NORVIR® ritonavir (ri-to-na-vir) Consumer Medicine Information (CMI)

What is in this leaflet Ask your doctor or pharmacist if flecainide, propafenone, you have any questions about why quinidine (used to correct it has been prescribed for you. This leaflet answers some common irregular heartbeats); questions about Norvir. Your doctor may have prescribed it • ranolazine (used to treat angina); It does not contain all the available for another purpose. • fusidic acid (an antibiotic); information. It does not take the This medicine is not addictive. • voriconazole (used to treat fungal place of talking to your doctor or This medicine is available only with infections); pharmacist. a doctor's prescription. • colchicine (used to treat gout) if All medicines have risks and There is not enough information to you have kidney and/or liver benefits. Your doctor has weighed recommend the use of this medicine problems; the risks of you taking this medicine for children under the age of 12 • astemizole, terfenadine against the benefits they expect it years. (antihistamines used to treat will have for you. allergy symptoms - these If you have any concerns about medicines may be available taking this medicine, ask your without prescription); doctor or pharmacist. Before you take Norvir • rifabutin (used to prevent certain Keep this leaflet with the medicine. infections) When you must not take it You may need to read it again. • blonanserin, clozapine, Do not take Norvir if you have an lurasidone, pimozide (used to allergy to: treat certain psychological and • any medicine containing emotional conditions); What Norvir is used ritonavir for • dihydroergotamine, ergotamine • any of the ingredients listed at (used to treat migraine headache); the end of this leaflet Norvir is used to treat HIV (Human • ergometrine, methylergometrine Immunodeficiency Virus) infections. Some symptoms of an allergic (used to stop excessive bleeding reaction may include: that may occur following It belongs to a group of medicines childbirth or an abortion); called protease inhibitors. • shortness of breath • cisapride (used to relieve certain Norvir works by interfering with an • wheezing or difficulty breathing stomach problems); enzyme that the HIV virus needs to • swelling of the face, lips, tongue • products containing St John's infect new cells. or other parts of the body wort (Hypericum perforatum) as It may be given alone or with certain • hives, rash or itching of the skin. this may stop Norvir from other anti-HIV medicines. Your Do not take Norvir if you are working properly. St John's wort doctor will determine which currently taking any of the is often used in herbal medicines medicines are best for you. following medicines: that you can buy yourself; Norvir has not been shown to • alfuzosin (used to treat enlarged • lomitapide (used to lower blood decrease the chance of transmitting prostate gland in men); cholesterol); HIV to a sexual partner. You must continue to use safe sexual practices • apalutamide (used to treat • neratinib (used for breast cancer); (e.g. condoms) while taking Norvir. prostate cancer); • lomitamide, lovastatin, • amiodarone, bepridil, simvastatin (used to lower blood dronedarone, encainide, cholesterol);

NORVIR® CMI 1 Version 24 • salmeterol (used as a long acting • diabetes, as there have been • ketoconazole (used to treat fungal reliever of asthma symptoms); reports of worsening of or the infections); • pethidine, piroxicam, development of diabetes in some • clarithromycin, dextropropoxyphene (used to patients taking this type of sulfamethoxazole/trimethoprim relieve pain); medicine. (used to treat infections); • sildenafil if you suffer from a Tell your doctor or pharmacist if • warfarin, rivaroxaban (used to lung disease called pulmonary you are pregnant, intend to become thin the blood); pregnant, or are breastfeeding. arterial hypertension that makes • trazodone, desipramine (used to breathing difficult. Patients Your doctor or pharmacist can treat depression); without this disease may use discuss the risks and benefits sildenafil for erectile dysfunction involved. • quetiapine (used to treat psychiatric disorders); under their doctor's supervision; If you have not told your doctor or • clorazepate, diazepam, estazolam, pharmacist about any of the above, • fluticasone, budesonide, triamcinolone (used to treat flurazepam, triazolam, oral tell them before you take Norvir. inflammation); midazolam, zolpidem (used to help you sleep and/or relieve Taking other medicines • disulfiram (used to treat alcohol anxiety). dependence); Tell your doctor or pharmacist if Read the list of medicines under you are taking any other • metronidazole (used to treat 'Taking other medicines' for medicines, including any that you certain parasite infections); information on certain other buy without a prescription from • sildenafil, avanafil, tadalafil, medicines which require special your pharmacy, supermarket or vardenafil (used to treat erectile care. health food store. dysfunction); Do not take Norvir after the expiry If Norvir is taken in combination • atorvastatin, rosuvastatin (used to date printed on the bottle or if the with other medicines, it is important lower blood cholesterol levels); packaging is damaged or shows that you also carefully read the • bupropion (used to help smoking signs of tampering. leaflets that are provided with these cessation); If it has expired or is damaged return other medicines. They may include • bosentan (used to treat a it to your pharmacist for disposal. additional information in those leaflets about situations when Norvir condition called pulmonary If you are not sure whether you arterial hypertension); should start taking this medicine, should be avoided. talk to your doctor. If you have any further questions • theophylline (used to treat about Norvir or the other chronic lung conditions); Before you start to take it medicines prescribed, please ask • abemaciclib, dasatinib, your doctor or pharmacist. Tell your doctor or pharmacist if encorafenib, ibrutinib, ivosidenib, you have any allergies to any other Some medicines and Norvir may neratinib, nilotinib, vincristine, medicines, foods, preservatives or interfere with each other. These vinblastine (used to treat different dyes. include: types of cancer); Tell your doctor or pharmacist if • digoxin (used to correct irregular • venetoclax, (used to treat chronic you have or have had any of the heartbeats); lymphocytic leukaemia (CLL)); following medical conditions: • didanosine, zidovudine, • elagolix (used for moderate to • liver problems or problems with delaviridine, efavirenz, severe pain associated with your pancreas. saquinavir, amprenavir, indinavir, endometriosis); • hepatitis B or C and are being nelfinavir, tipranavir, maraviroc, • fostamatinib (used for low blood treated with a combination of raltegravir (other antiviral platelet count); antiretroviral agents, as you may treatments); • buspirone (used to help you sleep be at a greater risk of developing • glecaprevir/pibrentasvir, and/or relieve anxiety) serious side effects. simeprevir (used to treat chronic These medicines may be affected by • haemophilia, as there have been hepatitis C); Norvir, or may affect how well it reports of increased bleeding in • fentanyl (used to relieve pain); works. You may need to use different patients with haemophilia who • rifabutin, bedaquiline, delamanid amounts of your medicine, or take are taking this type of medicine. (used to prevent/treat certain different medicines. infections);

