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.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan is and what it is used for 
2. What you need to know before you take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 
3. How to take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 
4. Possible side effects 
5. How to store Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 
6. Contents of the packaging and other information 

What Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan is and what it is used for

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan contains three active substances 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 disoproxil 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.

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 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 HIV1 infection under control for at least three months. Patients must not have shown treatment failure with previous HIV treatment.

What you need to know before you take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan

Do not take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan:

  • 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 pointes ).
  • 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan”):
    • 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 (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 to treat depression and anxiety)
    • voriconazole (used to treat fungal infections)
    • flecainide, metoprolol (for the treatment of irregular heartbeat)
    • certain antibiotics ( macrolides , fluoroquinolones , imidazole)
    • certain antifungal drugs (triazoles)
    • certain anti-malarial drugs
    • methadone (for the treatment of opioid dependence).

If you are taking any of these medicines, tell your doctor immediately. Taking these medicines together with Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan.

  • You can still transmit HIV infection while taking 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 efavirenz/emtricitabine/tenofovir disoproxil Mylan may still develop infections you or other illnesses associated with HIV – infection.
  • You must continue to be under medical supervision while taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan.
  • Inform your doctor:
    • if you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine or adefovir dipivoxil. Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 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. Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan is not recommended if you have moderate to severe kidney disease.
      Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may 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.
      Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan is not usually taken with other medicines that can damage the kidneys (see Other medicines and Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan ). 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,l, and phenytoin. If you are taking any of these medicines, your doctor may need to check the amount of the medicine in your blood to make sure that it is not affected when you take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan. 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan (see earlier in section 2, Do not take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan ).
      If you have a hepatitis B infection, your doctor will carefully choose the best treatment for you. Tenofovir disoproxil and emtricitabine, two of the active substances in Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, have some activity against hepatitis B virus even though emtricitabine is not approved for the treatment of hepatitis B infection. Your hepatitis symptoms may worsen after you stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan. Your doctor may then take blood tests regularly to check your liver function (see section 3, If you stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan).
    • 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, your doctor will monitor you closely.

When you start taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 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. Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may cause rash. If you notice symptoms of severe rash with blistering or fever, stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan and tell your doctor straight away. If you get a rash while taking another NNRTI, you may be at greater risk of getting a rash with Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan.
  • 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 that 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 infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines 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, inform your doctor immediately for the necessary treatment.
  • skeletal problems. Some patients taking combination antiviral therapy may develop a skeletal disease called osteonecrosis (dead bone tissue due to loss of blood supply to the skeleton). The duration of combination antiviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (severely weakened immune system), and high body mass index ( BMI ) can be some of the many risk factors for developing the disease. Signs of osteonecrosis are stiff and aching joints (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, talk to your doctor.
    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

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan should not be used in children and adolescents below 18 years. Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan has not yet been studied in children and adolescents.

Other medicines and Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan

You must not take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan with certain medicines. These medicines are listed under Do not take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, at the beginning of section 2. They include some common medicines and some herbal medicines (including St. John’s wort ) which may cause serious interactions.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Also, Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan should not be taken with other medicines containing efavirenz (unless your doctor recommends it), emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine, or adefovir dipivoxil.

Tell your doctor if you are taking other medicines that may damage your kidneys. Examples of such drugs are:

  • aminoglycosides, vancomycin (medicine for bacterial infection )
  • foskarnet, ganciclovir, cidofovir (medicines for viral infections)
  • amphotericin B, pentamidine (medicine for fungal infections)
  • interleukin2 (for the treatment of cancer)
  • non-steroidal anti-inflammatory drugs ( NSAIDs, to relieve skeletal or muscle pain)

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may interact with other medicines, including herbal medicines such as Ginkgo biloba extract. As a result, the amount of Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan or other medicines in the blood may be affected. This can lead to the medicines not working properly or the side effects getting worse. In some cases, your doctor may need to adjust your dose or check your blood levels. You must tell your doctor or pharmacist if you are taking any of the following:

