BIKTARVY 50 mg Фильм-Coated Таблетки

Содержание инструкции

1. Biktarvy 30 mg/120 mg/15 mg film-coated tablets
   1. What is Biktarvy and what is it used for
   2. What you need to know before taking Biktarvy
   3. How to take Biktarvy
   4. Possible side effects
   5. How to store Biktarvy
   6. Contents of the pack and other information
2. Biktarvy 50 mg/200 mg/25 mg film-coated tablets
   1. What is Biktarvy and what is it used for
   2. What you need to know before taking Biktarvy
   3. How to take Biktarvy
   4. Possible side effects
   5. How to store Biktarvy
   6. Contents of the pack and other information

Biktarvy 30 mg/120 mg/15 mg film-coated tablets

bictegravir/emtricitabine/tenofovir alafenamide

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

If Biktarvy has been prescribed for your child, please note that all the information contained in
this leaflet is intended for your child (in this case, read “your child” instead of “you”).
Contents of this leaflet

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

1. What is Biktarvy and what is it used for

Biktarvy contains three active ingredients:

• bictegravir, an antiretroviral medicine, known as an integrase strand transferinhibitor (INSTI)
• emtricitabina, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI)

Biktarvy is a single tablet for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults, adolescents and children aged 2 years and older, with a body weight of at least 14 kg.
Biktarvy reduces the amount of HIV in your body. This strengthens your immune system and reduces
the risk of developing illnesses related to HIV infection.

2. What you need to know before taking Biktarvy

Do not take Biktarvy

• If you are allergic to bictegravir, emtricitabine, tenofovir alafenamideor to any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
• rifampicinused to treat some bacterial infections, such as tuberculosis
• St John's wort( Hypericum perforatum), a herbal remedy used for depression and anxiety, or preparations containing it.
• If any of these conditions apply to you, do not take Biktarvy and tell your doctor immediately.

Warnings and precautions
Talk to your doctor before taking Biktarvy:

• If you have liver problems or a history of liver disease, including hepatitis.Patients with liver disease including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. If you have hepatitis B, your doctor will carefully assess the best treatment regimen for you.
• If you have hepatitis B.Liver problems may worsen when you stop taking Biktarvy.
• Do not stop taking Biktarvy if you have hepatitis B. Consult your doctor first. For more details, see section 3, Do not stop taking Biktarvy.
• If you have kidney disease or if tests have shown you have kidney problems.Your doctor may request blood tests to monitor how your kidneys are functioning at the beginning and during treatment with Biktarvy.

While taking Biktarvy
When you start taking Biktarvy, 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 Biktarvy for a long period of
time (see Warnings and precautions).
This medicine does not cure HIV infection. While you are taking Biktarvy you may still
develop infections or other diseases associated with HIV infection.

Children and adolescents
Do not give this medicine to children under 2 years of ageor weighing less than
14 kg, regardless of age. The use of Biktarvy in children under 2 years of age or weighing less than
14 kg has not yet been studied. For children and adolescents weighing 25 kg or
more, Biktarvy 50 mg/200 mg/25 mg film-coated tablets are available.
Bone loss has been reported in some children between 3 and less than 12 years of age who
received one of the active substances (tenofovir alafenamide) contained in Biktarvy. The long-term effects on
bone health and the risk of future fractures in children are uncertain. The doctor
will monitor the child's bone health as needed.

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

Medicines that must never be taken with Biktarvy:

• rifampicinused to treat some bacterial infections, such as tuberculosis
• St John's wort( Hypericum perforatum), a herbal remedy used for depression and anxiety, or preparations containing it.
• If you are taking any of these medicines, do not take Biktarvy and tell your doctor immediately.

Talk to your doctor if you are taking:

• medicines used to treat HIV and/or hepatitis B,containing:
• adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide or tenofovir disoproxil
• antibiotics used to treat bacterial infections,containing:
• azithromycin, clarithromycin, rifabutin or rifapentine
• anticonvulsantsused to treat epilepsy, containing:
• carbamazepine, oxcarbazepine, phenobarbital or phenytoin
• immunosuppressantsused to control the immune response after a transplant, containing ciclosporin
• medicines for the treatment of ulcerscontaining sucralfate
• Tell your doctor if you are taking any of these medicines.Do not stop treatment without contacting your doctor.

