Efavirenz/emtricitabine/tenofovir disoproxil Teva 600 mg/200 mg/245 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva 600 mg/200 mg/245 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva is and what it is used for
What you need to know before taking Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva
How to take Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva
Possible side effects
How to store Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva
Contents of the pack and other information

1. What Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva is and what it is used for

Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva contains three active substances used to treat human immunodeficiency virus (HIV) infection.

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

Each of these active substances is also known as an antiretroviral medicine. They work by interfering with the normal function of an enzyme (reverse transcriptase), which is essential for the virus to multiply.

Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva is a treatment for human immunodeficiency virus (HIV) infection in adults aged 18 years or older who have previously been treated with other antiretroviral medicines and who have HIV-1 infection under control for at least three months. Patients must not have experienced prior treatment failure with previous antiretroviral therapy for HIV infection.

2. What you need to know before taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva

Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Teva

if you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
if you have severe liver disease.
if you have a heart condition, such as an abnormal electrical signal known as QT interval prolongation, which puts you at high risk of serious heart rhythm problems (Torsade de Pointes).
if any of your family members (parents, grandparents, siblings) died suddenly due to a heart problem or were born with heart defects.
if your doctor has told you that you have high or low levels of electrolytes, such as potassium or magnesium, in your blood.
if you are currently taking any of the following medicines (see also “Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva with other medicines” ):
astemizole or terfenadine (used to treat hay fever or other allergies)
bepridil (used to treat heart conditions)
cisapride (used to treat heartburn)
elbasvir/grazoprevir (used to treat hepatitis C)
ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
midazolam or triazolam (used to help sleep)
pimozide, imipramine, amitriptyline, or clomipramine (used to treat certain mental health conditions)
St. John’s wort (Hypericum perforatum) (a herbal preparation used to treat depression and anxiety)
voriconazole (used to treat fungal infections)
flecainide, metoprolol (used to treat irregular heartbeats)
certain antibiotics (macrolides, fluoroquinolones, imidazoles)
triazole antifungals
certain antimalarials
methadone (used to treat opioid addiction).

??If you are taking any of these medicines, inform your doctor immediately. Taking these medicines with Efavirenz/Emtricitabine/Tenofovir disoproxil Teva could cause serious or potentially fatal side effects or may cause these medicines to stop working properly.

Warnings and precautions

Talk to your doctor or pharmacist before taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva.

While taking this medicine, you may still transmit HIV to others, even though effective antiretroviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medicine is not a cure for HIV infection. While you are taking efavirenz/emtricitabine/tenofovir disoproxil, you may still develop infections or other conditions associated with HIV infection.
While taking efavirenz/emtricitabine/tenofovir disoproxil, you must remain under your doctor’s supervision.
Talk to your doctor:
if you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. You should not take this medicine with any of these medicines.
if you have or have had kidney disease, or if blood tests have shown kidney problems. Efavirenz/emtricitabine/tenofovir disoproxil is not recommended if you have moderate to severe kidney disease.

Efavirenz/emtricitabine/tenofovir disoproxil may affect your kidneys. Before starting treatment, your doctor may order blood tests to check how well your kidneys are working. Your doctor may also order blood tests during treatment to monitor your kidney function.

Efavirenz/emtricitabine/tenofovir disoproxil is usually not taken with other medicines that may harm your kidneys (see Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva with other medicines). If this is unavoidable, your doctor will monitor your kidney function weekly.

if you have a heart condition, such as an abnormal electrical signal called QT interval prolongation.
if you have a history of mental health disorders, including depression, or alcohol or substance abuse. Inform your doctor immediately if you feel depressed, have suicidal thoughts, or experience unusual thoughts (see section 4, Possible side effects).
if you have a history of seizures (spasms or fits) or are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital, or phenytoin. If you are taking any of these medicines, your doctor may need to check your blood levels of anticonvulsant to ensure they are not affected while taking efavirenz/emtricitabine/tenofovir disoproxil. Your doctor may prescribe a different anticonvulsant.
if you have a history of liver disease, including active chronic hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with combination antiretrovirals, have a higher risk of severe and potentially fatal liver complications. Your doctor may perform blood tests to monitor your liver function or switch you to another medicine. Do not take efavirenz/emtricitabine/tenofovir disoproxil if you have severe liver disease (see earlier in section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Teva).

