Patient leaflet - Atripla
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) responsible for batch release
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Produ Characteristics, section 4.2).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKE AUTHORISATION
Periodic safety update reports (PSURs)
e set out in the list of Union ive 2001/83/EC and any
The requirements for submission of PSURs for this medicinal pro reference dates (EURD list) provided for under Article 107c(7) subsequent updates published on the European medicines we
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk management plan (RMP)
The marketing authorisation holder all perform the required pharmacovigilance activities
and interventions detailed in the agr P presented in Module 1.8.2 of the marketing authorisation
and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
- At the request of the European Medicines Agency;
- Whenever the risk management system is modified, especially as the result of new information
being rece at may lead to a significant change to the benefit/risk profile or as the result of
an importa armacovigilance or risk minimisation) milestone being reached.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
BOTTLE AND CARTON LABELLING
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1. NAME OF THE MEDICINAL PRODUCT
Atripla 600 mg/200 mg/245 mg film-coated tablets efavirenz/emtricitabine/tenofovir disoproxil
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2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 2 tenofovir disoproxil (as fumarate).
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3. LIST OF EXCIPIENTS
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4. PHARMACEUTICAL FORM AND CONTENTS
30 film-coated tablets
90 (3 bottles of 30) film-coated tablets
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5. METHOD AND ROUTE(S) OF ADMI
TION
Oral use.
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6. SPECIAL WARNI OF THE SIGHT
Read the package leaflet before use.
d reach of children.
T THE MEDICINAL PRODUCT MUST BE STORED OUT REACH OF CHILDREN
7. O
Keep out of the si
PIRY DATE
PECIAL WARNING(S), IF NECESSARY
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
Package leaflet: Information for the patient
Atripla 600 mg/200 mg/245 mg film-coated tablets
Efavirenz/emtricitabine/tenofovir disoproxil
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 si effects not listed in this leaflet. See section 4.
What is in this leaflet:
-
1.
-
2.
-
3.
-
4.
-
5.
-
6.
What Atripla is and what it is used for
What you need to know before you take Atripla
How to take Atripla
Possible side effects
How to store Atripla
Contents of the pack and other information
1.
What Atripla is and what it is used for
man immunodeficiency virus
Atripla contains three active substances that are use (HIV) infection:
Efavirenz is a non-nucleoside reverse tran
Emtricitabine is a nucleoside reverse tra
Tenofovir is a nucleotide reverse tra
inhibitor (NNRTI) se inhibitor (NRTI) ptase inhibitor (NtRTI)
Each of these active substances, also enzyme (reverse transcriptase) that is
s antiretroviral medicines, work by interfering with an tial for the virus to multiply.
Atripla is a treatment for and over who have previou infection under control for previous HIV the
Immunodeficiency Virus (HIV) infection in adults aged 18 years treated with other antiretroviral medicines and have their HIV-1 hree months. Patients must not have experienced failure of a
2.
Do
tripla
eed to know before you take Atripla
– if you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil or any of the other
ingredients of this medicine (listed in section 6).
if you have severe liver disease.
if you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval that puts you at high risk for severe heart rhythm problems (Torsade de Pointes).
if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
if you are currently taking any of the following medicines (see also “Other Medicines and
Atripla”):
-
- astemizole or terfenadine (used to treat hay fever or other allergies)
-
- bepridil (used to treat heart disease)
-
- cisapride (used to treat heartburn)
elbasvir/grazoprevir (used to treat hepatitis C)
ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
midazolam or triazolam (used to help you sleep) pimozide, imipramine, amitriptyline or clomipramine (used to treat certain me conditions)
St. John’s wort (Hypericum perforatum ) (a herbal preparation used for anxiety) voriconazole (used to treat fungal infections) flecainide, metoprolol (used to treat irregular heart beat) certain antibiotics (macrolides, fluoroquinolones, imidazole) triazole antifungal agents certain antimalarial agents methadone (used to treat opiate addiction)
nd
^ If you are taking any of these medicines, tell your doctorj with Atripla could cause serious or life-threatening side ef working properly.
