DESCOVY 200 mg / 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Descovy 200 mg/10 mg film-coated tablets

emtricitabine/tenofovir alafenamide

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Descovy and what is it used for
2. What you need to know before you take Descovy
3. How to take Descovy
4. Possible side effects
5. Storage of Descovy
6. Contents of the pack and other information

1. What is Descovy and what is it used for

Descovy contains two active substances:

• emtricitabine,an antiretroviral medicine of a type known as nucleoside reverse transcriptase inhibitors (NRTIs)
• tenofovir alafenamide,an antiretroviral medicine of a type known as nucleotide reverse transcriptase inhibitors (NtRTIs)

Descovy blocks the action of an enzyme called reverse transcriptase, 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 medicines, is used to treat HIV-1 infectionin adults and adolescents aged 12 years and older, who weigh at least 35 kg.

2. What you need to know before you take Descovy

Do not take Descovy:

• If you are allergic to emtricitabine, tenofovir alafenamideor any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

While taking this medicine, you can still transmit HIV to others, even if effective antiretroviral therapy reduces the risk. Consult your doctor about the precautions needed to avoid infecting others. This medicine is not a cure for HIV infection. While you are taking Descovy, you may still experience infections or illnesses associated with HIV.

Consult your doctor before taking 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 greater risk of serious and potentially life-threatening liver complications. If you have hepatitis B, your doctor will carefully consider the best treatment for you.

If you have hepatitis B, liver problems may get worse once you stop taking Descovy. Do not stop taking Descovy without talking to your doctor first: see section 3, Do not stop taking 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, tell 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 long time.

Children and adolescents

Do not give this medicine to childrenaged 11 years or younger or weighing less than 35 kg.

Descovy has not been studied in children aged 11 years or younger.

Other medicines and Descovy

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.Descovy may interact with other medicines. As a result, the levels of Descovy or other medicines in your blood may change. This may prevent your medicines from working properly or increase the risk of side effects. In some cases, your doctor may need to adjust the dose or check your blood levels.

Medicines used to treat hepatitis B infection:

Do not take Descovy with medicines that contain:

• tenofovir alafenamide

• tenofovir disoproxil

• lamivudine

• adefovir dipivoxil

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

Other types of medicines:

Consult your doctor if you are taking:

• antibioticsused to treat bacterial infections, including tuberculosis, that contain:

• rifabutin, rifampicin, and rifapentine

• antiviral medicines used to treat HIV:

• emtricitabine and tipranavir

• antiepilepticsused to treat epilepsy, such as:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin

• herbal medicinesused to treat depression and anxiety that contain:

• St. John's Wort (Hypericum perforatum)

• Tell your doctor if you are taking these or other medicines.Do not stop your treatment without consulting your doctor.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

• Use effective contraceptionwhile taking Descovy.

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

If you have taken Descovy during your pregnancy, your doctor may ask for regular blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

Do not breastfeed your child while taking Descovy.This is because one of the active substances in this medicine passes into breast milk. Breastfeeding is not recommended to avoid transmitting the virus to your child through breast milk.

Driving and using machines

Descovy may cause dizziness. If you feel dizzy while taking Descovy, do not drive or operate tools or machines.

3. How to take Descovy

Take this medicine exactly as your doctor has told you.

If you are not sure, consult your doctor or pharmacist again.

The recommended dose is:

Adults:one tablet a day, with or without food

Adolescents aged 12 years or older, weighing at least 35 kg:one tablet a day, with or without food

Do not chew, crush, or split the tablet.

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

If you are on dialysis,take the daily dose of Descovy after dialysis.

If you take more Descovy than you should

If you take more than the recommended dose of Descovy, you may be at greater risk of side effects from this medicine (see section 4, Possible side effects).

Consult your doctor immediately or go to the nearest emergency room. Take the pack of tablets with you to show what you have taken.

If you forget to take Descovy

It is important that you do not miss a dose of Descovy.

If you forget a dose:

• If you notice 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 notice 18 hours or moreafter the time you normally take Descovy, do not take the missed dose. Wait and take the next dose at the usual time.

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

Do not stop taking Descovy

Do not stop taking Descovy without talking to your doctor first.Stopping Descovy may seriously affect the success of future treatments. If you stop Descovy for any reason, consult your doctor before restarting Descovy.

When you notice that you have little Descovy 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 medicine is stopped, even for a short time. Your disease may then become more difficult to treat.

If you have both HIV and hepatitis B infection,it is very important not to stop taking Descovy without first talking to 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 can cause the hepatitis to get worse, which can be life-threatening.

