DESCOVY 200 mg/10 mg Film-Coated Tablets

Зміст інструкції

1. Descovy 200 mg/10 mg film-coated tablets
   1. What is Descovy 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
2. Descovy 200 mg/25 mg film-coated tablets
   1. What is Descovy and what is it 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

Descovy 200 mg/10 mg film-coated tablets

emtricitabine/tenofovir alafenamide

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Descovy and what it is used for

Descovy contains two active ingredients:

• 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
multiply. Descovy therefore reduces the amount of HIV in your body.
Descovy in combination with other medicines is used for the treatment of infection with the 1
human immunodeficiency virus (HIV-1)in adults and adolescents aged 12 years or 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 allergicto emtricitabine, to tenofovir alafenamideor to 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 diseases 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, treated with antiretrovirals, have a higher risk of serious liver complications and which can lead to death. If you have hepatitis B, your doctor will carefully evaluate the best therapeutic regimen for you.

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

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

While taking Descovy
When you start taking Descovy, be careful to:

• 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.

Kidney problems may occur during the intake of Descovy for a long period of
time (see Warnings and precautions).

Children and adolescents
Do not give this medicine to childrenaged 11 years or less or with a body weight less than
35 kg. The use of Descovy in children aged 11 years or less 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
amount of Descovy or other medicines in the blood may vary. This may prevent medicines from
working properly or may worsen their side effects. In some cases, your doctor may need to
adjust the dose or check blood levels.

Medicines used for the treatment of hepatitis B:
You must not take Descovy together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil
• Tell your doctorif you are taking any of these medicines.

Other types of medicines:
Talk to your doctor if you are taking:

• antibioticsused to treat bacterial infections, including tuberculosis, containing:
• rifabutin, rifampicin and rifapentine
• antiviral medicines used for the treatment of HIV:
• emtricitabine and tipranavir
• anticonvulsants,used to treat epilepsy, such as:
• carbamazepine, oxcarbazepine, phenobarbital and phenytoin
• herbal remediesused to treat depression and anxiety containing:
• St John's wort ( Hypericum perforatum)
• Tell your doctor if you are taking these or other medicines.Do not stop treatment without contacting your doctor.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
• If you become pregnant, tell your doctor immediately and ask about the potential benefits and risks of antiretroviral therapy for you and your baby.

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

Do not breastfeed during treatment with Descovy.The reason is that one of the active ingredients of this
medicine is excreted in breast milk.
Breastfeeding is not recommended for HIV-positive women as HIV infection can be
transmitted to the baby with breast milk.
If you are breastfeeding or are thinking about breastfeeding you should talk to your doctor as soon as possible.

Driving and operating machinery
Descovy can cause dizziness. If you experience dizziness while taking Descovy, do not drive and
do not use 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 your doctor has told you. If you are unsure, ask your doctor or pharmacist.

The recommended dose is:
Adults:one tablet a day, to be taken with or without food.

Adolescents aged 12 years or older, with a body weight of at least 35 kg: one tablet a day, to be 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 can divide it in half. Take both halves of the tablet one after the other, so as to take the entire dose. Do not store the divided 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 undergoing dialysis, take your daily dose of Descovy after completion of the dialysis.

If you take more Descovy than you should
If you take a dose of Descovy higher than that recommended, you may have a higher risk of the side effects of this medicine (see section 4, Possible side effects).
Contact your doctor or the nearest emergency center immediately. Bring the bottle of tablets with you so you can show what you have taken.

If you forget to take Descovy
It is important that you do not forget any dose of Descovy.
If you forget a dose :

• if you notice it within 18 hoursof the usual time of taking Descovy, you should take the tablet as soon as possible. Then take the next dose as usual.
• if you notice it after 18 hours or morefrom the usual time of taking Descovy, do not take 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 stop treatment with Descovy
Do not stop treatment with Descovywithout talking to your doctor. Stopping treatment with Descovy may seriously affect the effectiveness of subsequent treatment. If treatment with Descovy is interrupted for any reason, talk to your doctor before starting to take Descovy tablets again.

When your supply of Descovy begins to run low, ask your doctor or pharmacist for more. It is very important because the amount of virus can 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 an HIV infection and hepatitis B,it is very important not to stop treatment with Descovy without first contacting your doctor. It may be necessary to repeat 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, which may be potentially fatal.