Ask your doctor or pharmacist if you are taking:

• antacids, containing aluminium and/or magnesium hydroxide, to treat stomach ulcers, heartburn or acid reflux
• mineral or vitamin supplements,containing magnesium or iron
• Ask your doctor or pharmacist before taking Biktarvyif you are taking any of these medicines.
• Antacids and supplements containing aluminium and/or magnesium:you must take Biktarvy at least 2 hours beforeantacids or supplements containing aluminium and/or magnesium. Alternatively, you can take Biktarvy with food at least 2 hours after.However, if you are pregnant, read Pregnancy and breastfeeding.
• Iron supplements:you must take Biktarvy at least 2 hours beforeiron supplements, or you can take it with them at any time with food. However, if you are pregnant, read Pregnancy and breastfeeding.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant, are planning to become pregnant, or 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.
• Antacids and supplements containing aluminium and/or magnesium: during pregnancy you must take Biktarvy at least 2 hours beforeor 6 hours aftertaking antacids, medicines or supplements containing aluminium and/or magnesium.
• Supplements or medicines containing calcium and/or iron: during pregnancy you must take Biktarvy at least 2 hours beforeor 6 hours aftertaking supplements or medicines containing calcium and/or iron. Alternatively, you can take them together at any time with food.

If you have already taken Biktarvy 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 nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit of protection against HIV has outweighed the risk of adverse effects.

Do not breastfeed during treatment with Biktarvy.The reason is that some active substances of this
medicine are 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 using machines
Biktarvy can cause dizziness. If you experience dizziness while taking Biktarvy, do not drive or
ride a bicycle and do not use tools or machines.

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

3. How to take Biktarvy

Take this medicine always exactly as your doctor has told you. If you have any doubts ask your
doctor or pharmacist.
There are two dosages of Biktarvy tablets. Your doctor will prescribe the appropriate tablet
for your age and body weight.

The recommended dose is:
Children aged 2 years or older, with a body weight of at least 14 kg but less than
25 kg:one tablet a day, to be taken with or without food (one tablet of
30 mg/120 mg/15 mg).
Due to the bitter taste, it is recommended not to chew or crush the tablet.
If you have difficulty taking the whole tablet, you can divide it in half. Take the two parts of the
tablet one after the other to take the entire dose. Do not store the divided tablet.
The score line on the tablet is to facilitate breaking the tablet in case the child
has difficulty swallowing it whole.
The 90-day multipack contains three 30-day packs together.

• Ask your doctor or pharmacist if you are taking:
• antacids, containing aluminium and/or magnesium hydroxide, to treat stomach ulcers, heartburn or acid reflux
• mineral or vitamin supplementscontaining magnesium or iron
• See section 2 for more informationon taking these medicines with Biktarvy.

If you are undergoing dialysis, take the daily dose of Biktarvy after completion of the dialysis
treatment.

If you take more Biktarvy than you should
If you take a dose of Biktarvy higher than recommended, you may have a greater risk of
experiencing the possible side effects of this medicine (see section 4, Possible side

effects).
Contact your doctor or the nearest emergency room immediately. Bring the bottle or pack of
tablets with you so you can easily describe what you have taken.

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

• if you remember within 18 hoursof your usual time of taking Biktarvy, you should take the tablet as soon as possible. Then take the next dose as usual.
• if you remember after 18 hours or moreof your usual time of taking Biktarvy, do not take the forgotten dose. Wait and take the next dose at your usual time.

In case of vomitingoccurring within 1 hour of taking Biktarvy, take another tablet. In
case of vomiting after 1 hour (or more) of taking Biktarvy, do not take another tablet until the
next normally scheduled dose.

Do not stop taking Biktarvy
Do not stop taking Biktarvy without talking to your doctor.Stopping the
treatment with Biktarvy can seriously affect your response to subsequent treatment. If the
treatment with Biktarvy is interrupted for any reason, talk to your doctor before starting
to take Biktarvy tablets again.

When your supply of Biktarvy begins to run low, have another supply prescribed by your doctor or
pharmacist. It is very important because the amount of virus can start to increase if the
medicine is stopped even for a short period. The disease may become more difficult to
treat.

If you have both an HIV infection and hepatitis B,it is particularly important not to stop
taking Biktarvy 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 is not recommended as it may lead to
worsening of hepatitis, which can be potentially fatal.

