Norvir 100mg polvo para suspension oral

Label: Information for the User

Norvir 100 mg Powder for Oral Suspension

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 take 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 ingredient 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 aged 2 years and older, 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 headaches caused by migraines);
• ergonovine, methylergonovine (used to stop bleeding that may occur after childbirth or abortion);
• chlorazepate, diazepam, estazolam, flurazepam, triazolam or midazolam oral (taken by mouth) (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]);
• petidin, 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 lower cholesterol in the blood);
• neratinib (used to treat breast cancer);
• lomitapide (used to lower cholesterol in the blood);
• alfuzosin (used to treat an enlarged prostate);
• acid fusidic (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 stop working 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 (booster dose) 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 “Taking 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. Therefore, it is essential that you remain under the supervision of your doctor while taking Norvir.
• Although effective antiretroviral treatment reduces the risk of transmission, while you are taking this medication, you may still transmit HIV to others. Consult your doctor about what precautions are necessary to avoid infecting others.

Inform your doctor if you have or have had:

• liver disease.
• Hepatitis B or Cand are being treated with a combination of antiretroviral medications, as you have a higher risk of developing severe and potentially life-threatening liver damage. You may need to have blood tests to monitor your liver function.
• Hemophilia, as there have been cases of patients with hemophilia taking this type of medication (protease inhibitors) with increased bleeding. It is not known why this happens. You may need to receive additional medication to help 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 dose 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,nausea, vomiting, or stomach pain
, as these may be signs of pancreatitis. Some patients taking Norvir may develop pancreatitis 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.

• Joint stiffness, discomfort, and pain(especially in the hip, knee, and shoulder) and difficulty moving, inform your doctor, as it may be a sign of a problem 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, including 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.

The following precautions will be taken when Norvir is used at full doses. However, these precautions may also be necessary when taking Norvir at lower doses (booster doses) with other medications.

Inform your doctor if you are taking any of the following medications, as 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.
• Oral contraceptivescontaining 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 oral 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(for depression) 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 some 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. Therefore, you must inform your doctor if you are taking any medication, including 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);
• anticoagulants (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),e non-nucleoside reverse transcriptase inhibitors (INNTI) (delavirdine, efavirenz, nevirapine) and others (didanosine, maraviroc, raltegravir, zidovudine);
• tuberculosis medications (bedaquiline and delamanid);
• antiviral medications used to treat chronic hepatitis C virus (HCV) infection in adults (such as glecaprevir/pibrentasvirand 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. digoxin, 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, a medication used to treat gout.

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

Taking Norvir with food and drinks

See section 3.

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 (the active ingredient in Norvir) during pregnancy. In general, pregnant women received low doses (booster doses) 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 babies.

Driving and operating machinery

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

Follow exactly the administration instructions of 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.

For doses that represent exact amounts of 100 mg (100, 200, 300, 400, 500 or 600 mg), the contents of each packet must be mixed with a soft food (apple sauce or vanilla pudding) or mixed with a small amount of liquid (water, chocolate milk, formula milk) and consume the entire mixture.

For doses less than 100 mg, or doses that are between 100 mg amounts, the entire contents of the packet must be mixed with liquid, and administer the appropriate volume in ml as indicated by your doctor using the oral dosing syringe.

For administration through a feeding tube, follow the instructions in the section “How to prepare the correct dose of Norvir powder for oral suspension mixed with liquids?”.

Use water to mix this medication and follow the instructions for the feeding tube to administer the medication.and follow the instructions for the feeding tube to administer the medication.

The recommended doses of Norvir are:

• if Norvir is used to potentiate the effect of other anti-HIV medications, the normal dose for adults is 1 to 2 packets one or two times a day. For more information on dose recommendations, including those for children, read the prospectus for anti-HIV medications taken in combination with Norvir.

• if your doctor prescribes a full dose, adults can start with a dose of 3 packets in the morning and 3 packets 12 hours later, which will be gradually increased over a period of up to 14 days to reach the full dose of 6 packets twice a day. Children (2-12 years) will start with a lower dose than this 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 there is any side effect that 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 staying in the hospital, check that you have enough Norvir until you can get more.

Norvir powder for oral suspension has a taste that takes time to disappear. You can help to clarify that taste by taking peanut butter, chocolate cream, and almonds or blackberry syrup immediately after administering the dose.

Prepare only one dose at a time using the correct number of packets. When mixing the powder with food or liquids, ensure that you take the entire dose within two hours of preparation.You must not mixNorvir with anything else without asking your doctor or pharmacist first.

How to prepare the correct dose of Norvir powder for oral suspension mixed with food (complete packet)?

Follow the instructions below:

How to prepare the correct dose of Norvir powder for oral suspension mixed with liquids?

Follow the instructions below:

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 emergency department of the nearest hospital immediately.

If you forget to take Norvir

If you forget to take a dose, take it as soon as you remember. If the next dose is due soon, take only one dose. Do not take a double dose to make up for the missed doses.

If you stop taking Norvir

Even if you feel better, do not stop taking Norvir without consulting your doctor. If you take Norvir as instructed, you will have a better 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, 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 changes in liver function tests, hepatitis (inflammation of the liver), 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 of unknown or continuous cause, stop taking the medication, contact your doctor as soon as possible, or go to the nearest hospital emergency department.

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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through theSpanish System for the 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 powder for oral suspension after the expiration date shown on the package and container. The expiration date is the last day of the month indicated.

Norvir powder for oral suspension should be stored below 30°C.

Medicines should not be disposed of through drains.

Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Norvir

• The active ingredient is ritonavir. Each Norvir pack contains 100 mg of ritonavir.
• The other components are: copovidone, sorbitan laurate, anhydrous colloidal silica.

Appearance of the product and contents of the pack

Norvir oral powder for solution is presented in individual packs containing 100 mg of ritonavir. Each pack contains 30 packs, 1 mixing vial, and 2 oral dosing syringes.

Only some pack sizes may be marketed.

Norvir is also available as film-coated tablets containing 100 mg of ritonavir.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

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

Responsible manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen,

Germany

AbbVie Logistics B.V.,

Zuiderzeelaan 53,

8017 JV Zwolle,

Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization 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