Label: Information for the User

Norvir 100 mg Film-Coated Tablets

ritonavir

Read this label carefully before starting to take this medicine, as it contains important information for you or your child.

• Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What Norvir is and what it is used for

2.What you need to know before you or your child takes Norvir

3.How to take Norvir

4.Possible side effects

1. Storage of Norvir

6.Contents of the pack and additional information

Norvir contains the active substance ritonavir. Norvir is a protease inhibitor used to control HIV infection. Norvir is used in combination with other anti-HIV (antiretroviral) medications to control HIV infection. Your doctor will discuss with you which combination of medications is best for you.

Norvir is used in children 2 years of age or older and in adolescents and adults infected with HIV, the virus that causes AIDS

Do not take Norvir

• if you are allergic to ritonavir or any of the other components of Norvir (see section 6).

• if you have a severe liver disease.

• if you are currently taking any of the following medications:

• astemizole or terfenadine (usually used to treat allergy symptoms – these medications can be purchased over the counter);
• amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine (used to correct irregular heartbeats);
• dihydroergotamine, ergotamine (used to treat migraine headaches);

• ergonovine, methylergonovine (used to stop bleeding that may occur after childbirth or abortion);
• chlorazepate, diazepam, estazolam, flurazepam, triazolam, or midazolam oral (used to help you sleep and/or alleviate anxiety);
• clozapine, pimozide, (used to treat abnormal thoughts or feelings):
• quetiapine (used to treat schizophrenia, bipolar disorder, and major depressive disorder);
• lurasidone (used to treat depression);
• ranolazine (used to treat chronic chest pain [angina]);

• petidina, piroxicam, propoxifene (used to relieve pain);
• cisapride (used to relieve certain stomach pain);
• rifabutin (used to prevent/treat certain infections)*;
• voriconazole (used to treat fungal infections)*;

• simvastatin, lovastatin (used to reduce cholesterol in the blood);
• neratinib (used to treat breast cancer);
• lomitapide (used to reduce cholesterol in the blood);
• alfuzosin (used to treat an enlarged prostate);
• acetic acid (used to treat bacterial infections).
• sildenafil if you have a lung disease called pulmonary hypertension that makes it hard to breathe. Patients without this disease can use sildenafil to treat impotence (erectile dysfunction) under the supervision of your doctor (see sectionUse of Norvir with other medications);
• avanafil or vardenafil (used to treat impotence);
• colchicine (used to treat gout) if you have liver and/or kidney problems (see sectionUse of Norvir with other medications);
• products containing St. John's Wort (Hypericum perforatum) as it may cause Norvir to not work properly. St. John's Wort is often used in herbal supplements that can be purchased over the counter.

*Your doctor may decide that you take rifabutin and/or voriconazole with a lower dose (boosted) of Norvir but a full dose of Norvir should not be taken with these two medications.

If you are currently taking any of these medications, ask your doctor if you can change your medication while taking Norvir.

For the use of other medications that require special care, see the list included in the section “Use of Norvir with other medications”

Warnings and precautions

Consult your doctor before starting to take Norvir.

Important information

• If you take Norvir with other antiretroviral medications, it is essential that you read the prospectuses of these other medications carefully. In these prospectuses, you may find additional important information about situations in which you should avoid taking Norvir. If you have any questions about Norvir (ritonavir) or the other medications that have been prescribed for you, consult your doctor or pharmacist.
• Norvir does not cure HIV or AIDS infection.
• People taking Norvir may still develop infections or other diseases related to HIV or AIDS infection. It is, therefore, essential that you remain under the supervision of your doctor while taking Norvir.
• Although effective antiretroviral treatment reduces the risk of transmission, you may still transmit HIV to others while taking this medication. Consult your doctor about what precautions are necessary to avoid infecting others.