• Immediately tell your doctorabout 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 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.

Possible side effects: tell your doctor immediately

• Signs of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of previous opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation from previous infections can occur shortly after starting HIV 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 diseasescan also develop, in which the immune system attacks healthy tissue in the body, 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 these or any symptoms of inflammation or infection, tell your doctorimmediately.

Common side effects

(may affect up to 1 in 10 people)

• depression
• abnormal dreams
• headache
• dizziness
• diarrhoea
• feeling unwell (nausea)
• tiredness (fatigue)

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

• low red blood cell count (anaemia)
• vomiting
• stomach pain
• digestive problems causing discomfort after meals (dyspepsia)
• intestinal gas (flatulence)
• swelling of the face, lips, tongue or throat (angioedema)
• itching
• skin rash
• urticaria
• joint pain (arthralgia)
• suicidal thoughts and attempted suicide (especially in patients who have suffered from depression or have a history of mental health problems)
• anxiety
• sleep disorders

Blood tests may also show:

• higher levels of substances called bilirubin and/or serum creatinine in the blood

Rare side effects

(may affect up to 1 in 1000 people)

• Stevens-Johnson Syndrome (SJS) is a serious, potentially life-threatening condition that usually begins with flu-like symptoms. After a few days, other symptoms appear, including:
• painful, red or purple skin that looks burned and peels off
• blisters on skin, mouth, nose and genitals
• watery, red, painful eyes
• If you develop any of these symptoms, stop taking the medicine immediately and tell your doctor right away.
• If any of these side effects worsen, 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 Biktarvy 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
• aching and pains in the joints (especially in the hip, 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. Your doctor will check these changes.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Biktarvy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the outer packaging and on the
bottle or on the blisters after {Scad.}. 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 use if the seal on the bottle opening is broken or missing.
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 Biktarvy contains
The active substances arebictegravir, emtricitabine and tenofovir alafenamide.
Each Biktarvy tablet contains bictegravir sodium equivalent to 30 mg of bictegravir, 120 mg of
emtricitabine and tenofovir alafenamide fumarate equivalent to 15 mg of tenofovir alafenamide.

Other ingredients are

Tablet core
Microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E470b).

Film coating
Polyvinyl alcohol (E203), titanium dioxide (E171), macrogol (E1521), talc (E553b), red iron oxide
(E172), black iron oxide (E172).

Description of Biktarvy and contents of the pack
Biktarvy 30 mg/120 mg/15 mg film-coated tablets are pink, capsule-shaped,
film-coated and imprinted with “BVY” on one side and an incision line on the other side of the
tablet.
The tablets are supplied in a bottle. Not all pack sizes may be marketed.
Biktarvy is supplied in bottles of 30 tablets and in packs of 3 bottles, each containing
30 tablets. Each bottle also contains a desiccant, silica gel, which must remain in the
bottle to protect the tablets. The silica gel is contained in a separate sachet or jar and must not be swallowed.

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
Tél/Tel: + 32 (0) 24 01 35 50

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 (0) 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

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

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 (0) 210 8930 100

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

Österreich
Gilead Sciences GesmbH
Tel: + 43 (0) 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 (0) 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 (0) 22 262 8702

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

Portugal
Gilead Sciences, Lda.
Tel: + 351 (0) 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 (0) 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 (0) 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 medicine is available on the European Medicines Agency website, http://www.ema.europa.eu.

Biktarvy 50 mg/200 mg/25 mg film-coated tablets

bictegravir/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.

If Biktarvy has been prescribed for your child, please be aware that all the information contained in
this leaflet is intended for your child (in this case, read “your child” instead of “you”).
Contents of this leaflet

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

1. What is Biktarvy and what is it used for

Biktarvy contains three active ingredients:

• bictegravir, an antiviral medicine called an integrase strand transfer inhibitor (INSTI)
• emtricitabina, an antiviral medicine called a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide, an antiviral medicine called a nucleotide reverse transcriptase inhibitor (NtRTI)

Biktarvy is a single tablet for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults, adolescents and children aged 2 years and older, with a body weight of at least 14 kg.
Biktarvy reduces the amount of HIV in your body. This strengthens your immune system and reduces
the risk of developing illnesses related to HIV infection.

