EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA 600 mg/200 mg/245 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Efavirenz/Emtricitabine/Tenofovir Disoproxil Krka 600 mg/200 mg/245 mg Film-Coated Tablets

film-coated EFG

efavirenz/emtricitabine/tenofovir disoproxil (efavirenzum/emtricitabinum/tenofovirum disoproxilum)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Efavirenz/Emtricitabine/Tenofovir Disoproxil Krka and what is it used for
2. What you need to know before taking Efavirenz/Emtricitabine/Tenofovir Disoproxil Krka
3. How to take Efavirenz/Emtricitabine/Tenofovir Disoproxil Krka
4. Possible side effects
5. Storage of Efavirenz/Emtricitabine/Tenofovir Disoproxil Krka
6. Package contents and additional information

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

Efavirenz/Emtricitabine/Tenofovir Disoproxil Krka contains three active substancesused 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 antiretroviral medications, which work by interfering with the normal function of an enzyme (reverse transcriptase) essential for the virus to multiply.

Efavirenz/Emtricitabine/Tenofovir Disoproxil Krka is a treatment for Human Immunodeficiency Virus(HIV) infection in adults 18 years of age or olderwho have been previously treated with other antiretroviral medications and have had their HIV-1 infection under control for at least three months. Patients should not have experienced failure of a previous HIV infection treatment.

2. What you need to know before you start taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka

Do not take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka

• to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other components of this medication (included in section 6).

• if any of your relatives (parents, grandparents, brothers or sisters) have died suddenly due to a heart problem or were 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 currently takingany of the following medications (see also "Other medications and Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka"):

• astemizole or terfenadine(used to treat hay fever or other allergies)

• bepridil(used to treat heart diseases)
• 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 histamine headaches)
• midazolam or triazolam(used to facilitate sleep)
• pimozide, imipramine, amitriptyline, or clomipramine(used to treat certain mental problems)
• St. John's Wort (Hypericum perforatum)(herbal medicine used to treat depression and anxiety)
• voriconazole(used to treat fungal infections)
• flecainide, metoprolol(used to treat irregular heartbeats)
• certain antibiotics(macrolides, fluoroquinolones, imidazoles)
• antifungal triazoles
• certain antimalarials
• methadone(used to treat opioid addiction).

If you are taking any of these medications, inform your doctor immediately.Taking these medications with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka could produce serious and/or potentially fatal side effects or could cause these medications to stop working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka.

• While you are taking this medication you can still transmit HIV to others,although effective antiretroviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medication is not a cure for HIV infection. While you are taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, you may still suffer from infections or other diseases associated with HIV infection.

• While you are taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, you must remain under the supervision of your doctor.

• Tell your doctor:

• that contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. You should not take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka with any of these medications.

• or if tests have shown problems with your kidneys. Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka is not recommended if you have moderate to severe kidney disease.

Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka may affect your kidneys. Before starting treatment, your doctor may request blood tests to check your kidney function. Your doctor may also request blood tests during treatment to monitor your kidneys.

Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka is not normally taken with other medications that can damage your kidneys (see Taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka with other medications). If this is unavoidable, your doctor will monitor your kidney function once a week.

• If you have a heart condition, such as an abnormal electrical signal called QT interval prolongation.

• If you have a history of mental illness,including depression, or alcohol or substance abuse. Inform your doctor immediately if you feel depressed, have suicidal thoughts, or abnormal thoughts (see section 4, Possible side effects).

• If you have a history of seizures (spasms or attacks)or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital, and phenytoin. If you are taking any of these medications, your doctor may need to check the level of anticonvulsant medication in your blood to ensure that it is not affected while you are taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka. Your doctor may prescribe a different anticonvulsant.

• If you have a history of liver disease, including chronic active hepatitis.Patients with liver disease, including chronic hepatitis B or C, treated with combined antiretrovirals, have a higher risk of severe and potentially fatal liver complications. Your doctor may perform blood tests to monitor your liver or change you to another medication. If you have severe liver disease, do not take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka(see above, in section 2, Do not take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka).

