600 mg / 200 mg / 245 mg film-coated tablets 
efavirenz / emtricitabine / tenofovir disoproxil

1. What Atripla is and what it is used for

Atripla contains three active substances that are used to treat human immunodeficiency virus ( HIV ) infection :

  • Efavirenz is a nucleoside non-reverse transcriptase inhibitor (NNRTI)
  • Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
  • Tenofovir is a nucleotide-type reverse transcriptase inhibitor (NRTI)

These three active substances are antiretroviral drugs that act by affecting the normal function of an enzyme (reverse transcriptase) that the virus needs for its reproduction.

Atripla is a treatment for Human Immunodeficiency Virus ( HIV ) infection in adults aged 18 years and older who have previously been treated with other antiretroviral drugs and who have their HIV- 1 infection under control for at least three months. Patients must not have shown treatment failure with previous HIV treatment.

2. What you need to know before you take Atripla

Do not 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 heart problems, such as an arrhythmia called QT prolongation. This can lead to a high risk of developing severe heart rhythm problems ( torsade de points ).
  • If someone in your family (parents, grandparents, brothers, or sisters) has died suddenly due to heart problems 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 taking any of the following medicines at the same time (see also “Other medicines and Atripla”:- astemizole or terfenadine (used to treat hay fever or other allergies s)- bepridil (used to treat heart disease)- cisapride (used to treat heartburn)- elbasvir/grazoprevir (used to treat hepatitis C)- ergot alkaloids (eg ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)– midazolam or triazolam (sleeping pills)– pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions)– St. John’s wort ( Hypericum perforatum ) (an herbal medicine used for depression and anxiety)– voriconazole (used to treat fungal infections)– flecainide, metoprolol (for the treatment of irregular heartbeat)- certain antibiotics ( macrolides, fluoroquinolones, imidazole)- certain antifungal medicines (triazoles)certain medicines for malaria- methadone (for the treatment of opioid dependence).

→ If you are taking any of these medicines, tell your doctor immediately. Taking these medicines together with Atripla may cause serious or life-threatening side effects or counteract the effects of these medicines.

Warnings and cautions

Talk to your doctor or pharmacist before taking Atripla

  • You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others. This medicine does not cure HIV – infection. While taking Atripla you may still develop infections you or other illnesses associated with HIV – infection.
  • You must continue to be under medical observation while taking Atripla.
  • Inform your doctor :
    • if you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine, or adefovir dipivoxil. Atripla should not be taken with any of these medicines.
    • if you have or have had kidney disease or if tests have shown that you have kidney problems. Atripla is not recommended if you have moderate to severe kidney disease.

Atripla can affect your kidneys. Before starting treatment, your doctor may prescribe a blood test to check your kidney function. Your doctor may also prescribe blood tests during treatment to check your kidneys.

Atripla is not usually taken with other medicines that can damage the kidneys (see Other medicines and Atripla ). If this is unavoidable, your doctor will check your kidney function once a week.

  • if you have a heart condition, such as an abnormal electrical signal called an extended QT interval.
  • if you have had a mental illness including depression or drug or alcohol abuse. Talk immediately to your doctor if you feel depressed, have suicidal thoughts, or have strange thoughts (see section 4, Possible side effect s ).
  • if you have had seizures or if you are being treated with anticonvulsants such as carbamazepine, phenobarbital, and phenytoin. If you are taking any of these medicines, your doctor may need to check how much of the medicine is in your blood to ensure that it is not affected when you take Atripla. Your doctor may give you another medicine for seizures.
  • if you have had liver disease, including chronic active hepatitis. Patients with liver disease, including chronic hepatitis B or C, who are being treated with combination antivirals are at increased risk of serious and potentially life-threatening liver problems. Your doctor may take blood samples to check your liver function or allow you to switch to another medicine. If you have severe liver disease, do not take Atripla (see earlier in section 2, Do not take Atripla ).
    If you have hepatitis B infection
    , your doctor will carefully choose the best treatment for you. Tenofovir disoproxil and emtricitabine, two of the active substances of Atripla, have some activity against hepatitis B virus even though emtricitabine is not approved for the treatment of hepatitis B infection. The symptoms of your hepatitis may worsen after you stop taking Atripla. Your doctor may then take blood samples regularly to check your liver function (see section 3, If you stop taking Atripla ).
  • Whether or not you have had liver disease, your doctor will consider taking regular blood tests to check your liver function.
  • if you are over 65 years old. An insufficient number of patients over the age of 65 have been studied. If you are over 65 years of age and have been prescribed Atripla, your doctor will monitor you closely.