Inform your doctor if you have or have had:

• liver disease history.
• Hepatitis B or Cand are being treated with a combination of antiretroviral medications, as they have a higher risk of experiencing severe and potentially life-threatening adverse effects due to liver damage. You may need to have blood tests to monitor liver function.
• Hemophilia, as there have been cases of patients with hemophilia treated with this type of medication (protease inhibitors) experiencing increased bleeding. You may need to receive additional medication to facilitate blood clotting (Factor VIII) to control any bleeding.
• Erectile dysfunction,as medications used to treat erectile dysfunction may cause hypotension and prolonged erection.
• Diabetes, as there have been cases of worsening or development of diabetes (diabetes mellitus) in some patients taking protease inhibitors.
• Renal disease (kidney disease), as your doctor may need to check the dosage of other medications you are taking (such as protease inhibitors).

Inform your doctor if you experience:

• Diarrhea or vomitingthat does not improve (persistent), as it may reduce the effectiveness of the medications you are taking.
• Dizziness
,vomiting, or havestomach pain, as these may be signs of pancreatitis. Some patients taking Norvir may develop pancreas problems. Inform your doctor as soon as possible if this is your case.
• Symptoms of infection– inform your doctor immediately. Some patients with advanced HIV (AIDS) infection who start antiretroviral treatment may develop symptoms of infection they had in the past, even if they did not know they had them. It is believed that this occurs because the body's immune response improves and helps the body fight these infections.

In addition to opportunistic infections, you may also experience autoimmune disorders (a problem that occurs when the immune system attacks healthy body tissue) after starting treatment for your HIV infection. Autoimmune disorders may appear several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and spreading to the trunk, palpitations, tremors, or hyperactivity, please inform your doctor immediately to seek necessary treatment.

• Stiffness of joints, discomfort, and pain(especially of the hip, knee, and shoulder) and difficulty moving, inform your doctor, as it may be a sign of a condition that can destroy bone (osteonecrosis). Some patients taking antiretroviral medications may develop this disease.
• Muscle pain, discomfort, or weakness, particularly in combination with antiretroviral therapy including protease inhibitors and nucleoside analogs. In rare cases, these muscle disorders have been severe (see section 4.Adverse reactions).
• Dizziness, drowsiness, fainting, or irregular heartbeat, some patients taking Norvir may experience changes in the electrocardiogram (ECG). Inform your doctor if you have any heart or electrical conduction problems.
• If you have other health problems, consult your doctor as soon as possible.

Children and adolescents

Norvir is not recommended for use in children under 2 years of age.

Use of Norvir with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, even those purchased over the counter. There are some medications that you cannot use while taking Norvir. These medications are listed in section 2, under the title “Do not take Norvir”. There are some medications that can only be taken under certain circumstances, as described below.

When using Norvir at full doses, the following precautions will be taken. However, these precautions may also be necessary when taking low doses (boosted) of Norvir with other medications.

Inform your doctor if you are taking any of the medications listed below, special precautions are necessary.

• Sildenafil or tadalafilfor erectile dysfunction. You must reduce the dose and/or frequency of use of these medications to avoid hypotension and prolonged erection. Do not take Norvir with sildenafil if you also have pulmonary hypertension (see section 2.What you need to know before you or your child takes Norvir).
• Colchicine(for gout) as Norvir may increase the levels of this medication in the blood. You should not take Norvir with colchicine if you have liver and/or kidney problems (see also “Do not take Norvir” above).
• Digoxin(heart medication). Your doctor may need to adjust the dose of digoxin and monitor you while taking digoxin and Norvir.
• Contraceptiveshormonescontaining ethinyl estradiol, as Norvir may reduce the effectiveness of these medications. It is recommended to use a condom or another non-hormonal contraceptive method. You may also experience irregular uterine bleeding if you take this type of hormonal contraceptive with Norvir.
• Atorvastatin or rosuvastatin(for high cholesterol) as Norvir may increase the levels of these medications in the blood. Inform your doctor before taking cholesterol-lowering medications with Norvir (see“Do not take Norvir”above).
• Glucocorticoids(such as dexamethasone, fluticasone propionate, prednisolone, triamcinolone), as Norvir may increase the levels of these medications in the blood, which may lead to Cushing's syndrome (development of a rounded face) and reduce cortisol production. Your doctor may want to reduce the dose of glucocorticoids or monitor their adverse effects more closely.
• Trazodone(depression medication) as it may cause unwanted effects such as nausea, dizziness, low blood pressure, and drowsiness when taken with Norvir.
• Rifampicin and saquinavir(used for tuberculosis and HIV respectively) as they may cause severe liver damage when taken with Norvir.
• Bosentan, riociguat(used for pulmonary arterial hypertension), as the amount of this medication in the blood may increase when taken with Norvir.

