Norvir. 100 mg. 30 tablets
Norvir. 100 mg. 30 tablets
NORVIR WHAT IS AND WHAT IT IS USED
Norvir is a protease inhibitor used to control HIV infection . Norvir is used in combination with other anti-HIV drugs ( antiretroviral agents ) to control your HIV infection . Your doctor will discuss with you which is the best combination of drugs for you.
Norvir can be used at full dose , and the lower (called reinforcing effects of other drugs ) doses with other drugs.
2 . BEFORE YOU TAKE NORVIR
Do not take Norvir:
If you are allergic (hypersensitive) to ritonavir or any of the other ingredients of Norvir ( see section 6) ;
If you have severe liver disease ;
If you are taking any of these medicines:
astemizole or terfenadine (commonly used to treat allergy symptoms such medicines may be available without prescription ) ;
amiodarone, bepridil, encainide , flecainide , propafenone , quinidine ( used to improve irregular heartbeats ) ;
dihydroergotamine, ergotamine (used to treat migraine headaches) ;
ergonovine , methylergonovine (used to stop excessive bleeding that may occur after birth or abortion) ;
clorazepate , diazepam, estazolam , flurazepam , triazolam peroroalen (taken by mouth) midazolam (used to help you sleep and / or to relieve anxiety) ;
clozapine, pimozide ( used to treat abnormal ( unusual ) thoughts or feelings) ;
pethidine , piroxicam, propoxyphene (used to relieve pain) ;
cisapride (used to relieve certain stomach problems);
rifabutin ( used to prevent / treat certain infections ) *;
voriconazole (used to treat fungal infections ) *;
simvastatin, lovastatin ( used to lower blood cholesterol) ;
alfuzosin (used to treat enlarged prostate gland ) ;
fusidic acid (used in the treatment of a bacterial infection ) ;
sildenafil if you are suffering from a lung disease called pulmonary arterial hypertension that makes breathing difficult . Patients without disease can sildenafil for impotence (erectile dysfunction) under the supervision of their physician (see also section Taking other medicines) ;
products containing St. John's wort (Hypericum perforatum), as this may stop operation of Norvir. St. John's wort is often used in herbal medicines that you can buy yourself ( without a prescription ) .
* Your doctor may decide that it is possible to take rifabutin and / or voriconazole gain ( lower) dose Norvir, Norvir but should not be taken as a full dose together with these two drugs .
If you are currently taking any of these medicines, ask your doctor about switching to another medicine while taking Norvir. Often, these drugs may be replaced by other , suitable for use in this case .
Also read the list of drugs that require special attention in the section "Taking other medicines" by the leaflets of the other medicines you are taking.
Take special care with Norvir
When Norvir is taken in combination with other antiretroviral drugs , it is important to carefully read the enclosed leaflet of medicinal products. They may have more information on where Norvir should be avoided . If you have further questions about Norvir ( ritonavir) or other prescription drugs , ask your doctor or pharmacist.
Norvir does not cure HIV infection or AIDS .
People taking Norvir may still develop infections or other illnesses associated with HIV infection or AIDS . Therefore, it is important to remain under medical supervision while taking Norvir.
Norvir does not reduce the risk of transmitting HIV to others . It is necessary to take appropriate precautions to prevent transmission of the disease through sexual contact ( eg use of a condom) or blood ( You should not donate blood or sharing needles ) .
Tell your doctor if you have or have had:
History ( data) for liver disease ;
Hepatitis B or C and treated with a combination of antiretroviral agents due to the risk of severe and potentially life-threatening reaction , resulting in effects on the liver. You may need regular blood tests to monitor the proper function of your liver ;
Haemophilia, as there have been reports of increased bleeding in patients with haemophilia taking this type of medicine (protease inhibitors). The reason for this is not known. You may need additional medicine to help your blood clot (factor VIII), to control ( master ) bleeding ;
Erectile dysfunction , as the drugs used for the treatment of erectile dysfunction can lead to the appearance of hypotension and prolonged erection ;
Diabetes, because of reports of worsening or development of diabetes (diabetes mellitus) in some patients taking protease inhibitors;
Renal disease, as may be necessary your doctor to change the dose of other medications you are taking (eg, protease inhibitors).
