Label: information for the user

Odefsey 200mg/25mg/25mgfilm-coated tablets

emtricitabina/rilpivirina/tenofovir alafenamida

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

-This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist,even if they are adverse effects not listed in this label. See section4.

1.What isOdefseyand for what it is used

2.What you need to know before starting to takeOdefsey

3.How to takeOdefsey

4.Possible adverse effects

5.Storage ofOdefsey

6.Contents of the package and additional information

Odefsey is an antiviral medication used to treat infection with thehuman immunodeficiency virus (HIV).It is a single tablet containing a combination of three active ingredients:emtricitabine, rilpivirine, and tenofovir alafenamide. Each of these active ingredients acts by interfering with an enzyme called «reverse transcriptase», which is essential for the HIV‑1 virus to multiply.

Odefsey reduces the amount of HIV present in the body. This improves the immune system and decreases the risk of developing diseases associated with HIV infection.

Odefsey is used in adults and adolescents aged 12 years or older with a weight of at least 35 kg.

Do not takeOdefsey:

• if you are allergic to emtricitabine, rilpivirine, tenofovir alafenamideor to any of the other ingredients of this medicine (listed in section6).

• if you are taking any of the following medicines:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin(used to treat epilepsy and prevent seizures)
• rifabutin, rifampicin, andrifapentine(used to treat some bacterial infections such as tuberculosis)
• omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole(used to prevent and treat stomach ulcers, heartburn, and acid reflux disease)
• dexamethasone(a corticosteroid used to treat inflammation and suppress the immune system) when taken orally or injected (except as a single dose treatment)
• products containing St. John's Wort(Hypericum perforatum, a medicinal plant used to treat depression and anxiety)

?if you find yourself in any of these circumstances,do not take Odefsey and consult your doctor immediately.

Warnings and precautions

You must remain under your doctor's supervision while taking Odefsey.

While taking this medicineyou may still be able to transmit HIV to others,although 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 takingOdefseyyou may still experience infections or other diseases associated with HIV infection.

Consult your doctor before starting to take Odefsey:

• if you have liver problems or a history of liver disease, including hepatitis.Patients with liver disease, including chronic hepatitisB orC, treated with antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. If you have hepatitisB, your doctor will carefully consider the best treatment plan for you.

if you have hepatitisB, liver problems may worsen after stopping Odefsey administration. It is essential that you do not stop takingOdefseywithout first talking to your doctor: see section3,Do not interrupt treatment withOdefsey.

• if you are taking any medicine that may cause irregular heartbeat(Torsades de Pointes) potentially fatal.

While takingOdefsey

Once you start takingOdefsey, be aware of:

• signs of inflammation or infection
• joint pain, stiffness, or bone problems

?if you notice any of these symptoms, inform your doctor immediately.For more information, see section4,Adverse reactions.

You may experience kidney problems if you take Odefsey for a prolonged period.

Children and adolescents

Do not administer this medicine to children under 11years of age or weighing less than 35kg.Odefsey has not yet been studied in children under 11years of age or weighing less than 35kg.

Other medicines and Odefsey

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Odefsey may interact with other medicines. As a result, the blood levels of Odefsey or other medicines may be affected. This may prevent your medicines from working properly or worsen their potential side effects. In some cases, your doctor may need to adjust the dose or check your blood concentrations.

Medicines that should never be taken with Odefsey:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin(used to treat epilepsy and prevent seizures)
• rifabutin, rifampicin, andrifapentine(used to treat some bacterial infections such as tuberculosis)
• omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole(used to prevent and treat stomach ulcers, heartburn, and acid reflux disease)
• dexamethasone(a corticosteroid used to treat inflammation and suppress the immune system) when taken orally or injected (except as a single dose treatment)
• products containing St. John's Wort(Hypericum perforatum, a medicinal plant used to treat depression and anxiety)

?if you are taking any of these medicines,do not take Odefsey and consult your doctor immediately.

Other types of medicines:

Consult your doctor if you are taking:

• any medicine used to treat HIV

• any medicine that contains:

• tenofoviralafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil

• antibiotics used to treat bacterial infectionsthat contain:

• clarithromycin
• erythromycin

These medicines may increase the amount of rilpivirine and tenofovir alafenamide (components ofOdefsey) in the blood. Your doctor will administer a different medicine.