There are medications that should not be taken with Norvir because their effects may increase or decrease when taken together. In some cases, your doctor may need to perform certain tests, change the dose, or monitor you regularly. That is why you should inform your doctor if you are taking any medication, even those purchased over the counter or herbal products, although it is essential to mention the following:

• amphetamine or amphetamine derivatives;
• antibiotics (e.g. erythromycin, clarithromycin);
• cancer treatments (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine);
• blood thinners (e.g. rivaroxaban, vorapaxar, warfarin);
• antidepressants (e.g. amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone);
• antifungals (e.g. ketoconazole, itraconazole);
• antihistamines (e.g. loratadine, fexofenadine);
• antiretroviral medications including HIV protease inhibitors (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir) and non-nucleoside reverse transcriptase inhibitors (INNTI) (delavirdine, efavirenz, nevirapine) and others (didanosine, maraviroc, raltegravir, zidovudine);
• tuberculosis medications (bedaquiline and delamanid);
• antiviral medications for the treatment of chronic hepatitis C virus (HCV) infection in adults (e.g., glecaprevir/pibrentasvir and simeprevir);
• anxiolytics, buspirone;
• asthma medications, theophylline salmeterol;
• atovaquone, a medication used to treat certain types of pneumonia and malaria;
• buprenorphine, a medication used to treat chronic pain;
• bupropion, a medication used to quit smoking;
• epilepsy medications (e.g. carbamazepine, divalproex, lamotrigine, phenytoin);
• heart medications (e.g. disopyramide, mexiletine, and calcium channel blockers such as amlodipine, diltiazem, and nifedipine);
• immunosuppressants (e.g. cyclosporine, tacrolimus, everolimus);
• levothyroxine (used to treat thyroid problems);
• morphine and morphine derivatives used to treat severe pain (methadone, fentanyl);
• sleeping pills (e.g. alprazolam, zolpidem) and also midazolam administered by injection;
• tranquilizers (e.g. haloperidol, risperidone, thioridazine);
• colchicine, treatment for gout.

There are medications that you cannot take with Norvir. These are listed earlier in section 2.“Do not take Norvir”.

Taking Norvir with food and drinks

Norvir tablets should be taken with food.

Pregnancy and breastfeeding

It is very important that you consult your doctor if you think you are pregnant or are planning to become pregnant.

There is a lot of information about the use of ritonavir (active ingredient of Norvir) during pregnancy. In general, pregnant women received low doses (boosted) of ritonavir along with other protease inhibitors after the first three months of pregnancy. Norvir does not appear to increase the risk of birth defects compared to the general population.

Norvir may pass into breast milk. To avoid transmission of the infection, HIV-positive mothers should not breastfeed their children.

Driving and operating machinery

Norvir may cause dizziness. If you experience this effect, do not drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts. Take this medication one or two times a day, every day with food.

It is essential that Norvir tablets be swallowed whole and not chewed, broken, or crushed.

The recommended doses of Norvir are:

• If Norvir is used to enhance the effect of other HIV medications, the adult dose is 1 to 2 tablets one or two times a day. For more information on dosage recommendations, including those for children, read the prospectus for the HIV medications taken in combination with Norvir.

• If your doctor prescribes a full dose, adults can start with a dose of 3 tablets in the morning and 3 tablets 12 hours later, which will be gradually increased over a period of up to 14 days to reach the full dose of 6 tablets two times a day (a total of 1,200 mg per day). Children (2-12 years) will start with a lower dose and continue until the maximum allowed dose for their height.