Tell your doctor if you experience:
Changes in the distribution of adipose tissue of the body , accumulation or loss of body fat (see section 4 . Possible side effects) ;
Responding to (persistent ) diarrhea or vomiting, as this may reduce the positive effect of the medicines you are taking ;
Feeling sick (nausea) , vomiting, or abdominal pain, as this may be signs of inflammation of the pancreas ( pancreatitis) . Some patients taking Norvir can develop serious problems with their pancreas . If this happens to you, tell your doctor as soon as possible;
Symptoms of infection - inform your doctor immediately. Some patients with advanced HIV infection (AIDS) , soon after anti -HIV treatment may develop the symptoms of infections did not even know . It is assumed that this is due to the improvement of the immune response of the organism and its support to combat such infections ;
Once you start taking medicines to treat your HIV infection , in addition to opportunistic infections may occur and autoimmune disorders ( a condition that occurs when the immune system attacks healthy tissues of the body) . Autoimmune diseases may occur many months after the start of treatment. If you notice any signs of infection or other symptoms such as muscle weakness , weakness beginning in the arms and legs that move the body , palpitations, tremors, hyperactivity , tell your doctor immediately implementing the necessary treatment ;
Stiffness , aches and pains (especially of the hip , knee and shoulder) and difficulty in movement. Tell your doctor as this may be a sign of a problem , leading to the destruction of bone ( osteonecrosis ) . Some patients received multiple antiretroviral drugs can develop this disease ;
Muscle pain, tenderness or weakness, particularly with combination therapy including protease inhibitors and nucleoside analogues. On rare occasions these muscle disorders have been serious . (See point 4. Possible side effects) ;
Lightheadedness , dizziness , fainting , or abnormal heart rhythm. Some patients taking Norvir may have changes in the electrocardiogram ( ECG) . Tell your doctor if you have heart or conduction disorders ;
If you have any other health concerns, discuss them with your doctor as soon as possible .
Norvir is not recommended in children under 2 years of age.
Taking other medicines
There are some drugs that can not take Norvir with under any circumstances. They are listed above in Section 2, under "Do not take Norvir". There are some other drugs that can be taken only under certain circumstances described below. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following warnings apply when Norvir is taken in full dose. However, these warnings may apply to when Norvir is used in lower doses ( a booster) with other medicines.
Tell your doctor if you are taking any of the following medicines, as it requires special attention.
Sildenafil , tadalafil , vardenafil for impotence (erectile dysfunction) . It may be necessary to reduce the dose and frequency of administration of these drugs to avoid hypotension and prolonged erection. You should not take Norvir and seldanafil in case you are suffering from pulmonary arterial hypertension ( see also section 2 . Before you take Norvir). Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension ;
Digoxin ( heart medicine ) . Your doctor may decide that it is necessary to adjust the dose of digoxin and monitor you while taking digoxin and Norvir, to avoid heart problems;
Hormonal contraceptives containing ethinyl oestradiol as Norvir may reduce the effectiveness of these drugs. Instead, it is recommended to use a condom or other non-hormonal methods of birth control ( contraception ) . You may notice irregular ( non- menstrual ) uterine bleeding if you are taking this type of hormonal contraceptive Norvir;
Atorvastatin or rosuvastatin (for high cholesterol ) as Norvir may raise levels of these drugs in the blood. Talk to your doctor before taking any cholesterol -lowering drugs Norvir ( see also ' Do not take Norvir' above) ;
Steroids (e.g., dexamethasone , fluticasone propionate, prednisolone ) as Norvir may increase the levels of these drugs in the blood, which in turn cause Cushing's syndrome ( rounded face ) and a reduced production of the hormone cortisol. Your doctor may decide to reduce the steroid dose or monitor you more often for adverse effects;
Trazodone (a medicine for depression) because of the possibility of adverse effects such as nausea , dizziness, low blood pressure and fainting can occur when taken with Norvir;
Rifampicin and saquinavir (used for tuberculosis and HIV), because of the possibility of serious liver damage in case of intake Norvir;
Bosentan (used for pulmonary arterial hypertension) as Norvir may increase plasma levels of this drug .
