100 mg film-coated tablets,
ritonavir
What Norvir is and what it is used for
Norvir contains the active substance ritonavir. Norvir is a protease inhibitor and is used to control HIV infection. Norvir is used with other anti – HIV medicines (antiretroviral medicines) to control your HIV infection. Your doctor will discuss with you which combination of drugs is best for you.
Norvir is used by children 2 years of age and older, adolescents, and adults infected with HIV, the virus that causes AIDS.
What you need to know before you or your child take Norvir
Do not take Norvir
- if you are allergic to ritonavir or any of the other ingredients of this medicine (listed in section 6).
- if you have severe liver disease.
- if you are currently taking any of the following medicines:
- astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be over-the-counter);
- amiodarone , bepridil, dronedarone, encainide, flecainide , propafenone , quinidine (used to correct irregular heartbeat);
- dihydroergotamine, ergotamine (used to treat migraines );
- ergonovine, methylergonovine (used to stop heavy bleeding that may occur after childbirth or an abortion);
- chlorazepate, diazepam , estazolam, flurazepam, triazolam or oral (swallowed) midazolam (used to help you sleep and / or to relieve anxiety);
- clozapine, pimozide (used to treat abnormal thoughts and feelings);
- quetiapine (used to treat schizophrenia, bipolar disorder and major depression);
- lurasidone (used to treat depression);
- ranolazine (used to treat chronic chest pain [angina]);
- pethidine, piroxicam, propoxifene (used to relieve pain);
- cisapride (used to relieve certain stomach ailments);
- rifabutin (used to prevent / treat certain infections ) *
- voriconazole (used to treat fungal infections) *
- simvastatin , lovastatin (used to lower blood cholesterol);
- neratinib (used to treat breast cancer);
- lomitapide (used to lower blood cholesterol);
- alfuzosin (used to treat enlarged prostate gland);
- fusidic acid (used to treat bacterial infections);
- sildenafil if you have a lung disease called pulmonary arterial hypertension which causes difficulty breathing. Patients without this disease may use sildenafil for impotence ( erectile dysfunction ) under the supervision of a physician (see section Other medicines and Norvir );
- avanafil and vardenafil (used to treat erectile dysfunction )
- colchicine (used to treat gout ) if you have kidney and / or liver problems (see the section on Other medicines and Norvir );
- products containing St. John ‘s wort ( Hypericum perforatum ) as these may prevent Norvir from working properly. St. John’s wort is often used in herbal remedies that you can buy yourself.
* Your doctor may decide that you can take rifabutin and/or voriconazole with a booster (lower dose ) of Norvir but a full dose of Norvir should not be taken with these two medicines.
If you are currently taking any of these medicines, ask your doctor if it is possible to switch to another medicine while you are taking Norvir.
Also, read the list of medicines under ‘Other medicines and Norvir’ when using certain medicines that require special care.
Warnings and cautions
Talk to your doctor before taking Norvir
Important information
- If Norvir is taken in combination with other antiretroviral medicines, it is important that you also carefully read the package leaflet that comes with these medicines. There may be additional information about situations when Norvir should be avoided. If you have any further questions on the use of Norvir (ritonavir) or any of the other medicines, contact your doctor or pharmacist.
- Norvir does not cure HIV infection or AIDS .
- Those taking Norvir may still develop infection or other conditions associated with HIV infection or AIDS . It is therefore important that your doctor follows you up while you are taking Norvir.
- You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary measures to avoid infecting others.
Tell your doctor if you have/had:
- Previous liver disease.
- Hepatitis B or C and is treated with a combination of antiretroviral drugs because you then have an increased risk of severe and potentially life-threatening reactions due to the effect on the liver. Regular blood tests may be required to check that the liver is functioning properly.
- Hemophilia , as there are reports of increased bleeding in patients with haemophilia taking this type of medicine ( protease inhibitor ). The reason for this is not known. You may need more medication to help the blood clot ( factor VIII ), to be able to control any bleeding.
- Impotence ( erectile dysfunction ), as drugs used to treat erectile dysfunction can cause low blood pressure and prolonged erection .
- Diabetes , as there are reports of worsening or development of diabetes ( diabetes mellitus ) in some patients taking protease inhibitors .
- Kidney disease , as your doctor may need to check the dose of one of your other medicines (such as protease inhibitors ).