• Tell your doctor immediatelyabout any new or unusual symptoms you experience after stopping treatment, especially symptoms that are normally 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 everybody gets them.

Serious possible side effects: inform your doctor immediately

• Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (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. These symptoms are thought to be due to an improvement in the body's immune response, which allows it to fight infections that may be present without obvious symptoms.
• Autoimmune diseases(the immune system attacks healthy tissue in the body) can also occur when you start taking medicines for HIV infection. Autoimmune diseases can develop many months after starting treatment. Pay attention to any symptoms of infection or other symptoms such as:
• muscle weakness
• weakness starting in the hands and feet and progressing to the trunk
• palpitations, tremor or hyperactivity
• If you notice 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 pain
• intestinal gas ( flatulence)
• skin rash
• tiredness ( fatigue)

Uncommon side effects
( may affect up to 1 in 100 people)

• low red blood cell count ( anaemia)
• digestive problems that cause discomfort after meals ( dyspepsia)
• swelling of the face, lips, tongue or throat ( angioedema)
• itching
• hives
• joint pain ( arthralgia)
• If any of these side effects get worse, tell your doctor.

Other possible side effects observed during HIV treatment
The frequency of the following side effects is not known (frequency cannot be estimated on the
basis of available data).

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

During HIV therapy, there may be an increase in weight and levels of lipids and glucose
in the blood. This is partly related to the restoration of health and lifestyle and, in the case of
blood lipids, sometimes can be related to the HIV medicines themselves. The doctor will check
these changes.

Reporting of side effects
If you get any side effects, 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 which is stated on the package and the bottle after
{Scad.}. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Keep the bottle tightly
closed.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Descovy contains
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).

Description of Descovy and contents of the pack
Descovy film-coated tablets are grey, rectangular, imprinted on one side with “GSI” and
on the other side with the number “210”.
Descovy is supplied in bottles of 30 tablets (with the desiccant silica gel, which must remain in the
bottle to protect the tablets). The silica gel is contained in a sachet or a separate jar
and must not be swallowed.
The following pack sizes are available: outer packaging containing 1 bottle of
30 film-coated tablets and 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 Authorisation 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, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV

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

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

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

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

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

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

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

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

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

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

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

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

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

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

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

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

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

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

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

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

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

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

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

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

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

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

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

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.

Descovy 200 mg/25 mg film-coated tablets

emtricitabine/tenofovir alafenamide

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Descovy and what is it used for

Descovy contains two active ingredients:

• 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
multiply. Descovy therefore reduces the amount of HIV in your body.
Descovy in combination with other medicines is used for the treatment of infection with the human 1
immunodeficiency virus (HIV-1)in adults and adolescents aged 12 years or 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 allergicto emtricitabine, to tenofovir alafenamideor to 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 diseases 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, treated with antiretrovirals, have a higher risk of serious liver complications and that can lead to death. If you have hepatitis B, your doctor will carefully assess the best therapeutic 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
talking to your doctor: see section 3, Do not stop taking Descovy.

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

While you take Descovy
When you start taking Descovy, be careful to:

• 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.

Kidney problems may occur while taking Descovy for a long period of
time (see Warnings and precautions).

Children and adolescents
Do not give this medicine to childrenaged 11 years or under or with a body weight of less than
35 kg. The use of Descovy in children aged 11 years or under 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
amount of Descovy or other medicines in the blood may vary. This may prevent medicines from
working properly or may worsen their side effects. In some cases, your doctor may need to
adjust the dose or check blood levels.

Medicines used for the treatment of hepatitis B:
You must not take Descovy together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil
• Tell your doctorif you are taking any of these medicines.

Other types of medicines:
Talk to your doctor if you are taking:

• antibioticsused 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 remediesused to treat depression and anxiety containing:
• St John's wort ( Hypericum perforatum)
• Tell your doctor if you are taking these or other medicines.Do not stop treatment without contacting your doctor.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
• If you become pregnant, tell your doctor immediately and ask about the potential benefits and risks of antiretroviral therapy for you and your baby.

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

Do not breastfeed during treatment with Descovy.The reason is that one of the active ingredients of 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 are thinking about breastfeeding you should talk to your doctor as soon as possible.

Driving and operating machinery
Descovy can cause dizziness. If you experience dizziness while taking Descovy, do not drive and
do not use 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 your doctor has told you. If you are unsure, ask your doctor or pharmacist.

