STOCRIN®
efavirenz
50 mg, 100 mg & 200 mg capsules
50 mg, 200 mg & 600 mg tablets
What is in this leaflet
This leaflet answers some common questions about STOCRIN. 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 STOCRIN against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor,
pharmacist or treatments officer at your local AIDS Council.
Keep this leaflet with the medicine. You may need to read it again.
What STOCRIN is used for
STOCRIN is used to help treat HIV (Human Immunodeficiency Virus) infection.
It is used in combination with other appropriate medicines used to treat the
HIV virus. Examples include protease inhibitors such as indinavir (CRIXIVAN®)
and nelfinavir (Viracept*). They also include nucleoside analogue reverse
transcriptase inhibitors (NRTIs) such as zidovudine (AZT, Retrovir*) or
lamivudine (3TC*).
STOCRIN belongs to a group of medicines called non-nucleoside reverse
transcriptase inhibitors. It works by interrupting the formation of new HIV
particles in already infected cells. When HIV is attacked by STOCRIN, the
virus is not able to reproduce normally. This helps reduce the amount of virus
in the blood. Although STOCRIN helps reduce the amount of virus in the blood
and thus increases the CD4 count, it has not yet been shown to improve
survival or slow the progression of the disease.
You may continue to develop infections or other illnesses associated with
HIV disease while you are taking STOCRIN.
Before you take STOCRIN
When you must not take it
Do not take STOCRIN if:
- you have an allergy to STOCRIN or any of the ingredients listed at the
end of this leaflet - the packaging is torn or shows signs of tampering
- you are pregnant or are planning to become pregnant (if you are please
inform your doctor immediately) - you are breast feeding or plan to breast feed
It is not known whether STOCRIN passes into breast milk. You should not
breast-feed if you are taking STOCRIN. - the expiry date 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 STOCRIN, talk to your
doctor.
Do not give STOCRIN to children under 3 years of age or those who weigh
less than 13 kg. The safety and effectiveness in these children has not been
established. STOCRIN capsules or tablets can be given to children 3 years of
age and older who are able to swallow capsules or tablets.
Before you start to take it
Tell your doctor if:
- you have any allergies to any other medicines or any other substances,
such as foods, preservatives or dyes - you have any medical conditions, especially the following:
- liver disease, including chronic hepatitis B or C
- high cholesterol
If you have not told your doctor about any of the above, tell them before
you take any STOCRIN.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines
that you buy without a prescription from your pharmacy, supermarket or health
food shop.
Some medicines should not be taken with STOCRIN as they may cause a
life-threatening interaction. These include:
- terfenadine (Teldane*) and astemizole (Hismanal*), antihistamines used
for hayfever and other allergic conditions - cisapride (Prepulsid*), used to treat stomach reflux
- triazolam (Halcion*), used to treat anxiety, depression or for
sleeplessness - midazolam (Hypnovel*), used as a sedative before surgical procedures
- ergot derivatives used for treatment of migraine and during labour/
childbirth - pimozide, used to treat psychiatric conditions
- bepridil, used to treat angina.
The generally recommended dose of STOCRIN must not be taken with the
generally recommended dose of voriconazole, a medicine that is used to treat
fungal infections. STOCRIN may make voriconazole less likely to work. Also,
voriconazole may make side effects from STOCRIN more likely. An increased dose
of voriconazole may be taken at the same time as a reduced dose of efavirenz,
but you must check with your doctor first.
Some other medicines and STOCRIN may interfere with each other
These include:
- saquinavir (Invirase*), a protease inhibitor used to treat HIV infection
- atazanavir, a protease inhibitor
- clarithromycin, an antibiotic used to treat bacterial infections
- rifampicin and rifabutin (Mycobutin*) antibiotics used to treat TB and
infections caused by MAC - ethinyl oestradiol, used in some oral contraceptives
- St. John's Wort (Hypericum perforatum), a herbal product sold as
a dietary supplement - methadone, used to treat opioid dependence
- sertraline, an antidepressant
- itraconazole, used to treat fungal infections
- atorvastatin, pravastatin, or simvastatin (lipid-lowering medicines,
also called statins) - carbamazepine (used to prevent seizures)
- diltiazem or similar medicines (called calcium channel blockers), used
to treat angina pectoris and hypertension.
These medicines may be affected by STOCRIN, or may affect how well it
works. You may need different amounts of your medicine, or you may need to
take different medicines.
STOCRIN is taken in combination with other medicines commonly used to help
treat HIV-infection. These include the protease inhibitors and nucleoside
analogue reverse transcriptase inhibitors (NRTIs). The optimal dose of
indinavir, when given in combination with STOCRIN, is not known.
Make sure your doctor and pharmacist know about all of the medicines,
including herbal products and dietary supplements, you are taking, as they
have more information on medicines to be careful with or avoid while taking
STOCRIN.
How to take STOCRIN
How much to take
Take STOCRIN only when prescribed by your doctor. Your doctor will
tell you how many capsules or tablets you need to take each day.
For adults and children weighing more than 40 kg, the normal dose is 600 mg
once daily (that is three 200 mg capsules, or one 600 mg tablet, once a day).
It is important that you are started and continue on this dose.
The dose for children weighing 40 kg or less is calculated by body weight
and is taken once daily as shown below.
| Body Weight kg |
STOCRIN Capsules and Tablets Dose (mg) |
|---|---|
| 13 to < 15 | 200 |
| 15 to < 20 | 250 |
| 20 to < 25 | 300 |
| 25 to < 32.5 | 350 |
| 32.5 to < 40 | 400 |
| ≥ 40 | 600 |
Follow all directions given to you by your doctor carefully. They may
differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or
pharmacist for help.
How to take it
Swallow STOCRIN with a glass of water or other liquid.
It does not matter if you take STOCRIN with or without food.
When to take it
Your doctor may ask you to take STOCRIN at bedtime to avoid or reduce
certain adverse effects, such as dizziness and sleepiness.
How long to take it
STOCRIN helps control your HIV infection but does not cure it. Therefore
STOCRIN must be taken every day. Continue taking STOCRIN for as long as your
doctor prescribes.
Do not stop taking STOCRIN or change the dose without first checking with
your doctor. Do not let yourself run out of medicine over weekends or on
holidays.
If you have a break in therapy or reduce your dose temporarily, the virus
may develop resistance and therefore STOCRIN may no longer be effective. If,
for any reason, your therapy with STOCRIN is interrupted or stopped, tell your
doctor.
If you forget to take it
If you miss a dose, take it as soon as you remember, and then go back to
taking your capsules as you would normally. However, if it is almost time for
your next dose, skip the dose you missed and take your next dose when you are
meant to.
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 that you missed.
If you have trouble remembering to take your capsules or tablets, ask your
pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or National Poisons Centre (telephone
0800 POISON or 0800 764 766) for advice, or go to accident and emergency at
your nearest hospital, if you think that you or anyone else may have taken too
much STOCRIN. Do this even if there are no signs of discomfort or poisoning.
While you are using STOCRIN
Things you must do
Report any changes in your condition to your doctor immediately.
This is to make sure that any infections which occur due to your low immunity
(called opportunistic infections) are treated promptly. Continue to use safer
sexual practices.
In some patients with advanced HIV infection (AIDS) and a history of
opportunistic infection, signs and symptoms of inflammation from previous
infections may occur when combination antiretroviral treatment is started.
STOCRIN has not been shown to decrease the chance of transmitting HIV to
others through sexual contact or blood contamination.
Women taking STOCRIN should avoid pregnancy. Use barrier contraception even
if you are using other methods (eg. Oral contraceptive pill or other hormonal
contraceptives).
If you become pregnant while taking STOCRIN, tell your doctor immediately.
If you are about to be started on any new medicine tell your doctor and
pharmacist that you are taking STOCRIN.
Tell all the doctors, dentists and pharmacists who are treating you that
you are taking STOCRIN.
Things you must not do
Do not stop taking STOCRIN or change the dose without first checking with
your doctor. Do not let yourself run out of medicine over weekends or on
holidays.
If you have a break in therapy or reduce your dose temporarily, the virus
may develop resistance and therefore STOCRIN may no longer be effective. If,
for any reason your therapy with STOCRIN is interrupted or stopped, tell your
doctor.