When you start taking Atripla, you should be observant of:

  • symptoms such as dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These side effects can occur in the first 1 to 2 days after treatment and usually disappear after 2 to 4 weeks.
  • symptoms of the rash. Atripla can cause a rash. If you see symptoms of severe rash with blistering or fever, stop taking Atripla and tell your doctor straight away. If you have had a rash while taking another NNRTI, you may be at greater risk of getting a rash with Atripla.
  • symptoms of inflammation or infection. In some patients with advanced HIV – infection ( AIDS ) and a history of opportunistic infection, you may be signs and symptoms of inflammation from previous infections you may occur soon after anti- HIV started. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present but without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection.In addition to opportunistic infections, autoimmune disorders (conditions in which the immune system attacks healthy body tissue) can also occur after you start taking medication to treat your HIV infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, informs your doctor immediately for the necessary treatment.
  • skeletal problems. Some patients receiving combination antiretroviral therapy may develop a skeletal disease called osteonecrosis (skeletal tissue dies due to lost blood supply to the skeleton). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system,, and higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms. Bone problems (sometimes resulting in fractures s) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects s ).

Children and young people

Atripla should not be given to children and adolescents under 18 years of age. Atripla has not yet been studied in children and adolescents.

Pregnancy and breastfeeding

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 become pregnant during treatment with Atripla or for 12 weeks thereafter. Your doctor may ask you to take a pregnancy test to make sure you are not pregnant before starting treatment with Atripla.

If you could become pregnant during treatment with Atripla, you must use a reliable barrier contraceptive method (eg condoms) together with other contraceptive methods such as tablets ( birth control pills ) or other hormonal contraceptive methods (eg implants , injections ).

Efavirenz, one of the ingredients of Atripla, may remain in the blood for some time after stopping treatment. You should therefore continue to use contraception, as described above, for 12 weeks after stopping Atripla.

Tell your doctor immediately if you are pregnant or planning to become pregnant. If you are pregnant, you should only take Atripla if you and your doctor decide that there is a clear need.

Serious malformations have been observed in fetal animals and in neonates to 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 ask you to have regular blood tests and other tests to check your baby’s development. For children whose mothers took NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.

Do not breast-feed during treatment with Atripla. Both HIV and the ingredients in Atripla can be transferred to breast milk and can seriously harm your baby.

Driving and using machines

Atripla may cause dizziness, impaired concentration, and drowsiness. If you get these symptoms, do not drive, use any tools or machines.

Atripla contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Atripla

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

One tablet once a day by mouth. Atripla is recommended to be taken on an empty stomach (usually defined as 1 hour before or 2 hours after a meal), preferably at bedtime. This may help reduce certain side effects (eg dizziness, drowsiness). Swallow whole 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 to treat your HIV – infection.

If you take more Atripla than you should

If you accidentally take too many tablets of Atripla, you may be at greater risk of any side effect s of this medicine (see section 4, Possible side effect s ). Contact your doctor or nearest emergency department for advice. Save the jar so you can easily describe what you took.

If you forget to take Atripla

It is important that you do not miss any dose of Atripla.

If you miss a dose of Atripla within 12 hours of the time it is usually taken, take it as soon as possible, and then take the next dose at its usual time.

If it is almost time (less than 12 hours) for the next dose, do not take the missed dose. Wait and take the next dose at its regular time. Do not take a double dose to make up for a forgotten tablet.

If you vomit the tablet (within 1 hour of taking Atripla), take a new tablet. Do not wait until it is time for your next tablet. You do not need to take a new tablet if you vomit more than 1 hour after taking Atripla.

If you stop taking Atripla

Do not stop taking Atripla without talking to your doctor. Discontinuation of treatment with Atripla can seriously affect how you respond to treatment in the future. If you have stopped taking Atripla, talk to your doctor before taking Atripla again. If you have problems or need to adjust the dose, your doctor may consider giving you the ingredients of Atripla separately.