• antifungals used to treat fungal infections:

• ketoconazole
• fluconazole
• itraconazole
• posaconazole
• voriconazole

These medicines may increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will administer a different medicine.

• medicines for stomach ulcers, acid reflux, or heartburnsuch as:

• antacids(aluminum/magnesium hydroxide or calcium carbonate)
• antagonists H2(famotidine, cimetidine, nizatidine, or ranitidine)

These medicines may decrease the blood levels of rilpivirine (a component of Odefsey). If you are taking one of these medicines, your doctor will administer a different medicine or recommend how and when to take this medicine:

• if you are taking an antacid,take it at least 2hours before or at least 4hours after Odefsey.

• if you are taking an H2antagonist, take it at least 12hours before or at least 4hours after Odefsey. H2antagonists can only be taken once a day if you are taking Odefsey. H2antagonists should not be taken twice a day. Consult your doctor to indicate an alternative regimen (see How to take Odefsey).

• ciclosporin,a medicine used to reduce the activity of the immune system of theorganism:

This medicine may increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will administer a different medicine.

• methadone,a medicine used to treat opioid addiction, as your doctor may need to change your methadone dose.

• dabigatran etexilate, a medicine used to treat cardiovascular disease, as your doctor may need to monitor the concentrations of this medicine in your blood.

?consult your doctor if you are taking any of these medicines. Do not interrupt your treatment without consulting your doctor.

Pregnancy and breastfeeding

• if you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.
• Use an effective method ofcontraceptionwhile taking Odefsey.

Consult your doctor or pharmacist before using any medicine if you are pregnant.

If you have taken Odefsey during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took HIV-1 nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Do not breastfeed your child during treatment with Odefsey. This is because some of the active ingredients of this medicine pass into breast milk. It is recommended that you do not breastfeed to avoid transmitting the virus to the child through breast milk.

Driving and operating machines

Do not drive or operate machines if you feel tired, drowsy, or experience dizziness after taking your medicine.

Odefsey contains lactose

if your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

?if you find yourself in any of these circumstances,consult your doctor before starting to take Odefsey.

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

The recommended dose is:

Adults:a tablet per day with food

Adolescents aged 12 years or older, weighing at least 35 kg:a tablet per day with food

Do not chew, crush, or divide the tablet.

If you are taking an antacid, such as aluminum/magnesium hydroxide or calcium carbonate, take it at least 2 hours before or at least 4 hours after Odefsey.

If you are taking an H2 antagonist, such as famotidine, cimetidine, nizatidine, or ranitidine, take it at least 12 hours before or at least 4 hours after Odefsey. H2 antagonists can only be taken once a day if you are taking Odefsey. H2 antagonists should not be taken twice a day. Consult with your doctor for an alternative regimen.

If you are on dialysis, take your daily dose of Odefsey once dialysis is completed.

If you take more Odefsey than you should

If you accidentally take more than the recommended dose of Odefsey, you may be at a higher risk of experiencing possible side effects with this medication (see section 4, Possible side effects).

Consult your doctor immediately or go to the nearest emergency service. Keep or bring the tablet container with you so that you can easily describe what you have taken.

If you forget to take Odefsey

It is very important not to forget a dose of Odefsey.

If you forget a dose:

• If you realize within 12 hours of the time you normally take Odefsey, take the tablet as soon as possible. Take the tablet always with food. Then take the next dose as usual.
• If you realize 12 hours or more after the time you normally take Odefsey, do not take the missed dose. Wait and take the next dose, with food, at the usual time.

If you vomit before 4 hours have passed since taking Odefsey, take another tablet with food.If you vomit more than 4 hours after taking Odefsey, you do not need to take another tablet until the next scheduled tablet.

Do not interrupt treatment with Odefsey

Do not interrupt treatment with Odefsey without first speaking with your doctor.Interrupting Odefsey may severely affect your response to future treatments. If Odefsey is interrupted for any reason, consult with your doctor before restarting tablet intake of Odefsey.

When you see that you have little Odefsey left, go to your doctor or pharmacist to get more. This is very important, as the amount of virus may start to increase if the medication is interrupted, even for a short period of time. It is possible that the disease will then become more difficult to treat.

