Crixivan

This leaflet answers some common questions about CRIXIVAN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking CRIXIVAN against the benefits they expect it will have for you.

You may need to read it again.

CRIXIVAN, a protease inhibitor, is used to help treat HIV (Human Immunodeficiency Virus) infection. It should be used in combination with other appropriate medicines used to treat HIV. If combination therapy is not possible it may be used alone.

CRIXIVAN is not recommended in children under the age of 18 years.

CRIXIVAN belongs to a group of medicines called HIV protease inhibitors. It works in a different way to the other medicines used to treat HIV. CRIXIVAN works by interrupting the formation of new HIV particles in already infected cells. When HIV is attacked by CRIXIVAN, the virus is not able to reproduce normally. This helps reduce the amount of virus in the body and helps protect new cells from infection. CRIXIVAN helps reduce the amount of virus in the body and thus increases the CD4 count.

You may continue to develop infections or other illnesses associated with HIV disease while you are taking CRIXIVAN.

In addition, the following medicines should not be taken with CRIXIVAN:

These medicines may be affected by CRIXIVAN, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Take CRIXIVAN and didanosine at least one hour apart on an empty stomach.

Your doctor will tell you how many capsules you need to take each day.

However, this dose may be decreased if you have liver disease due to cirrhosis or are taking certain medicines, such as ketoconazole. Your doctor will discuss the risks and benefits of decreasing the dose because dosage reduction may be associated with a decrease in effectiveness against the HIV infection.

They may differ from the information contained in this leaflet.

The period around taking your capsules is the 'dose window' - when you must watch what you eat and drink. Remember 3-2-1:

3 hour period made up of:

2 hours before each dose

1 hour after each dose

Swallowing CRIXIVAN with water ensures maximum absorption and effectiveness. However, if you do not like water, CRIXIVAN can be swallowed with skim milk, juice (except grapefruit), coffee or tea.

Grapefruit juice significantly reduces the absorption of CRIXIVAN, therefore decreasing its effectiveness.

CRIXIVAN is absorbed well enough with small amounts of light food. Examples of light food are dry toast with jam, juice (except grapefruit) and coffee with skim milk and sugar, or corn flakes with skim milk and sugar.

Taking CRIXIVAN with a meal that is high in calories, fat and protein reduces your body's ability to absorb the medicine and in turn reduces its effectiveness. You can indulge in high energy foods outside the 3-hour dose window.

However, taking CRIXIVAN on an empty stomach improves absorption. This means not eating during the 3-hour dose window.

do not eat for two hours before and one hour after taking your dose.

if you need to eat during a 3-hour dose window make sure it's only small amounts of light food.

do not eat heavy food (high-fat, high-protein, high-calorie) during the 3-hour dose windows.

Keeping to the 8-hour interval between doses of CRIXIVAN is important because keeping a constant level of CRIXIVAN in the body helps prevent resistance. Resistance means that the medicine may lose its effectiveness over time.

CRIXIVAN helps control your HIV infection but does not cure it. Therefore CRIXIVAN must be taken every day.

If you have a break in therapy or reduce your dose temporarily, the virus may develop resistance and therefore CRIXIVAN may no longer be effective.

If you take too many capsules, you may experience nausea, vomiting, diarrhoea, blood in the urine, or sudden severe back pain which may be caused by kidney stones.

This is to help reduce the possibility of kidney stones, which may be caused by the capsules. What you drink throughout the day depends on whether you are inside or outside your dose windows, however water is preferable. Outside your dose windows you can have any drink to help keep your fluids up. Drink tea, coffee and alcohol in moderation as they can cause dehydration. Try to get used to ordering a glass of water to drink with them. Remember, you have to drink even more fluid if you are exercising, dancing or are in a hot climate.

There have been some reports of diabetes and increased blood glucose, also called hyperglycaemia, in people treated with protease inhibitors. In some of these people this led to ketoacidosis, a serious condition resulting from poorly controlled blood glucose. Before starting protease inhibitors, some people already had diabetes, others did not. Some people required adjustments to their diabetes medicines, while others needed new diabetes medicines.

Severe muscle pain and weakness have occurred in people taking protease inhibitors, including CRIXIVAN, together with cholesterol-lowering medicines called 'statins'.

This is to make sure that any infections which occur due to your low immunity (called opportunistic infections) are treated promptly.

Symptoms of inflammation include redness, swelling, heat and pain. These symptoms have been reported in some patients who have previously had an infection when combination therapy that included CRIXIVAN was started.

CRIXIVAN has not been shown to decrease the chance of transmitting HIV to a sexual partner.

If you have a break in therapy or reduce your dose temporarily, the virus may develop resistance and therefore CRIXIVAN may no longer be effective.

CRIXIVAN generally does not cause problems with your ability to drive a car or operate machinery. However, as with many medicines, CRIXIVAN may cause dizziness in some people. Make sure you know how you react to CRIXIVAN before you drive a car or operate machinery.

CRIXIVAN helps most people with HIV infection, but it may have unwanted side effects. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Frequently it is difficult to tell whether side effects are the result of taking CRIXIVAN, effects of the HIV disease or side effects of other medicines you may be taking. For this reason it is very important to inform your doctor of any change in your condition. Your doctor may want to change your dose or advise you to stop taking CRIXIVAN.

These are usually mild side effects.

Because these side effects are serious, you may need urgent medical attention.

There have been some reports of bleeding episodes in people with haemophilia who are taking CRIXIVAN or other protease inhibitors.

Other side effects not listed above may also occur in some patients. The long-term effects of CRIXIVAN are unknown at this time.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

If you take the capsules out of the bottle they may not keep well, as they are affected by moisture. The original bottle contains a desiccant (silica gel in a small container) to help remove the moisture.

Heat and dampness can destroy some medicines.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

CRIXIVAN comes in two strengths:

Active ingredient:

Inactive ingredients:

CRIXIVAN does not contain gluten, sucrose, tartrazine or any other azo dyes.