Invirase Consumer Medicine Information

Saquinavir

200mg hard gelatin capsules

What is in this leaflet

This leaflet answers some common questions about INVIRASE capsules.

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 your taking INVIRASE capsules against the benefits expected for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What INVIRASE is used for

INVIRASE contains the active ingredient saquinavir.

INVIRASE belongs to a group of medicines called anti-HIV (Human Immunodeficiency Virus) medicines. Within this group, INVIRASE belongs to a class of medicines called HIV protease inhibitors. INVIRASE is used for the treatment of HIV infection. It works by interfering with the way the virus reproduces itself.

INVIRASE should only be given in combination with ritonavir (Norvir®) and other medicines to treat the HIV virus.

Your doctor, however, may have prescribed INVIRASE for another purpose.

Ask your doctor if you have any questions why INVIRASE has been prescribed for you.

INVIRASE is not addictive.

This medicine is available only with a doctor's prescription.

Before you take INVIRASE

When you must not take it

Do not take INVIRASE if:

  1. you have had an allergic reaction to INVIRASE or any ingredients listed at the end of this leaflet
    INVIRASE capsules contain 63.3mg lactose. This quantity is probably not sufficient to cause symptoms in lactose-intolerant people.
  2. you are taking certain other medicines
    These medicines are:-
    • terfenadine and astemizole, antihistamines used to treat allergic conditions
    • cisapride (Prepulsid®), a medicine used to treat stomach reflux
    • pimozide (Orap®), a medicine used to treat mental health problems
    • rifampicin (Rifadin®, Rifinah®) and rifabutin (Mycobutin®), medicines used to treat serious infections
  3. you have severe liver disease
  4. the package is torn or shows signs of tampering
  5. the expiry date printed on the pack has passed
    If you take this medicine after the expiry date has passed, it may not work as well.
    6.

If you are not sure if you should be taking INVIRASE, talk to your doctor.

Safety and effectiveness of INVIRASE in children less than 16 years of age has not been established.

Before you start to take it

Tell your doctor if:

  1. you are pregnant or plan to become pregnant
    It is not known whether INVIRASE is harmful to an unborn baby when taken by a pregnant woman. If there is a need to take INVIRASE when you are pregnant your doctor will discuss the risks and benefits to you and the unborn baby.

  2. you are breast-feeding or plan to breast-feed
    It is not known whether INVIRASE passes into breast milk. Breast-feeding is not recommended if you are taking INVIRASE. Additionally, HIV-infected women are recommended not to breastfeed in order to avoid the HIV virus being passed on to the baby.

  3. you have any other health problems including:
    • severe kidney disease
    • liver disease
    • haemophilia (a condition where patients have a tendency to bleed and bruise easily)
    • diabetes
    • high cholesterol levels
  4. you are allergic to any other medicines, foods, dyes or preservatives
    5.

If you have not told your doctor about any of the above, tell your doctor before you take INVIRASE.

Taking certain foods

Some foods may affect the way INVIRASE works. These foods include:

  • grapefruit juice

Your doctor or pharmacist has more information. Please talk to your doctor or pharmacist with regard to taking grapefruit juice while you are on INVIRASE.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food shop.

Other medicines may interfere with INVIRASE. These medicines include:

  • ketoconazole (Nizoral®), fluconazole (Diflucan®), itraconazole (Sporanox®) and miconazole (Daktarin®, Fungo®, Micreme®, AFT-Miconazole®), medicines used to treat fungal infections
  • carbamazepine (Tegretol®, Teril®), and phenytoin (Dilantin®), phenobarbitone (Gardenal®), medicines used to treat epilepsy
  • some calcium channel blockers, heart or blood pressure medicines
  • clarithromycin (Klacid®, Klacid HP7®, Losec HP7®), azithromycin (Zithromax®), erythromycin (E-Mycin®, ERA®), and quinupristin/dalfopristin (Synercid®), antibiotics used to treat bacterial infections
  • midazolam (Hypnovel®, Hypam®) and triazolam (Halcion®, Trycam®), medicines to help you sleep at night or before surgery
  • alprazolam (Xanax®), a medicine used to treat anxiety
  • ritonavir (Norvir®), indinavir (Crixivan®), nelfinavir (Viracept®), nevirapine (Viramune®), delavirdine and efavirenz (Stocrin®), which are other anti-HIV medicines
  • sildenafil (Viagra®), a medicine used to treat impotence
  • simvastatin (Lipex®, Zocor®), atorvastatin (Lipitor®), cerivastatin and lovastatin, medicines used to lower cholesterol levels in the blood
  • fentanyl (Durogesic®, Sublimaze®, Bupafen®, Marcain® with fentanyl) and alfentanil (Rapifen®), strong pain killers usually used in anaesthesia
  • ergotamine (Cafergot®),a medicine used to treat migraine headaches
  • cyclosporin (Neoral®, Sandimmum®) and tacrolimus (Prograf®), medicines used for organ transplant
  • warfarin (Coumadin®, Marevan®), a blood thinner
  • amiodarone (Aratac®, Cordarone®), quinidine and disopyramide (Rythmodan®), medicines used to treat irregular heartbeat
  • quinine, a medicine used to treat night cramps and malaria
  • dapsone, an anti-infective medicine used to treat tuberculosis and leprosy
  • dexamethasone (Decadron®), an anti-inflammatory agent
  • garlic capsules
  • St. John's wort (hypericum perforatum), which is a herbal product
  • metoclopramide (Maxolon®, Metamide®, Paramax®), a medicine which increases emptying of the stomach contents
  • nefazodone (Serzone®), a medicine for mental illness
  • ranitidine (Zantac®, Arrow-ranitidine®, Gavilast®, Apo-ranitidine®), a medicine used to treat ulcers of the gut and stomach reflux

These medicines may be affected by INVIRASE or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking INVIRASE.