Do not give STOCRIN to anyone 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 STOCRIN
affects you. STOCRIN may cause dizziness, sleepiness or affect concentration
in some people, especially after the first one or two days. Make sure you know
how you react to STOCRIN before you drive a car or operate machinery.
Adverse Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking STOCRIN.
STOCRIN helps most people with HIV infection, but it may have unwanted
adverse effects. All medicines can have adverse effects. Sometimes they are
serious, most of the time they are not. You may need medical treatment if you
get some of the adverse effects.
Frequently it is difficult to tell whether adverse effects are the result
of taking STOCRIN, effects of the HIV disease or adverse 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 STOCRIN.
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:
- skin rash
- nausea
- dizziness
- headache
- fatigue
- insomnia (sleeplessness)
- drowsiness
- unable to concentrate
- abnormal dreaming
These are the more common adverse effects of STOCRIN. They generally
resolve after the first few weeks. Taking STOCRIN at night may help to reduce
some of these adverse effects.
Tell your doctor immediately or go to accident and emergency at your
nearest hospital if you develop any of the following:
- any severe skin reaction
- pinkish, itchy swellings on the skin, also called hives or nettlerash
- seizures (have a "fit" or convulsion)
Because these adverse effects are serious, you may need urgent medical
attention.
Rarely, some patients have more serious symptoms that may affect mood or
the ability to think clearly. These include depression, suicidal thoughts,
angry behaviour and strange thoughts. Some patients have actually committed
suicide. These problems tend to occur more often in those who have a history
of mental illness.
Other rarely reported adverse effects include stomach ache, blurred vision,
breast enlargement in men, liver failure, inflammation of the pancreas, and
increased fat appearing in areas such as the neck, breasts, abdomen and back.
Other adverse effects not listed above may also occur in some patients. The
long-term effects of STOCRIN are unknown at this time. Tell your doctor if you
notice any other effects.
Do not be alarmed by this list of possible adverse effects. You may not
experience any of them.
After using STOCRIN
Storage
Keep your capsules/tablets in the original container until it is time to
take them.
If you take the capsules/tablets out of the container they may not keep
well, as they are affected by moisture
Keep STOCRIN in a cool dry place where the temperature stays below 30°C. Do
not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where 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 the capsules/tablets, or the
capsules/tablets have passed their expiry date, ask your pharmacist what to do
with any that are left over.
Product description
What it looks like
STOCRIN capsules come in three strengths:
- 50 mg - white and gold capsule with 3805 marked in purple on the capsule
- 100 mg - white capsule with 3807 marked in purple on the capsule
- 200 mg - gold capsule with 3809 marked in purple on the capsule
STOCRIN tablets come in three strengths:
- 50 mg - yellow round shaped tablet with 113 engraved on one side and
plain on the other. - 200 mg - yellow round shaped tablet with 223 engraved on one side and
plain on the other. - 600 mg - yellow modified capsular shaped tablet with 225 engraved on one
side and plain on the other.
A bottle of STOCRIN 50 mg capsules contains 30 capsules.
A bottle of STOCRIN 100 mg capsules contains 30 capsules.
A bottle of STOCRIN 200 mg capsules contains 90 capsules.
A bottle of STOCRIN 50 mg tablets contains 30 tablets.
A bottle of STOCRIN 200 mg tablets contains 90 tablets.
A bottle of STOCRIN 600 mg tablets contains 30 tablets.
Ingredients
Active ingredient:
- efavirenz
Inactive ingredients:
Capsules
- Lactose monohydrate
- Magnesium stearate
- Sodium lauryl sulphate
- Sodium starch glycolate
- Gelatine
- Titanium dioxide
- Yellow iron oxide (50 and 200 mg capsule)
- Silicon dioxide
- Cochineal carminic acid (E120)
- Indigo carmine (E132)
Tablets
- Croscarmellose sodium
- Microcrystalline cellulose
- Sodium lauryl sulphate
- Hydroxypropyl cellulose
- Lactose monohydrate
- Magnesium stearate
- Hypromellose (E464)
- Titanium dioxide (E171)
- Macrogol 400
- Carnauba wax
- Yellow iron oxide
The 50 mg, 200 mg, and 600 mg tablets are not printed with ink.
STOCRIN does not contain gluten, sucrose, tartrazine or any other azo dyes.