2. What you need to know before taking Biktarvy

Do not take Biktarvy

• If you are allergic to bictegravir, emtricitabine, tenofovir alafenamideor to any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
• rifampicinused to treat some bacterial infections, such as tuberculosis
• St John's wort( Hypericum perforatum), a herbal remedy used for depression and anxiety, or preparations containing it.
• If any of these conditions apply to you, do not take Biktarvy and tell your doctor immediately.

Warnings and precautions
Talk to your doctor before taking Biktarvy:

• If you have liver problems or a history of liver disease, including hepatitis.Patients with liver disease including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. If you have hepatitis B, your doctor will carefully assess the best treatment regimen for you.
• If you have hepatitis B.Liver problems may worsen when you stop taking Biktarvy.
• Do not stop taking Biktarvy if you have hepatitis B. Consult your doctor first. For more details, see section 3, Do not stop taking Biktarvy.
• If you have kidney disease or if tests have shown you have kidney problems.Your doctor may request blood tests to monitor how well your kidneys are working at the beginning and during treatment with Biktarvy.

While taking Biktarvy
When you start taking Biktarvy, 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 long-term use of Biktarvy
(see Warnings and precautions).
This medicine does not cure HIV infection. While you are taking Biktarvy you may still
develop infections or other diseases associated with HIV infection.

Children and adolescents
Do not give this medicine to children and adolescentswith a body weight less than 25 kg, regardless of age. For children aged 2 years and over with a body weight of at least 14 kg
but less than 25 kg, Biktarvy 30 mg/120 mg/15 mg film-coated tablets are available.
The use of Biktarvy in children under 2 years of age or with a body weight less than 14 kg has not
been studied yet.
Bone loss has been reported in some children between 3 and less than 12 years of age who
received one of the active substances (tenofovir alafenamide) contained in Biktarvy. The long-term
effects on bone health and the risk of future fractures in children are uncertain. The doctor
will monitor the child's bone health as needed.

Other medicines and Biktarvy
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.Biktarvy can interact with other medicines. As a result, the
amount of Biktarvy or the other medicines in your blood can be changed. 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 check blood levels.

Medicines that must never be taken with Biktarvy:

• rifampicinused to treat some bacterial infections, such as tuberculosis
• St John's wort( Hypericum perforatum), a herbal remedy used for depression and anxiety, or preparations containing it.
• If you are taking any of these medicines, do not take Biktarvy and tell your doctor immediately.

Talk to your doctor if you are taking:

• medicines used to treat HIV and/or hepatitis B,containing:
• adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide or tenofovir disoproxil
• antibiotics used to treat bacterial infections,containing:
• azithromycin, clarithromycin, rifabutin or rifapentine
• anticonvulsantsused to treat epilepsy, containing:
• carbamazepine, oxcarbazepine, phenobarbital or phenytoin
• immunosuppressantsused to control the immune response after a transplant, containing ciclosporin
• medicines for the treatment of ulcerscontaining sucralfate
• Tell your doctor if you are taking any of these medicines.Do not stop taking the treatment without contacting your doctor.

Ask your doctor or pharmacist if you are taking:

• antacids, containing aluminium and/or magnesium hydroxide, to treat stomach ulcers, heartburn or acid reflux
• mineral or vitamin supplements,containing magnesium or iron
• Ask your doctor or pharmacist before taking Biktarvyif you are taking any of these medicines.
• Antacids and supplements containing aluminium and/or magnesium:you should take Biktarvy at least 2 hours beforeantacids or supplements containing aluminium and/or magnesium. Alternatively, you can take Biktarvy with food at least 2 hours after.However, if you are pregnant, read Pregnancy and breastfeeding.
• Iron supplements:you should take Biktarvy at least 2 hours beforeiron supplements, or you can take it with food at any time. However, if you are pregnant, read Pregnancy and breastfeeding.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant, or are planning to become pregnant, 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.
• Antacids and supplements containing aluminium and/or magnesium: during pregnancy you should take Biktarvy at least 2 hours beforeor 6 hours aftertaking antacids, medicines or supplements containing aluminium and/or magnesium.
• Calcium and/or iron supplements or medicines: during pregnancy you should take Biktarvy at least 2 hours beforeor 6 hours aftertaking calcium and/or iron supplements or medicines. Alternatively, you can take them together with food at any time.