Ask your doctor or pharmacist if you are not sure about this list of medicines.

How to take INVIRASE

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

How much to take

Take INVIRASE exactly as prescribed by your doctor.

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

INVIRASE should only be given in combination with ritonavir (Norvir®), a medicine used to treat HIV.

The usual dose for combination therapy is five 200mg capsules of INVIRASE, two times a day (a total of ten INVIRASE capsules per day), with one 100mg capsule of ritonavir (Norvir®), two times a day (a total of two Norvir® capsules per day).

Both medicines should be taken at the same time.

How to take it

Swallow capsules whole with a glass of water.

When to take it

Take INVIRASE within two hours after a meal to ensure maximum absorption and effectiveness.

Taking your capsules at the same time each day will have the best effect on the HIV infection. It will also help you remember to take the capsules.

How long to take INVIRASE

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

Continue taking INVIRASE for as long as your doctor prescribes.

If you forget to take INVIRASE

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember together with some food and then go back to taking it as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering your dose, ask your pharmacist for some hints.

In case of an overdose

Immediately telephone your doctor or the National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for advice or go to your nearest Accident and Emergency Centre if you think that you or anyone else may have taken too much INVIRASE. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking INVIRASE

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking INVIRASE.

Continue to use safe sexual practices while taking INVIRASE. INVIRASE has not been shown to decrease the chance of giving HIV to your partner.

Tell your doctor if you become pregnant while taking INVIRASE.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel the capsules are not helping your condition.

You should always report any changes in your condition to your doctor to ensure that any infections which occur due to your low immunity, caused by HIV, (called opportunistic infections), are treated promptly.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

If you have liver disease, your doctor may want to take regular blood samples while you are taking INVIRASE.

Things you must not do

Do not stop taking INVIRASE or change the dose without first checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Do not give INVIRASE to anyone else even if they have the same condition as you.

Do not use INVIRASE to treat other complaints unless your doctor says to.

Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how INVIRASE affects you.

As with many medicines, INVIRASE may cause dizziness in some people. Make sure you know how you react to INVIRASE before you drive a car or operate machinery.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking INVIRASE.

INVIRASE helps most people with HIV infection but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious. 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 INVIRASE, 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 INVIRASE.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • diarrhoea
  • stomach discomfort or pain, wind (flatulence), constipation
  • feeling sick (nausea) or vomiting
  • dizziness, headache
  • tiredness, weakness
  • mouth ulcers
  • tingling or numbness in fingers and toes
  • skin problems such as itching and rash.

These are the more common side effects of INVIRASE.

Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following:

  • confusion
  • unsteady walking
  • feeling weak
  • suicidal thoughts or tendencies
  • severe skin reactions
  • fever, chills
  • pain in many joints
  • sharp pain coming from your lower back (kidney stones)
  • sharp pain shooting from the front of your stomach to the back (infected pancreas)
  • severe constipation and/or stomach cramping
  • cold or white extremities
  • yellowing of the skin and/or eyes
  • swelling due to build up of fluid around the stomach
  • severe headache
  • bleeding or bruising more easily than normal

These may be serious side effects. You may need urgent medical attention.

There are some side effects that may occur with the protease inhibitor class of medicines. INVIRASE belongs to this class of medicines. The following side effects have been reported in patients taking protease inhibitors:

  • diabetes
  • body fat distribution changes, including loss of fat from the limbs and increased fat around the stomach; in women breast enlargement can also occur

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

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

After taking INVIRASE

Storage

Keep your capsules in the bottle until it is time to take them.

If you take the capsules out of the bottle they may not keep well.

Keep INVIRASE in a cool dry place where the temperature stays below 25°C.

Do not store it, or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep INVIRASE where young children cannot reach it.

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

Disposal

If your doctor tells you to stop taking INVIRASE, or the medicine has passed its expiry date, ask your pharmacist what to do with any capsules that are left over.

Product Description

Availability

INVIRASE comes in one capsule strength, 200mg.

INVIRASE comes in amber glass bottle packs of 270 capsules.

What INVIRASE looks like

INVIRASE capsules are light brown and green in colour with a hard gelatin shell. Each half of the capsule is marked with "ROCHE" and the code "0245".

Ingredients

Active ingredient - saquinavir
  • each capsule contains 200 mg saquinavir free base as saquinavir mesylate.
Inactive ingredients

The capsules also contains:

  • lactose, microcrystalline cellulose, polyvidone K30, sodium starch glycollate, talc, magnesium stearate

The capsule shell consists of:

  • gelatin, water and the colours iron oxide black, red and yellow, FD& C blue 2 and titanium dioxide.

INVIRASE capsules are gluten free.

This leaflet was prepared on 10 February 2004.