600 mg / 200 mg / 245 mg film-coated tablets
efavirenz / emtricitabine / tenofovir disoproxil
1. What Emtenef is and what it is used for
Emtenef contains three active substances that are used to treat human immunodeficiency virus ( HIV ) infection :
- Efavirenz is a nucleoside-type non-reverse transcriptase inhibitor (NNRTI).
- Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI).
- Tenofovir is a reverse nucleotide-type 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.
Emtenef 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.
Efavirenz, emtricitabine, and tenofovir disoproxil contained in Emtenef may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Emtenef
Do not use Emtenef
- 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, e.g. potassium or magnesium, in the blood.
- if you are taking any of the following medicines at the same time :
- astemizole or terfenadine (used to treat hay fever or other allergies )
- bepridil (used to treat heart disease)
- cisapride (used to treat heartburn)
- 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 with Emtenef 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 Emtenef.
- You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss the necessary steps to avoid infecting others with your doctor. This medicine does not cure HIV – infection. While taking this medicine, you may still develop infections you or other illnesses associated with HIV – infection.
- You must continue to be under medical supervision while taking this medicine.
Inform your doctor:
- if you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine or adefovir dipivoxil. This medicine 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. This medicine is not recommended if you have moderate to severe kidney disease.
This medicine 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.
This medicine is not usually taken with other medicines that can damage the kidneys (see Other medicines and Emtenef ). 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 this medicine. 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 Emtenef (see earlier in section 2, Do not take Emtenef ).
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 this medicine, 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 this medicine. Your doctor may then take blood samples regularly to check your liver function (see section 3, If you stop taking Emtenef ).
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 this medicine, your doctor will monitor you closely.
When you start taking Emtenef, 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. This medicine may cause a rash. If you see symptoms of severe rash with blistering or fever, stop taking Emtenef 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 this medicine.
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 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.
Skeletal problems (which sometimes lead to fractures ) can also occur due to damage to the renal tubules (see section 4, Possible side effects ).
Children and young people
Emtenef should not be given to children and adolescents under 18 years of age.
The use of this drug has not yet been studied in children and adolescents.
Other medicines and Emtenef
You must not take certain medicines with Emtenef. These are listed under Do not take Emtenef, at the beginning of section 2 and include some common medicines and certain 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, this medicine should not be taken with other medicines containing efavirenz (unless your doctor recommends it), emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine,e 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)
- interleukin -2 (for the treatment of cancer)
- non-steroidal anti-inflammatory drugs ( NSAIDs, to relieve skeletal or muscle pain)
Emtenef may interact with other medicines, including herbal medicines such as Ginkgo biloba extract. As a result, the amount of this medicine 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 take this medicine 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 fatal, 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,r 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.
- Medicines used for the treatment of infection with the hepatitis C virus: boceprevir, simeprevir, sofosbuvir / velpatasvir, sofosbuvir / velpatasvir / voxilaprevir.
- Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin, simvastatin. This medicine may reduce the number of statins in your 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. Emtenef may reduce the number of antiepileptic drugs in the blood. Carbamazepine may reduce the amount of efavirenz, one of the ingredients of this medicine, 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. This medicine 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: This medicine may reduce the amount of atovaquone / proguanil or artemeter / lumefantrine in your blood.
- Hormonal contraceptives, such as birth control pills, an injected contraceptive (eg Depo-Provera), or a contraceptive implant (eg Nexplanon): You must always use a reliable barrier contraceptive method (see Pregnancy and breast-feeding ). Emtenef may have a worse effect on hormonal contraceptives. Pregnancy has occurred in women taking efavirenz, one of the ingredients of this medicine, while using a contraceptive implant, although it has not been established that efavirenz treatment was the reason for the lack of contraceptive 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 this medicine, your doctor may need to adjust your dose of calcium channel blockers.
- 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 this medicine, your doctor will make frequent checks on your plasma levels of the immunosuppressive medicine 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, breastfeeding, and fertility
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 Emtenef 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 this medicine.
If you could become pregnant during treatment with Emtenef, 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 this medicine, 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 Emtenef.
Tell your doctor immediately if you are pregnant or planning to become pregnant. If you are pregnant, you should only take Emtenef 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 Emtenef during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to check your baby’s development. For children with a mother who has taken NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.
Do not breast-feed during treatment with Emtenef. Both HIV and the ingredients in this medicine can be transferred to breast milk and can seriously harm your baby.
Driving and using machines
Emtenef may cause dizziness, impaired concentration, and drowsiness. If you get these symptoms, do not drive, use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Emtenef contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. next to “sodium-free”.
How to use Emtenef
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. Emtenef 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 the tablet whole with water.
Emtenef must be taken every day.
If your doctor decides to stop one of the components of this medication, you may be given efavirenz, emtricitabine, and/or tenofovir disoproxil separately or with other medicines to treat your HIV – infection.
If you use more Emtenef than you should
If you accidentally take too many Emtenef tablets, you may be more likely to experience any side effects from this medicine (see section 4, Possible side effects ).
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Save the tablet pack so you can easily describe what you took.
If you forget to use Emtenef
You mustn’t a dose of Emtenef.
If you miss a dose of Emtenef within 12 hours of the time it is usually taken, take it as soon as possible, and then take the next dose at its regular 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 Emtenef), 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 the tablet.
If you stop using Emtenef
Do not stop taking Emtenef without talking to your doctor. Discontinuation of treatment with this medicine can seriously affect how you respond to treatment in the future. If you have stopped taking this medicine, talk to your doctor before taking the tablets again. If you have problems or need to adjust the dose, your doctor may consider giving you the ingredients of this medicine 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 become 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 in this medicine). If treatment with this medicine 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 rare (may affect up to 1 in 1,000 people) but serious side effects 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 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 include 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 user in 10):
- 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
- 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.
5. How to store Emtenef
- 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 carton after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
- Shelf life in the opened package: 30 days.
- 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. Each Emtenef film-coated tablet contains 600 mg efavirenz, 200 mg emtricitabine, and 245 mg tenofovir disoproxil (as succinate).
- The other ingredients are microcrystalline cellulose (E462), croscarmellose sodium type A (E468), hydroxypropylcellulose (E463), sodium lauryl sulfate (E487), magnesium stearate (E470b), poloxamer 407, and red iron oxide (E172).
- Other ingredients in the film coating are polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), red iron oxide (E172), and black iron oxide (E172).
What the medicine looks like and the contents of the pack
Emtenef film-coated tablets are pink, capsule-shaped tablets, smooth on both sides, measuring 11 mm x 22 mm. They are supplied in jars, containing 30 tablets, packed in a carton. Each jar contains the desiccant silica gel, which must be stored in the jar to protect your tablets. The silica gel is in a separate container and should not be swallowed.
The following pack sizes are available:
30 (1 x 30) film-coated tablets
90 (3 x 30) film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Centrafarm Services BV
New Donk 9
4879 AC Etten-Leur
Netherlands
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark