NORVIR®
PLEASE READ THIS INFORMATION CAREFULLY
What is in this leaflet
This leaflet answers some common questions about NORVIR.
It does not contain all of the available information. It does not take the
place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of
you taking NORVIR against the benefits they expect it will have on you.
If you have any concerns about taking this medicine, talk to your doctor
or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What NORVIR is used for
NORVIR is used in the treatment of HIV (Human Immunodeficiency Virus)
infections. It may be given alone or with certain other anti-HIV medicines. Your
doctor will determine which medicines are best for you.
The safety and efficacy in children under 12 years of age has not been
established
NORVIR belongs to a group of medicines called HIV protease inhibitors. It
helps control the HIV infection by inhibiting or interfering with the protease
enzyme that the HIV virus needs to infect new cells.
NORVIR has not been shown to decrease the
chance of transmitting HIV to a sexual partner. You must continue to use safe
sexual practices (e.g. Condoms) while taking NORVIR.
NORVIR is available only with a doctor's prescription.
NORVIR is not addictive.
Before you take NORVIR
Do not take NORVIR if
- you have an allergy to the active ingredient, ritonavir
- you are allergic to any of the ingredients listed at the end of this
leaflet - the packaging is torn or shows signs of tampering
- the expiry date printed on the pack has passed. If you take this medicine
after the expiry date has passed, it may not work.
If you are not sure whether you should start taking NORVIR, talk to your
doctor.
Before you start to take or are given NORVIR you must tell your doctor if
- you are pregnant or plan to become pregnant.
Your doctor will discuss the risks and benefits of taking NORVIR when
pregnant. - you are breastfeeding or plan to breastfeed.
Your doctor will discuss the risks and benefits of taking NORVIR when
breastfeeding. - you have, or have ever had, any other health problems or medical
conditions, including liver problems. - you are allergic to any other medicines, foods, dyes or preservatives.
If you have not told your doctor or pharmacist about any of the above,
tell them before you start taking or are given NORVIR.
Taking other medicines
It is important to tell your doctor if you are taking any other medicines,
including medicines you can buy without a prescription from a pharmacy,
supermarket or health food shop.
Some medicines should not be used with NORVIR. Your doctor or pharmacist will
advise you which medicines to be careful with or avoid while taking NORVIR.
Your doctor or pharmacist have a complete list of medicines which interfere
with NORVIR. Some of the medicines you must avoid while taking NORVIR are listed
below:
Anti-Migraine Drugs
Ergotamine, Dihydroergotamine
Anticoagulent Drugs
Warfarin
Analgesics/Narcotics
Pethidine, Dextropropoxyphene, Piroxicam, Meperidine, Propoxyphene
Antidepressants
Bupropion
Antiinfectives:
Rifabutin
Cardiovascular agent:
Amiodarone, Flecainide, Quinidine
Gastrointestinal agents:
Cisapride
Lipid Lowering Agents:
Simvastatin
Psychotropics:
Clozapine, Pimozide Alprazolam, Clorazepate, Diazepam, Midazolam, Triazolam,
Zolpidem
Other:
St. John's Wort (Hypericum perforatum).
There are many other drugs which may be affected by NORVIR. Your doctor may
need to prescribe different amounts of your medicine for you to take. Check with
your doctor who will have a complete list of medicines which interfere with
NORVIR.
Other interactions
NORVIR affects the way oral contraceptives work. Another form of
contraception should be used whilst you are taking NORVIR.
Grapefruit juice is not expected to affect the absorption of ritonavir.
How to take NORVIR
How much to take and when to take it
Take NORVIR only when prescribed by your doctor. Norvir may be prescribed
in combination with other appropriate medicines. Your doctor will tell you how
much to take and when to take it.
The usual dose is 600mg of ritonavir twice a day (7.5mL of oral solution or 6
capsules).
Take your NORVIR at regular twelve-hour intervals at about the same time
each day. This will have the best effect on the HIV infection. It will also
help you remember when to take your medicine.
Follow all directions given to you by your doctor carefully. This may
differ from the information contained in this leaflet.
If you do not understand the instructions on the box/bottle, ask your doctor
or pharmacist for help.
How to take it
NORVIR is administered orally and should preferably be taken with meals.
The oral solution dosage cup should be cleaned immediately with hot soapy
water after use. The dosage cup must be dry prior to use. Shake the
bottle well before use.
