Patient Leaflet Updated 15-May-2026 | Aurobindo Pharma - Milpharm Ltd.
Efavirenz/emtricitabine/tenofovir disoproxil Milpharm 600 mg/200 mg/245 mg film-coated tablets
Efavirenz/emtricitabine/tenofovir disoproxil 600 mg/200 mg/ 245 mg film-coated tablets
Efavirenz/emtricitabine/tenofovir disoproxil
1. What Efavirenz/emtricitabine/tenofovir disoproxil is and what it is used for
2. What you need to know before you take Efavirenz/emtricitabine/tenofovir disoproxil
3. How to take Efavirenz/emtricitabine/tenofovir disoproxil
4. Possible side effects
5. How to store Efavirenz/emtricitabine/tenofovir disoproxil
6. Contents of the pack and other information
Efavirenz/emtricitabine/tenofovir disoproxil contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply.
Immunodeficiency Virus (HIV) infection in adults aged 18 years and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months. Patients must not have experienced failure of a previous HIV therapy.
Talk to your doctor or pharmacist before taking Efavirenz/emtricitabine/tenofovir disoproxil
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, show some activity against hepatitis B virus although emtricitabine is not approved for the treatment of hepatitis B infection. Symptoms of your hepatitis may become worse after discontinuation of Efavirenz/emtricitabine/tenofovir disoproxil. Your doctor may then conduct blood tests at regular intervals in order to check how well your liver is working (see section 3, If you stop taking Efavirenz/emtricitabine/ tenofovir disoproxil).
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mass. The most pronounced bone loss was seen in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
Overall the effects of tenofovir disoproxil on long-term bone health and future fracture risk in adult and paediatric patients are uncertain.
You must not take Efavirenz/emtricitabine/tenofovir disoproxil with certain medicines.
These are listed under Do not take Efavirenz/emtricitabine/tenofovir disoproxil, at the start of section 2. They include some common medicines and some herbal preparations (including St. John’s wort) which can cause serious interactions.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Also, Efavirenz/emtricitabine/tenofovir disoproxil should not be taken with any other medicines that contain efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil.
Tell your doctor if you are taking other medicines which may damage your kidneys. Some examples include:
Efavirenz/emtricitabine/tenofovir disoproxil may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. As a result, the amounts of Efavirenz/ emtricitabine/tenofovir disoproxil or other medicines in your blood may be affected. This may stop your medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels. It is important to tell your doctor or pharmacist if you are taking any of the following:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women should not get pregnant during treatment with Efavirenz/emtricitabine/ tenofovir disoproxil and for 12 weeks thereafter. Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with Efavirenz/ emtricitabine/tenofovir disoproxil.
If you could get pregnant while receiving Efavirenz/emtricitabine/tenofovir disoproxil, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection). Efavirenz, one of the active components of Efavirenz/emtricitabine/ tenofovir disoproxil, may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking Efavirenz/emtricitabine/tenofovir disoproxil.
Tell your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should take Efavirenz/emtricitabine/tenofovir disoproxil only if you and your doctor decide it is clearly needed.
Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
If you have taken Efavirenz/emtricitabine/tenofovir disoproxil during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Do not breast-feed during treatment with Efavirenz/emtricitabine/tenofovir disoproxil.
Both HIV and the ingredients of Efavirenz/emtricitabine/tenofovir disoproxil may pass through breast milk and cause serious harm to your baby.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Efavirenz/emtricitabine/tenofovir disoproxil may cause dizziness, impaired concentration and drowsiness. If you are affected, do not drive and do not use any tools or machines.
This medicine contains less than 1 mmol sodium (23 mg) per each tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
One tablet taken each day by mouth. Efavirenz/emtricitabine/tenofovir disoproxil should be taken on an empty stomach (commonly defined as 1 hour before or 2 hours after a meal) preferably at bedtime. This may make some side effects (for example, dizziness, drowsiness) less troublesome. Swallow Efavirenz/emtricitabine/tenofovir disoproxil whole with water.
