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EFAVIRENZ 600 MG FILM-COATED TABLETS

Active substance(s): EFAVIRENZ

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 your doctor,
pharmacist or nurse. 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 contains the active substance efavirenz, which
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. It is used by adults,
adolescents and children aged 3 years and older.
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. This will strengthen your
immune system and reduce the risk of developing
illnesses linked to HIV infection.
2. WHAT YOU NEED TO KNOW Before you
take Efavirenz
Do not take Efavirenz
• if you are allergic to efavirenz or any of the other
ingredients of this medicine 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 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,
although the risk is lowered by effective antiretroviral
therapy. Discuss with your doctor the precautions needed
to avoid infecting other people. 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 lifethreatening 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. In
addition to the opportunistic infections, autoimmune
disorders (a condition that occurs when the immune
system attacks healthy body tissue) may also occur
after you start taking medicines for the treatment of
your HIV infection. Autoimmune disorders may occur
many months after the start of treatment. If you notice

any symptoms of infection or other symptoms such as
muscle weakness, weakness beginning in the hands
and feet and moving up towards the trunk of the body,
palpitations, tremor or hyperactivity, please inform
your doctor immediately to seek necessary treatment.
• 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
pains (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.
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 a herbal remedy (St. John's wort) which
can cause serious interactions.
Tell your doctor, pharmacist or nurse if you are taking,
have recently taken or might take any other medicines.
Efavirenz may interact with other preparations,
including herbal medicine such as Ginkgo biloba
extracts. 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 or pharmacist 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
* the combination tablet containing efavirenz,
emtricitabine and tenofovir, which is currently
known as Atripla. Efavirenz should not be taken with
Atripla unless recommended by your doctor since it
contains efavirenz, the active ingredient of Efavirenz.
• Medicines used to treat infection with the hepatitis C
virus: boceprevir, telaprevir, simeprevir.
• 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 (antifungal):
* 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 malaria:
- artemether/lumefantrine: Efavirenz may reduce the
amount of artemether/lumefantrine in your blood
- atovaquone/proguanil: Efavirenz may reduce the
amount of atovaquone/proguanil 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.
• Bupropion (a medicine used to treat depression or
to help you stop smoking): your doctor may need to
change your dose of bupropion.
• Diltiazem or similar medicines (called calcium channel
blockers, which are medicines typically used for high
blood pressure or heart problems): 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, breast-feeding and
fertility'). 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 or acenocoumarol (medicines used to reduce
clotting of the blood): your doctor may need to adjust
your dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts (a herbal preparation)
Taking Efavirenz with food and drink
Taking Efavirenz on an empty stomach, may reduce the
undesirable effects. Grapefruit juice should be avoided
when taking this medicine.
Pregnancy and breast-feeding
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.
11300222 MI-03

Date: 26 Jan 2015
Description Efavirenz 600mg 30, 60, 90, 100, 30 x 1, 500
Component Type Leaflet
Affiliate Item Code 559590
Superceded Affiliate Item Code 466985
TrackWise PR No. 559590
MA No. 04569/1303
Packing Site/Printer N/A
Supplier Code 11300222 MI-03
Sign-offs

Pharma Code 1191
SAP No. N/A
Vendor Job No. 244189
Proof No. 2
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

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1

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Page Count

1/2

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Non-Print
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with
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Dimensions 175 x 500mm

Body Text Size 9 pt

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 or a
combination medicine containing efavirenz, emtricitabine
and tenofovir during pregnancy. If you have taken
efavirenz or the combination tablet containing efavirenz,
emtricitabine, and tenofovir 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
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Efavirenz
Always take this medicine exactly as your doctor or
pharmacist has told you. It is recommended that the
tablet be swallowed whole with water. Check with your
doctor or pharmacist if you are not sure. Your doctor
will give you instructions for proper dosing.
• The dose for adults is 600 mg once daily.
• The dose for Efavirenz may need to be increased or
decreased if you are also taking certain medicines
(see section 2, “Other medicines and Efavirenz”).
• 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.
• However, if administered together with rifampicin,
other efavirenz formulations may be used to give a
total dose of 800 mg.
• 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
• Efavirenz film-coated tablets are not suitable for
children weighing less than 40 kg.
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 paediatric dosing (3 to 17 years).
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, pharmacist or nurse.
4. Possible side effects

• tiredness
• feeling worried, feeling depressed
Tests may show:
• increased liver enzymes in the blood
• increased triglycerides (fatty acids) in the blood
Uncommon (affects 1 to 10 users in 1,000)
• nervousness, forgetfulness, confusion, fitting
(seizures), abnormal thoughts
• blurred vision
• a 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, StevensJohnson 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
Tests may show:
• increased cholesterol in the blood
Rare (affects 1 to 10 users in 10, 000)
• 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
• unexplained feelings of distress not associated with
hallucinations, but it may be difficult to think clearly
or sensibly
• suicide
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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk.
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 the sight and reach of children.
Do not use this medicine after the expiry date, which
is stated on the blister or bottle after 'EXP'. The expiry
date refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
The in-use shelf-life of the product when stored in
HDPE bottles is 100 days.
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
The active substance is efavirenz.
Each film-coated tablet contains 600 mg of efavirenz.
The other ingredients are cellulose microcrystalline,
croscarmellose sodium, hydroxypropyl cellulose,
lactose monohydrate (see section 2 'Efavirenz contains
lactose'), silica colloidal anhydrous, magnesium stearate,
hypromellose (E464), macrogol 400, titanium dioxide
(E171), iron oxide yellow (E172) and iron oxide red (E172).
What Efavirenz looks like and contents of the pack
Efavirenz tablets are yellow, capsule shaped biconvex
bevelled edge film-coated tablets marked with 'M' on
one side and 'EV6' on the other side.

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.

Efavirenz is available in blisters of 30, 60, 90, 100
film-coated tablets, perforated unit dose blisters of
30 x 1 film-coated tablets, and in plastic bottles of 30,
500 film-coated tablets.

The most notable unwanted effects reported with
Efavirenz in combination with other anti-HIV medicines
are skin rash and nervous system symptoms.

Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

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.

Not all pack sizes may be marketed.

Manufacturer:
Generics[UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland

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.
Tell your doctor if you notice any of the following
side effects:
Very common (affects more than 1 user in 10)
• skin rash
Common (affects 1 in 10 users in 100)
• abnormal dreams, difficulty concentrating, dizziness,
headache, difficulty sleeping, drowsiness, problems
with coordination or balance
• stomach pain, diarrhoea, feeling sick (nausea), vomiting
• itching

This leaflet was last revised in: 559590
01/2015 11300222 MI-03

Date: 26 Jan 2015
Description Efavirenz 600mg 30, 60, 90, 100, 30 x 1, 500
Component Type Leaflet
Affiliate Item Code 559590
Superceded Affiliate Item Code 466985
TrackWise PR No. 559590
MA No. 04569/1303
Packing Site/Printer N/A
Supplier Code 11300222 MI-03
Sign-offs

Pharma Code 1191
SAP No. N/A
Vendor Job No. 244189
Proof No. 2
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

Time: 09:52
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 175 x 500mm

Body Text Size 9 pt

Expand view ⇕

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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