily (i.e. every 12 hours), in combination with other antiretroviral medicines.
• Alternatively, ALUVIA 100/25 film-coated tablets may be dosed as 800/200 mg once daily. ALUVIA 100/25 must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital and phenytoin.

Use in children

Aluvia 100/25 should not be given once daily in children. The doctor will decide the correct dose (i.e. number of tablets) based on the child’s height and weight.

ALUVIA 100/25 can have side effects. Not all side effects reported for ALUVIA 100/25 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking ALUVIA 100/25 and tell your doctor immediately or go to casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, 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 a serious allergic reaction to ALUVIA 100/25. You may need urgent medical attention or hospitalisation.

More frequent:

• diarrhoea;
• nausea;
• upper respiratory tract infection

Frequent:

• 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- Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis (inflammation of the pancreas).
• 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

Keep ALUVIA 100/25 out of the reach and sight of children. ALUVIA 100/25 film-coated tablets do not require any special storage conditions. Store at or below room temperature (below 30 ºC) in its original package. Do not transfer it to any other container. Do not use after the expiry date on the label/carton/bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Be sure that if you throw any medicine away, it is out of reach of children.