Norvir 100 mg Tablets

NORVIR is in a class of medicines called the HIV protease inhibitors. NORVIR is used in combination with other anti-HIV medicines to treat human immunodeficiency virus (HIV) infection.

Do not take NORVIR:

• If you are hypersensitive (allergic) to ritonavir or any of the other ingredients of NORVIR as listed in ‘other ingredients’ see below section 6
• If you have severe liver disease
• Do not take NORVIR if you are taking any of the following medications

• amiodarone, bepridil, encainide, flecainide, propafenone, quinidine, digoxin (used to correct irregular heart beat)
• apalutamide (used for prostate cancer)
• neratinib (used for breast cancer)
• cisapride (used to relieve some types of stomach problems)
• dihydroergotamine, ergotamine, (used to treat migraine headache)
• lovastatin and simvastatin (used to treat elevated cholesterol)
• midazolam, triazolam (used to relieve anxiety and/or trouble sleeping)
• pimozide (used to treat schizophrenia)
• quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder)
• lurasidone (used to treat depression)
• ranolazine (used to treat chronic chest pain [angina])
• lomitapide (used to lower blood cholesterol)
• alfuzosin (used to treat enlarged prostate gland)
• fusidic acid (used to treat infections)
• avanafil or vardenafil (used to treat erectile dysfunction)
• colchicine (used to treat gout) if you have kidney and/or liver problems
• rifampicin (used to treat tuberculosis and leprosy)
• salmeterol (used to treat asthma)
• sildenafil (used to treat pulmonary arterial hypertension)
• St. John’s Wort (herbal product sold as a dietary supplement)
• Voriconazole (used for treatment of fungal infections)

Warnings and precautions

• If you are taking certain medicines (see Other medicines and NORVIR ). These could cause serious side effects that could cause death. Before you take NORVIR, you must tell your doctor about all the medicines you are taking or are planning to take. These include other prescription and non-prescription medicines and herbal supplements.
• Some patients taking NORVIR can develop serious problems with their pancreas (pancreatitis), which may cause death. Tell your doctor as soon as possible if you have nausea, vomiting, or abdominal pain. These may be signs of pancreatitis.
• Blood tests in patients taking NORVIR may show possible liver problems. People with liver disease such as Hepatitis B and Hepatitis C who take NORVIR may have worsening liver disease. Liver problems including rare cases of death have occurred in patients taking NORVIR. It is unclear if NORVIR caused these liver problems because some patients had other illnesses or were taking other medicines.
• Some patients have large increases in triglycerides and cholesterol (fats in the blood).
• Diabetes and high blood sugar (hyperglycemia) may occur if you are taking protease inhibitors such as NORVIR. You may develop diabetes before starting protease inhibitors. If you are taking NORVIR your diabetes medication may need changing.

If you have liver problems or are infected with Hepatitis B or Hepatitis C (an infection of the liver). Talk to your doctor before taking NORVIR.

If you have haemophilia (a disease that affects the ability of your blood to clot properly and causes increased bleeding) and are taking protease inhibitors such as NORVIR you may have increased bleeding. It is not known whether the protease inhibitors caused these problems. Be sure to tell your doctor if you have haemophilia types A and B.

Changes in body fat have been seen in patients taking medicines such as NORVIR to treat HIV. These changes may include increased amount of fat in the upper back and neck (‘buffalo hump’), breast and around the trunk. Loss of fat from the legs, arms and face may also happen.

NORVIR does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex and do not use or share dirty needles.

NORVIR does not cure HIV infection or AIDS. People taking NORVIR may still get opportunistic infections or other conditions that happen with HIV infection.

If you are feeling sick (nausea), vomiting (throwing up) or have stomach pain, these may be signs of inflammation of the pancreas (pancreatitis). Some patients taking NORVIR can develop serious problems with their pancreas. Tell your doctor as soon as possible if this applies to you.

Some patients with advanced HIV infection (AIDS) who then start anti-HIV treatment may develop the symptoms of infections they have had in the past even if they didn’t know they had had them. It is believed that this happens because the body's immune response improves and helps the body to fight these infections.

Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving, may occur and this may be a sign of a problem that can destroy bone (osteonecrosis).

If you are taking NORVIR with some medicines used to treat allergies, medicines used to relieve anxiety and/or trouble sleeping, medicines used to correct irregular heart beat and medicines used to treat migraine headache they may cause serious adverse events.

Always take NORVIR exactly as your doctor has instructed you. 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 or pharmacist.

Dosage:

• Your doctor will prescribe the correct dose for you.
• Take NORVIR oral powder or solution with food if possible.
• Take NORVIR tablets with food.
• NORVIR tablets should be swallowed whole and not chewed, broken or crushed.
• NORVIR oral powder can be sprinkled on soft food such as apple sauce or dessert pudding or mixed with a suitable liquid such as water, chocolate milk, or infant formula.
• For doses of exactly 100 mg amounts (100, 200, 300, 400, 500, or 600 mg) pour the entire content of each sachet over soft food (apple sauce or vanilla pudding) or mix with a small amount of liquid (water, chocolate milk, or infant formula) and consume entire serving.
• For doses less than 100 mg amounts or doses between 100 mg amounts, the content of the entire sachet is to be mixed with a liquid and then dosed by the appropriate ml volume as told to you by your doctor using the oral dosing syringe.

Administering with food

• The entire contents of each sachet are to be poured over a small amount of soft food (e.g. apple sauce or vanilla pudding). All the mixed soft food must be administered within 2 hours.