Efavirenz/emtricitabine/tenofovir disoproxil must be taken every day.
If your doctor decides to stop one of the components of Efavirenz/emtricitabine/tenofovir disoproxil, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection.
If you accidentally take too many Efavirenz/emtricitabine/tenofovir disoproxil tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Contact your doctor or nearest emergency department for advice.
Keep the tablet bottle with you so that you can easily describe what you have taken.
It is important not to miss a dose of Efavirenz/emtricitabine/tenofovir disoproxil.
If you do miss a dose of Efavirenz/emtricitabine/tenofovir disoproxil within 12 hours of when it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
If it is almost time (less than 12 hours) for your next dose anyway, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten tablet.
If you throw up the tablet (within 1 hour after taking Efavirenz/emtricitabine/tenofovir disoproxil), you should take another tablet. Do not wait until your next dose is due. You do not need to take another tablet if you were sick more than 1 hour after taking Efavirenz/ emtricitabine/tenofovir disoproxil.
Don’t stop taking Efavirenz/emtricitabine/tenofovir disoproxil without talking to your doctor. Stopping Efavirenz/emtricitabine/tenofovir disoproxil can seriously affect your response to future treatment. If Efavirenz/emtricitabine/tenofovir disoproxil is stopped, speak to your doctor before you restart taking Efavirenz/emtricitabine/tenofovir disoproxil tablets.
Your doctor may consider giving you the components of Efavirenz/emtricitabine/tenofovir disoproxil separately if you are having problems or need your dose adjusted.
When your supply of Efavirenz/emtricitabine/tenofovir disoproxil starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The virus may then become harder to treat.
If you have both HIV infection and hepatitis B, it is especially important not to stop your Efavirenz/emtricitabine/tenofovir disoproxil treatment without talking to your doctor first.
Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of the three components of Efavirenz/emtricitabine/tenofovir disoproxil). If Efavirenz/emtricitabine/tenofovir disoproxil is stopped your doctor may recommend that you resume hepatitis B treatment. You may require blood tests to check how your liver is working for 4 months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you think you may have lactic acidosis, contact your doctor immediately.
The following side effects are uncommon (may affect up to 1 in 100 people):
Psychiatric side 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 who have a history of mental illness. Always notify your doctor immediately if you have these symptoms.
Side effects to the liver: If you are also infected with hepatitis B virus, you may experience a worsening of hepatitis after discontinuation of treatment (see section 3).
The following side effects are rare (may affect up to 1 in 1,000 people):
If you think that you may have any of these serious side effects, talk to your doctor.
The following side effects are very common (may affect more than 1 in 10 people)
Tests may also show:
The following side effects are common (may affect up to 1 in 10 people)
Tests may also show:
The following side effects are uncommon (may affect up to 1 in 100 people):
Tests may also show:
The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
The following side effects are rare (may affect up to 1 in 1,000 people)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton or label after EXP. The expiry date refers to the last day of that month.
Store below 30°C. Keep the bottle tightly closed in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is efavirenz, emtricitabine and tenofovir disoproxil.
Each Efavirenz/emtricitabine/tenofovir disoproxil film-coated tablet contains 600 mg efavirenz, 200 mg emtricitabine and 245 mg tenofovir disoproxil (as fumarate).
The other ingredients are:
Tablet core: Croscarmellose sodium, microcrystalline cellulose, hydroxypropyl cellulose low substituted, hydroxypropylcellulose, sodium laurilsulfate, hypromellose and magnesium stearate
Film coating: Poly vinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) and iron oxide black (E172)
Film-coated tablet.
Efavirenz/emtricitabine/tenofovir disoproxil 600 mg/ 200 mg/245 mg film-coated tablets
Pink colored, oval shaped, biconvex, film coated tablets, debossed with ‘EET’ on one side and plain on the other side.
Efavirenz/emtricitabine/tenofovir disoproxil film-coated tablets are available in HDPE bottle pack.
HDPE bottle pack: 30 film-coated tablets.
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This leaflet was last revised in 10/2025.
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