Tell your doctor if you experience :
- Diarrhea or vomiting that does not improve (lasting), as this may reduce the effect of the medicines you are taking.
- Nausea, vomiting or abdominal pain , as this may be a sign of inflammation of the pancreas ( pancreatitis ). Some patients taking Norvir may develop serious problems with their pancreas . Tell your doctor as soon as possible if this applies to you.
- Symptoms of infection – contact your doctor immediately. Some patients with advanced HIV infection ( AIDS ) who are starting treatment for HIV may have symptoms from previous infections that they did not know they had. This is probably due to the body’s improved immune response which enables the body to fight these infections . In addition to the opportunistic infections, autoimmune diseases (a condition that occurs when the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat your HIV infection .. Autoimmune diseases can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and goes up in the body, palpitations, tremors or hyperactivity, inform your doctor immediately for the necessary treatment.
- Stiffness in joints, pain and aches (especially hips, knees and shoulders) and difficulty moving, tell your doctor as this may be a sign of a disease that can destroy bones ( osteonecrosis ). Some patients receiving combination antiretroviral therapy may develop this disease.
- Muscle aches, soreness and weakness , especially in combination with antiretroviral therapy that includes protease inhibitors and nucleoside analogues . On rare occasions, these muscle problems have been severe. (See section 4. Possible side effects )
- Dizziness, fainting or abnormal heartbeat. Some patients taking Norvir may experience electrocardiogram ( ECG ) changes. Tell your doctor if you have a heart defect or conduction disturbances in the heart.
- If you have any other questions concerning your health, discuss these with your doctor as soon as possible.
Children and young people
Norvir is not recommended for use in children under 2 years of age.
Other medicines and Norvir
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. There are medicines that you can not take with Norvir at all. They are listed earlier in section 2, under ‘Do not take Norvir’. Other medicines can only be used in special circumstances described below.
The following warnings apply when Norvir is taken as a full dose. These warnings may also apply when Norvir is used at lower doses (boosters) with other medicines.
Tell your doctor if you are taking any of the medicines listed below, as special care should be taken.
- Sildenafil or tadalafil for impotence ( erectile dysfunction ). The dose and / or frequency of use of these drugs may need to be reduced to avoid low blood pressure and prolonged erection . You should not take Norvir with sildenafil if you have pulmonary arterial hypertension (see also section 2. What you need to know before you or your child take Norvir ). Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension .
- Colchicine (for gout ) as Norvir may increase blood levels of this medicine. You must not take Norvir with colchicine if you have kidney and / or liver problems (see also Do not take Norvir above).
- Digoxin (heart medicine). Your doctor may need to adjust your digoxin dose and you should check if you are taking digoxin and Norvir to avoid heart problems.
- Hormonal contraceptives containing ethinyl estradiol as Norvir may reduce the effect of these drugs. It is recommended that condoms or other non-hormonal contraceptive methods be used instead. You may also experience irregular 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 medicines in the blood. Talk to your doctor before taking any cholesterol-lowering medicines with Norvir (see also Do not take Norvir above).
- Steroids (eg dexamethasone, fluticasone propionate, prednisolone , triamcinolone) as Norvir may increase blood levels of these drugs which may lead to Cushing’s syndrome (development of a round face) and reduce the production of the hormone et cortisol . Your doctor may lower the dose of a steroid and monitor your side effects closely.
- Trazodone (antidepressant) as side effects such as nausea, dizziness, low blood pressure and fainting may occur when taking Norvir at the same time.
- Rifampicin and saquinavir (used to treat tuberculosis and HIV respectively ) as severe liver damage can occur if you take Norvir at the same time.
- Bosentan , riociguat (used to treat pulmonary arterial hypertension ) as Norvir may increase the blood levels of this medicine.
