Label:information for the user

Genvoya 150mg/150mg/200mg/10mg film-coated tablets

Elvitegravir/cobicistat/emtricitabina/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 section 4 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 not listed in this label.

1.What is Genvoya and for what it is used

2.What you need to knowbefore starting to take Genvoya

3.How to take Genvoya

4.Possible adverse effects

5.Storage of Genvoya

6.Contents of the package and additional information

If Genvoya has been prescribed for your child, note that all the information in this label is directed at your child (in this case, when reading “you” substitute it with “your child”).

Genvoya contains four active ingredients:

• elvitegravir,a medication known as an integrase inhibitor
• cobicistat,a pharmacokinetic enhancer of the effects of elvitegravir
• emtricitabine,a medication known as a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide,a medication known as a nucleotide reverse transcriptase inhibitor (NtRTI)

Genvoya is a single tablet for thetreatment of human immunodeficiency virus type 1 (HIV-1)infection in adults, adolescents, and children aged 6years or older, who weigh at least 25kg.

Genvoyareduces the amount of HIV present in the body. This will improve the immune system and decrease the risk of developing diseases associated with HIV infection.

Do not take Genvoya:

• If you are allergic to elvitegravir, cobicistat, emtricitabina, tenofovir alafenamida, or any of the other components of this medication (listed in section 6 of this leaflet).

• If you are taking one of the following medications:

• alfuzosin (used to treat an enlarged prostate)
• dabigatran (used to prevent and treat blood clots)
• amiodarone, quinidine (used to correct irregular heartbeats)
• carbamazepine, phenobarbital, phenytoin (used to prevent seizures)
• rifampicin (used to prevent and treat tuberculosis and other infections)
• dihydroergotamine, ergometrine, ergotamine (used to treat migraines)
• cisapride (used to alleviate certain stomach problems)
• St. John's Wort (Hypericum perforatum, a plant-based medication used to treat depression and anxiety)or products containing it
• lovastatin, simvastatin (used to reduce cholesterol in the blood)
• pimozide, lurasidone (used to treat abnormal thoughts or feelings)
• sildenafil (when used to treat pulmonary arterial hypertension, a lung disease that makes it difficult to breathe)
• midazolam administered orally, triazolam (used to help sleep and/or alleviate anxiety)

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

Warnings and precautions

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

While taking this medication, you may still transmit HIV to others, although effective antiviral treatment reduces the risk. Consult your doctor about the necessary precautions to avoid infecting others.This medication is not a cure for HIV infection. While you are taking Genvoya, you may still experience infections or other diseases associated with HIV infection.

Consult your doctor before starting to take Genvoya:

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

If you have hepatitis B, liver problems may worsen after stopping Genvoya administration. It is essential not to stop taking Genvoya without first consulting your doctor: see section 3, Do not interrupt Genvoya treatment.

While taking Genvoya:

Once you start taking Genvoya, be aware of:

• Signs of inflammation or infection
• Pain, stiffness, or bone problems

?If you notice any of these symptoms, inform your doctor immediately.For more information, see section 4, Possible side effects.

Children and adolescents

Do not administer this medication to children aged 5 years or younger, or weighing less than 25 kg, regardless of age. Genvoya has not yet been studied in children aged 5 years or younger.

Other medications and Genvoya

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

Medications that should never be taken with Genvoya:

• alfuzosin (used to treat an enlarged prostate)
• amiodarone, quinidine (used to correct irregular heartbeats)
• carbamazepine, phenobarbital, phenytoin (used to prevent seizures)
• dabigatran (used to prevent and treat blood clots)
• rifampicin (used to prevent and treat tuberculosis and other infections)
• dihydroergotamine, ergometrine, ergotamine (used to treat migraines)
• cisapride (used to alleviate certain stomach problems)
• St. John's Wort (Hypericum perforatum, a plant-based medication used to treat depression and anxiety)or products containing it
• lovastatin, simvastatin (used to reduce cholesterol in the blood)
• pimozide, lurasidone (used to treat abnormal thoughts or feelings)
• sildenafil (when used to treat pulmonary arterial hypertension, a lung disease that makes it difficult to breathe)
• midazolam administered orally, triazolam (used to help sleep and/or alleviate anxiety)

?If you are taking any of these medications, do not take Genvoya and inform your doctor immediately.