Your doctor will indicate the appropriate dose that you should take.

You must take Norvir every day to control HIV, regardless of how you feel. If any side effect prevents you from taking Norvir as instructed, inform your doctor immediately. During diarrhea episodes, your doctor may decide that you need additional monitoring.

Always have a sufficient amount of Norvir on hand so that you do not run out. When traveling or needing to stay in the hospital, check that you have enough Norvir until you can obtain more.

If you take more Norvir than you should

If you take too much Norvir, you may experience numbness, tingling, or a prickling sensation. If you realize that you have taken more Norvir than you should, contact your doctor or the nearest hospital emergency service immediately.

If you forget to take Norvir

If you forget to take a dose, take it as soon as possible. If the time for the next dose is near, take only one dose. Do not take a double dose to compensate for the missed doses.

If you stop taking Norvir

Although you may feel better, do not stop taking Norvir without consulting your doctor. If you take Norvir as instructed, you will have a greater chance of delaying the development of resistance to this medication.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to health recovery and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, Norvir can cause side effects, although not everyone will experience them. When Norvir is used with other antiretroviral medications, the side effects also depend on those other medications. That's why it's very important to read the adverse reactions section of the prospectus for these medications carefully.

Very common:can affect more than 1 in 10 people

Common:can affect up to 1 in 10 people

Uncommon:can affect up to 1 in 100 people

Rare:can affect up to 1 in 1000 people

Inform your doctor if you feel dizzy (nausea), are vomiting, or have stomach pain, as these may be symptoms of pancreatitis. Also, inform your doctor if you experience joint stiffness, discomfort, and pain (especially in the hip, knee, and shoulder) and difficulty moving, as this may be a sign of osteonecrosis. See section 2.What you need to know before you or your child take Norvir.

There have been cases of increased bleeding in patients with hemophilia A and B during treatment with this or another protease inhibitor. If this happens, consult your doctor immediately.

It has been reported that patients taking Norvir have presented alterations in liver function tests, hepatitis (liver inflammation), and rarely jaundice. Some people had another disease or were taking other medications. Some people with liver disease or hepatitis may have worsened.

Cases of muscle pain, discomfort, or weakness, particularly when taking cholesterol-lowering medications in combination with antiretroviral therapy, including protease inhibitors and nucleoside analogs, have been described. In rare cases, these muscle disorders were severe (rhabdomyolysis). In the case of muscle pain, discomfort, weakness, or cramps of unknown or continuous cause, stop taking the medication, contact your doctor as soon as possible, or go to the nearest hospital emergency room.

Inform your doctor immediately if, after taking Norvir, you experience any symptoms that may suggest an allergic reaction, such as skin rash, hives, or difficulty breathing.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist, go to the emergency room, or, if urgent, seek immediate medical help.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use Norvir after the expiration date indicated on the label of the bottle.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Norvir

-The active ingredient is ritonavir. Each film-coated tablet contains 100 mg of ritonavir.

-The other components are:copovidone, sorbitan laurate, anhydrous calcium hydrogen phosphate, anhydrous colloidal silica, and sodium stearate fumarate.

-The components of the film coating are:hypromellose, titanium dioxide, macrogol, hydroxypropylcellulose, talc, anhydrous colloidal silica, and polysorbate 80.

Appearance of the product and contents of the pack

Norvir film-coated tablets are white andhave a debossed impression (Abbott logo) and the code “NK”.

There are three pack sizes of Norvir film-coated tablets available:

• 1 bottle of 30 tablets
• 1 bottle of 60 tablets
• Multi-pack containing 3 bottles each containing 30 film-coated tablets (90 tablets)

Only some pack sizes may be marketed.

Norvir is also supplied as an oral suspension powder containing 100 mg of ritonavir.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Manufacturers:

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder.

This leaflet was last revised in

The detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu