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EFAVIRENZ SANDOZ 600 MG FILM-COATED TABLETS

Active substance(s): EFAVIRENZ

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ12501LT01B

Efavirenz 600 mg Film-coated Tablets
efavirenz
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet (See section 4).
What is in this leaflet
1. What Efavirenz is and what it is used for
2. What you need to know before you take Efavirenz
3. How to take Efavirenz
4. Possible side effects
5. How to store Efavirenz
6. Contents of the pack and other information

1

What Efavirenz is and what it is
used for

Efavirenz belongs to a class of antiretroviral medicines
called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). It is an antiretroviral medicine that
fights human immunodeficiency virus (HIV)
infection by reducing the amount of the virus in blood.
Your doctor has prescribed Efavirenz for you because
you have HIV infection. Efavirenz taken in combination
with other antiretroviral medicines reduces the amount of
the virus in the blood.

2

What you need to know before
you take Efavirenz

Do not take Efavirenz

• if you are allergic (hypersensitive) to efavirenz or
any of the other ingredients of Efavirenz (listed in
section 6). Contact your doctor or pharmacist for
advice.
• if you have severe liver disease.
• if you are currently taking any of the following
medicines:
- astemizole or terfenadine (used to treat allergy
symptoms)
- bepridil (used to treat heart disease)
- cisapride (used to treat heartburn)
- ergot alkaloids (for example, ergotamine,
dihydroergotamine, ergonovine, and
methylergonovine)(used to treat migraine and cluster
headaches)
- midazolam or triazolam (used to help you
sleep)
- pimozide (used to treat certain mental conditions)
- St. John’s wort (Hypericum perforatum (a herbal
remedy used for depression and anxiety).
If you are taking any of these medicines, tell
your doctor immediately. Taking these medicines
with Efavirenz could create the potential for serious
and/or life-threatening side-effects or stop Efavirenz from
working properly.

Warnings and precautions

Talk to your doctor or pharmacist before taking Efavirenz
• Efavirenz must be taken with other
medicines that act against the HIV virus.
If Efavirenz is started because your current treatment
has not prevented the virus from multiplying, another
medicine you have not taken before must be started at
the same time.
• You can still pass on HIV when taking this
medicine, so it is important to take precautions to
avoid infecting other people through sexual contact
or blood transfer. This medicine is not a cure for HIV
infection and you may continue to develop infections
or other illnesses associated with HIV disease.
• You must remain under the care of your doctor while
taking Efavirenz.
• Tell your doctor:
- if you have a history of mental illness,
including depression, or of substance or alcohol
abuse. Tell your doctor immediately if you feel
depressed, have suicidal thoughts or have strange
thoughts (see section 4, Possible side effects).
- if you have a history of convulsions (fits or
seizures) or if you are being treated with
anticonvulsant therapy such as carbamazepine,
phenobarbital and phenytoin. If you are taking any
of these medicines, your doctor may need to check
the level of anticonvulsant medicine in your blood to
ensure that it is not affected while taking Efavirenz.
Your doctor may give you a different anticonvulsant.
- if you have a history of liver disease,
including active chronic hepatitis.
Patients with chronic hepatitis B or C and treated
with combination antiretroviral agents have a
higher risk for severe and potentially life-threatening
liver problems. Your doctor may conduct blood
tests in order to check how well your liver is
working or may switch you to another medicine.
If you have severe liver disease, do not
take Efavirenz (see section 2, Do not take
Efavirenz).
• Once you start taking Efavirenz, look out
for:
- signs of dizziness, difficulty sleeping,
drowsiness, difficulty concentrating or
abnormal dreaming.
These side effects may start in the first 1 or 2 days of
treatment and usually go away after the first
2 to 4 weeks.
- any signs of skin rash. If you see any signs of a
severe rash with blistering or fever, stop taking
Efavirenz and tell your doctor at once. If you had a
rash while taking another NNRTI, you may be at a
higher risk of getting a rash with Efavirenz.
- any signs of inflammation or infection.
In some patients with advanced HIV infection (AIDS)
and a history of opportunistic infection, signs and
symptoms of inflammation from previous infections
may occur soon after anti-HIV treatment is started.
It is believed that these symptoms are due to an
improvement in the body’s immune response,
enabling the body to fight infections that may have
been present with no obvious symptoms. If you
notice any symptoms of infection, please tell your
doctor immediately.
- changes in body fat. Redistribution, accumulation
or loss of body fat may occur in patients receiving
combination antiretroviral therapy. Tell your doctor
if you notice changes in your body fat.