Medications used to treat hepatitis B virus infection:

Do not take Genvoya with medications that contain:

• tenofovir alafenamida

• tenofovir disoproxil
• lamivudina
• adefovir dipivoxil

?Consult your doctor if you are taking any of these medications.

Other types of medications:

Consult your doctor if you are taking:

• antifungals, used to treat fungal infections, such as:

• ketoconazole, itraconazole, voriconazole, posaconazole, and fluconazole

• antibiotics, used to treat bacterial infections, including tuberculosis, that contain:

• rifabutin, clarithromycin, and telithromycin

• antidepressants, used to treat depression:

• medications containing trazodone or escitalopram

• sedatives and hypnotics, used to treat anxiety:

• buspirona, clorazepato, diazepam, estazolam, furazepam, zolpidem, and lorazepam

• immunosuppressants, used to control the body's immune response after a transplant, such as:

• ciclosporina, sirolimus, and tacrolimus

• corticosteroids, including:

• betametasona, budesonida, fluticasona, mometasona, prednisona, triamcinolona.

These medications are used to treat allergies, asthma, inflammatory bowel disease, eye, joint, and muscle inflammation, and other inflammatory conditions.If alternatives cannot be used, only use after a clinical evaluation and with close monitoring by your doctor to assess the adverse effects of corticosteroids.

• medications used to treat diabetes:

• metformina

• birth control pill, used to prevent pregnancy

• medications for erectile dysfunction, used to treat impotence, such as:

• sildenafil, tadalafilo, and vardenafilo

• heart medications, such as:

• digoxina, disopiramida, flecainida, lidocaína, mexiletina, propafenona, metoprolol, timolol, amlodipino, diltiazem, felodipino, nicardipino, nifedipino, and verapamilo

• medications used to treat pulmonary arterial hypertension:

• bosentan and tadalafilo

• anticoagulants, used to prevent and treat blood clots, such as:

• apixabán, edoxabán, rivaroxabán, and warfarina

• bronchodilators, used to treat asthma and other lung problems:

• salmeterol

• medications to reduce cholesterol, such as:

• atorvastatina and pitavastatina

• medications used to treat gout:

• colchicina

?Inform your doctor if you are taking these or other medications.Do not interrupt your treatment without consulting your doctor.

• antacids, used to treat heartburn or acid reflux (see also section 3, How to take Genvoya).

?If you are taking an antacid or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Genvoya.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

• Inform your doctor immediately if you are pregnant, think you may be pregnant, or intend to become pregnant.Pregnant women should not take Genvoya. The amount of this medication in the blood may decrease during pregnancy, making it less effective.
• Use an effective method of contraception while taking Genvoya.
• Do not breastfeed your child during treatment with Genvoya.This is because some of the active ingredients in this medication pass into breast milk. It is recommended not to breastfeed to avoid transmitting the virus to the child through breast milk.

Driving and operating machinery

Genvoya may cause dizziness. If you experience dizziness during treatment with Genvoya, do not drive, ride a bike, or operate tools or machines.

Genvoya contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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 and children aged 6years or older, weighing at least 25kg:a tablet per day with food

Do not chew or crush the tablet.

If you have difficulty swallowing the entire tablet, you can break it in half. Swallow the two halves of the tablet one after the other to take the full dose. Do not store the broken tablet.

Always take the recommended dose prescribed by your doctor.This is to ensure that your medication is completely effective, and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to.