The oral solution has a lingering aftertaste. It can be mixed with ENSURE®,
ADVERA® or chocolate milk to improve the taste. Do not mix NORVIR
with water.
Eating salty foods or drinking fluids before and after taking NORVIR may help
clear the aftertaste from your mouth.
Taking antacids with NORVIR has not been studied.
How long to take it
NORVIR helps control your HIV infection but does not cure it. Therefore,
NORVIR must be taken every day. Continue taking NORVIR for as long as your
doctor prescribes. You may continue to develop infections or other illnesses
associated with HIV disease while you are taking NORVIR.
If you forget to take it
If it is almost time for you to take 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, and then go back to taking your medicine as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or
pharmacist.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering to take your NORVIR, ask your pharmacist for
some hints.
If you take too much NORVIR (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone
in Australia 13 11 26, in New Zealand 0800 POISON or 0800 764 766) for advice,
or go to casualty at your nearest hospital if you think that you or anyone else
may have taken too much NORVIR. Do this even if there are no signs of discomfort
or poisoning. You may need urgent medical attention. Keep telephone numbers for
these places/services handy.
While you are taking NORVIR
Things you must do:
Tell your doctor if you become pregnant while taking NORVIR.
Tell your doctor or pharmacist that you are taking NORVIR if you are about
to be started on any new medicine.
Tell all the doctors, dentists, and pharmacists who are treating you that
you are taking NORVIR.
Things you must not do:
Do not stop taking NORVIR or change the dose without first checking with
your doctor. Do not let yourself run out of medicine over weekends or on
holidays.
Do not give this medicine to any one else, even if they have the same
condition as you.
Things to be careful of:
Be careful driving or operating machinery until you know how NORVIR
affects you. NORVIR generally does not cause problems with your ability to
drive a car or operate machinery. However, as with many medicines, NORVIR may
cause dizziness in some people. Make sure you know how you react to NORVIR
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 NORVIR.
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 NORVIR, 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 NORVIR.
Ask your doctor or pharmacist to answer any questions you may have.
While you are taking NORVIR
Tell your doctor if you experience any of the following:
- nausea, vomiting
- diarrhoea
- feeling of weakness
- abdominal pain
- headache
- tingling sensation
- change in taste sensation
These are the more common side effects of NORVIR.
Side effects including fits, body fat changes, dehydration (possibly from
nausea and/or diarrhoea), fainting and renal problems have been reported.
Rare side effects include throat irritation, dizziness, muscle aches and
pains, and rash.
Other effects include diabetes or increased sugar levels in the blood.
Other side effects not listed may also occur in some patients. The
longterm effects of NORVIR are unknown at this time. Tell your doctor if you
notice any other effects.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
After using NORVIR
Storage
NORVIR soft capsules should be refrigerated at 2-8°C. However, refrigeration
is not required if you use the capsules within 30 days and store them below
25°C. Do not freeze the capsules and protect them from excessive heat.
NORVIR oral solution should NOT be refrigerated. Store at room temperature
between 20°C and 25°C. Use before expiry date. It should be stored in the
original container with the cap tightly closed and protected from excessive
heat. Shake well before use.
Disposal
If your doctor tells you to stop taking NORVIR, or your medicine has
passed its expiry date, ask your pharmacist what to do with any medicine that is
left over.
Product Description
What it looks like
NORVIR comes in two dosage forms:
NORVIR Soft capsules are white capsules imprinted with the Abbott
logo, "DS" and "100". There are two presentations for the capsules: in bottles
containing 84 capsules.
NORVIR oral solution is an orange-coloured liquid supplied in
amber-coloured bottles. A bottle contains 240mL.
Ingredients
Each NORVIR capsule contains 100mg of ritonavir dissolved in ethanol,
oleic acid, butylated hydroxytoluene and PEG 35 castor oil. Other ingredients
include gelatin, sorbitol special, glycerol, titanium dioxide (white colour),
coconut oil, lecithin and black ink containing propylene glycol, black iron
oxide, polyvinyl acetate phthalate, polyethylene glycol and ammonium hydroxide.
NORVIR oral solution contains 600mg/7.5ml of ritonavir dissolved in
alcohol, water, PEG 35 castor oil and propylene glycol. Other ingredients
include saccharin sodium, citric acid anhydrous, peppermint oil, caramel
flavouring and sunset yellow dye (E110).