NORVIR® CMI 2 Version 24 Your doctor or pharmacist has more How to take it taking your medicine as you would information on medicines to be normally. Take Norvir with food. Swallow careful with or to avoid while taking tablets whole with a full glass of This may increase the chance of Norvir. water. Do not break, crush or getting an unwanted side effect. Other interactions chew. Ask your doctor or pharmacist if you are not sure what to do. There are many other medicines that When to take it Ask your pharmacist for hints if may not mix with Norvir because Take your Norvir at regular you have trouble remembering their effects could potentially twelve-hour intervals at about the when to take your medicine. increase or decrease when taken same time each day. together. In some cases your doctor If you take too much may need to perform certain tests, Taking it at the same time each day (overdose) change the dose or monitor you will have the best effect. It will also regularly. This is why you should tell help you remember when to take Immediately telephone your your doctor if you are taking any your medicine. doctor, or the Poisons Information medicines or herbal products, Centre (0800 POISON or 0800 764 including those you have bought How long to take it 766), or go to Accident and yourself. Your doctor may need to Continue taking your medicine for Emergency at your nearest prescribe different amounts of your as long as your doctor tells you. hospital, if you think you or medicine for you to take, or put you anyone else may have taken too Norvir is not a cure for your HIV on a different medicine altogether much Norvir. infection, but helps control it. Norvir affects the way oral Therefore, Norvir must be taken Do this even if there are no signs of contraceptives or patches work. every day. discomfort or poisoning. Another form of contraception Tell your doctor straight away if a You may need urgent medical should be considered whilst you are side effect is preventing you from attention. taking Norvir. taking Norvir. Symptoms of an overdose may Norvir interacts with sildenafil, include tingling, prickling, or tadalafil and vardenafil, which are Always keep enough Norvir on hand so you don't run out. numbness of the skin. used for erectile dysfunction. The dosage of these medicines should be When you travel or need to stay in reduced to avoid damage to the the hospital, make sure you have penis. You must not take Norvir with enough Norvir to last until you can While you are using sildenafil if you also suffer from get a new supply. Norvir pulmonary arterial hypertension. Do not stop taking Norvir without talking to your doctor, even if you Things you must do feel better. Tell your doctor or pharmacist How to take Norvir Taking Norvir as recommended immediately if you become should give you the best chance of pregnant while you are taking this Follow all directions given to you delaying resistance to the medicines. medicine. by your doctor or pharmacist You may continue to develop Norvir may pass into breast milk. To carefully. infections or other illnesses associated with HIV disease while avoid transmitting the infection, They may differ from the you are taking Norvir. mothers with HIV should not breast information contained in this leaflet. feed their babies. If you do not understand the If you forget to take it Remind your doctor that you are instructions on the bottle, ask your taking Norvir if you are about to If it is almost time for you to take doctor or pharmacist for help. be started on any new medicine. your next dose, skip the dose you Tell any other doctors, dentists and How much to take and when missed and take your next dose pharmacists who treat you that to take it when you are meant to. you are taking this medicine. Do not take a double dose to make The usual dose is 600 mg (6 tablets) up for the dose that you missed. Tell your surgeon that you are of ritonavir taken twice a day. taking this medicine if you are Otherwise, take it as soon as you going to have surgery. remember, and then go back to