The recommended dose is:
Adults:one tablet a day, to be taken with or without food.

Adolescents aged 12 years or older, with a body weight of at least 35 kg: one tablet a day, to be 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 can divide it in half. Take both halves of the tablet one after the other, so as to take the entire dose. Do not store the divided 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 undergoing dialysis, take your daily dose of Descovy after completion of the dialysis.

If you take more Descovy than you should
If you take a dose of Descovy higher than that recommended, you may have a higher risk of the side effects of this medicine (see section 4, Possible side effects).
Contact your doctor or the nearest emergency center immediately. Bring the bottle of tablets with you so you can show what you have taken.

If you forget to take Descovy
It is important that you do not forget any dose of Descovy.
If you forget a dose :

• if you realize this within 18 hoursof the usual time of taking Descovy, you should take the tablet as soon as possible. Then take the next dose as usual.
• if you realize this after 18 hours or moreof the usual time of taking Descovy, do not take the forgotten 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 stop treatment with Descovy
Do not stop treatment with Descovywithout talking to your doctor. Stopping treatment with Descovy may seriously affect the effectiveness of subsequent treatment. If treatment with Descovy is interrupted for any reason, talk to your doctor before starting to take Descovy tablets again.

When your supply of Descovy begins to run low, ask your doctor or pharmacist for more. It is very important because the amount of virus can 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 an HIV infection and hepatitis B,it is very important not to stop treatment with Descovy without first contacting your doctor. It may be necessary to repeat 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, which may be potentially fatal.

• Tell your doctor immediatelyabout any new or unusual symptoms you notice after stopping treatment, especially symptoms that are normally associated with hepatitis B infection.

If you have any questions about using 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: inform your doctor immediately

• Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (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. These symptoms are thought to be due to an improvement in the body's immune response, which allows it to fight infections that may be present without obvious symptoms.
• Autoimmune diseases(the immune system attacks healthy tissue in the body) can also develop when you start taking medicines for HIV infection. Autoimmune diseases can develop many months after starting treatment. Pay attention to any symptoms of infection or other symptoms such as:
• muscle weakness
• weakness starting in the hands and feet and progressing to the trunk
• palpitations, tremor or hyperactivity
• If you notice 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 pain
• intestinal gas ( flatulence)
• skin rash
• tiredness ( fatigue)

Uncommon side effects
( may affect up to 1 in 100 people)

• low red blood cell count ( anaemia)
• digestive problems that cause discomfort after meals ( dyspepsia)
• swelling of the face, lips, tongue or throat ( angioedema)
• itching
• hives
• joint pain ( arthralgia)
• If any of these side effects get worse, tell your doctor.

Other possible side effects observed during HIV treatment
The frequency of the following side effects is not known (frequency cannot be estimated on the
basis of 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 caused by reduced blood supply to the bone). Taking this type of medicine for a prolonged period, taking corticosteroids, drinking alcohol, having a weakened immune system and being overweight may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
• joint stiffness
• discomfort and pain in the joints (especially in the hips, knees and shoulders)
• difficulty moving
• If you notice any of these symptoms, tell your doctor.

During HIV therapy, weight and levels of lipids and glucose in the blood may increase.
This is partly related to the restoration of health and lifestyle and, in the case of blood lipids, sometimes may be related to the HIV medicines themselves. The doctor will check
these changes.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 which is stated on the package and the bottle after
{Scad.}. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Keep the bottle tightly
closed.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Descovy contains
The active ingredients areemtricitabine and tenofovir alafenamide. Each film-coated Descovy tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of
tenofovir.

Other ingredients are

Tablet core:
Microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating:
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, indigo carmine aluminum lake (E132).

Description of Descovy and contents of the pack
Descovy film-coated tablets are blue, rectangular, imprinted on one side with “GSI” and
on the other side with the number “225”.
Descovy is supplied in bottles of 30 tablets (with a desiccant, silica gel, which must remain in the
bottle to protect the tablets). The silica gel is contained in a sachet or a separate jar
and must not be swallowed.
The following pack sizes are available: outer packaging containing 1 bottle of
30 film-coated tablets and 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 Authorisation 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 medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV

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

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

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

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

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

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

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

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

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

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

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

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

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

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

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

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

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

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

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

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

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

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

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

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

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

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

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

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700
Further details on this medicine are available on the website of the European Medicines Agency, http://www.ema.europa.eu.