Administering with liquid

• The entire contents of each sachet should be suspended in 9.4 mL of liquid (water, chocolate milk, or infant formula)
• The oral dosing syringe and mixing cup should be dry prior to use.
• Draw up 9.4 mL of liquid using the provided oral dosing syringe, remove the bubbles, and transfer the liquid to the mixing cup. All measuring should be done in mL using the syringe.
• Pour the entire contents of 1 sachet (100 mg) into the mixing cup.
• Close the lid and shake hard for at least 90 seconds until all the lumps have dissolved.
• Let the liquid stand for 10 minutes for most of the bubbles to disappear.
• Use the provided oral dosing syringe to measure and administer the prescribed volume is sure to remove the bubbles prior to dose administration.
• Once the powder is mixed, the dosage must be consumed within 2 hours.
• Discard any mixture remaining in the mixing cup.

Prepare only one dose at a time using the correct number of sachets. When mixing the powder with food or liquid, be sure to take the whole dose within 2 hours. Do not mix Norvir with anything else without talking to your doctor or pharmacist.

You should always use the measuring cup provided with the medicine to take your NORVIR in order to make sure you take the right dose. Wash the measuring cup after use with dish soap and warm water as soon as you can. The cup should be dry prior to re-use.

When your NORVIR 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 NORVIR and become harder to treat.

Be sure to set up a schedule and follow it carefully.

Only take medicine that has been prescribed specifically for you. Do not give NORVIR to others or take medicine prescribed for someone else.

If you take more NORVIR than you should

If you think that you took more than the prescribed dose of NORVIR, contact your doctor or go to the nearest hospital.

NORVIR should be kept out of reach of young children.

If you forget to take NORVIR

It is important that you do not miss any dose. If you miss a dose of NORVIR, 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 NORVIR.

NORVIR can have side effects. Not all side effects reported for NORVIR are included in this leaflet. Should your general health worsen while taking NORVIR , please consult your doctor, pharmacist or other health care professional for advice.

The frequent side effects reported are: diarrhoea, vomiting, nausea, abdominal pain, feeling weak/tired, headache and dizziness, loss of appetite, changes in taste and tingling feeling or numbness in hands or feet or around the lips.

Less frequent side effects are: heart attack, diabetes and kidney failure.

Allergic reactions ranging from mild to severe have occurred in patients taking NORVIR.

Frequent side effects

• Sore throat
• Allergic reaction including rash (may be red, raised, and itchy) severe swelling of the skin and other tissues
• Weight loss
• Dehydration, increase in cholesterol, gout, swelling of hands and feet
• Agitation, confusion, mood alteration, nervousness
• Tingling sensation or numbness in the hands, feet or around the lips and mouth.
• Bad taste in the mouth; dizziness
• Blurred vision, painful eye, sensitivity to light
• Low blood pressure and feeling faint, when getting up, increase in heart beat/rate
• Cough
• Stomachache, vomiting, diarrhoea, nausea, dry mouth, wind, indigestion, mouth ulcer
• Inflammation of the liver and yellowing of the skin or whites of the eye
• Skin disorders (rash, redness dry skin, inflammation, swelling of the skin, itchiness), acne
• Muscular pain
• Joint pain and back pain

Increase/decrease in urination, reduced kidney function

Feeling weak/tired, fever

Changes in liver function tests

Flushing, feeling hot

Less frequent side effects

• Changes in blood test results, Low levels of blood platelets
• High levels of sugar in the blood
• Buzzing/roaring sound in the ear, Pain in the ear, Imbalance
• Abnormal dream, difficulty in paying attention, convulsions (fits)
• Change in the heart rate, fainting
• Shortness of breath, nose bleeding
• Decreased sexual drive
• Severe diarrhoea, constipation, blood in the stool

Tell your doctor if you feel sick (nauseous), are vomiting, or have stomach pain, because these may be signs of an inflamed pancreas. Also tell your doctor if you experience joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving, as this may be a sign of osteonecrosis.

Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice, have been reported in patients taking Norvir. Some people had other illnesses or were taking other medicines. People with liver disease or hepatitis may have worsening liver disease.

There have been reports of muscle pain, tenderness or weakness, particularly when taking medicines to lower cholesterol in combination with antiretroviral therapy, including protease inhibitors and nucleoside analogues. On rare occasions these muscle disorders have been serious (rhabdomyolysis). In the event of unexplained or continual muscle pain, tenderness, weakness or cramps, stop taking the medicine, contact your doctor as soon as possible or go to the nearest hospital.

If you have questions about side effects, ask your doctor, or pharmacist. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of NORVIR. Healthcare professionals, patients and caregivers are also asked to report any suspected adverse reaction to AbbVie (Pty) Ltd via this e-mail address: [email protected]

Keep NORVIR and all other medicines out of reach of children.

NORVIR ORAL POWDER

• NORVIR oral powder must be stored below 30 °C. The reconstituted powder must be consumed within 2 hours.
• Avoid exposure to excessive heat.
• The oral dosing syringe and mixing cup should be cleaned immediately with warm water and soap after use. When cleaned immediately, the residue is removed. The oral dosing syringe and mixing cup should be dry prior to use.

NORVIR 100 mg Tablet

• Should be stored at room temperature (below 30 °C).
• Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, and it is out of reach of children.
• Do not use NORVIR if you notice ‘visible sign of deterioration’.
• Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains of sewerage systems (e.g toilets).