What is it and how is it used?
Norvir is a protease inhibitor used to control HIV infection. Norvir is used in combination with other anti-HIV medicines (antiretrovirals) to control your HIV infection. Your doctor will discuss with you the best combination of medicines for you.
Norvir can be used at full dose on its own, or at lower doses (called booster doses) with other medicines.
What do you have to consider before using it?
Do not take Norvir
* 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 must not be taken together with these two medicines.
If you are currently taking any of these medicines, ask your doctor about switching to a different medicine while you are taking Norvir. Often, there are other medicines you can take instead.
Also read the list of medicines other ‘Taking other medicines’ for use with certain other medicines which require special care.
Take special care with Norvir
Important information
Tell your doctor if you have/had:
Tell your doctor if you experience:
Norvir is not recommended in children below 2 years of age.
Taking other medicines
There are some medicines you cannot take at all with Norvir. These are listed earlier in Section 2, under ‘Do not take Norvir’. There are some other medicines that can only be used under certain circumstances as 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 as a full dose. However, these warnings may also apply when Norvir is used in lower doses (a booster) with other medicines.
Tell your doctor if you are taking any of the medicines listed below, as special care should be taken.
There are medicines that may not mix with Norvir because their effects could increase or decrease when taken together. In some cases your doctor may need to perform certain tests, change the dose or monitor you regularly. This is why you should tell your doctor if you are taking any medicines, including those you have bought yourself or herbal products, but it is especially important to mention these:
There are some medicines you cannot take at all with Norvir. These are listed earlier in section 2, under ‘Do not take Norvir’.
Taking Norvir with food and drink
Norvir should preferably be taken with food.
Pregnancy and breast-feeding
If you think you are pregnant or you are planning to become pregnant, it is very important that you discuss this with your doctor.
There is very little information on the use of ritonavir (the active ingredient in Norvir) during pregnancy. In general, the pregnant mothers received ritonavir after the first three months of pregnancy at a lower dose (booster) along with other protease inhibitors. Norvir did not appear to increase the chance of developing birth defects compared to the general population.
It is not known if Norvir passes into breast milk. To avoid transmitting the infection, mothers with HIV should not breast feed their babies.
Driving and using machines
Norvir can cause sleepiness and dizziness. If you are affected do not drive or use machinery.
Important information about some of the ingredients of Norvir
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per maximum dose of 600 mg.
Norvir contains polyoxyl 35 castor oil which may cause stomach upset and diarrhoea.
How is it used?
Always take Norvir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is taken by mouth usually two times every day. Norvir should preferably be taken with food.
Recommended doses of Norvir are:
Your doctor will advise you on the dosage to be taken.
Like all anti-HIV medications, Norvir should be taken every day to help control your HIV, no matter how much better you feel. If a side effect is preventing you from taking Norvir as directed, tell your doctor straight away. During episodes of diarrhoea your doctor may decide that extra monitoring is needed.
Always keep enough Norvir on hand so you don't run out. When you travel or need to stay in the hospital, make sure you have enough Norvir to last until you can get a new supply.
If you take more Norvir than you should
Numbness, tingling, or a “pins and needles” sensation may occur if you take too much Norvir. If you realise you have taken more Norvir than you were supposed to, contact your doctor or the Accident and Emergency Department of your nearest hospital straight away.
If you forget to take Norvir
If you miss a dose, take the missed dose as soon as possible. If it is nearly time for the next dose, just take that one. 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. Taking Norvir as recommended should give you the best chance of delaying resistance to the medicines.
What are possible side effects?
Like all medicines, Norvir can cause side effects, although not everybody gets them. Also, the side effects of Norvir when used with other antiretroviral medicines are dependent on the other medicines. So it is important that you carefully read the side effects section of the leaflets that are provided with these other medicines.
The frequency of possible side effects listed below is defined using the following convention:
Very common side effects:
Common side effects:
Uncommon side effects:
Rare side effects:
Other side effects that have been reported with Norvir: low levels of blood platelets, kidney failure, seizures (fits), fainting and feeling faint when getting up, abnormally heavy periods. It is not known how frequently these effects may occur.
Tell your doctor if you fee sick (nauseous), are vomiting, or have stomach pain, because these may be signs of an inflamed pancreas. Also tell your doctor if you experience joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving, as this may be a sign of osteonecrosis. See also section 2 Before you take Norvir.
Side effects associated with combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and internal organs, breast enlargement and fatty lumps on the back of the neck ("buffalo hump"). The cause and long-term health effects of these conditions are not known. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, increased fats in the blood and resistance to insulin (insulin will not work as effectively).
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor. Should this happen to you, seek immediate advice from your doctor.
Cases of diabetes mellitus or increased blood sugars have been reported in patients receiving Norvir or other protease inhibitors.
Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice, have been reported in patients taking Norvir. Some people had other illnesses or were taking other medicines. People with liver disease or hepatitis may have worsening of liver disease.
There have been reports of muscle pain, tenderness or weakness, particularly when taking medicines 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 the event of unexplained or continual muscle pain, tenderness, weakness or cramps, stop taking the medicine, contact your doctor as soon as possible or go to the Accident and Emergency Department of your nearest hospital.
Inform your doctor as soon as possible if you experience any symptoms that suggest an allergic reaction after taking Norvir such as rash, hives or breathing difficulties.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, contact your doctor, pharmacist, Accident and Emergency department or if it is urgent get immediate medical help.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Norvir after the expiry date on the bottle or from a bottle which has been stored unrefrigerated for more than 30 days. The expiry date refers to the last day of that month.
Norvir soft capsules should be stored in a refrigerator (2º - 8ºC) until they are dispensed. Refrigeration is not required if used within 30 days and stored below 25°C. Do not store Norvir soft capsules in extreme heat or cold (such as in a car during hot or very cold weather, or in your freezer).
It is important to keep Norvir in the bottle it came in. Don't transfer it to any other container.