If you have a hepatitis B infection, your doctor will carefully consider the best treatment plan for you. Tenofovir disoproxil and emtricitabine, two of the active ingredients in Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, show some activity against the hepatitis B virus, although emtricitabine is not authorized for the treatment of hepatitis B infection. Your hepatitis symptoms may worsen after stopping Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka. Your doctor may perform blood tests at regular intervals to monitor your liver (see section 3, If you stop treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka).

• Regardless of whether you have a history of liver disease, your doctor will consider regular blood tests to monitor your liver.

• If you are over 65 years old.The number of patients over 65 years old who have been studied is insufficient. If you are over 65 years old and have been prescribed Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, your doctor will monitor you carefully.

• Once you start taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, be aware of:

• Signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams.These side effects may start in the first 1 or 2 days of treatment and usually disappear after the first 2 to 4 weeks.

• Any sign of skin rash.Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka may cause skin rashes. If you notice any sign of a severe skin rash with blisters or fever, stop taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka and inform your doctor immediately. If you have had a skin rash while taking another NNRTI, you may have a higher risk of having a skin rash with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka.

• Any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation of previous infections may appear soon after starting antiviral treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight infections that were present without any apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medications for the treatment of your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves towards the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

• Bone problems.Some patients who receive combined antiretroviral treatment may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combined antiretroviral treatment, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. The symptoms of osteonecrosis are stiffness in the joints, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, inform your doctor.

Bone problems (sometimes resulting in fractures) due to damage to the cells of the renal tubule (see section 4, Possible side effects) may also occur.

Children and adolescents

• Do not administer Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka to children and adolescentsunder 18 years of age. The use of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka has not been studied in children and adolescents.

Other medications and Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka

You should not take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka with certain medications.

These are listed under Do not take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, at the beginning of section 2. These include some common medications and some herbal medicines (including St. John's Wort) that can cause serious interactions.

Tell your doctoror pharmacist if you are taking, have recently taken, or may need to take any other medication.

In addition, you should not take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka with any other medication that contains efavirenz (unless your doctor recommends it), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Tell your doctorif you are taking other medications that can damage your kidneys.

Some examples include:

• aminoglycosides, vancomycin (medications for bacterial infections)
• foscarnet, ganciclovir, cidofovir (medications for viral infections)
• amphotericin B, pentamidine (medications for fungal infections)

• interleukin-2 (to treat cancer)
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka may interact with other medications, including herbal medicines such as Ginkgo biloba extract. This may result in the amounts of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka or other medications in your blood being affected. This may prevent the medications from working properly or may worsen some side effects. In some cases, your doctor may need to adjust your dose or check the levels in your blood. It is important that you inform your doctor or pharmacist if you are taking any of the following:

• Medications that contain didanosine (for HIV infection):taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka with other antiviral medications that contain didanosine may increase the levels of didanosine in your blood and may reduce the count of CD4 cells. When medications that contain tenofovir disoproxil and didanosine are taken together, rare cases of pancreatitis and lactic acidosis (excess of lactic acid in the blood) have been reported, sometimes fatal. Your doctor will carefully consider whether to treat you with medications that contain tenofovir and didanosine.

• Other medications used for HIV infection:the following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or atazanavir boosted by ritonavir or saquinavir. Your doctor may consider prescribing a different medication or changing the dose of the protease inhibitors. Also, inform your doctor if you are taking maraviroc.

• Medications used to treat hepatitis C virus infection:boceprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.

• Medications used to lower fat in the blood (also called statins):atorvastatin, pravastatin, simvastatin. Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka may reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and consider changing the dose of the statin if necessary.

• Medications used to treat seizures/attacks (anticonvulsants):carbamazepine, phenytoin, phenobarbital. Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka may reduce the amount of anticonvulsant in your blood. Carbamazepine may reduce the amount of efavirenz, one of the components of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, in your blood. Your doctor may need to consider prescribing a different anticonvulsant.

• Medications used to treat bacterial infections,including tuberculosis and Mycobacterium avium complex related to AIDS: 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.

• Medications used to treat fungal infections (antimycotics):itraconazole or posaconazole. Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka may reduce the amount of itraconazole or posaconazole in your blood. Your doctor may need to consider prescribing a different antimycotic.