Some medicines may not be taken with Norvir as their effects may increase or decrease when taken together. In some cases, your doctor may need to take some tests, change the dosage or check you regularly. Therefore, you should tell your doctor if you are taking other medicines, including those you have bought yourself or herbal medicines, but it is especially important to mention these:
- amphetamine or amphetamine derivative;
- antibiotics (eg erythromycin, clarithromycin);
- cancer drugs (eg abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine);
- drugs used to treat platelet deficiency (eg fostamatinib);
- anticoagulants (eg rivaroxaban, vorapaxar, warfarin );
- antidepressants (eg amitriptyline, desipramine, fluoxetine , imipramine, nefazodone, nortriptyline, paroxetine , sertraline , trazodone);
- antifungals (eg ketoconazole , itraconazole);
- antihistamines (eg loratadine , fexofenadine);
- antiretroviral medicinal products including HIV protease inhibitors ( amprenavir , atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir), non-nucleoside reverse transcriptase inhibitors (NNRTIs) (delavirdine, ravapine, efavirenz, maravapine, );
- drugs against tuberculosis (bedacillin and delamanide);
- antiviral drugs used to treat chronic hepatitis C ( HCV ) infection in adults (eg glekaprevir / pibrentasvir and simeprevir);
- antianxiety drugs, buspirone;
- asthma medication, theophylline, salmeterol;
- atovaquone, a drug used to treat a specific type of pneumonia and malaria;
- buprenorphine, a drug used in the treatment of chronic pain;
- bupropion, a drug used for smoking cessation;
- epilepsy drugs (eg carbamazepine, divalproex, lamotrigine, phenytoin );
- cardiac drugs (eg disopyramide , mexiletine and calcium channel antagonists such as amlodipine, diltiazem and nifedipine);
- immune system (eg cyclosporine, tacrolimus, everolimus);
- levothyroxine (used to treat thyroid problems);
- morphine and morphine-like drugs used in the treatment of severe pain (eg methadone , fentanyl );
- hypnotics (eg alprazolam, zolpidem) and also midazolam given as an injection;
- sedatives (eg haloperidol , risperidone , thioridazine)
- colchicine, a treatment for gout;
There are certain medicines that you can not take with Norvir at all. These are listed earlier in section 2. under ‘Do not take Norvir’.
Norvir with food and drink
Norvir tablets should be taken with food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you must consult your doctor before taking this medicine.
There is a lot of information about the use of ritonavir (the active substance in Norvir) during pregnancy. After the first three months, in most cases, pregnant women received ritonavir at lower doses (booster) with other protease inhibitors. Norvir does not appear to increase the risk of malformations compared with the rest of the population.
Norvir can pass into breast milk. To avoid transmitting the infection, women with HIV infection should not breastfeed their children.
Driving and using machines
Norvir may cause dizziness. If you are affected, do not drive or use machines.
How to take Norvir
Norvir tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Take this medicine once or twice a day with food. Show larger
| It is important that Norvir tablets are swallowed whole and not chewed, divided, or crushed. |
Recommended doses of Norvir are:
- If Norvir is used to enhance the effect of certain other anti – HIV medicines, the most common dose is one to 1 to 2 tablets for adults once or twice daily. For more detailed dosing recommendations, including those for children, read the package leaflet for the other anti- HIV medicines that Norvir is given with.
- If your doctor prescribes a full dose , adults can start with 3 tablets in the morning and 3 tablets 12 hours later, gradually increasing the dose one over a 14-day period to achieve the full dose of 6 tablets twice daily (total 1200 mg per day) . Children (2 – 12 years) start with a smaller dose and continue up to the dose that is maximum allowed for their size.
Your doctor will tell you which dose to use.
Norvir should be taken daily to help keep your HIV infection under control no matter how much better you feel. If a side effect prevents you from taking Norvir as prescribed, you must tell your doctor immediately. During periods of diarrhea, your doctor may decide that extra checks are needed.
Always have enough Norvir on hand so that it does not run out. When you travel or need to be hospitalized, make sure you have enough Norvir so that you have enough until you can get more.
If you take more Norvir than you should
Numbness, tingling, or ant crawling can occur if you take too much Norvir. If you find that you have taken more Norvir than you should, contact your doctor immediately or go to the emergency department at the nearest hospital.
If you forget to take Norvir
If you miss a dose, take the missed dose as soon as possible. If it is soon time for your next dose, just take it. Do not take a double dose to make up for a forgotten dose.
If you stop taking Norvir
Even if you feel better, do not stop taking Norvir without talking to your doctor. Using Norvir as prescribed, should give you the best opportunity to delay the development of resistance to the drug.
Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them. When Norvir is used with other antiretroviral medicines, the side effects are dependent on the other medicines. Therefore, it is important that you carefully read the side effects section of the package leaflet that comes with these medicines.
| Very common: may affect more than 1 user in 10 | |
|---|---|
| • pain in the upper or lower abdomen• vomiting• diarrhea (may be severe)•nausea• reddening of the skin, feeling hot•headache•dizziness•sore throat•cough• indigestion or indigestion | Tingling or numbness in the hands, feet, or around the lips and mouth• feeling of weakness / tiredness• bad taste in the mouth• nerve damage that can cause weakness or pain•itching•rash• joint and back pain |
| Common: may affect up to 1 in 10 users | |
|---|---|
| • allergic reactions including rash (maybe red, increased, itchy), severe swelling of the skin and other tissues• difficulty sleeping•concern• increased cholesterol levels• increased levels of triglycerides•gout•gastric haemorrhage• hepatitis and yellowish color of the skin and whites of the eyes• denser water discharge• impaired renal function• cramps• reduced platelet count• thirst (dehydration)• Abnormally abundant menstruation | •inflated stomach• loss of appetite could sores• muscle pain, tenderness or weakness•fever•weight loss• laboratory tests: changes in results from blood tests (eg composition of substances in the blood and number of blood cells)•confusion• difficulty retaining attention• fainting• dimsyn• swelling of the hands and feet• high blood pressure• low blood pressure and fainting when getting up• cold hands and feet• acne |
| Uncommon: may affect up to 1 in 100 people | |
|---|---|
| • heart attack•diabetes | kidney failure |
| Rare: may affect up to 1 in 1000 people | |
|---|---|
| • severe or life-threatening skin reaction including blisters (Stevens-Johnson syndrome, toxic epidermal necrolysis ) | • severe allergic reactions• elevated blood sugar levels |
| No known frequency: can not be calculated from the available data |
| • kidney stones ar |
Tell your doctor if you feel nauseous, vomit or have abdominal pain as these may be signs of an inflamed pancreas. Also tell your doctor if you have joint stiffness, aches, and pains (especially in the hip, knee, and shoulder) and difficulty moving, as this may be a sign of osteonecrosis. See also section 2. What you need to know before you or your child takes Norvir.
In patients with hemophilia type A and B, there have been reports of an increased tendency to bleed when taking this or another protease inhibitor. If this happens to you, talk to your doctor straight away.
There are reports of abnormal liver values, hepatitis ( inflammation of the liver), and, in rare cases, jaundice in patients taking Norvir. Some people had other illnesses or were on other medications. People who already have liver disease or hepatitis may get worse.
There are reports of muscle pain, soreness, or weakness in the muscles, especially with concomitant use of cholesterol-lowering drugs in combination with antiretroviral therapy including protease inhibitors and nucleoside analogs. In rare cases, these muscle problems have been severe ( rhabdomyolysis ). In case of unexplained or persistent muscle pain, soreness, weakness, or cramps, stop taking the medicine, contact your doctor as soon as possible or go to the emergency room at the nearest hospital.
Tell your doctor immediately if you get any symptoms that indicate an allergic reaction after taking Norvir, such as itching, rash, or difficulty breathing.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, emergency department or if you have an emergency, seek medical advice immediately.
How to store Norvir
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original jar. Moisture sensitive.
Do not use this medicine if you notice any discoloration.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is ritonavir. Each film-coated tablet contains 100 mg ritonavir.
- The other ingredients of the tablet are copovidone, sorbitan laurate, anhydrous calcium hydrogen phosphate, anhydrous colloidal silica, sodium stearyl fumarate.
- The coating of the tablet consists of: hypromellose, titanium dioxide, macrogol, hydroxypropylcellulose, talc, colloidal anhydrous silica, polysorbate 80.
What the medicine looks like and contents of the pack
Norvir film-coated tablets are white and imprinted with [Abbott logo] and the code “NK”.
Three packs are available for Norvir tablets:
- 1 jar with 30 tablets
- 1 jar with 60 tablets
- Multipack containing 3 jars, each containing 30 film-coated tablets (90 tablets)
Not all packaging may be marketed.
Norvir is also available as a powder for an oral suspension containing 100 mg ritonavir.
Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Manufacturer
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Information provided by:
AbbVie AB
Box 1523
171 29 Solna
Tel: 08-684 44600