When your tablets start to run out, be sure to get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase as soon as you stop taking the medicine, even if it is only for a short time. The virus can then becomes more difficult to treat.

If you have both HIV – infection and hepatitis B, it is especially important not to stop treatment without first talking to your doctor. Some patients’ blood tests or symptoms have shown that their hepatitis worsens when treatment is stopped with emtricitabine or tenofovir disoproxil (two of the three ingredients of Atripla). If treatment with Atripla is stopped, your doctor may recommend that you resume hepatitis B treatment. You may need to submit blood samples for 4 months after stopping treatment to check your liver function. In some patients with advanced liver or cirrhosis of the liver, discontinuation of treatment is not recommended as this may lead to hepatitis one worsens, which can be life-threatening.

 Tell your doctor immediately about new or unusual symptoms that occur after stopping treatment, especially symptoms associated with hepatitis B infection.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible serious side effects: contact a doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (can occur in up to 1 in 1,000 patients) but serious side effect that can be life-threatening.

The following side effects may be signs of lactic acidosis:

  • deep, rapid breathing
  • fatigue
  • nausea, vomiting, and abdominal pain

→ If you think you have lactic acidosis, contact your doctor immediately.

Other possible serious side effect s

The following side effects are uncommon (may affect up to 1 in 100 people):

  • allergic reactions (hypersensitivity) that can cause severe skin reactions ( Stevens-Johnson syndrome, erythema multiforme, see section 2)
  • swelling of the face, lips, tongue, or throat
  • angry behavior, suicidal thoughts, strange thoughts, paranoia, inability to think clearly, the influence of mood, see or hear things that do not really exist (hallucinations), suicide attempts, personality changes ( psychosis ), catatonia (the patient ends up in an immobile and dumb state for a period)
  • abdominal pain (stomach) caused by inflammation of the pancreas
  • forgetfulness, confusion, seizures, incoherent speech, tremor (tremors)
  • yellow skin or yellow eyes, itching or pain in the abdomen (stomach) caused by inflammation of the liver
  • damage to the renal tubules.

Mental side effects are in addition to the side effects listed above, imagination (false beliefs), neuroses. Some patients have committed suicide. The problems tend to occur more often in those who have previously had a mental illness. Always contact your doctor immediately if you experience these symptoms.

Hepatic side effects: If you also have a hepatitis B virus infection, you may experience a worsening of your hepatitis when treatment is stopped (see section 3).

The following side effects are rare (may affect up to 1 in 1,000 people):

  • liver failure, which in some cases leads to death or liver transplantation. Most cases have occurred in patients who already had liver disease, but there have been a few reports of patients without existing liver disease.
  • kidney inflammation, that you urinate a lot, and that you feel thirsty
  • back pain caused by kidney problems, including kidney failure. Your doctor may take blood samples to check that your kidneys are working properly
  • Impaired bone hardness (which causes bone pain and sometimes leads to fractures ) can occur due to damage to kidney tubules’
  • fatty liver.

→ Contact your doctor if you think you may have any of these serious side effects.

The most common side effects are

The following side effects are very common (may affect more than 1 in 10 people):

  • dizziness, headache, diarrhea, nausea, vomiting
  • rash (including red spots or spots sometimes with blistering and swelling of the skin), which may be allergic reactions
  • feeling weak

Samples can also show:

  • lowering of phosphate levels in the blood
  • elevated levels of creatine kinases in the blood that can cause muscle pain and muscle weakness

Other possible side effects are

The following side effects are common (may affect up to 1 in 10 people):

  • allergic reactions
  • coordination and balance disorders
  • worried or depressed
  • difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
  • pain, abdominal pain
  • indigestion which results in discomfort after meals, feeling of bloating, flatulence
  • no appetite
  • fatigue
  • itching
  • discoloration of the skin including dark spots on the skin that often begin on the hands and soles of the feet

Samples can also show:

  • low white blood cell count (a decrease in white blood cell count may make you more likely to get an infection )
  • liver and pancreatic disorders
  • elevated levels of fatty acids ( triglycerides ), bilirubin in the blood, or elevated blood sugar

The following side effects are uncommon (may affect up to 1 in 100 people):

  • muscle breakdown, muscle pain, or muscle weakness
  • anemia (low red blood cell count )
  • a feeling of tingling or dizziness, wheezing, ringing, or other persistent soundss in the ears
  • dimsyn
  • frostbite
  • breast augmentation in men
  • reduced sexual drive
  • herds
  • dry mouth
  • increased appetite

Samples can also show:

  • decreased potassium levels in the blood
  • elevated creatinine levels in the blood
  • protein is in the urine
  • elevated blood cholesterol levels

Muscle breakdown decreased bone hardness (which causes bone pain and sometimes leads to fractures ), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood can occur due to damage to kidney tubules.