- bone problems. Some patients taking
combination antiretroviral therapy may develop a
bone disease called osteonecrosis (death of bone
tissue caused by loss of blood supply to the bone).
The length of combination antiretroviral therapy,
corticosteroid use, alcohol consumption, severe
immunosuppression, higher body mass index,
among others, may be some of the many risk factors
for developing this disease. Signs of osteonecrosis
are joint stiffness, aches and pain (especially of the
hip, knee and shoulder) and difficulty in movement. If
you notice any of these symptoms please inform your
doctor.

Children and Adolescents

Efavirenz is not suitable for children weighing less than
40 kg. Other efavirenz formulations are available in the
market for these patients. You should refer to the
accompanying package leaflet of suitable formulations
for the paediatric posology (3 to 17 years).
Other medicines and Efavirenz
You must not take Efavirenz with certain
medicines. These are listed under ‘Do not take
Efavirenz’, at the start of Section 2. They include some
common medicines and herbal remedy (St. John’s wort)
which can cause serious interactions.
Please tell your doctor or pharmacist if you are
taking or have recently taken or might take any other
medicines, including medicines obtained without a
prescription and herbal remedies.
Efavirenz may interact with other medicines. As a result,
the amounts of Efavirenz or other medicines in your
blood may be affected. This may stop the medicines
from working properly, or may make any side effects
worse. In some cases, your doctor may need to adjust
your dose or check your blood levels. It is important
to tell your doctor if you are taking any of the
following:
• Other medicines used for HIV infection:
- protease inhibitors: darunavir, indinavir, lopinavir/
ritonavir, ritonavir, ritonavir boosted atazanavir,
saquinavir or fosamprenavir/saquinavir. Your doctor
may consider giving you an alternative medicine or
changing the dose of the protease inhibitors.
- maraviroc
- a combination medicine containing efavirenz,
emtricitabine and tenofovir, which is currently
known as Atripla. Efavirenz should not be taken
with Atripla since it contains efavirenz, the active
ingredient of Efavirenz.
• Medicines used to treat bacterial infections,
including tuberculosis and AIDS-related
mycobacterium avium complex: clarithromycin,
rifabutin, rifampicin. Your doctor may consider
changing your dose or giving you an alternative
antibiotic. In addition, your doctor may prescribe
a higher dose of Efavirenz.
• Medicines used to treat fungal infections
(antifungals):
- voriconazole. Efavirenz may reduce the amount of
voriconazole in your blood and voriconazole may
increase the amount of efavirenz in your blood. If
you take these two medicines together, the dose of
voriconazole must be increased and the dose of
efavirenz must be reduced. You must check with
your doctor first.
- itraconazole. Efavirenz may reduce the amount of
itraconazole in your blood.
- posaconazole. Efavirenz may reduce the amount of
posaconazole in your blood.
• Medicines used to treat convulsions/seizures
(anticonvulsants): carbamazepine, phenytoin,
phenobarbital. Efavirenz can reduce or increase the
amount of anticonvulsant in your blood.
Carbamazepine may make Efavirenz less likely to
work. Your doctor may need to consider giving you a
different anticonvulsant.
• Medicines used to lower blood fats (also
called statins): atorvastatin, pravastatin, simvastatin.
Efavirenz can reduce the amount of statins in your
blood. Your doctor will check your cholesterol levels
and will consider changing the dose of your statin, if
needed.
• Methadone (a medicine used to treat opiate
addiction): your doctor may need to change your
dose of methadone.
• Sertraline (a medicine used to treat depression):
your doctor may need to change your dose of
sertraline.
• Diltiazem or similar medicines (called
calcium channel blockers): when you start taking
Efavirenz, your doctor may need to adjust your dose
of the calcium channel blocker.
• Immunosuppressants such as cyclosporine,
sirolimus, or tacrolimus (medicines used to
prevent organ transplant rejection): when you start
or stop taking Efavirenz, your doctor will closely
monitor your plasma levels of the immunosuppressant
and may need to adjust its dose.
• Hormonal contraceptive, such as birth
control pills, an injected contraceptive (for
example, Depo-Provera), or a contraceptive
implant (for example, Implanon): you must also use a
reliable barrier method of contraception (see
Pregnancy and breast-feeding). Efavirenz may make
hormonal contraceptives less likely to work.
Pregnancies have occurred in women taking
Efavirenz while using a contraceptive implant,
although it has not been established that the Efavirenz
therapy caused the contraceptive to fail.
• Warfarin (a medicine used to reduce clotting of the
blood): your doctor may need to adjust your dose of
warfarin.