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 Efavirenz/Emtricitabine/Tenofovir disoproxil Teva, show some activity against the hepatitis B virus, although emtricitabine is not authorized for the treatment of hepatitis B infection. Symptoms of your hepatitis may worsen after stopping efavirenz/emtricitabine/tenofovir disoproxil. Your doctor may perform regular blood tests to monitor your liver function (see section 3, If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva).

Regardless of whether you have a history of liver disease, your doctor will consider performing regular blood tests to monitor your liver function.
if you are over 65 years old. The number of patients over 65 years of age studied is insufficient. If you are over 65 and have been prescribed efavirenz/emtricitabine/tenofovir disoproxil, your doctor will monitor you closely.
Once you start taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva, be alert for:
Signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These side effects may begin within the first 1 or 2 days of treatment and usually resolve after the first 2 to 4 weeks.
Any sign of skin rash. Efavirenz/emtricitabine/tenofovir disoproxil may cause skin rashes. If you notice signs of a severe rash with blisters or fever, stop taking efavirenz/emtricitabine/tenofovir disoproxil and contact your doctor immediately. If you previously had a rash while taking another NNRTI, you may be at higher risk of developing a rash with efavirenz/emtricitabine/tenofovir disoproxil.
Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting antiretroviral treatment. These symptoms are believed to result from improved immune response, allowing the body to fight infections that were previously present without apparent symptoms. If you notice any signs of infection, please inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition where the immune system attacks healthy body tissue) may also occur after you start taking medicines for your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upward toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately for appropriate treatment.

Bone problems. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death due to loss of blood supply to the bone). Risk factors for developing this condition include long duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder) and difficulty moving. If you experience any of these symptoms, inform your doctor.

Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to renal tubule cells (see section 4, Possible side effects).

Inform your doctor if you have bone pain or fractures.

Tenofovir disoproxil may also cause bone mineral loss. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

In general, the long-term effects of tenofovir disoproxil on bone health and the future risk of fractures in adult and pediatric patients are uncertain.

Inform your doctor if you know you have osteoporosis.

Patients with osteoporosis have a higher risk of fractures.

Children and adolescents

Do not give efavirenz/emtricitabine/tenofovir disoproxil to children and adolescents under 18 years of age. The use of efavirenz/emtricitabine/tenofovir disoproxil in children and adolescents has not yet been studied.

Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva with other medicines

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Additionally, efavirenz/emtricitabine/tenofovir disoproxil must not be taken with any other medicine containing efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Tell your doctor if you are taking other medicines that may harm your kidneys. Some examples include:

aminoglycosides, vancomycin (medicines for bacterial infections)
foscarnet, ganciclovir, cidofovir (medicines for viral infections)
amphotericin B, pentamidine (medicines for fungal infections)
interleukin-2 (for cancer treatment)
non-steroidal anti-inflammatory drugs (NSAIDs, for relieving bone or muscle pain).

Efavirenz/emtricitabine/tenofovir disoproxil may interact with other medicines, including herbal medicines such as Ginkgo biloba extracts. This may result in altered blood levels of efavirenz/emtricitabine/tenofovir disoproxil or other medicines. This could prevent the medicines from working properly or worsen side effects. In some cases, your doctor may need to adjust your dose or monitor blood levels. It is important that you inform your doctor or pharmacist if you are taking any of the following:

