Descovy

Package leaflet: Information for the user

Descovy 200 mg/10 mg film-coated tablets

emtricitabine/tenofovir alafenamide
Read this entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 belonging to the class of nucleoside reverse transcriptase inhibitors (NRTIs)
• Tenofovir alafenamide, an antiretroviral medicine belonging to the class of nucleotide reverse transcriptase inhibitors (NtRTIs)

Descovy blocks the action of the reverse transcriptase enzyme, which is essential for the virus to replicate. Descovy therefore reduces the amount of HIV in your body.
Descovy, in combination with other medicines, is used for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with a body weight of at least 35 kg.

2. What you need to know before taking Descovy

Do not take Descovy

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

Warnings and precautions
While taking Descovy, you must continue to be monitored by your doctor.
This medicine does not cure HIV infection. While taking Descovy, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Descovy:

• If you have or have had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, who are treated with antiretrovirals have an increased risk of serious liver complications that may be fatal. If you have hepatitis B, your doctor will carefully evaluate the most appropriate treatment regimen for you.

If you have hepatitis B, liver problems may worsen when you stop treatment with Descovy. Do not stop treatment with Descovy without speaking to your doctor: see section 3, Do not stop treatment with Descovy.

• Your doctor may decide not to prescribe Descovy if your virus has a specific resistance mutation, as Descovy may not effectively reduce the amount of HIV in your body.
• If you have kidney disease or if tests have shown kidney problems. Your doctor may request blood tests to monitor how well your kidneys are functioning at the beginning and during treatment with Descovy.

While taking Descovy
When 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.
Kidney problems may occur during long-term use of Descovy (see Warnings and precautions).

Children and adolescents
Do not give this medicine to children aged 11 years or younger or weighing less than 35 kg. The use of Descovy in children aged 11 years or younger has not yet been studied.

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

Medicines used to treat hepatitis B:
You must not take Descovy together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil

Tell 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
• anticonvulsants, used to treat epilepsy, such as:
  • carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
• herbal remedies 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 treatment without contacting your doctor.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
• If you become pregnant, inform your doctor immediately and discuss the potential benefits and risks of antiretroviral therapy for you and your baby.

If you have taken Descovy during pregnancy, your doctor may regularly perform blood tests and other diagnostic examinations to monitor your baby’s development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
Do not breastfeed during treatment with Descovy. This is because one of the active substances in this medicine is excreted in breast milk.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Descovy may cause dizziness. If dizziness occurs while taking Descovy, do not drive and do not operate tools or machinery.

Descovy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Descovy

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: one tablet daily, taken with or without food.
Adolescents aged 12 years and older, weighing at least 35 kg: one tablet daily, taken with or without food.
Due to the bitter taste, it is recommended not to chew or crush the tablet.
If you have difficulty swallowing the tablet whole, you may split it in half. Take both halves of the tablet one after the other to ensure you receive the full dose. Do not store the split tablet.
Always take the dose prescribed by your doctor. This is important to ensure that your medicine remains 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 undergoing dialysis, take your daily dose of Descovy after completion of dialysis.
If you take more Descovy than you should
If you take more Descovy than prescribed, you may have an increased risk of side effects from this medicine (see section 4, Possible side effects).
Contact your doctor or the nearest emergency department immediately. Take the bottle of tablets with you so you can show what you have taken.
If you forget to take Descovy
It is important not to miss any doses of Descovy.
If you forget a dose:

• if you remember within 18 hours of your usual dosing time, take the tablet as soon as possible. Then take your next dose at the usual time.
• if you remember more than 18 hours after your usual dosing time, do not take the missed dose. Wait and take your next dose at the usual time.