Warnings and precautions
tely. Taking these medicines ts or stop these medicines from
Talk to your doctor or pharmacist before taking Atripla.
You can still pass on HIV when antiretroviral therapy. Discuss wi
people. This medicine is no develop infections or other i
is medicine, although the risk is lowered by effective r doctor the precautions needed to avoid infecting other or HIV infection. While taking Atripla you may still
ses associated with HIV infection.
You must remain un
care of your doctor while taking Atripla.
Tell your d
ou are taking other medicines that contain efavirenz, emtricitabine, tenofovir oproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil. Atripla should not taken with any of these medicines.
if you have or have had kidney disease, or if tests have shown problems with your kidneys. Atripla is not recommended if you have moderate to severe kidney disease.
Atripla may affect your kidneys. Before starting treatment, your doctor may order blood tests to assess kidney function. Your doctor may also order blood tests during treatment to monitor your kidneys.
Atripla is not usually taken with other medicines that can damage your kidneys (see Other medicines and Atripla ). If this is unavoidable, your doctor will monitor your kidney function once a week.
if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
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 Atripla. Your doctor may give you a different anticonvulsant.
if you have a history of liver disease, including chronic active hepatitis. Patients wi liver disease including chronic hepatitis B or C, who are treated with combination antiretrovirals, have a higher risk of severe and potentially life-threatening liver Your doctor may conduct blood tests in order to check how well your liver is may switch you to another medicine. If you have severe liver disease, Atripla (see earlier in section 2, Do not take Atripla).
s.
ing or
e
If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. Tenofovir disoproxil and emtricitabine, two of the active substances in Atripla, show some activity against hepatitis B virus although emtricitabine is not approved for the treatment of hepatitis B infection. Symptoms of your hepatitis may become worse after discontinuation of Atripla. Your may then conduct blood tests
at regular intervals in order to check how well your li working (see section 3, If you
stop taking Atripla).
Independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working.
if you are over 65. Insufficient numbers of patients over 65 years of age have been studied. If you are over 65 years of age and are prescribed Atripla, your doctor will monitor you carefully.
out for:
Once you start taking Atr
signs of dizziness, iculty sleeping, drowsiness, difficulty concentrating or abnormal dream. 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
f skin rash. Rashes may be caused by Atripla. If you see any signs of a rash with blistering or fever, stop taking Atripla and tell your doctor at once. If d a rash while taking another NNRTI, you may be at higher risk of getting a rash 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 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 at once.
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.
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.
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see secti Possible side effects ). Tell your doctor if you have bone pain or fractures.
Tenofovir disoproxil (a component of Atripla) may also cause loss of b the effects of tenofovir disoproxil on long-term bone health and future adult patients are uncertain. Tell your doctor if you know you suffer fro Patients with osteoporosis are at a higher risk of fractures.
verall, in teoporosis.
Children and adolescents
Do not give Atripla to children and adolescents under 18 children and adolescents has not been studied.
Other medicines and Atripla
age. The use of Atripla in
You must not take Atripla with certain medicine the start of section 2. They include some comm St. John’s wort) which can cause serious intera
Tell your doctor or pharmacist if you ar medicines.
ese are listed under Do not take Atripla, at ines and some herbal preparations (including
, have recently taken or might take any other
Also, Atripla should not be taken with any other medicines that contain efavirenz (unless
recommended by your lamivudine or adefovir
ricitabine, tenofovir disoproxil, tenofovir alafenamide, or
Tell your doctor if you are taking other medicines which may damage your kidneys. Some examples include:
-
– aminoglycosides, vancomycin (medicines for bacterial infections)
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– foscarnet, ganciclovir, cidofovir (medicines for viral infections)
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– a ricin B, pentamidine (medicines for fungal infections)
in-2 (to treat cancer)
steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains) la may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. As a result, the amounts of Atripla or other medicines in your blood may be affected. This may stop your 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:
Medicines containing didanosine (for HIV infection): Taking Atripla with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts. Inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported rarely when medicines
containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
Other medicines used for HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir boosted atazanavir or saquinavir. Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors. Also, tell your doctor if you are taking maraviroc.