Medicines containing didanosine (for HIV infection): Taking efavirenz/emtricitabine/tenofovir disoproxil with other antiviral medicines containing didanosine may increase didanosine levels in your blood and reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been reported when medicines containing tenofovir disoproxil and didanosine are taken together. Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
Other medicines used for HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or atazanavir boosted with ritonavir or saquinavir. Your doctor may consider prescribing a different medicine or adjusting the dose of protease inhibitors. Also, inform your doctor if you are taking maraviroc.
Medicines used to treat hepatitis C virus infection: Glecaprevir/pibrentasvir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
Medicines used to lower blood fat (also called statins): Atorvastatin, pravastatin, simvastatin. Efavirenz/emtricitabine/tenofovir disoproxil may reduce statin levels in the blood. Your doctor will check your cholesterol levels and consider adjusting the statin dose if necessary.
Medicines used to treat seizures/fits (anticonvulsants): Carbamazepine, phenytoin, phenobarbital. Efavirenz/emtricitabine/tenofovir disoproxil may reduce anticonvulsant levels in the blood. Carbamazepine may reduce efavirenz levels, one of the components of efavirenz/emtricitabine/tenofovir disoproxil, in the blood. Your doctor may need to consider prescribing a different anticonvulsant.
Medicines used to treat bacterial infections, including tuberculosis and AIDS-related Mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin. Your doctor may need to consider changing the dose or prescribing an alternative antibiotic. Additionally, your doctor may consider prescribing an additional dose of efavirenz to treat your HIV infection.
Medicines used to treat fungal infections (antifungals): Itraconazole or posaconazole. Efavirenz/emtricitabine/tenofovir disoproxil may reduce itraconazole or posaconazole levels in the blood. Your doctor may need to consider administering a different antifungal.
Medicines used to treat malaria: Atovaquone/proguanil or artemether/lumefantrine. Efavirenz/emtricitabine/tenofovir disoproxil may reduce atovaquone/proguanil or artemether/lumefantrine levels in the blood.
Hormonal contraceptives, such as birth control pills, an injectable contraceptive (e.g., Depo-Provera), or a contraceptive implant (e.g., Implanon): You should also use a reliable barrier method of contraception (see Pregnancy and breastfeeding). Efavirenz/emtricitabine/tenofovir disoproxil may alter the effectiveness of hormonal contraceptives. Cases of pregnancy have been reported in women taking efavirenz, a component of efavirenz/emtricitabine/tenofovir disoproxil, while using a contraceptive implant, although a causal link with efavirenz treatment has not been established.
Sertraline, a medicine used to treat depression, as your doctor may need to adjust the sertraline dose.
Bupropion, a medicine used to treat depression or to help you quit smoking, as your doctor may need to adjust the bupropion dose.
Diltiazem or similar medicines (called calcium channel blockers): when starting treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor will need to adjust the dose of the calcium channel blocker.
Medicines used to prevent organ rejection after transplantation (also called immunosuppressants) such as cyclosporine, sirolimus, or tacrolimus. Both when starting and stopping treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor will carefully monitor your immunosuppressant blood levels and may need to adjust your dose.
Warfarin or acenocoumarol (medicines used to reduce blood clotting): Your doctor may need to adjust your warfarin or acenocoumarol dose.
Ginkgo biloba extracts (herbal medicine).
Metamizole, a medicine used to treat pain and fever.
Praziquantel, a medicine used to treat parasitic infections.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Women must not become pregnant during treatment with efavirenz/emtricitabine/tenofovir disoproxil or within 12 weeks after stopping treatment.

Your doctor may request a pregnancy test to ensure you are not pregnant before starting treatment with efavirenz/emtricitabine/tenofovir disoproxil.

If you could become pregnant while receiving efavirenz/emtricitabine/tenofovir disoproxil, you must use a reliable barrier method of contraception (e.g., a condom) along with other contraceptive methods, including oral contraceptives (the pill) or other hormonal contraceptives (e.g., implants, injections). Efavirenz, one of the active substances in efavirenz/emtricitabine/tenofovir disoproxil, may remain in your blood for some time after stopping treatment. Therefore, you should continue using contraceptive measures as indicated above for 12 weeks after stopping efavirenz/emtricitabine/tenofovir disoproxil.

Inform your doctor immediately if you become pregnant or plan to become pregnant. You should only take efavirenz/emtricitabine/tenofovir disoproxil during pregnancy if both you and your doctor decide it is clearly necessary.

Serious birth defects have been observed in newborn animals and humans whose mothers were treated with efavirenz during pregnancy.

Consult your doctor or pharmacist before taking any medicine.

If you have taken efavirenz/emtricitabine/tenofovir disoproxil during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby’s development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects.

