Atripla
efavirenz, emtricitabine, tenofovir disoproxil
Efavirenz/emtricitabine/tenofovir disoproxil
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 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
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Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply.
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.
St. John’s wort (Hypericum perforatum) (a herbal preparation used for depression and anxiety)
→ If you are taking any of these medicines, tell your doctor immediately. Taking these medicines with Atripla could cause serious or life-threatening side effects or stop these medicines from working properly.
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Talk to your doctor or pharmacist before taking Atripla.
You must remain under the care of your doctor while taking Atripla.
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 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 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 doctor may then conduct blood tests at regular intervals in order to check how well your liver is working (see section 3, If you stop taking Atripla).
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Independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working.
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 (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.
Tenofovir disoproxil (a component of Atripla) may also cause loss of bone mass. Overall, the effects of tenofovir disoproxil on long-term bone health and future fracture risk in adult patients are uncertain. Tell your doctor if you know you suffer from osteoporosis. Patients with osteoporosis are at a higher risk of fractures.
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You must not take Atripla with certain medicines. These are listed under Do not take Atripla, at the start of section 2. They include some common medicines and some herbal preparations (including St. John’s wort) which can cause serious interactions.
Also, Atripla should not be taken with any other medicines that contain efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil.
aminoglycosides, vancomycin (medicines for bacterial infections)
foscarnet, ganciclovir, cidofovir (medicines for viral infections)
amphotericin B, pentamidine (medicines for fungal infections)
interleukin-2 (to treat cancer)
non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Atripla 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:
containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
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.
glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
may consider giving you an additional dose of efavirenz to treat your HIV infection.
Atripla can reduce the amount of itraconazole or posaconazole in your blood. Your doctor may
need to consider giving you a different antifungal.
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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). 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.
will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
may need to adjust your dose of warfarin or acenocoumarol.
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.
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.
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.
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This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
One tablet taken each day by mouth. Atripla should be taken on an empty stomach (commonly defined as 1 hour before or 2 hours after a meal) preferably at bedtime. This may make some side
effects (for example, dizziness, drowsiness) less troublesome. Swallow Atripla whole with water. Atripla must be taken every day.
If your doctor decides to stop one of the components of Atripla, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection.
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.
It is important not to miss a dose of Atripla.
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→ Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
If you have any further questions on the use 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 medicines, this medicine can cause side effects, although not everybody gets them.
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.
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 inflammation of the 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 1 in every 1,000 patients):
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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 a lot of urine and feeling thirsty
back pain caused by kidney problems, including kidney failure. Your doctor may do blood tests to see if your kidneys are working properly
softening of the bones (with bone pain and sometimes resulting in fractures) which may occur due to damage to the kidney tubule cells
fatty liver
→ If you think that you may have any of these serious side effects, talk to your doctor. Most frequent side effects
The following side effects are very common (these may affect more than 1 in 10 patients)
dizziness, headache, diarrhoea, feeling sick (nausea), being sick (vomiting)
rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions
feeling 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
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 prone to 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 100 patients):
breakdown of muscle, muscle pain or weakness
anaemia (low red blood cell count)
a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears
blurred vision
chills
breast enlargement in males
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decreased sexual drive
flushing
dry mouth
increased appetite
Tests may also show:
decreases in potassium in the blood
increases in creatinine in the blood
proteins in urine
increased cholesterol in the blood
The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
The following side effects are rare (these may affect up to 1 in every 1,000 patients)
itchy rash to the skin caused by a reaction to sunlight
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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
The active substances are efavirenz, emtricitabine and tenofovir disoproxil. Each Atripla film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate).
The other ingredients in the tablet are croscarmellose sodium, hyprolose, magnesium stearate,
microcrystalline cellulose, sodium laurilsulfate. Refer to section 2 “Atripla contains sodium”.
The other ingredients in the tablet film coating are iron oxide black, iron oxide red, macrogol 3350, poly(vinyl alcohol), talc, titanium dioxide.
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Atripla film-coated tablets are pink, capsule shaped tablets, engraved on one side with the number “123” and plain on the other side. Atripla comes in bottles of 30 tablets (with a silica gel sachet that must be kept in the bottle to help protect your tablets). The silica gel desiccant is contained in a separate sachet and should not be swallowed.
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: Gilead Sciences Ireland UC Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer:
Gilead Sciences Ireland UC
IDA Business & Technology Park Carrigtohill
County Cork Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Gilead Sciences Belgium SRL-BV Tél/Tel: + 32 (0) 24 01 35 50
Gilead Sciences Poland Sp. z o.o. Tel.: + 48 (0) 22 262 8702
Gilead Sciences Ireland UC Тел.: + 353 (0) 1 686 1888
Gilead Sciences Belgium SRL-BV Tél/Tel: + 32 (0) 24 01 35 50
Gilead Sciences s.r.o.
Tel: + 420 (0) 910 871 986
Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1888
Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98
Gilead Sciences Poland Sp. z o.o.
Tel.: +48 (0) 22 262 8702
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849
Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: + 30 210 8930 100
Gilead Sciences GesmbH Tel: + 43 1 260 830
Gilead Sciences, S.L. Tel: + 34 91 378 98 30
Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
Gilead Sciences
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Tél: + 33 (0) 1 46 09 41 00
Gilead Sciences, Lda. Tel: + 351 21 7928790
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
Gilead Sciences Sweden AB Sími: + 46 (0) 8 5057 1849
Gilead Sciences Slovakia s.r.o. Tel: + 421 (0) 232 121 210
Gilead Sciences S.r.l. Tel: + 39 02 439201
Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: + 30 210 8930 100
Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849
Gilead Sciences Poland Sp. z o.o. Tel.: + 48 (0) 22 262 8702
Gilead Sciences Ireland UC Tel: + 44 (0) 8000 113 700
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