Medicines used to treat infection with the hepatitis C virus: elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin, simvastatin. Atripla 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.
Medicines used to treat convulsions/seizures (anticonvulsants): Carbamazepine, phenytoi phenobarbital. Atripla can reduce the amount of the anticonvulsant in your blood.
Carbamazepine can reduce the amount of efavirenz, one of the components of Atripla blood. Your doctor may need to consider giving you a different anticonvulsant.
Medicines used to treat bacterial infections, including tuberculosis and AI mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin. Your docto to consider changing your dose or giving you an alternative antibiotic. In addition, your doctor
may consider giving you an additional dose of efavirenz to treat your Medicines used to treat fungal infections (antifungals): Itraconazol
Atripla can reduce the amount of itraconazole or posaconazole in need to consider giving you a different antifungal.
Medicines used to treat malaria: Atovaquone/proguanil o
may reduce the amount of atovaquone/proguanil or arte Hormonal contraceptive, such as birth control pills, example, Depo-Provera), or a contraceptive implant also use a reliable barrier method of contraception (see
may need
fection.
saconazole.
ur blood. Your doctor may
er/lumefantrine. Atripla efantrine in your blood.
injected contraceptive (for example, Implanon): You must regnancy and breast-feeding ). Atripla
may make hormonal contraceptives less likely to work. Pregnancies have occurred in women taking efavirenz, a component of Atripla, while using a contraceptive implant, although it has not been established that the efavirenz therapy caused the contraceptive to fail.
Sertraline, a medicine used to treat ssion, as your doctor may need to change your dose of
sertraline.
Bupropion , a medicine used to treat depression or to help you stop smoking, as your doctor may need to change your dose of bupropion.
Diltiazem or similar medicines (called calcium channel blockers): When you start taking Atripla, your doctor may need to adjust your dose of the calcium channel blocker.
Medicines used to nt organ transplant rejection (also called immunosuppressants) ,
limus or tacrolimus. When you start or stop taking Atripla your doctor
will closely
such as cyclosporine,
our plasma levels of the immunosuppressant and may need to adjust its
cy and breast-feeding
acenocoumarol (medicines used to reduce clotting of the blood): Your doctor adjust your dose of warfarin or acenocoumarol.
ba extracts (herbal preparation).
izole , a medicine used to treat pain and fever.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women should not get pregnant during treatment with Atripla 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 Atripla.
If you could get pregnant while receiving Atripla , 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, one of the active
components of Atripla, 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 Atripla.
Tell your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should take Atripla only if you and your doctor decide it is clearly needed.
Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
If you have taken Atripla during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Do not breast-feed during treatment with Atripla. Both HIV and the ingredients pass through breast milk and cause serious harm to your baby.
pla may
Driving and using machines
Atripla may cause dizziness, impaired concentration and drowsin drive and do not use any tools or machines.
Atripla contains sodium
This medicine contains less than 1 mmol sodium (23 mg ‘sodium-free’.
blet, that is to say essentially
are affected, do not
3. How to take Atripla
Always take this medicine exactly or pharmacist if you are not sure.
ctor or pharmacist has told you. Check with your doctor
The recommended dose is:
One tablet taken each day defined as 1 hour before o effects (for examp
Atripla must b
If your doc emtricitabi HIV infect
If you tak
very day.
. Atripla should be taken on an empty stomach (commonly urs after a meal) preferably at bedtime. This may make some side ss, drowsiness) less troublesome. Swallow Atripla whole with water.
cides to stop one of the components of Atripla, you may be given efavirenz, ne and/or tenofovir disoproxil separately or with other medicines for the treatment of your ion.
e more Atripla than you should
If you accidentally take too many Atripla tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects ). Contact your doctor or nearest emergency department for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.
