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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Macleods

600 mg/200 mg/245 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. 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 pass it on to others, even if they have the same symptoms as yours, because it may harm them.
If you get any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods is and what it is used for

Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods 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) that is essential for the virus to replicate.

Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods 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 have had their HIV-1 infection under control for at least three months. Patients must not have experienced prior treatment failure for HIV infection.

2. What you need to know before starting Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods

Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods:

if you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or to 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 called QT prolongation, which puts you at high risk of serious heart rhythm problems (Torsade de Pointes).
if any of your family members (parents, grandparents, siblings) have 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 “Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods”):
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 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)
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 Macleods could cause serious and/or potentially fatal side effects and/or may cause these medicines to stop working properly.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

This medicine is not a cure for HIV infection. While you are taking this medicine, you may still develop infections or other illnesses associated with HIV infection.
While taking this medicine, you must remain under your doctor’s supervision.

Tell your doctor:

if you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. This medicine must not be taken with any of these medicines.
if you have or have had kidney disease, or if blood tests have shown 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 request blood tests to check your kidney function. Your doctor may also request regular blood tests during treatment to monitor your kidneys.

This medicine should normally not be taken with other medicines that may harm your kidneys (see Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods 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 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 experience unusual thoughts (see section 4, Possible side effects).
if you have a history of seizures (spasms or fits) or if you 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 Macleods. 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 antiretroviral therapy, have an increased 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 Macleods if you have severe liver disease (see earlier in section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods).

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

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 of age. The number of patients over 65 years old studied is insufficient. If you are over 65 and have been prescribed this medicine, your doctor will monitor you closely.

Once you start taking Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods, 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. This medicine may cause skin rashes. If you notice signs of a severe rash with blisters or fever, stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods 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 this medicine.
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 anti-HIV treatment. These symptoms are believed to result from improved immune response, enabling 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 (manifesting as persistent or worsening bone pain and sometimes leading to fractures) due to damage to renal tubule cells (see section 4, Possible side effects). Inform your doctor if you experience bone pain or fractures.

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

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

Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Numerous risk factors for developing this condition include 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 notice any of these symptoms, inform your doctor.

Inform your doctor if you have osteoporosis, a history of bone fractures, or bone problems.

Children and adolescents

Do not give Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods to children and adolescents under 18 years of age. The use of this medicine has not been studied in children and adolescents.

Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods

You must not take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods with certain medicines. These are listed under Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods, 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.

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

Additionally, this medicine must not be taken with any other medicine containing efavirenz (unless your doctor advises otherwise), 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 treating cancer)
non-steroidal anti-inflammatory drugs (NSAIDs, for relieving bone or muscle pain).

Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods may interact with other medicines, including herbal medicines such as Ginkgo biloba extracts. This may result in altered blood levels of this medicine 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 to inform your doctor or pharmacist if you are taking any of the following:

Medicines containing didanosine (for HIV infection): taking this medicine with other antiviral medicines containing didanosine may increase didanosine levels in your blood and may reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), some fatal, have been reported when 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 by ritonavir or saquinavir. Your doctor may consider prescribing a different medicine or adjusting the dose of the protease inhibitors. Also, inform your doctor if you are taking maraviroc.
Medicines used to treat hepatitis C virus infection: elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
Medicines used to lower blood fat (also called statins): atorvastatin, pravastatin, simvastatin. This medicine may reduce statin levels in the blood. Your doctor will check your cholesterol levels and may consider adjusting the statin dose if necessary.
Medicines used to treat seizures/fits (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods may reduce anticonvulsant levels in the blood. Carbamazepine may reduce efavirenz levels, one of the components of this medicine. Your doctor may need to consider prescribing a different anticonvulsant.
Medicines used to treat bacterial infections, including tuberculosis and Mycobacterium avium complex associated with 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.
Medicines used to treat fungal infections (antifungals): itraconazole or posaconazole. This medicine may reduce itraconazole or posaconazole levels in the blood. Your doctor may need to consider using a different antifungal.
Medicines used to treat malaria: atovaquone/proguanil or artemether/lumefantrine. This medicine may reduce atovaquone/proguanil or artemether/lumefantrine levels in the blood.
Hormonal contraceptives, such as birth control pills, injectable contraceptives (e.g., Depo-Provera), or contraceptive implants (e.g., Implanon): you must also use a reliable barrier method (see Pregnancy and breastfeeding). Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods may interfere with hormonal contraceptives. Cases of pregnancy have been reported in women taking efavirenz, a component of this medicine, while using contraceptive implants, although a causal link to 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 quit smoking, as your doctor may need to adjust the bupropion dose.
Diltiazem or similar medicines (called calcium channel blockers): when starting treatment with this medicine, your doctor may need to adjust your calcium channel blocker dose.
Medicines used to prevent organ rejection after transplantation (also called immunosuppressants) such as cyclosporine, sirolimus, or tacrolimus. Both when starting and stopping treatment with this medicine, your doctor will closely 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 Macleods or within 12 weeks after treatment ends. Your doctor may require a pregnancy test to confirm you are not pregnant before starting this medicine.