Do not take antacids or multivitamins at the same timeas Genvoya. If you are taking an antacid such as aluminum/magnesium hydroxide or amultivitamin supplement, take it at least 4hours before or at least 4hours after Genvoya.

If you receive dialysis, take the daily dose of Genvoya once dialysis is completed.

If you take more Genvoya than you should

If you accidentally take more than the recommended dose of Genvoya, you may be at a higher risk of experiencing possible side effects with this medication (see section4,Side effects).

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

If you forget to take Genvoya

It is essential that you do not forget a dose of Genvoya.

If you forget a dose:

• If you realize within 18hoursafter the time you normally takeGenvoya, you must take the tablet as soon as possible. Take the tablet always with food. Then take the next dose as usual.
• If you realize 18hoursor moreafter the time you normally takeGenvoya, do not takethe missed dose. Wait and take the next dose, with food, at the usual time.

If you vomit before 1hour after taking Genvoya,take another tablet with food.

Do not interrupt treatment with Genvoya

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

When you see that you have little Genvoya 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 hepatitisB,it is especially important not to suspend your treatment with Genvoya 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, it is not recommended to suspend treatment as this may cause a worsening of your hepatitis, a situation that can be potentially fatal.

?Talk to your doctor immediatelyabout new or unusual symptoms after suspending treatment, particularly symptoms associated with hepatitisB infection.

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

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

Like all medications,this medicationcan produce side effects, although not all people will experience them. When treating HIV infection, it is not always possible to distinguish whether some unwanted effects are due to Genvoya or to other medications being taken at the same time or to the HIV disease itself.

Severe side effects: report to a 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 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.

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

-muscle weakness

-weakness starting in the hands and feet and moving to the trunk

-palpitations, tremors, or hyperactivity

?If you notice any of the above side effects, report them to your doctor immediately.

Frequent side effects

(may affect more than 1 in 10people)

• nausea (gagging)

Common side effects

(may affect up to 1 in 10people)

• abnormal dreams
• headache
• dizziness
• diarrhea
• vomiting
• stomach pain
• gas (flatulence)
• skin rash
• fatigue (fatigue)

Rare side effects

(may affect up to 1 in 100people)

• low red blood cell count (anemia)
• thoughts of suicide and suicide attempts (in patients who have had depression or mental health problems previously), depression
• digestive problems that cause discomfort after eating (dispepsia)
• swelling of the face, lips, tongue, or throat (angioedema)
• itching (prurito)
• hives (urticaria)

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

Other effects that may be observed during HIV treatment

The frequency of the following side effects is unknown (the frequencycannot be estimated from the available data).

• Bone problems.Some patients treated with combined antiretroviral medications like Genvoya 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 very weakened immune system, and being overweight may besome of the many risk factors for developing this disease. The signs of osteonecrosis are:

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

?If you notice any of these symptoms, report them to your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly throughthenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter 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 disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Genvoya

The active ingredients areelvitegravir, cobicistat, emtricitabina, and tenofovir alafenamide. Each Genvoya film-coated tablet contains 150mg of elvitegravir, 150mg of cobicistat, 200mg of emtricitabina, and tenofovir alafenamide fumarate equivalent to 10mg of tenofovir alafenamide.

The other components are

Core tablet:

Lactose (in the form of monohydrate), microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate.

Film coating::

Polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), aluminium lake indigo carmine (E132), yellow iron oxide (E172).

Appearance of the product and contents of the pack

The Genvoya film-coated tablets are green, capsule-shaped tablets, marked on one face with “GSI” and on the other with the number “510”. Genvoya is presented in bottles of 30tablets (with 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.

This medicinal product is available in packs of 1bottle of 30film-coated tablets and in packs of 90(3bottles of 30)film-coated tablets.Only some pack sizes may be marketed.

Marketing authorisation holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible person

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For further information about this medicinal product, please contact the representative in your country of the marketing authorisation holder:

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

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