Efavirenz with food and drink

Taking Efavirenz on an empty stomach, may reduce the
undesirable effects.
Continued on next page >>

Pregnancy breast-feeding and fertility
Women should not get pregnant during
treatment with Efavirenz and for 12 weeks
thereafter. Your doctor may require you to take a
pregnancy test to ensure you are not pregnant before
starting treatment with Efavirenz.
If you could get pregnant while receiving
Efavirenz, you need to use a reliable form of barrier
contraception (for example, a condom) with other
methods of contraception including oral (pill) or other
hormonal contraceptives (for example, implants,
injection). Efavirenz may remain in your blood for a time
after therapy is stopped. Therefore, you should continue
to use contraceptive measures, as above, for 12 weeks
after you stop taking Efavirenz.
Tell your doctor immediately if you are
pregnant or intend to become pregnant.
If you are pregnant, you should take Efavirenz only if
you and your doctor decide it is clearly needed. Ask
your doctor or pharmacist for advice before taking any
medicine.
Serious birth defects have been seen in unborn animals
and in the babies of women treated with efavirenz
during pregnancy. If you have taken Efavirenz during
your pregnancy, your doctor may request regular blood
tests and other diagnostic tests to monitor the
development of your child.
You should not breast feed your baby if you are
taking Efavirenz.

Driving and using machines

Efavirenz may cause dizziness, impaired
concentration, and drowsiness. If you are
affected, do not drive and do not use any tools or
machines.

Efavirenz contains lactose

This medicine contains 100.3 mg of lactose
monohydrate in each 600-mg daily dose.
If you have been told by your doctor that you have an
intolerance to some sugars, such as lactose, contact
your doctor before taking this medicine. Other efavirenz
formulations are available in the market for these patients.

3

How to take Efavirenz

Always take Efavirenz exactly as your doctor has told
you. It is recommended that the tablet be swallowed
whole with water. You should check with your doctor or
pharmacist if you are not sure. Your doctor will give you
instructions for proper dosing.
• Efavirenz is for oral use. Efavirenz is recommended
to be taken on an empty stomach preferably at
bedtime. This may make some side effects (for
example, dizziness, drowsiness) less troublesome. An
empty stomach is commonly defined as 1 hour before
or 2 hours after a meal.
• The dose for adults is 600 mg once daily. However, if
administered together with rifampicin, other efavirenz
formulations may be used to give a total dose of
800 mg.
• The dose for Efavirenz may need to be increased
or decreased if you are also taking certain medicines
(see Taking other medicines).
• Efavirenz must be taken every day.
• Efavirenz should never be used alone to treat HIV.
Efavirenz must always be taken in combination with
other anti-HIV medicines.

Use in children and adolescents

• The dose for children weighing 40 kg or more is
600 mg once daily. Other formulations of efavirenz
are available for patients who need some dose
adjustment. You should refer to the accompanying
package leaflet of suitable formulations for the
paediatric posology (3 to 17 years).
The tablet can be divided into equal doses.
The tablets can be divided in case of difficulty
swallowing.

If you take more Efavirenz than you
should

If you take too much Efavirenz, contact your doctor or
nearest emergency department for advice. Keep the
medicine container with you so that you can easily
describe what you have taken.

If you forget to take Efavirenz

Try not to miss a dose. If you do miss a dose, take the
next dose as soon as possible, but do not take a double
dose to make up for a forgotten dose. If you need help
in planning the best times to take your medicine, ask
your doctor or pharmacist.