  • Medicines containing didanosine (for HIV – infection ): If you are taking efavirenz/emtricitabine/tenofovir disoproxil Mylan together with other antiviral medicines that contain didanosine, blood levels of didanosine and increase CD4 cell counts. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), in some cases with a fatal outcome, have been reported during concomitant treatment with drugs containing tenofovir disoproxil and didanosine. Your doctor will carefully consider whether you can be treated with medicines containing tenofovir and didanosine.
  • Other medicines used to treat HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir with an increased dose of atazanavir or saquinavir. Your doctor may consider giving you alternative medicines or changing the dose of one of your protease inhibitors. Also, tell your doctor if you are taking maraviroc.
  • Drugs used to treat infection by the hepatitis C virus:elbasvir / grazoprevir, glekaprevir / pibrentasvir, sofosbuvir / velpatasvir, sofosbuvir / velpatasvir / voxilaprevir.
  • Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin, simvastatin. Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may reduce the number of statins in the blood. Your doctor will check your cholesterol level and, if necessary, consider changing your statin dose.
  • Medicines used to treat seizures ( antiepileptic drugs ): Carbamazepine, phenytoin, phenobarbital. Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may reduce the amount of antiepileptic in your blood. Carbamazepine may reduce the amount of efavirenz, one of the ingredients in Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, in the blood. Your doctor may consider giving you another antiepileptic drug.
  • Drugs for the treatment of bacterial infection s, including tuberculosis and AIDS-related mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin. Your doctor may consider changing your dose or giving you another antibiotic. Your doctor may also consider adding a dose of efavirenz to treat your HIV – infection.
  • Medicines used to treat fungal infections: Itraconazole or posaconazole. Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may reduce the amount of itraconazole or posaconazole in the blood. Your doctor may consider giving you another medicine for a fungal infection.
  • Medicines used to treat malaria: Atovaquone / proguanil or artemeter / lumefantrine: Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may reduce the amount of atovaquone / proguanil or artemeter / lumefantrine in the blood.
  • Hormonal contraceptives, such as birth control pills, an injected contraceptive (eg Depo-Provera), or a contraceptive implant (eg Implanon): You must always use a reliable barrier contraceptive method (see Pregnancy and breast-feeding ). Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may impair hormonal contraceptives. Pregnancy has occurred in women taking efavirenz, one of the ingredients in Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, while using a contraceptive implant, although it has not been established that efavirenz treatment was the reason for the lack of a preventive effect.
  • Sertraline, a medicine used to treat depression, your doctor may change your dose of sertraline.
  • Bupropion, a medicine used to treat depression or to help quit smoking, your doctor may change your dose of bupropion.
  • Diltiazem or similar medicines (so-called calcium channel blockers ): When you start taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, your doctor may need to adjust your dose of the calcium channel blocker.
  • Drugs used to prevent rejection of transplanted organs (and also called immunosuppressive drugs) such as cyclosporine, sirolimus, or tacrolimus. When you start or stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, your doctor will closely monitor your plasma levels of the immunosuppressive drug and may need to adjust its dose.
  • Warfarin or acenocoumarol (medicines used to inhibit blood clotting ): Your doctor may need to adjust your dose of warfarin or acenocoumarol.
  • Extract of Ginkgo biloba (an herbal medicine).

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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan or for 12 weeks thereafter. Your doctor may ask you to take a pregnancy test to make sure you are not pregnant before starting your treatment with Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan.

If you could become pregnant during treatment with Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, 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, injection ). Efavirenz, one of the ingredients of Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, may remain in the blood for some time after stopping treatment. Therefore, you should continue to use contraception, as described above, for 12 weeks after stopping Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan.

Tell your doctor immediately if you are pregnant or planning to become pregnant. If you are pregnant, you should take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan only if you and your doctor decide that there is a clear need.

Serious malformations have been observed in fetal animals and neonates to women treated with efavirenz during pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

If you have taken Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan. Both HIV and the ingredients in Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan can be transferred to breast milk and can seriously harm your baby.

Driving and using machines

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may cause dizziness, impaired concentration, and drowsiness. If you get these symptoms, do not drive, use any tools or machines.

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan contains excipients

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan contains sodium and lactose

This medicine contains 7.5 mg sodium metabisulphite per tablet, which in rare cases causes hypersensitivity reactions and bronchospasm. It contains less than 1 mmol sodium (23 mg) sodium per dose, ie essentially ‘sodium-free’. Each tablet also contains 105.5 mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan

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. Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan is recommended for use 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan whole with water.

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan should be taken daily.

If your doctor decides to stop one of the ingredients in the efavirenz/emtricitabine/tenofovir disoproxil Mylan, you can get efavirenz, emtricitabine, and/or tenofovir disoproxil separately or with other medicines to treat your HIV – infection.

If you take more Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan then you should

If you accidentally take too many tablets of efavirenz/emtricitabine/tenofovir disoproxil Mylan, 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan

It is important not to miss a dose of Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan.

If you miss a dose of Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan within 12 hours of the usual time, 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan), 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 Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan.

If you stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan

Do not stop taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan without telling your doctor. Discontinuation of Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan may seriously affect your response to treatment in the future. If you have stopped taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan, talk to your doctor before taking Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan tablets again. If you have problems or need to adjust your dose, your doctor may consider giving you the ingredients of Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan separately.

When your Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan tablets start to run out, make sure you 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 become more difficult to treat.