There drugs are not to be confused with Norvir, since their effects can be increased or decreased in the case of co-administration . In some cases your doctor may decide that it is necessary to carry out certain studies , dose changes or you regularly follow . Therefore, you should tell your doctor about all the medicines you are taking , including those obtained without a prescription to all plant products , it is especially important to mention the following :
amphetamine or amphetamine derivatives ;
antibiotics (e.g. erythromycin, clarithromycin) ;
agents for the treatment of malignant diseases (e.g., dasatinib , nilotinib , vincristine , vinblastine ) ;
anticoagulants (eg rivaroxaban , warfarin ) ;
antidepressants (e.g., amitriptyline , desipramine , fluoxetine, imipramine, nortriptyline , paroxetine , sertraline , trazodone ) ;
antifungals ( eg, ketoconazole , itraconazole ) ;
antihistamines (e.g. loratadine , fexofenadine ) ;
antiretroviral medicines including HIV- protease inhibitors and non-nucleoside reverse transcriptase inhibitors (NNRTI)];
buspirone , a drug for anxiety ;
theophylline , salmeterol asthma medications ;
atovaquone , a medicine used in the treatment of certain types of pneumonia and malaria ;
buprenorphine, a drug used for the treatment of chronic pain ;
bupropion, a medicine used to help stop smoking;
drugs for epilepsy ( eg carbamazepine, divalproex , lamotrigine, phenytoin) ;
Heart medicines ( eg digoxin, disopyramide , mexiletine and calcium channel antagonists such as amlodipine , diltiazem and nifedipine ) ;
drugs affecting the immune system ( eg, cyclosporine , tacrolimus, everolimus ) ;
Morphine and morphine-like drugs used to treat pain (e.g., methadone, fentanyl) ;
sleeping " pills " for example . ( alprazolam , zolpidem ) and midazolam administered by injection ;
tranquilizers (e.g., haloperidol , risperidone, thioridazine ) ;
warfarin, used to thin ( density reduction ) of blood ;
colchicine for the treatment of gout .
Norvir should be used with disulfiram ( a drug used for the treatment of alcoholism ), and metronidazole ( medicine used in certain bacterial infections) due to the potential for interaction of these drugs with the information contained in the oral solution of alcohol.
There are some medications that can be taken with Norvir under any circumstances. They are listed above in Section 2, under "Do not take Norvir".
Taking Norvir with food and drink
Norvir tablets should be taken with food ..
Pregnancy and lactation
If you think you are pregnant or planning a pregnancy is very important to discuss this with your doctor.
There is very little information on ritonavir (the active ingredient in Norvir) during pregnancy . Typically , pregnant women received ritonavir after the first trimester of pregnancy , at a lower dose ( such as an amplifier ) , together with other protease inhibitors. Norvir has shown an increased risk of developing birth defects compared with the general population.
It is not known if Norvir passes into breast milk . To avoid transmitting the infection , mothers with HIV should not breastfeed their babies.
Driving and using machines
Norvir may cause drowsiness and dizziness. If this happens to you , do not drive or operate machinery.
3 . HOW TO TAKE NORVIR
Always take Norvir exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist. This medicine is taken orally , usually twice a day every day. Norvir tablets should be taken with food , as this can affect the absorption of Norvir from your body.
It is important Norvir tablets should be swallowed whole and not chewed, broken or crushed.
Recommended doses of Norvir are:
if Norvir is used to enhance the effects of other anti-HIV drugs , the usual adult dose is 1 to 2 tablets , once or twice daily. For more detailed information on dosage recommendations , including those for children , see the Package Leaflet of anti -HIV drugs , which combines Norvir;
If your doctor prescribes a full dose , adults may be started at a dose of 3 tablets in the morning and 3 tablets 12 hours later , gradually increasing over a period of up to 14 days to the full dose of 6 tablets twice daily ( total 1200 mg daily) . Children (aged 2-12 ) will start with a lower dose of this and continue up to the maximum allowed dose for their age .
Your doctor will give you the necessary advice about the dose you should be taking.
Like all anti -HIV drug , Norvir should be taken every day to help control your disease (HIV), regardless of the improvements you have. If a side effect is preventing you from taking Norvir, tell your doctor immediately . If you have episodes of diarrhea , your doctor may decide that you need additional monitoring .
You should always keep enough Norvir, lest you find yourself suddenly without medicine. When you travel or need to stay in the hospital , make sure you have enough Norvir, while he may be a new supply .
If you take more dose Norvir
May appear tingling, numbness or a feeling of " pins and needles" if you take too much Norvir. If you find that you take more than the required amount of Norvir, immediately contact your doctor or emergency medical care at the nearest hospital .
If you forget to take Norvir
If you miss a dose, take the missed dose as soon as possible . Do not take a double dose to make up for missed .
If you stop taking Norvir
Even if you feel better, do not stop taking Norvir, without discussing it with your doctor. Taking Norvir according to the recommendations will give you the greatest opportunity to delay the development of drug resistance .
4 . POSSIBLE SIDE EFFECTS
As with all medications , Norvir can cause side effects , although not everyone gets them. Furthermore, when used with other antiretroviral drugs , side effects of Norvir depend on other medications. Therefore , it is important to carefully read the side effects section in the leaflets of the other drugs.
The frequency of the following possible side effects are defined as follows :
Very common: affects more than 1 in 10 patients ;
Common: affects 1 to 10 of 100 patients ;
Uncommon: affects 1 to 10 of 1000 patients ;
Rare: affects 1 to 10 of 10 000 patients ;
Very rare: affects less than 1 in 10,000 patients ;
Not known: frequency can not be estimated from available data.
