Label: information for the user

Descovy 200 mg/25 mg film-coated tablets

emtricitabine/tenofovir alafenamide

This medicine is subject to additional monitoring, which will facilitate 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 refer to 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Descovy contains two active ingredients:

• emtricitabina,a type of antiretroviral medication known as a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide,a type of antiretroviral medication known as a nucleotide reverse transcriptase inhibitor (NtRTI)

Descovy blocks the action of the reverse transcriptase enzyme, which is essential for the multiplication of the virus. Therefore, Descovy reduces the amount of HIV present in the body.

Descovy in combination with other medications is used for thetreatment of human immunodeficiency virus 1 (HIV-1) infectionin adults and adolescents aged 12 years or older, who weigh at least 35 kg.

Do not take Descovy:

• If you are allergic to emtricitabine, tenofovir alafenamide or to any of the other ingredientsof this medication (listed in section 6 of this leaflet).

Warnings and precautions

You must remain under the supervision of your doctor while taking Descovy.

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

Consult your doctor before starting to take Descovy:

• If you have liver problems or have had 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 fatal liver complications. If you have hepatitis B, your doctor will carefully consider the best treatment regimen for you.

If you have hepatitis B, liver problems may worsen after stopping Descovy administration. Do not stop taking Descovy without first talking to your doctor: see section 3, Do not interrupt treatment with Descovy.

• Your doctor may not prescribe Descovy if the virus has a K65R mutation.

While taking Descovy

Once you start taking Descovy, 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 section 4, Possible side effects.

Although kidney problems have not been observed with Descovy, there is a possibility that you may experience kidney problems if you take Descovy for a prolonged period.

Children and adolescents

Do not administer this medication to children11 years of age or younger or weighing less than 35 kg.

Descovy has not yet been studied in children 11 years of age or younger.

Other medications and Descovy

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.Descovy may interact with other medications.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 used to treat hepatitis B virus infection:

Do not take Descovy with medications that contain:

• Tenofovir alafenamide

• Tenofovir disoproxil

• Lamivudine

• Adefovir dipivoxil

• Consult your doctorif you are taking any of these medications.

Other types of medications:

Consult your doctor if you are taking:

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• antibiotics, used to treat bacterial infections including tuberculosis, thatcontain:
• • Rifabutin, rifampicin and rifapentine

• Antiviral medications used to treat HIV:

• Antiepileptic medications, used to treat epilepsy, such as:

• Herbal medications, used to treat depression and anxiety thatcontain:
• • St. John's Wort (Hypericum perforatum)

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

• Use an effective method of contraceptionwhile taking Descovy.

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

If you have taken Descovy during pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took ITIAN during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Do not breastfeed your child during treatment with Descovy.This is because one of theactive ingredients in this medication passes 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 machinery

Descovy may cause dizziness. If you experience dizziness during treatment with Descovy, do not drive or operate tools or machinery.

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:one tablet per day, with or without food

Adolescents 12 years of age or older, weighing at least 35 kg:one tablet per day with orwithout food

Do not chew, crush, or divide the tablet.

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

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

If you take more Descovy than you should

If you take more than the recommended dose of Descovy, you may be at a higher risk of adverse effects from this medication (see section 4,Possible adverse effects).

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

If you forget to take Descovy

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

If you forget a dose:

• If you realize within 18 hoursafter the time you normally take Descovy,take the tablet as soon as possible. Then take the next dose as usual.

• If you realize 18 hours or moreafter the time you normally take Descovy, do nottake the missed dose. Wait and take the next dose at the usual time.

If you vomit within 1 hour of taking Descovy,take another tablet.

Do not interrupt treatment with Descovy

Do not interrupt treatment with Descovy without first speaking with your doctor.Interrupting Descovymay severely affect the proper functioning of future treatments. If Descovy is interrupted for any reason, consult with your doctor before restarting the tablet intake of Descovy.

When you see that you have little Descovy left,visit your doctor or pharmacist to obtain more. This is very important, as the virus load 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 infection,it is very important not to stop takingDescovy without first speaking with your doctor. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to a worsening of hepatitis, a situation that can be potentially fatal.

• Talk to your doctor immediatelyabout new or unusual symptoms after stopping yourtreatment, particularly symptoms associated with hepatitis B virus 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.

Severe side effects: report to a doctor immediately

• Any sign of inflammation or infection.In some patients with advanced HIV (AIDS) infection 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 antiretroviral treatment. It is believed that these symptoms are due to an improvement in the immune system's response, which allows it to fight off infections that may have been present without obvious symptoms.

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

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

Very common side effects

(may affect more than 1 in 10 people)

• Nausea (gag reflex)

Common side effects

(may affect up to 1 in 10 people))

• Abnormal dreams

• Headache

• Dizziness

• Diarrhea

• Vomiting

• Abdominal pain

• Gas (flatulence)

• Rash

• Fatigue (fatigue)

Uncommon side effects

(may affect up to 1 in 100 people))

• Low red blood cell count (anemia)

• Digestive problems that cause discomfort after meals (dispepsia)

• Swelling of the face, lips, tongue, or throat (angioedema)

• Itching (pruritus)

• Hives (urticaria)

• Joint pain (arthritis)

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 combined antiretroviral medications such as Descovy may develop a bone disease calledosteonecrosis(death of bone tissue 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 be some of the many risk factors for developing this disease. The signs of osteonecrosis are:

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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 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 through thenational notification system included in theAppendix V.

By reporting side effects, you can contribute to providing more information about 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.

Composition of Descovy

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

The other components are

Tablet core:

Microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating:

Polvinyl alcohol, titanium dioxide, macrogol 3350, talc, aluminium lake indigo carmine (E132).

Appearance of the product and contents of the pack

Descovy film-coated tablets are blue, rectangular tablets, marked on one face with “GSI” and on the other with the number “225”.

Descovy is presented in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect the tablets). The silica gel desiccant is contained in a separate sachet or container, and must not be taken.

This medicinal product is available in packs of 1 bottle of 30 film-coated tablets and in packs of 60 (2 bottles of 30) and 90 (3 bottles 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 for manufacturing:

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

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

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For detailed information about this medicinal product, please visit the website of the European Medicines Agency: http://www.ema.europa.eu.