The following side effects are rare (may affect up to 1 in 1,000 people):

  • the itchy rash caused by a reaction to sunlight

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 can and on the carton after {EXP} The expiration date is the last day of that month.

Store in the original package. Moisture sensitive. Close the jar tightly.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are efavirenz, emtricitabine, and tenofovir disoproxil. One Atripla film-coated tablet contains 600 mg efavirenz, 200 mg emtricitabine, and 245 mg tenofovir disoproxil (as fumarate).

The other ingredients in the tablet are croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. See section 2, “Atripla contains sodium”.

The other ingredients in the tablet film casing are black iron oxide, red iron oxide, macrogol 3350, poly (vinyl alcohol), talc, titanium dioxide.

What the medicine looks like and the contents of the pack

Atripla film-coated tablets are pink, capsule-shaped tablets marked with the number “123” on one side and unmarked on the other side. Atripla comes in jars of 30 tablets (with a sachet of silica jelly that must be stored in the jar to protect your tablets). The desiccant, the silica gel, is stored in a separate portion bag and should not be swallowed.

The following pack sizes are available: Outer cartons containing 1 can of 30 film-coated tablets or 90 (3 cans of 30) film-coated

tablets. Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Gilead Sciences Ireland UC

Carrigtohill

Country Cork, T45 DP77

Ireland

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine:
Belgium / Belgique / BelgienGilead Sciences Belgium SPRL-BVBATel: + 32 (0) 24 01 35 50 LithuaniaGilead Sciences Poland Sp. z ooTel .: + 48 (0) 22 262 8702
BulgariaGilead Sciences Ireland UCTel .: + 353 (0) 1 686 1888 Luxembourg / LuxemburgGilead Sciences Belgium SPRL-BVBATel: + 32 (0) 24 01 35 50
Czech RepublicGilead Sciences sroTel: + 420 (0) 910 871 986 HungaryGilead Sciences Ireland UCTel: + 353 (0) 1 686 1888
MaltaGilead Sciences Ireland UCTel: + 353 (0) 1 686 1888
GermanyGilead Sciences GmbHTel: + 49 (0) 89 899890-0 The NetherlandsGilead Sciences Netherlands BVTel: + 31 (0) 20 718 36 98
EestiGilead Sciences Poland Sp. z ooTel .: + 48 (0) 22 262 8702
GreeceGilead Sciences Μλλάς Μ.ΕΠΕ.:Ηλ: + 30 210 8930 100 AustriaGilead Sciences GesmbHTel: + 43 1 260 830
SpainGilead Sciences, SLTel: + 34 91 378 98 30 PolandGilead Sciences Poland Sp. z ooTel: + 48 22 262 8702
FranceGilead SciencesTel: + 33 (0) 1 46 09 41 00 PortugalGilead Sciences, Lda.Tel: + 351 21 7928790
CroatiaGilead Sciences Ireland UCTel: + 353 (0) 1 686 1888 RomaniaGilead Sciences Ireland UCTel: + 353 (0) 1 686 1888
IrelandGilead Sciences Ireland UCTel: + 353 (0) 214 825 999 SloveniaGilead Sciences Ireland UCTel: + 353 (0) 1 686 1888

Slovak RepublicGilead Sciences Slovakia sroTel: + 421 (0) 232 121 210
ItalyGilead Sciences SrlTel: + 39 02 439201
ΚύπροςGilead Sciences Μλλάς Μ.ΕΠΕ.:Ηλ: + 30 210 8930 100
LatviaGilead Sciences Poland Sp. z ooTel .: + 48 (0) 22 262 8702 United KingdomGilead Sciences LtdTel: + 44 (0) 8000 113 700

Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Muhammad Nadeem

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