If you have both HIV and hepatitis B, it is especially important not to suspend your treatment with Odefsey without first speaking with your doctor. You may need to have blood tests for several months after suspending treatment. In some patients with advanced liver disease or cirrhosis, treatment is not recommended as this may lead to worsening of hepatitis, a potentially fatal condition.

?Talk to your doctor immediately about new or unusual symptoms after suspending treatment, particularly symptoms associated with hepatitis B infection.

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

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

Possible side effects: inform your doctor immediately

• Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight off infections that may have been present without obvious symptoms.

• Autoimmune disorders may also occur, in which the immune system attacks healthy tissues in the body, after starting HIV treatment. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms, such as:

-muscle weakness

-weakness that starts in the hands and feet and moves to the trunk

-palpitations, tremors, or hyperactivity

?If you notice any of these symptoms or any signs of inflammation or infection, inform your doctor immediately.

Very common side effects

(may affect more than 1 in 10 peoplepeople)

• difficulty sleeping (insomnia)
• headache
• dizziness
• nausea (gag reflex)

Lab tests may also show:

• increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood
• increased levels of liver enzymes in the blood

Common side effects

(may affect up to 1 in 10 peoplepeople)

• loss of appetite
• depression
• abnormal dreams
• sleep disorders
• depressed mood
• drowsiness
• fatigue
• stomach pain or discomfort
• vomiting (vomiting)
• gas (flatulence)
• dry mouth
• diarrhea
• eruption

Lab tests may also show:

• low white blood cell count (a reduced white blood cell count may make you more prone to infection)

• low platelet count (a type of blood cell that participates in blood clotting)

• decreased hemoglobin in the blood
• increased levels of triglycerides, bilirubin, or lipase in the blood

Rare side effects

(may affect up to 1 in 100 peoplepeople)

• signs or symptoms of inflammation or infection
• low red blood cell count (anemia)
• severe skin reactions, including rash accompanied by fever, swelling, and liver problems
• digestive problems that cause discomfort after eating
• swelling of the face, lips, tongue, or throat (angioedema)
• itching (pruritus)
• hives (urticaria)
• joint pain (arthralgia)

?If you consider any of the side effects you are experiencing to be severe, inform your doctor.

Other effects that may be observed during HIV treatment

The frequency of the following side effects is unknown (the frequency cannot be estimated from the available data).

• Bone problems. Some patients treated with combination antiretroviral medications such as Odefsey may develop a bone disease calledosteonecrosis(bone tissue death due to a loss of blood supply to the bone). Taking this type of medication for a prolonged period, taking corticosteroids, drinking alcohol, having a severely weakened immune system, and being overweight may be some of the many risk factors for developing this disease. The signs of osteonecrosis are:

• joint stiffness
• joint pain and discomfort (especially in the hip, knee, and shoulder)
• difficulty moving

?If you notice any of these symptoms, inform your doctor.

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

Reporting side effects

If you experienceany type of side effect, consult your doctororpharmacist,even if it is apossibleside effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after {CAD}. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Keep the bottle perfectly closed.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Odefsey Composition

The active ingredients areemtricitabina, rilpivirina, and tenofovir alafenamida. Each Odefsey film-coated tablet contains 200mg of emtricitabina, rilpivirina hydrochloride equivalent to 25mg of rilpivirina, and tenofovir alafenamida fumarate equivalent to 25mg of tenofovir alafenamida.

The other components are

Tablet core:

Sodium croscarmellose, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, poloxamer 20, povidone.

Film coating:

Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).

Appearance of the product and contents of the pack

Odefsey is a grey tablet, in capsule shape, film-coated, marked on one face with “GSI” and “255” on the other face. Odefsey is available in bottles of 30tablets and in packs of 3 bottles, each containing 30 tablets. Each bottle contains a silica gel desiccant that should be kept in the bottle to help protect the tablets. The silica gel desiccant is contained in a separate sachet or container and should not be taken.

Only some pack sizes may be marketed.

Marketing authorization holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible person

Gilead Sciences Ireland UC

IDA Business and Technology Park

Carrigtohill

County Cork

Ireland

For further information about this medicinal product, please consult the representative of the marketing authorisation holder:

Last update of the summary of product characteristics: <{MM/AAAA}><{month AAAA}>.

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