Descovy 200 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Descovy 200 mg/10 mg film-coated tablets

emtricitabine/tenofovir alafenamide

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Descovy is and what it is used for

Descovy contains two active substances:

• emtricitabine, an antiretroviral medicine of a type known as nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide, an antiretroviral medicine of a type known as nucleotide reverse transcriptase inhibitor (NtRTI)

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

Descovy, in combination with other medicines, is used for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and adolescents 12 years of age and older who weigh at least 35 kg.

2. What you need to know before starting to take Descovy

Do not take Descovy:

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

Warnings and precautions

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

While taking this medicine, you can still transmit HIV to others, even though effective antiretroviral treatment reduces the risk. Consult your doctor about which precautions are necessary to avoid infecting other people. This medicine is not a cure for HIV infection. While you are taking Descovy, you may still experience infections or other conditions associated with HIV infection.

Talk to 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, who are treated with antiretrovirals, have an increased risk of serious and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.

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

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

While taking Descovy

Once you start taking Descovy, be alert for:

• 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 develop kidney problems if you take Descovy for a prolonged period.

Children and adolescents

Do not give this medicine to children aged 11 years or younger or who weigh less than 35 kg.

The use of Descovy has not yet 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 need to take any other medicines. Descovy may interact with other medicines. As a result, blood levels of Descovy or other medicines may change. This could prevent your medicines from working properly or worsen their possible side effects. In some cases, your doctor may need to adjust your dose or monitor your blood levels.

Medicines used to treat hepatitis B virus infection:

You must not take Descovy with medicines containing:

• tenofovir alafenamide

• tenofovir disoproxil

• lamivudine

• adefovir dipivoxil

• Consult your doctor if you are taking any of these medicines.

Other types of medicines:

Talk to your doctor if you are taking:

• antibiotics used to treat bacterial infections including tuberculosis, containing:

• rifabutin, rifampicin, and rifapentine

• antiviral medicines used to treat HIV:

• emtricitabine and tipranavir

• antiepileptic medicines used to treat epilepsy, such as:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin

• herbal medicines used to treat depression and anxiety containing:

• St. John’s wort (Hypericum perforatum)

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

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, talk to your doctor before using this medicine.

• Use an effective method of contraception while taking Descovy.

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

If you have taken Descovy during pregnancy, your doctor may recommend regular blood tests and other diagnostic tests to monitor your baby's development. In babies whose mothers took ITIAN during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects occurring.

Do not breastfeed while being treated with Descovy. This is because one of the active substances in this medicine passes into breast milk. You are advised not to breastfeed in order to avoid transmitting the virus to your baby through breast milk.

Driving and using machines

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

3. How to take Descovy

Follow exactly the instructions for taking this medicine as given by your doctor.

If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults: one tablet daily, with or without food

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

Do not chew, crush, or split the tablet.

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

If you are on dialysis, take your daily dose of Descovy after dialysis is complete.

If you take more Descovy than you should

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

Contact your doctor immediately or go to the nearest emergency department. Take the medicine container with you so you can show what you have taken.

If you forget to take Descovy

It is important not to miss a dose of Descovy.

If you miss a dose:

• If you remember within 18 hours of the time you usually take Descovy, take the tablet as soon as possible. Then take the next dose at your usual time.

• If you remember 18 hours or more after the time you usually take Descovy, do not take the missed dose. Wait and take the next dose at your usual time.

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

Do not stop taking Descovy

Do not stop treatment with Descovy without first speaking to your doctor. Stopping Descovy may seriously affect the effectiveness of future treatments. If Descovy is stopped for any reason, consult your doctor before restarting Descovy tablets.

When you notice that you are running low on Descovy, contact your doctor or pharmacist to obtain more. This is very important, as the amount of virus may start to increase if the medicine is interrupted, even for a short period of time. The disease may then become more difficult to treat.

If you have both HIV infection and hepatitis B, 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 may cause a worsening of hepatitis, a condition that could potentially be fatal.

• Contact your doctor immediately about any new or unusual symptoms after stopping your treatment, particularly symptoms you associate with hepatitis B virus infection.