If you stop taking Efavirenz

When your Efavirenz supply starts to run low, get more
from your doctor or pharmacist. This is very important
because the amount of virus may start to increase if the
medicine is stopped for even a short time. The virus may
then become harder to treat.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Common side effects: may affect up to 1 in 10
people
• abnormal dreams, difficulty concentrating, dizziness,
headache, difficulty sleeping, drowsiness, problems
with coordination or balance
• stomach pain, diarrhoea, feeling sick (nausea),
vomiting
• itching
• tiredness
• feeling worried, feeling depressed.
Uncommon side effects: may affect up to 1 in 100
people
• nervousness, forgetfulness, confusion, fitting (seizures),
abnormal thoughts
• blurred vision
• feeling of spinning or tilting (vertigo)
• pain in the abdomen (stomach) caused by
inflammation of the pancreas
• allergic reaction (hypersensitivity) that may cause
severe skin reactions (erythema multiforme,
Stevens-Johnson syndrome)
• yellow skin or eyes, itching, or pain in the abdomen
(stomach) caused by inflammation of the liver
• breast enlargement in males
• angry behaviour, mood being affected, seeing or
hearing things that are not really there (hallucinations),
mania (mental condition characterised by episodes of
overactivity, elation or irritability), paranoia, suicidal
thoughts
• whistling, ringing or other persistent noise in the ears
• tremor (shaking)
• flushing.
Rare side effects: may affect up to 1 in 1,000 people
• itchy rash caused by a reaction to sunlight
• Liver failure, in some cases leading to death or liver
transplant, has occurred with efavirenz. Most cases
occurred in patients who already had liver disease,
but there have been a few reports in patients without
any existing liver disease.
Combination antiretroviral therapy may change your
body shape, by changing the way body fat is distributed.
You may lose fat from your legs, arms and face, gain fat
around the abdomen (tummy) and other internal organs,
get larger breasts or fatty lumps on the back of the neck
(‘buffalo hump’). The cause and long-term health effects
of these conditions are not yet known.
Combination antiretroviral therapy may also cause
raised lactic acid and sugar in the blood, increased fat
levels in the blood (hyperlipaemia) and resistance to
insulin. Your doctor will test for these changes.
Reporting of side effects
If you get any side effects, talk to your doctor
or, pharmacist. This includes any side effects
not listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme: www.mhra.gov.uk/yellowcard. By
reporting side effects, you can help provide
more information on the safety of this
medicine.

5

How to store Efavirenz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the bottle label or blister and on the carton
after EXP. The expiry date refers to the last day of that
month.
This medicine does not require any special storage
conditions.
After first opening of the bottle: use within 2 months.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you
no longer use. These measures will help protect the
environment.

6

Contents of the pack and other
information

What Efavirenz contains

Each film-coated tablet contains 600 mg of the active
substance efavirenz.
The other ingredients of the tablet core are:
croscarmellose sodium, microcrystalline cellulose,
sodium laurilsulfate, hydroxypropylcellulose, lactose
monohydrate, and magnesium stearate.
The film-coating contains: hypromellose (E464),
quinoline yellow aluminium lake (E104), titanium dioxide
(E171), macrogol and iron oxide red (E172).

What Efavirenz looks like and contents of
the pack

Efavirenz is a yellow film-coated tablet of capsule shape
(9.6 x 19.2 mm) with a break line on both sides. The
tablet can be divided into equal doses.
Efavirenz are supplied in:
• HDPE bottles with a child-resistant polypropylene
closure sealed with liner and containing a silica gel
packet: 30, 90 (3x30) or 120 (4x30) film-coated
tablets.
• White opaque PVC/Aclar/Al blisters: 10, 28, 30, 50,
60, 84, 90, 100 or 120 film-coated tablets.
Not all pack sizes may be marketed.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
When treating HIV infection, it is not always possible to
tell whether some of the unwanted effects are caused by
Efavirenz or by other medicines that you are taking at
the same time, or by the HIV disease itself.
The most notable unwanted effects reported with
efavirenz in combination with other anti-HIV medicines
are skin rash and nervous system symptoms.
You should consult your doctor if you have a rash, since
some rashes may be serious; however, most cases of
rash disappear without any change to your treatment
with Efavirenz. Rash was more common in children than
in adults treated with efavirenz.

Marketing Authorisation Holder

Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, United Kingdom.

Manufacturer

Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or

The nervous system symptoms tend to occur when
treatment is first started, but generally decrease in the
first few weeks. In one study, nervous system symptoms
often occurred during the first 1-3 hours after taking a
dose. If you are affected your doctor may suggest that
you take Efavirenz at bedtime and on an empty stomach.
Some patients have more serious symptoms that may
affect mood or the ability to think clearly. Some patients
have actually committed suicide. These problems tend to
occur more often in those who have a history of mental
illness.
Always notify your doctor immediately if you have these
symptoms or any side effects while taking Efavirenz.

LEK S.A.,
ul. Domaniewska 50 C, 02-672 Warszawa, Poland

Tell your doctor if you notice any of the
following side effects:

This leaflet was last revised in 07/2013.

Very common side effects: may affect more than
1 in 10 people
• skin rash.

or
Salutas Pharma GmbH,
Dieselstr. 5, 70839 Gerlingen, Germany
or
S.C. Sandoz,
S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures,
Romania.

SZ12501LT01B

draft: 44066088
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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