• Talk to your doctor immediatelyabout new or unusual symptoms after stopping treatment, especially symptoms that you associate with hepatitis B infection.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects: tell a doctor immediately

• 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 occur soon after starting antiretroviral therapy. It is believed that these symptoms are due to an improvement in the body's immune response, enabling it to fight infections that may have been present without obvious symptoms.

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

• muscle weakness
• weakness starting in the hands and feet and moving towards the trunk
• palpitations, tremors, or hyperactivity

• If you notice any of the above side effects, tell your doctor immediately.

Very common side effects

(may affect more than 1 in 10 people)

• nausea

Common side effects

(may affect up to 1 in 10 people)

• abnormal dreams

• headache

• dizziness

• diarrhea

• vomiting

• stomach pain

• gas (flatulence)

• rash

• fatigue

Uncommon side effects

(may affect up to 1 in 100 people)

• anemia (low red blood cell count)

• indigestion (dyspepsia)

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

• itching (pruritus)

• hives (urticaria)

• joint pain (arthralgia)

• If you think any of the side effects you are experiencing are serious, tell your doctor.

Other effects that may be seen during HIV treatment

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

• Bone problems.Some patients treated with combination antiretroviral therapy, including Descovy, may develop a bone disease called osteonecrosis(death of bone tissue due to loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak 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 stiffness (especially in the hip, knee, and shoulder)
  • difficulty moving
• If you notice any of these symptoms, tell your doctor.

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

Reporting side effects

If you experience 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 the Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Descovy

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 and blister after “EXP”. The expiry date refers to the last day of the month stated.

Store in the original package to protect from moisture. Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

The active ingredients areemtricitabine and tenofovir alafenamide. Each Descovy film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.

The other ingredients are

Tablet core:

Microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating:

Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide black (E172).

Appearance and Packaging of the Product

Descovy film-coated tablets are gray, rectangular tablets, marked on one side with “GSI” and on the other with the number “210”.

Descovy is available in bottles of 30 tablets (with a desiccant packet of silica gel that should be kept in the bottle to help protect the tablets). The desiccant packet of silica gel is contained in a separate pouch or container and should not be swallowed.

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. Not all pack sizes may be marketed.

Marketing Authorization Holder:

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer:

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

België/Belgique/BelgienLietuva

Gilead Sciences Belgium SPRL-BVBA Gilead Sciences Poland Sp. z o.o.

Tel: + 32 (0) 24 01 35 50 Tel: +48 22 262 8702

????????Luxembourg/Luxemburg

Gilead Sciences Ireland UC Gilead Sciences Belgium SPRL-BVBA

Tel: + 353 (0) 1 686 1888 Tel: + 32 (0) 24 01 35 50

Česká republikaMagyarország

Gilead Sciences s.r.o. Gilead Sciences Ireland UC

Tel: + 420 910 871 986 Tel: + 353 (0) 1 686 1888

DanmarkMalta

Gilead Sciences Sweden AB Gilead Sciences Ireland UC

Tlf: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1 686 1888

DeutschlandNederland

Gilead Sciences GmbH Gilead Sciences Netherlands B.V.

Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98

EestiNorge

Gilead Sciences Poland Sp. z o.o. Gilead Sciences Sweden AB

Tel: +48 22 262 8702 Tlf: + 46 (0) 8 5057 1849

ΕλλάδαÖsterreich

Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH

Τηλ: + 30 210 8930 100 Tel: + 43 1 260 830

EspañaPolska

Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.

Tel: + 34 91 378 98 30 Tel: +48 22 262 8702

FrancePortugal

Gilead Sciences Gilead Sciences, Lda.

Tél: + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790

HrvatskaRomânia

Gilead Sciences Ireland UC Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888 Tel: + 353 (0) 1 686 1888

IrelandSlovenija

Gilead Sciences Ireland UC Gilead Sciences Ireland UC

Tel: +353 (0) 214 825 999 Tel: + 353 (0) 1 686 1888

ÍslandSlovenská republika

Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.

Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210

ItaliaSuomi/Finland

Gilead Sciences S.r.l. Gilead Sciences Sweden AB

Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849

ΚύπροςSverige

Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB

Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849

LatvijaUnited Kingdom

Gilead Sciences Poland Sp. z o.o. Gilead Sciences Ltd.

Tel: +48 22 262 8702 Tel: + 44 (0) 8000 113 700

Date of Last Revision of this Leaflet:<{MM/AAAA}> <{month AAAA}>.

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