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

4. Possible adverse effects

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

Possible serious adverse effects: consult a doctor immediately

• Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) who have previously suffered opportunistic infections (infections occurring in people with a weakened immune system), signs and symptoms of inflammation from prior infections may occur shortly after starting antiretroviral treatment.

It is believed that these symptoms are due to an improvement in the body's immune response, which enables it to fight infections that may have been present without obvious symptoms.

• Autoimmune disorders (the immune system attacks the body's healthy tissues) may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after treatment has started. Be alert for any symptoms of infection or other symptoms such as:

• muscle weakness

• weakness beginning in the hands and feet and moving towards the trunk

• palpitations, tremor, or hyperactivity

• If you experience any of the adverse effects described above, inform your doctor immediately.

Very common adverse effects

(may affect more than 1 in 10 people)

• nausea (feeling sick)

Common adverse effects

(may affect up to 1 in 10 people)

• abnormal dreams
• headache
• dizziness
• diarrhoea
• vomiting
• stomach pain
• gas (flatulence)
• rash
• tiredness (fatigue)

Uncommon adverse effects

(may affect up to 1 in 100 people)

• low red blood cell count (anaemia)

• digestive problems causing discomfort after meals (dyspepsia)

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

• itching (pruritus)

• hives (urticaria)

• joint pain (arthralgia)

• If you consider any of the adverse effects you experience to be severe, inform your doctor.

Other effects that may occur during HIV treatment

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

• Bone problems. Some patients treated with combination antiretroviral medicines such as Descovy may develop a bone disease called osteonecrosis (death of bone tissue due to loss of blood supply to the bone). Prolonged use of this type of medication, corticosteroid use, alcohol consumption, having a very weak immune system, and being overweight may be among the many risk factors for developing this disease. Signs of osteonecrosis include:

• • joint stiffness
  • joint discomfort and pain (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 in blood glucose and lipid levels. This may be partly related to improved health and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V.

By reporting adverse 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 on the bottle after "EXP". The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

The active substances are emtricitabine 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 components are

Tablet core:

Microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating:

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

Nature of the product and contents of the container

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

Descovy is available in bottles of 30 tablets (with a silica gel desiccant which should 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 swallowed.

This medicine is available in packs containing 1 bottle of 30 film-coated tablets, packs of 60 (2 bottles of 30) and 90 (3 bottles of 30) film-coated tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

Manufacturer responsible for batch release:

Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SPRL-BVBA Gilead Sciences Poland Sp. z o.o.
Tél/Tel: +32 (0) 24 01 35 50 Tel: +48 22 262 8702

???????? Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SPRL-BVBA
???.: +353 (0) 1 686 1888 Tél/Tel: +32 (0) 24 01 35 50

Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: +420 910 871 986 Tel: +353 (0) 1 686 1888

Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf: +46 (0) 8 5057 1849 Tel: +353 (0) 1 686 1888

Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: +49 (0) 89 899890-0 Tel: +31 (0) 20 718 36 98

Eesti Norge
Gilead Sciences Poland Sp. z o.o. Gilead Sciences Sweden AB
Tel: +48 22 262 8702 Tlf: +46 (0) 8 5057 1849

Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.Ε.Π.Ε. Gilead Sciences GesmbH
Τηλ: +30 210 8930 100 Tel: +43 1 260 830

España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: +34 91 378 98 30 Tel: +48 22 262 8702

France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél: +33 (0) 1 46 09 41 00 Tel: +351 21 7928790

Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888 Tel: +353 (0) 1 686 1888

Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: +353 (0) 214 825 999 Tel: +353 (0) 1 686 1888

Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.
Sími: +46 (0) 8 5057 1849 Tel: +421 232 121 210

Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: +39 02 439201 Puh/Tel: +46 (0) 8 5057 1849

Κύπρος Sverige
Gilead Sciences Ελλάς Μ.Ε.Π.Ε. Gilead Sciences Sweden AB
Τηλ: +30 210 8930 100 Tel: +46 (0) 8 5057 1849

Latvija United Kingdom
Gilead Sciences Poland Sp. z o.o. Gilead Sciences Ltd.
Tel: +48 22 262 8702 Tel: +44 (0) 8000 113 700

Date of the most recent revision of this leaflet: <MM/YYYY> .

Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.