If you could become pregnant while taking Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods, you must use a reliable barrier method (e.g., condom) together with other contraceptive methods, including oral contraceptives (the pill) or other hormonal contraceptives (e.g., implants, injections). Efavirenz, one of the active ingredients in this medicine, may remain in your blood for some time after stopping treatment. Therefore, you must continue using contraceptive measures as described above for 12 weeks after stopping this medicine.

Inform your doctor immediately if you become pregnant or plan to become pregnant. If you are pregnant, you should only take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods if 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 using any medicine.

If you have taken Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby’s development. In children whose mothers took NNRTIs 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 Macleods. Both HIV and the ingredients of this medicine can pass into breast milk and may cause serious harm to the baby.

Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or planning to breastfeed, you should consult your doctor as soon as possible.

Driving and using machines

Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods 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 contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, it is “sodium-free”.

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

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

One tablet daily, taken orally. Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods should be taken on an empty stomach (usually defined as one hour before or two hours after a meal), preferably at bedtime. This may make some of the adverse effects (for example, dizziness, drowsiness) less troublesome. Swallow the tablet whole with a glass of water.

Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods must be taken daily.

If your doctor decides to discontinue one of the components of this medicine, 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 Macleods than you should

If you accidentally take too many tablets of Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods, you may be at an increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible adverse effects). If you have taken more Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

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

It is important that you do not miss a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods.

If you miss a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil within 12 hours of when you usually take it, 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 the 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 Macleods), 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 vomited more than one hour after taking this medicine.

If you interrupt treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods

Do not interrupt treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil without first talking to your doctor. Interrupting treatment with this medicine may seriously affect your response to future treatments. If you interrupt treatment with this medicine, consult your doctor before restarting the tablets. Your doctor may consider giving you the components of this medicine separately if you have problems or require dose adjustments.

When your supply of Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods starts to run out, request a new supply from your doctor or pharmacist. This is extremely important because the amount of virus may start to increase if you stop taking the medicine, even for a short period of time. In such cases, the virus may become more difficult to treat.

If you have both HIV infection and hepatitis B, it is especially important not to stop treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil without first talking to your doctor. 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 this medicine). If you stop treatment with this medicine, your doctor may recommend resuming treatment for hepatitis B. You may need blood tests to monitor liver function during the four months following discontinuation of treatment. In some patients with advanced liver disease or cirrhosis, discontinuation of treatment is not recommended, as this may lead to 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 adverse effects

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

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious possible adverse effects: tell your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare adverse effect (may affect up to 1 in 1,000 patients) but serious and potentially fatal. The following adverse 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 adverse effects

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

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

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

liver failure, which in some cases leads to death or liver transplant. Most cases occurred in patients who already had liver disease, but there have been 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), which may occur due to damage to kidney tubule cells
fatty liver

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

More common adverse effects

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

dizziness, headache, diarrhea, 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 adverse effects

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

allergic reactions
balance and coordination disorders
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
fatigue
itching
changes in skin color 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)
problems with the liver and pancreas
increased levels of fatty acids (triglycerides), bilirubin, or blood sugar levels

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

muscle rupture, muscle pain, muscle weakness
anemia (low red blood cell count)
sensation of spinning or moving sideways (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 levels in blood
protein in urine
increased cholesterol levels in blood

In case of damage to kidney tubule cells, 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 adverse effects are rare (may affect up to 1 in 1,000 patients):

skin rash with itching caused by a reaction to sunlight

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efavirenz/Emtricitabine/Tenofovir Disoproxil Macleods

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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

After first opening the bottle, use within 90 days.

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

6. Contents of the pack and other information

Composition of Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods

The active substances 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 fumarate).
The other components in the tablet are microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate, pregelatinized maize starch, isopropyl alcohol.
The other components of the tablet coating are partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), red iron oxide (E172), black iron oxide (E172).

Appearance of the product and contents of the pack

Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods are pink, capsule-shaped, biconvex, film-coated tablets, marked on one side with “CL 81” and plain on the other.

Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods is available in bottles of 30 and 90 tablets with a silica gel desiccant packet. The silica gel desiccant must not be swallowed.

This medicine is available in the following pack sizes: packs of 30 (1 bottle containing 30 film-coated tablets) and 90 (3 bottles containing 30 film-coated tablets each) film-coated tablets.

This medicine is also available in unit dose blister packs.

Unit dose blister pack: 30 and 90 film-coated tablets

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona,

Spain

Manufacturer

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

Heumann Pharma GmbH & Co. Generica KG,

Suedwestpark 50

90449 Nuremberg

Germany

Date of the most recent revision of this leaflet: February 2026

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/)