NORVIR® CMI 3 Version 24 Tell your doctor that you are inform your doctor of any change in • muscle aches taking this medicine if you are your condition. • fever about to have any blood tests. Your doctor may want to change • pain It may interfere with the results of your dose or advise you to stop • weight loss some tests. taking Norvir. • laboratory test results: changes in Keep all of your doctor's Ask your doctor or pharmacist to blood test results (such as blood appointments so that your progress answer any questions you may can be checked. have. chemistry and blood count) • kidney stones Your doctor may do some tests from Tell your doctor or pharmacist if time to time to make sure the you notice any of the following and Tell your doctor as soon as possible medicine is working and to prevent they worry you: if you notice any of the following: unwanted side effects. • nausea, vomiting • dehydration (thirst) Things you must not do • diarrhoea • diabetes (high sugar levels in the blood which may be accompanied • feeling of weakness Do not take this medicine to treat by symptoms like frequent any other complaints unless your • stomach ache urination, excessive thirst, lack of doctor or pharmacist tells you to. • headache energy) Do not give your medicine to • tingling sensation • jaundice (yellowing of the skin or anyone else, even if they have the • change in taste sensation whites of eyes) same condition as you. • feeling weak / tired • muscle pain, tenderness or Do not stop taking Norvir, or weakness change the dosage, without The above list includes the more • hepatitis (inflammation of the checking with your doctor. common side effects of your medicine. They are usually mild and liver) Things to be careful of short-lived. The above list includes serious side The following side effects have also effects that may require medical Be careful driving or operating been reported: attention. Serious side effects are machinery until you know how rare. Norvir affects you. • allergic reactions including skin rashes (may be red, raised, itchy), If any of the following happen, tell Norvir generally does not cause severe swelling of the skin and your doctor immediately or go to problems with your ability to drive a other tissues Accident and Emergency at your car or operate machinery. However, nearest hospital: as with many medicines, Norvir may • difficulty in breathing • severe or life threatening skin cause dizziness, sleepiness and • flushing of the skin reaction including blisters nausea in some people. • dizziness (Stevens Johnson syndrome and Make sure you know how you react • inability to sleep (insomnia) Toxic Epidermal Necrolysis) to Norvir before you drive a car or • serious allergic reaction operate machinery. • anxiety (anaphylaxis) • sleepiness Side effects • high levels of sugar in the blood • numbness The above list includes very serious Tell your doctor or pharmacist as • unusual sensitivity of the skin soon as possible if you do not feel side effects. You may need urgent • heartburn well while you are taking Norvir. medical attention. These side effects • sore throat are rare. Do not be alarmed by this list of possible side effects. You may not • increased cough Tell your doctor or pharmacist if you notice anything else that is experience any of them. • wind (flatulence) making you feel unwell. Frequently, it is difficult to tell • loss of appetite whether side effects are the result of Other side effects not listed above • dry mouth taking Norvir, effects of the HIV may occur in some people. disease or side effects of other • belching medicines you may be taking. For • mouth ulcer this reason, it is very important to • sweating

NORVIR® CMI 4 Version 24 After using Norvir • hypromellose • titanium dioxide Storage • macrogol 400 Keep your tablets in the bottle • hydroxypropylcellulose until it is time to take them. • talc - purified If you take the tablets out of the • macrogol 3350 bottle they may not keep well. • polysorbate 80 Keep your tablets in a cool dry place where the temperature stays Supplier below 30ºC.

Do not store Norvir or any other Norvir is supplied in New Zealand medicine in the bathroom, near a by: sink, or on a windowsill. Do not leave it in the car. AbbVie Limited 6th Floor, 156-158 Victoria St Heat and dampness can destroy some Wellington 6011 medicines. Keep it where children cannot ® Registered Trademark reach it.

A locked cupboard at least one-and- This leaflet was prepared in a-half metres above the ground is a good place to store medicines. April 2020

Disposal Version 24 If your doctor tells you to stop taking this medicine, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like Norvir film coated tablets are white debossed with Abbott logo and the code "NK", and are supplied in bottles containing 30 tablets.

Ingredients Norvir film coated tablets contain 100 mg ritonavir with the following inactive ingredients: • copovidone • calcium hydrogen phosphate anhydrous • sorbitan monolaurate • silica - colloidal anhydrous • sodium stearylfumarate

NORVIR® CMI 5 Version 24