Do not breastfeed your baby during treatment with efavirenz/emtricitabine/tenofovir disoproxil. Both HIV and the ingredients of efavirenz/emtricitabine/tenofovir disoproxil can pass into breast milk and cause serious harm to the baby.

Driving and using machines

Efavirenz/emtricitabine/tenofovir disoproxil may cause dizziness, difficulty concentrating, and drowsiness. If you are affected, do not drive and do not operate tools or machinery.

Efavirenz/Emtricitabine/Tenofovir disoproxil Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., essentially “sodium-free”.

3. How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Teva

Take this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Recommended dose:

One tablet daily, taken orally. Efavirenz/emtricitabine/tenofovir disoproxil should be taken on an empty stomach (typically defined as one hour before or two hours after a meal), preferably at bedtime. This may help make some of the side effects (e.g., dizziness, drowsiness) less bothersome. Swallow the efavirenz/emtricitabine/tenofovir disoproxil tablet whole with a glass of water.

Efavirenz/emtricitabine/tenofovir disoproxil must be taken daily.

If your doctor decides to discontinue one of the components of efavirenz/emtricitabine/tenofovir disoproxil, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or in combination with other medicines for the treatment of HIV infection.

If you take more Efavirenz/Emtricitabine/Tenofovir disoproxil Teva than you should

If you accidentally take too many tablets of efavirenz/emtricitabine/tenofovir disoproxil, you may be at an increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Contact your doctor or go to the nearest emergency department. Bring the tablet packaging with you so that you can clearly describe what you have taken.

If you forget to take Efavirenz/Emtricitabine/Tenofovir disoproxil Teva

It is important that you do not miss a dose of efavirenz/emtricitabine/tenofovir disoproxil.

If you miss a dose of efavirenz/emtricitabine/tenofovir disoproxil within 12 hours of your usual time, take it as soon as possible, then take your next dose at the usual time.

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

If you vomit the tablet (within 1 hour after taking efavirenz/emtricitabine/tenofovir disoproxil), you should take another tablet. Do not wait until it is time for your next dose. You do not need to take another tablet if you vomited more than one hour after taking efavirenz/emtricitabine/tenofovir disoproxil.

If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva

Do not stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva without first talking to your doctor. Stopping treatment with efavirenz/emtricitabine/tenofovir disoproxil may seriously affect your response to future treatments. If you stop taking efavirenz/emtricitabine/tenofovir disoproxil, consult your doctor before restarting the tablets. Your doctor may consider giving you the components of efavirenz/emtricitabine/tenofovir disoproxil separately if you have problems or if your dose needs to be adjusted.

When you run out of Efavirenz/Emtricitabine/Tenofovir disoproxil Teva, ask your doctor or pharmacist for more. This is extremely important because the amount of virus may start to increase if you stop taking the medicine, even for a short time. In this case, the virus may become more difficult to treat.

If you have both HIV infection and hepatitis B at the same time, it is especially important not to stop your treatment with efavirenz/emtricitabine/tenofovir disoproxil without first talking to your doctor. Some patients have had blood test results or symptoms indicating that their hepatitis worsened after stopping emtricitabine or tenofovir disoproxil (two of the three components of this medicine). If you stop treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor may recommend that you restart treatment for hepatitis B. You may need blood tests to monitor liver function for up to 4 months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as this may cause worsening of hepatitis, which could be life-threatening.

Contact your doctor immediately about any new or unusual symptoms after stopping your treatment, particularly symptoms you associate with hepatitis B virus infection.

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

4. Possible side effects

During HIV treatment, there may be an increase in weight and in blood lipid and glucose levels. This may be partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to antiretroviral medicines themselves. Your doctor will monitor these changes.