If you vomit within 1 hour after taking Descovy, take another tablet.
Do not stop treatment with Descovy
Do not stop treatment with Descovy without talking to your doctor. Stopping treatment with Descovy may seriously affect the effectiveness of subsequent treatment. If treatment with Descovy is stopped for any reason, talk to your doctor before restarting Descovy tablets.
When your supply of Descovy starts to run out, get a new supply from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped, even for a few days. The disease may become more difficult to treat.
If you have both HIV infection and hepatitis B, it is very important not to stop treatment with Descovy without first contacting your doctor. Blood tests may need to be repeated for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which can be potentially fatal.
Contact your doctor immediately if you notice any new or unusual symptoms after stopping treatment, particularly symptoms normally associated with hepatitis B infection.
If you have any questions about how to use 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 possible side effects: tell your doctor immediately

• Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) who have previously had opportunistic infections (infections occurring in people with weakened immune systems), signs and symptoms of inflammation from prior infections may occur shortly after starting antiretroviral therapy. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that may have been present without obvious symptoms.
• Autoimmune disorders (the immune system attacks healthy body tissues) may also occur when you start taking medicines for HIV infection. Autoimmune disorders may occur many months after starting treatment. Be alert for any signs of infection or other symptoms such as:
  • muscle weakness
  • weakness starting in the hands and feet and progressing towards the trunk
  • palpitations, tremor, 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)

• feeling unwell (nausea)

Common side effects
(may affect up to 1 in 10 people)

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

Uncommon side 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
• hives
• joint pain (arthralgia)

If any of the side effects worsen, tell your doctor.
Other possible side effects observed during HIV treatment
The frequency of the following side effects is unknown (frequency cannot be estimated from the available data).

• Bone problems. Some patients taking combination antiretroviral medicines such as Descovy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Taking this type of medicine for a prolonged period, use of corticosteroids, alcohol consumption, having a weakened immune system, and being overweight may be some of the many risk factors for developing this condition. Signs of osteonecrosis include:
  • joint stiffness
  • discomfort and pain in the joints (especially in hips, knees, and shoulders)
  • difficulty moving If you notice any of these symptoms, tell your doctor.

During HIV treatment, an increase in body weight and in blood levels of lipids and glucose may occur. This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, may sometimes be related to the HIV medicines themselves. Your doctor will monitor these changes.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Descovy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after {Exp.}. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly closed.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Descovy contains
The active substances are emtricitabine and tenofovir alafenamide. Each film-coated tablet of Descovy contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
The other components are
Tablet core:
Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Film coating:
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, black iron oxide (E172).

Description of the appearance of Descovy and pack contents
Descovy film-coated tablets are grey, rectangular, marked on one side with "GSI" and on the other side with the number "210".
Descovy is supplied in bottles containing 30 tablets (with a silica gel desiccant, which must remain in the bottle to protect the tablets). The silica gel is contained in a separate sachet or canister and must not be swallowed.
The following pack sizes are available: outer packaging containing 1 bottle with 30 film-coated tablets, outer packaging containing 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: +32 (0) 24 01 35 50

България (Bulgaria)
Gilead Sciences Ireland UC
Тел.: +353 (0) 1 686 1888

Česká republika (Czech Republic)
Gilead Sciences s.r.o.
Tel: +420 910 871 986

Danmark (Denmark)
Gilead Sciences Sweden AB
Tlf: +46 (0) 8 5057 1849

Deutschland (Germany)
Gilead Sciences GmbH
Tel: +49 (0) 89 899890-0

Eesti (Estonia)
Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

Ελλάδα (Greece)
Gilead Sciences Ελλάς Μ.Ε.Π.Ε.
Τηλ: +30 210 8930 100

España (Spain)
Gilead Sciences, S.L.
Tel: +34 91 378 98 30

France
Gilead Sciences
Tél: +33 (0) 1 46 09 41 00

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

Ireland
Gilead Sciences Ireland UC
Tel: +353 (0) 214 825 999

Ísland (Iceland)
Gilead Sciences Sweden AB
Sími: +46 (0) 8 5057 1849

Italia (Italy)
Gilead Sciences S.r.l.
Tel: +39 02 439201

Κύπρος (Cyprus)
Gilead Sciences Ελλάς Μ.Ε.Π.Ε.
Τηλ: +30 210 8930 100

Latvija (Latvia)
Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

Lietuva (Lithuania)
Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: +32 (0) 24 01 35 50

Magyarország (Hungary)
Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

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

Nederland (Netherlands)
Gilead Sciences Netherlands B.V.
Tel: +31 (0) 20 718 36 98

Norge (Norway)
Gilead Sciences Sweden AB
Tlf: +46 (0) 8 5057 1849

Österreich (Austria)
Gilead Sciences GesmbH
Tel: +43 1 260 830

Polska (Poland)
Gilead Sciences Poland Sp. z o.o.
Tel: +48 22 262 8702

Portugal
Gilead Sciences, Lda.
Tel: +351 21 7928790

România (Romania)
Gilead Sciences (GSR) S.R.L.
Tel: +40 31 631 18 00

Slovenija (Slovenia)
Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

Slovenská republika (Slovakia)
Gilead Sciences Slovakia s.r.o.
Tel: +421 232 121 210

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: +46 (0) 8 5057 1849

Sverige (Sweden)
Gilead Sciences Sweden AB
Tel: +46 (0) 8 5057 1849

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: +44 (0) 8000 113 700

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

Patient Information Leaflet: Information for the User

Descovy 200 mg/25 mg film-coated tablets

emtricitabine/tenofovir alafenamide
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 belonging to the class of nucleoside reverse transcriptase inhibitors (NRTIs)
• tenofovir alafenamide, an antiretroviral medicine belonging to the class of nucleotide reverse transcriptase inhibitors (NtRTIs)

Descovy blocks the action of the reverse transcriptase enzyme, which is essential for the virus to replicate.
Therefore, Descovy reduces the amount of HIV in your body.
Descovy, in combination with other medicines, is used for the treatment of human immunodeficiency
virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with a body weight of at least 35 kg.

2. What you need to know before taking Descovy

Do not take Descovy

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

Warnings and precautions
While taking Descovy, you must continue to be monitored by your doctor.
This medicine does not cure HIV infection. While taking Descovy, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Descovy:

• If you have or have had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of serious liver complications that may lead to death. If you have hepatitis B, your doctor will carefully evaluate the most appropriate treatment regimen for you.

If you have hepatitis B infection, liver problems may worsen when you stop treatment with Descovy. Do not stop treatment with Descovy without speaking to your doctor: see section 3, Do not stop taking Descovy.

• Your doctor may decide not to prescribe Descovy if your virus has a specific resistance mutation, as Descovy may not effectively reduce the amount of HIV in your body.
• If you have kidney disease or if blood tests have shown kidney problems. Your doctor may request blood tests to monitor how well your kidneys are functioning, both at the beginning and during treatment with Descovy.

While taking Descovy
When 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 further information, see section 4, Possible side effects.
Kidney problems may occur during long-term use of Descovy (see Warnings and precautions).

Children and adolescents
Do not give this medicine to children aged 11 years or younger or weighing less than 35 kg. The use of Descovy in children aged 11 years or younger has not yet been studied.

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

Medicines used to treat hepatitis B:
You must not take Descovy together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudina
• adefovir dipivoxil

Tell 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
• Anticonvulsants, used to treat epilepsy, such as:
  • carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
• Herbal remedies used to treat depression and anxiety containing:
  • St. John’s wort ( Hypericum perforatum )

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

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
• If you become pregnant, inform your doctor immediately and discuss the potential benefits and risks of antiretroviral therapy for you and your baby.

If you have taken Descovy during pregnancy, your doctor may regularly perform blood tests and other diagnostic examinations to monitor your baby’s development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.

Do not breastfeed while taking Descovy. This is because one of the active substances in this medicine is excreted in breast milk.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Descovy may cause dizziness. If dizziness occurs while taking Descovy, do not drive and do not operate tools or machinery.

Descovy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Descovy

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: one tablet daily, taken with or without food.
Adolescents aged 12 years and older, weighing at least 35 kg: one tablet daily, taken with or without food.
Due to its bitter taste, it is recommended not to chew or crush the tablet.
If you have difficulty swallowing the tablet whole, you may split it in half. Take both halves of the tablet one after the other, to ensure the full dose is taken. Do not store the split tablet.
Always take the dose prescribed by your doctor. This is important to ensure that your medicine remains 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 undergoing dialysis, take your daily dose of Descovy after completion of dialysis.
If you take more Descovy than you should
If you take more Descovy than prescribed, you may have an increased risk of experiencing side effects (see section 4, Possible side effects).
Contact your doctor or the nearest emergency department immediately. Take the bottle of tablets with you so you can show what has been taken.
If you forget to take Descovy
It is important not to miss any doses of Descovy.
If you miss a dose:

• if you remember within 18 hours of your usual time of taking 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 your usual time of taking Descovy, do not take the missed dose. Wait and take the next dose at your usual time.