If you forget to take Atripla
It is important not to miss a dose of Atripla.
If you do miss a dose of Atripla within 12 hours of when it is usually taken , take it as soon as you can, and then take your next dose at its regular time.
If it is almost time (less than 12 hours) for your next dose anyway, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten tablet.
If you throw up the tablet (within 1 hour after taking Atripla) , you should take another tablet. Do not wait until your next dose is due. You do not need to take another tablet if you were sick more than 1 hour after taking Atripla.
If you stop taking Atripla
Don’t stop taking Atripla without talking to your doctor. Stopping Atripla can seriously your response to future treatment. If Atripla is stopped, speak to your doctor before you restart taking Atripla tablets. Your doctor may consider giving you the components of Atripla se f you are
having problems or need your dose adjusted.
When your supply of Atripla 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 both HIV infection and hepatitis B, it is especially i t not to stop your Atripla
treatment without talking to your doctor first. Some patients have ood tests or symptoms
indicating that their hepatitis has got worse after stopping emtricit or tenofovir disoproxil (two of
the three components of Atripla). If Atripla is stopped your doctor may recommend that you resume hepatitis B treatment. You may require blood tests to check howyour liver is working for 4 months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
^ Tell your doctor immediately about neWOr unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
If you have any further questions
4. Possible side effects
e of this medicine, ask your doctor or pharmacist.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Like all
Po
s, this medicine can cause side effects, although not everybody gets them.
rious side effects: tell your doctor immediately
Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in every 1,000 patients) but serious side effect that can be fatal. The following side effects may be signs of lactic acidosis:
-
– deep rapid breathing
-
– drowsiness
-
– feeling sick (nausea), being sick (vomiting) and stomach pain.
^ If you think you may have lactic acidosis, contact your doctor immediately.
Other possible serious side effects
The following side effects are uncommon (these may affect up to 1 in every 100 patients):
allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
swelling of the face, lips, tongue or throat
angry behaviour, suicidal thoughts, strange thoughts, paranoia, unable to think clearly, mood being affected, seeing or hearing things that are not really there (hallucinations), suicide attempts, personality change (psychosis), catatonia (a condition in which the patient is rendered motionless and speechless for a period).
pain in the abdomen (stomach), caused by inflammation of the pancreas
forgetfulness, confusion, fitting (seizures), incoherent speech, tremor (shaking)
yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammat liver
damage to kidney tubules
Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis. Some patients have 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.
Side effects to the liver: If you are also infected with hepatitis B virus, you may experience a worsening of hepatitis after discontinuation of treatment (see section 3).
The following side effects are rare (these may affect up to
ery 1,000 patients):
liver failure, in some cases leading to death or liver transplant. Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease
inflammation of the kidney, passing f urine and feeling thirsty
back pain caused by kidney problem uding kidney failure. Your doctor may do blood tests
to see if your kidneys are working properly
softening of the bones (wi due to damage to the kidn fatty liver
ain and sometimes resulting in fractures) which may occur cells
^ If you think that yoo
Most frequent si
The follo
ve any of these serious side effects, talk to your doctor.