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

Possible serious side effects: tell your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare side effect (may affect up to 1 in 1,000 patients) but serious, and can be life-threatening. The following side effects may be signs of lactic acidosis:
deep, rapid breathing
drowsiness
nausea, vomiting, and stomach pain

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

Other possible serious side effects

The following side effects are uncommon (may affect up to 1 in 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
aggressive behaviour, suicidal thoughts, abnormal thoughts, paranoia, inability to think clearly, mood disturbances, hallucinations (seeing or hearing things that are not really there), suicide attempts, personality changes (psychosis), catatonia (a condition in which the patient becomes immobile and unable to speak for a period of time)
abdominal (stomach) pain caused by inflammation of the pancreas
forgetfulness, confusion, spasms (seizures), incoherent speech, tremor (shaking)
yellowing of the skin or eyes, itching, or abdominal (stomach) pain caused by inflammation of the liver
kidney tubule damage

Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis. Some patients have died by suicide. These problems tend to occur more frequently in those with a history of mental illness. Always inform your doctor immediately if you experience these symptoms.

Liver-related side effects: if you are also infected with hepatitis B virus, you may experience worsening of hepatitis after stopping treatment (see section 3).

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

liver failure, which in some cases has led to death or liver transplantation. Most cases occurred in patients who already had liver disease, but there have been some reports in patients without prior liver disease
kidney inflammation, increased urine volume, and feeling thirsty
back pain due to kidney problems, including kidney failure. Your doctor may perform blood tests to check whether your kidneys are functioning properly.
weakening of the bones (with bone pain and sometimes leading to fractures) that may result from damage to kidney tubule cells
fatty liver

If you think you may have any of these serious side effects, speak with your doctor.

More common side effects

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

dizziness, headache, diarrhoea, feeling unwell (nausea), vomiting
skin rashes (including red spots or pimples, sometimes with blisters and skin swelling), which may be allergic reactions
weakness

Blood tests may also show:

decreased phosphate levels in blood
increased levels of creatine kinase in blood, which may cause muscle pain and weakness

Other possible side effects

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

allergic reactions
disturbances in balance and coordination
feelings of anxiety or depression
difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
pain, stomach ache
digestive problems with discomfort after meals, feeling bloated (gas), flatulence
loss of appetite
tiredness
itching
changes in skin colour such as darkening of the skin in patches, often starting on the hands and soles of the feet

Blood tests may also show:

low white blood cell count (a reduced number of white blood cells may make you more prone to infections)
liver and pancreas problems
increased fatty acids (triglycerides), bilirubin, or blood sugar levels

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

muscle rupture, muscle pain or weakness
anaemia (low red blood cell count)
sensation of spinning or swaying (dizziness), ringing, buzzing, or other persistent noises in the ears
blurred vision
chills
breast enlargement in men
loss of sexual appetite
flushing
dry mouth
increased appetite

Blood tests may also show:

decreased potassium levels in blood
increased creatinine in blood
protein in urine
increased cholesterol in blood

If kidney tubule cells are damaged, muscle rupture, weakening of the bones (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphate in blood may occur.

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

skin rash with itching caused by a reaction to sunlight

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, carton, or bottle after EXP. The expiry date refers to the last day of the month indicated.

Blister: Store in the original packaging to protect from moisture. This medicine does not require any special storage temperature.

Bottle: Store in the original packaging to protect from moisture. Keep the bottle tightly closed. This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva

The active substances are efavirenz, emtricitabine and tenofovir disoproxil. Each Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.22 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
The other ingredients are microcrystalline cellulose, sodium croscarmellose, mannitol (E421), hydroxypropylcellulose, low-substituted hydroxypropylcellulose, poloxamer 407, crospovidone, hypromellose, hydrogenated vegetable oil, sodium stearyl fumarate.
The other ingredients of the coating (Opadry II 85F240144 PINK) are partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, carmine (E120).

Appearance of the product and contents of the pack

Efavirenz/Emtricitabine/Tenofovir Disoproxil Teva film-coated tablets are pink, oval-shaped, marked with “TEE” on one side of the tablet and smooth on the other side. Bottles may contain an HDPE container with silica gel which should remain in the bottle to help protect the tablets. The silica gel container must not be swallowed.

The following pack sizes are available:

Blister packs: 10, 30, 90 film-coated tablets and unit dose packs of 30x1 film-coated tablets.

Bottle: 30 tablets and a multi-pack containing 90 tablets (3 packs of 30) film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

31-546 Kraków

Poland

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren, Baden-Wuerttemberg

Germany

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25,

10000 Zagreb

Croatia

Date of the most recent revision of this leaflet: July 2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)