If you vomit within 1 hour of taking Descovy, take another tablet.
Do not stop taking Descovy
Do not stop taking Descovy without talking to your doctor. Stopping treatment with Descovy may seriously affect the effectiveness of subsequent treatment. If treatment with Descovy is stopped for any reason, talk to your doctor before restarting Descovy tablets.
When your supply of Descovy starts to run out, get more from your doctor or pharmacist. This is very important because the amount of virus may begin to increase if the medicine is stopped, even for a few days. The disease may become more difficult to treat.
If you have both HIV infection and hepatitis B, it is very important not to stop treatment with Descovy without first consulting your doctor. Blood tests may need to be repeated for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which could potentially be fatal.
Contact your doctor immediately if you notice any new or unusual symptoms after stopping treatment, particularly symptoms typically associated with hepatitis B infection.
If you have any 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 everyone will experience them.
Serious possible side effects: inform your doctor immediately

• Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) who have previously had opportunistic infections (infections occurring in people with weakened immune systems), signs and symptoms of inflammation from prior infections may occur shortly after starting antiretroviral therapy. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that may have been present without obvious symptoms.
• Autoimmune disorders (the immune system attacks healthy body tissues) may also occur when you start taking medicines for HIV infection. Autoimmune disorders may appear several months after starting treatment. Be alert for any signs of infection or other symptoms such as:
  • muscle weakness
  • weakness starting in the hands and feet and progressing towards the trunk
  • palpitations, tremor, or hyperactivity If you experience any of the side effects described above, inform your doctor immediately.

Very common side effects
(may affect more than 1 in 10 people)

• feeling unwell (nausea)

Common side effects
(may affect up to 1 in 10 people)

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

Uncommon side 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
• hives
• joint pain (arthralgia)

If any of the side effects worsen, inform your doctor.
Other possible side effects observed during HIV treatment
The frequency of the following side effects is unknown (the frequency cannot be determined from the available data).

• Bone problems. Some patients taking combination antiretroviral medicines such as Descovy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Prolonged use of such medicines, use of corticosteroids, alcohol consumption, having a weakened immune system, and being overweight may be among the many risk factors for developing this condition. Signs of osteonecrosis include:
  • joint stiffness
  • discomfort and pain in the joints (especially in the hips, knees, and shoulders)
  • difficulty moving If you notice any of these symptoms, inform your doctor.

During HIV treatment, an increase in body weight and in blood levels of lipids and glucose may occur. This is partly related to improved health status and lifestyle, and, in the case of blood lipids, sometimes related to the HIV medicines themselves. Your doctor will monitor these changes.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Descovy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after {Exp.}. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Descovy contains
The active substances are emtricitabine and tenofovir alafenamide. Each film-coated tablet of Descovy contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir.
The other components are
Tablet core:
Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Film coating:
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, indigo carmine aluminium lake (E132).

Description of the appearance of Descovy and contents of the pack
Descovy film-coated tablets are blue, rectangular, and engraved with "GSI" on one side and the number "225" on the other.
Descovy is supplied in bottles containing 30 tablets (with a silica gel desiccant, which should remain in the bottle to protect the tablets). The silica gel is contained in a separate sachet or canister and must not be ingested.
The following pack sizes are available: outer packaging containing 1 bottle with 30 film-coated tablets; outer packaging containing 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 24 01 35 50 Tel: +353 (0) 1 686 1888

България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 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 Ireland UC Gilead Sciences Sweden AB
Tel: +353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849

Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. 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 (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: + 40 31 631 18 00

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.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849

Latvija United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888 Tel: + 44 (0) 8000 113 700

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