If you have both HIV – infection and hepatitis B, it is especially important not to stop taking efavirenz/emtricitabine/tenofovir disoproxil Mylan 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 in Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan). If treatment with Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan 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 disease or cirrhosis, it is not recommended that treatment be discontinued as this may lead to worsening of hepatitis A, which may be fatal.

Inform 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 may sometimes be a link 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: inform your doctor immediately

  • Lactic acidosis (excess lactic acid in the blood) is rare (can occur in up to 1 in 1,000 patients) but serious side effects that can be life-threatening. The following side effects may be signs of lactic acidosis:
  • deep, rapid breathing
  • drowsiness
  • 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 during 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 )
  • the feeling of tingling or dizziness, wheezing, ringing, or another persistent sound in the ears
  • dimsyn
  • frostbite
  • breast augmentation in men
  • reduced sexual drive
  • herds
  • dry mouth
  • appetite increase

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

5. How to store Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan

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 the carton after “EXP”.

The expiration date is the last day of the specified month.

Cans of 30 tablets:  Write the date the can was opened on the label and/or carton in the designated area. Use within 60 days from the first opening.

Do not store above 25 ° C. Store in the original package. Sensitive to light.

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. A film-coated tablet Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan contains 600 mg efavirenz, 200 mg emtricitabine and 245 mg tenofovir disoproxil (as maleate).
  • The other ingredients in the tablet are croscarmellose sodium, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, sodium metabisulfite, lactose monohydrate, and red iron oxide (E172).
  • This medicine contains sodium metabisulfite and lactose. See section 2.
  • The other ingredients in the tablet film casing are yellow iron oxide (E172), red iron oxide (E172), macrogol, poly (vinyl alcohol), talc, titanium dioxide (E171).

What the medicine looks like and the contents of the pack

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan film-coated tablets are pink capsule-shaped tablets, marked with “M” on one side and “TME” on the other.

This medicine is available in plastic bottles containing desiccant labeled “DO NOT CONSUME” and 30 tablets and in multiple packs of 90 tablets in 3 cans, each containing 30 or 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Mylan SAS

117 Allée des Parcs

69800 Saint-Priest

France

Manufacturer

Mylan Hungary Kft

Mylan utca 1, Komárom, 2900,

Hungary

McDermott Laboratories Limited t / a Gerard Laboratories t / a Mylan Dublin

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Mylan Germany GmbH

Branch release Bad Homburg vd Hoehe,

Benzstrasse 1, Bad Homburg vd Hoehe, Hesse, 61352,

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienMylan bvba / sprlTel: + 32 (0) 2 658 61 00 LithuaniaMylan Healthcare UABTel: +370 5 205 1288
BulgariaMailan LODTel: +359 2 44 55 400 Luxembourg / LuxemburgMylan bvba / sprlTel: + 32 (0) 2 658 61 00(Belgium / Belgium)
Czech RepublicMylan Healthcare CZTel: +420 222 004 400 HungaryMylan EPD KftTel: + 36 1 465 2100
DenmarkMylan Denmark ApSTel: +45 28 11 69 32 MaltaVJ Salomone Pharma LtdTel: + 356 21 22 01 74
GermanyMylan Healthcare GmbHTel: +49 800 0700 800 The NetherlandsMylan BVTel: +31 (0) 20 426 3300
EestiBGP Products Switzerland GmbH Eesti subsidiaryTel: +372 6363 052 NorwayMylan Healthcare Norge ASTel: + 47 66 75 33 00
GreeceGenerics Pharma Hellas ΕΠΕ:Ηλ: +30 210 993 6410 AustriaArcana Arzneimittel GmbHTel: +43 1 416 2418
SpainMylan Pharmaceuticals, SLTel: + 34 900 102 712 PolandMylan Sp. Healthcare z ooTel: + 48 22 546 64 00
FranceMylan SASTel: +33 4 37 25 75 00 PortugalMylan, Lda.Tel: + 351 21 412 72 56
CroatiaMylan Hrvatska dooTel: +385 1 23 50 599 RomaniaBGP Products SRLTel: + 40 372 579 000
IrelandMylan Ireland LimitedTel: + 353 (0) 87 1694982 SloveniaMylan Healthcare dooTel: + 386 1 23 63 180
IcelandIcepharma hfTel: +354 540 8000 Slovak RepublicMylan sroTel: +421 2 32 199 100
ItalyMylan Italia SrlTel: + 39 02 612 46921 Finland / FinlandMylan Finland OYPuh / Tel: +358 20 720 9555
LatviaMylan Healthcare SIATel: +371 676 055 80 Great Britain (Northern Ireland)Mylan IRE Healthcare Limited+353 18711600

Muhammad Nadeem

Leave a Reply