ects are very common (these may affect more than 1 in 10 patients) ss, headache, diarrhoea, feeling sick (nausea), being sick (vomiting)
(including red spots or blotches sometimes with blistering and swelling of the skin), may be allergic reactions
ing weak
Tests may also show:
- decreases in phosphate levels in the blood
- increased levels of creatine kinase in the blood that may result in muscle pain and weakness
Other possible side effects
The following side effects are common (these may affect up to 1 in 10 patients)
allergic reactions
disturbances of coordination and balance
feeling worried or depressed
difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
pain, stomach pain
problems with digestion resulting in discomfort after meals, feeling bloated, wind (flatulence)
loss of appetite
tiredness
itching
changes in skin colour including darkening of the skin in patches often starting on hands and soles of feet
Tests may also show:
- low white blood cell count (a reduced white blood cell count can make you more pron
infection)
- liver and pancreas problems
- increased fatty acids (triglycerides), bilirubin or sugar levels in the blood
The following side effects are uncommon (these may affect up to 1 in every 1
breakdown of muscle, muscle pain or weakness
ersistent noise in the ears
anaemia (low red blood cell count)
a feeling of spinning or tilting (vertigo), whistling, ringing blurred vision chills
breast enlargement in males decreased sexual drive flushing dry mouth increased appetite
Tests may also show:
- decreases in potassium in t
- increases in creatinine in th
- proteins in urine
- increased cholestero
lood
The breakdown of fractures), muscle occur due to dama
e, softening of the bones (with bone pain and sometimes resulting in uscle weakness and decreases in potassium or phosphate in the blood may idney tubule cells.
The follo
ide effects are rare (these may affect up to 1 in every 1,000 patients)
rash to the skin caused by a reaction to sunlight
e effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.5. How to store Atripla
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 bottle and carton after {EXP}. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
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 Atripla contains
The active substances are efavirenz, emtricitabine and tenofovir disoproxil. Each Atrip film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and tenofovir disoproxil (as fumarate).
The other ingredients in the tablet are croscarmellose sodium, hyprolose, microcrystalline cellulose, sodium laurilsulfate. Refer to section 2 “Atrip The other ingredients in the tablet film coating are iron oxide black, iron macrogol 3350, poly(vinyl alcohol), talc, titanium dioxide.
stearate,
contains sodium”. de red,
What Atripla looks like and contents of the pack
Atripla film-coated tablets are pink, capsule shaped tablets, engra
“123” and plain on the other side. Atripla comes in bottles o must be kept in the bottle to help protect your tablets). The s separate sachet and should not be swallowed.
one side with the number
ablets (with a silica gel sachet that
ilica gel desiccant is contained in a
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder a
facturer
Marketing Authorisation Holder: Gilead Sciences Ireland UC Carrigtohill
County Cork, T45 DP77
Ireland
Manufactur Gilead Scie IDA Busine Ca Co r any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
d UC nology Park
België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50
Lietuva
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 (0) 22 262 8702
Efcnrapun
Gilead Sciences Ireland UC
Ten.: + 353 (0) 1 686 1888
Česká republika
Gilead Sciences s.r.o.
Tel: + 420 (0) 910 871 986
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Gilead Sciences Belgium SRL-BV
Tel/Tel: + 32 (0) 24 01 35 50
Magyarorszag
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888
Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849
Deutschland
Gilead Sciences GmbH Tel: + 49 (0) 89 899890–0
Eesti
Gilead Sciences Poland Sp. z o.o.
Tel.: +48 (0) 22 262 8702
EXXáóa
Gilead Sciences EZZàç M.EnE.
Tql: + 30 210 8930 100
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Gilead Sciences, S.L.
Tel: + 34 91 378 98 30
Norge
Gilead Sciences Sweden
Tlf: + 46 (0) 8 5057 184
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Tel: + 353 (0) 1 686 1888
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Tel: + 31 (0) 20 718 36 98
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Tel: + 43 1 2
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Gilead Sciences
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Ireland
Gilead Sciences Ireland
Tel: + 353 (0) 214
Ísland
Gilead Scie
Sími: + 4
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Italia
Sciences S.r.l.
39 02 439201
Gilead Sciences, Lda. Tel: + 351 21 7928790
Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 (0) 232 121 210
Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849
Kùnpoç
Gilead Sciences EÂÂàç M.EnE.
Tql: + 30 210 8930 100
Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849
Latvija
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 (0) 22 262 8702
United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700
This leaflet was last revised in.
Detailed information on this medicine is available on the European Medicines Agency web site:
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