• Medications used to treat malaria:atovaquone/proguanil or artemether/lumefantrine. Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in your blood.

• Hormonal contraceptive, 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 contraceptive method (see Pregnancy and breastfeeding). Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka may alter the effectiveness of hormonal contraceptives. There have been cases of pregnancy in women taking efavirenz, a component of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, while using a contraceptive implant, although it has not been established that treatment with efavirenz was the cause of the contraceptive failure.

• Sertraline, a medication used to treat depression, as your doctor may need to change the dose of sertraline.

• Bupropion, a medication used to treat depression or to help you stop smoking, as your doctor may need to change the dose of bupropion.

• Diltiazem or similar medications (called calcium antagonists):when you start treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, your doctor will need to adjust the dose of the calcium antagonist.

• Medications used to prevent organ rejection after transplantation (also called immunosuppressants)such as cyclosporine, sirolimus, or tacrolimus. Both when you start treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka and when you stop it, your doctor will carefully monitor your blood levels of the immunosuppressant and may need to adjust the dose you receive.

• Warfarin or acenocoumarol(medications used to reduce blood clotting): your doctor may need to adjust your dose of warfarin or acenocoumarol.

• Ginkgo biloba extract(herbal medicine).

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 medication.

Women should not become pregnant during treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka or in the 12 weeks following treatment. Your doctor may request a pregnancy test to ensure that you are not pregnant before starting treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka.

If you could become pregnant while taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, you should use a reliable barrier contraceptive method (e.g., condom) in addition to other contraceptive methods, including oral contraceptives or other hormonal contraceptives (e.g., implants, injections). Efavirenz, one of the active ingredients of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, may remain in your blood for some time after stopping treatment.

3. How to take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

One tablet a day, orally. Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka should be taken on an empty stomach (usually defined as one hour before or two hours after a meal) and preferably at bedtime. This may make some of the adverse effects (such as dizziness, drowsiness) less problematic. Swallow Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka whole with a glass of water.

Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka should be taken daily.

If your doctor decides to discontinue one of the components of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, they may give you efavirenz, emtricitabine, and/or tenofovir disoproxil separately or with other medications for the treatment of HIV infection.

If you take more Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka than you should

If you accidentally take too many Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka tablets, you may be at a higher risk of experiencing possible adverse effects with this medication (see section 4, Possible adverse effects). Consult your doctor or it is advised that you go to the nearest emergency service. Bring the bottle of tablets with you so that you can easily describe what you have taken.

If you forget to take Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka

It is essential that you do not forget a dose of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka.

If you forget a dose of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka within 12 hours of when you normally take it, take it as soon as you can, and then take your next dose at your usual time.

If it is almost time for your next dose (less than 12 hours),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 missed doses.

If you vomit the tablet (within 1 hour after taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka),you should take another tablet. Do not wait until the time of your next dose. You do not need to take another tablet if you vomit more than one hour after taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka.

If you stop treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka

Do not stop treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka without talking to your doctor first.Stopping treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka can severely affect your response to future treatments. If you stop treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka, consult your doctor before restarting the tablets. Your doctor may consider giving you the components of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka separately if you have problems or if your dose needs to be adjusted.

When your supply of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka is running low, ask your doctor or pharmacist for more. This is extremely important because the amount of virus will start to multiply if you stop taking the medication, even if it's just for a short time. In this case, the virus may become more difficult to treat.

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

Talk to your doctor immediately about new or unusual symptoms after stopping treatment, especially symptoms that you associate with hepatitis B virus infection.

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

4. Possible adverse effects

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

Like all medications, this medication can cause adverse effects, although not all people experience them.