Very common side effects:
upper and lower abdominal pain ;
numbness or tingling in hands, feet or around the lips and mouth ;
diarrhea ( may be severe ) ;
feeling sick ( nausea) ;
feeling of weakness / fatigue ;
redness, feeling of warmth ;
unpleasant taste in the mouth;
nerve damage , which can cause weakness and pain;
sore throat ;
upset stomach or indigestion ;
pain in the joints and back.
Common side effects:
allergic reactions, including skin rashes ( may be red , raised, itchy) , severe swelling of skin and other tissues ;
flatulence ( flatulence ) ;
loss of appetite ;
ulcers in the mouth ;
muscle pain ( pain), tenderness or weakness ;
changes in fat distribution (see Adverse effects associated with combination antiretroviral therapy below) ;
laboratory results : changes in blood test results (such as blood chemistry tests and determining the number of blood cells ) ;
difficulty sleeping (insomnia ) ;
increased cholesterol ;
increased triglycerides ;
difficult and attention ;
gastrointestinal bleeding ;
inflammation of the liver and yellowing of the skin or whites of the eyes ;
blurred vision ;
swelling of the hands and feet ;
high blood pressure ;
more frequent urination ;
low blood pressure and feeling faint when standing ;
reduced kidney function ;
convulsions ( seizures) ;
cold hands and feet ;
low levels of platelets in the blood ;
thirst (dehydration ) ;
unusually heavy menstruation .
Uncommon side effects:
renal failure ;
Rare side effects:
severe or life-threatening skin reactions, including bladder ( Steven Johnson Syndrome toxic epidermal necrolysis) ;
severe allergic reactions ( anaphylaxis) ;
high levels of blood sugar .
Tell your doctor if you are sick ( nausea) , vomiting, or abdominal pain, as these may be signs of inflammation of the pancreas. Tell your doctor in case of stiffness , aches and pains (especially of the hip , knee and shoulder) and difficulty in movement , as this may be a sign of osteonecrosis. See also section 2 Before you take Norvir.
Adverse effects associated with combination antiretroviral therapy may cause changes in body shape due to fat redistribution. This may include loss of fat from legs, arms and face, increased fat in the abdomen ( belly) and other internal organs , breast enlargement and fatty lumps on the back of the neck ( 'buffalo hump'). Causes and long-term health effects of these conditions are not known. Combination antiretroviral therapy may also cause raised lactic acid and blood sugar , increased blood fats and insulin resistance ( insufficient effectiveness of insulin ) .
In patients with hemophilia type A and B have been reports of increased bleeding while taking this medicine or other protease inhibitors. If this happens to you , immediately contact your doctor for advice.
Reported cases of diabetes or high blood sugar in patients taking Norvir or other protease inhibitors.
Abnormal values in liver function tests , hepatitis (inflammation of the liver) and jaundice rarely in patients taking Norvir. Some people had other illnesses or were taking other medicines. In people with liver disease or hepatitis may have worsening liver disease .
There are reports of muscle pain , fatigue or weakness, particularly in patients taking drugs 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 case of unexplained or persistent muscle pain, tenderness , weakness or cramps , stop taking the drug and seek as quickly as possible with your doctor or go to the nearest hospital for emergency care.
Tell your doctor as soon as possible if, after taking Norvir have symptoms that suggest the development of an allergic reaction such as rash , hives , or difficulty breathing .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor, pharmacist or seek medical attention at the nearest emergency room care.
5 . HOW TO STORE NORVIR
Keep out of reach of children.
Do not use Norvir after the expiry date stated on the label . The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original bottle to protect from moisture.
6 . ADDITIONAL INFORMATION
What does Norvir
The active substance is ritonavir. Each tablet contains 100 mg of ritonavir.
The other ingredients of the tablet are : copovidone , sorbitan laurate, calcium hydrogen phosphate anhydrous , silicon dioxide, colloidal anhydrous , sodium stearyl fumarate.
The film coating contains hypromellose , titanium dioxide , macrogol , hydroxypropyl cellulose , talc , silica , colloidal anhydrous , polysorbate 80 .
Norvir looks like and contents of the pack
Norvir film-coated tablets are white , debossed [ logo Abbott] and "NK".
Norvir tablets are available in three sizes:
1 bottle of 30 tablets;
1 bottle of 60 tablets;
3 bottles of 30 tablets (90 tablets).
Not all pack sizes may be marketed.
Norvir is also supplied as an oral solution comprising 80 mg / ml and ritonavir as soft gelatin capsules containing 100 mg of ritonavir.