Severe adverse effects: inform your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare but severe adverse effect (it can affect up to 1 in 1,000 patients) that can be fatal. The following adverse effects may be signs of lactic acidosis:
• deep and rapid breathing
• drowsiness
• nausea, vomiting, and stomach pain

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

Other severe adverse effects

The following adverse effects are uncommon(they can affect up to 1 in 100 patients):

• allergic reaction (hypersensitivity) that can cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
• swelling of the face, lips, tongue, or throat
• aggression, suicidal thoughts, abnormal thoughts, paranoia, inability to think clearly, mood changes, vision or hearing things that are not really there (hallucinations), suicidal attempts, personality changes (psychosis), catatonia (a condition in which the patient remains immobile and unable to speak for a period of time).
• stomach pain caused by pancreatitis
• forgetfulness, confusion, seizures (convulsions), incoherent speech, tremors (shaking)
• yellow skin or eyes, itching, or stomach pain caused by liver inflammation
• kidney tubule damage

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

Adverse effects on the liver: if you are also infected with the hepatitis B virus, you may experience worsening of hepatitis after stopping treatment (see section 3).

The following adverse effects are rare(they can affect up to 1 in 1,000 patients):

• liver failure, which in some cases leads to death or liver transplantation. Most cases occurred in patients who already had liver disease, but there have been some reports in patients without previous liver disease
• kidney inflammation, increased urine volume, and feeling of thirst
• back pain due to kidney problems, including kidney failure. Your doctor may perform blood tests to see if your kidneys are working properly.
• weakening of the bones (with bone pain and which sometimes ends in fractures) that can occur due to damage to the kidney tubule cells
• fatty liver

If you think you may have any of these severe adverse effects, talk to your doctor.

More frequent adverse effects

The following adverse effects are very common(they can affect more than 1 in 10 patients):

• dizziness, headache, diarrhea, feeling of discomfort (nausea), vomiting
• rashes (including red spots or pimples, sometimes with blisters and swelling of the skin), which can be allergic reactions
• weakness

Tests may also show:

• decreased phosphate levels in the blood
• increased creatine kinase levels in the blood, which can cause muscle pain and weakness

Other possible effects

The following adverse effects are common(they can affect up to 1 in 10 patients):

• allergic reactions
• balance and coordination disorders
• feeling of worry or depression
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• pain, stomach pain
• digestive problems with discomfort after meals, feeling bloated (gases), gas (flatulence)
• loss of appetite
• fatigue
• itching
• changes in skin color, such as darkening of the skin in patches, often starting on the hands and soles of the feet.

Tests may also show:

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

The following adverse effects are uncommon(they can affect up to 1 in 100 patients):

• muscle breakdown, muscle pain, muscle weakness
• anemia (low red blood cell count)
• feeling of spinning or moving sideways (vertigo), ringing, buzzing, or other persistent noises in the ears
• blurred vision
• chills
• breast enlargement in men
• loss of sexual desire
• flushing
• dry mouth
• increased appetite

Tests may also show:

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

In the case of kidney tubule cell damage, muscle breakdown, weakening of the bones (with bone pain and which sometimes ends in fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur.

The following adverse effects are rare(they can affect up to 1 in 1,000 patients):

• skin rash with itching, caused by a reaction to sunlight

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medication.

5. Storage of Efavirenz/Emtricitabina/Tenofovir disoproxilo Krka

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the bottle and carton after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep the bottle tightly closed to protect it from moisture.

The validity period after the first opening is 2 months, if not stored above 25°C.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Efavirenz/Emtricitabina/Tenofovir disoproxil Krka

• The active ingredients are efavirenz, emtricitabine, and tenofovir disoproxil. Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine, and 245 mg of tenofovir disoproxil (as succinate).
• The other ingredients are:

Core of the tablet:microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, sodium croscarmellose, red iron oxide (E172), magnesium stearate, stearic acid fumarate, and sodium.

Film coating:poly (vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, red iron oxide (E172), yellow iron oxide (E172). See section 2 "Efavirenz/Emtricitabina/Tenofovir disoproxil Krka contains sodium".

Appearance of the Product and Package Contents

Efavirenz/Emtricitabina/Tenofovir disoproxil Krka film-coated tablets (tablets) are light orange-pink, oval, biconvex, with beveled edges. Tablet dimensions: 20 x 11 mm.

Efavirenz/Emtricitabina/Tenofovir disoproxil Krka is available in bottles of 30 film-coated tablets with a child-resistant closure, with an incorporated desiccant that helps protect the tablets from moisture.

The following package sizes are available: boxes containing 1 bottle of 30 film-coated tablets or 90 (3 bottles of 30) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.