If you have already taken Biktarvy during pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor your baby’s development. In children whose mothers have taken nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.

Do not breastfeed while taking Biktarvy.This is because some of the active substances in this
medicine are excreted in breast milk. Breastfeeding is not recommended for HIV-positive women as
HIV infection can be passed on 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 using machines
Biktarvy can cause dizziness. If you experience dizziness while taking Biktarvy, do not drive or
ride a bicycle and do not use tools or machines.

Biktarvy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially
‘sodium-free’.

3. How to take Biktarvy

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
There are two dosages of Biktarvy tablets. Your doctor will prescribe the appropriate tablet for your age and body weight.

The recommended dose is:
Adults, adolescents and children weighing at least 25 kg:one tablet a day, to be taken with or without food (one 50 mg/200 mg/25 mg tablet).
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 the two parts of the tablet one after the other to take the entire dose. Do not store the divided tablet.
The 30-day blister pack of Biktarvy contains four blister strips of 7 tablets and one blister strip of 2 tablets. To help you keep track of taking the medicine for 30 days, the 7-tablet blister strips have the days of the week printed on them, and you can write the relevant days of the week on the 2-tablet blister strip.
The 90-day multiple pack contains three 30-day packs together.

• Ask your doctor or pharmacist if you are taking:
• antacids, containing aluminium and/or magnesium hydroxide, to treat stomach ulcers, heartburn or acid reflux
• mineral supplementsor vitaminscontaining magnesium or iron
• See section 2 for more informationon taking these medicines with Biktarvy.

If you are undergoing dialysis, take your daily dose of Biktarvy after completion of the dialysis treatment.

If you take more Biktarvy than you should
If you take a dose of Biktarvy higher than recommended, you may have an increased risk of experiencing the possible side effects of this medicine (see section 4, Possible side effects).

side effects).
Contact your doctor or the nearest emergency room immediately. Bring the bottle or pack of tablets with you so you can easily describe what you have taken.

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

• if you remember within 18 hoursof your usual time of taking Biktarvy, you should take the tablet as soon as possible. Then take your next dose as usual.
• if you remember after 18 hours or moreof your usual time of taking Biktarvy, do not take the missed dose. Wait and take your next dose at your usual time.

In case of vomitingthat occurs within 1 hour of taking Biktarvy, take another tablet. In case of vomiting after 1 hour (or more) of taking Biktarvy, do not take another tablet until your next regularly scheduled dose.

Do not stop taking Biktarvy
Do not stop taking Biktarvy without talking to your doctor.Stopping treatment with Biktarvy can seriously affect your response to subsequent treatment. If treatment with Biktarvy is interrupted for any reason, talk to your doctor before starting to take Biktarvy tablets again.

When your supply of Biktarvy begins to run low, have more obtained from your doctor or pharmacist. It is very important because the amount of virus can start to increase if the medicine is stopped even for a short period. The disease may become more difficult to treat.

If you have both an HIV infection and hepatitis B,it is particularly important not to stop treatment with Biktarvy without first contacting your doctor. You may need to repeat blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as it may lead to a worsening of hepatitis, which can be potentially fatal.

• Immediately inform your doctorof any new or unusual symptoms observed 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.

Possible side effects: tell your doctor immediately

• Signs of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of previous opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting HIV 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 diseasesmay also develop, in which the immune system attacks healthy tissue in the body, when you start taking medicines for HIV infection. Autoimmune diseases can appear 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 these or any symptoms of inflammation or infection, tell your doctorimmediately.

Common side effects

(may affect up to 1 in 10 people)

• depression
• abnormal dreams
• headache
• dizziness
• diarrhoea
• feeling unwell (nausea)
• tiredness (fatigue)

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

• low red blood cell count (anaemia)
• vomiting
• stomach pain
• digestive problems causing discomfort after meals (dyspepsia)
• intestinal gas (flatulence)
• swelling of the face, lips, tongue or throat (angioedema)
• itching
• skin rash
• hives
• joint pain (arthralgia)
• suicidal thoughts and attempted suicide (especially in patients who have suffered from depression or have a history of mental health problems)
• anxiety
• sleep disorders

Blood tests may also show:

• higher levels of substances called bilirubin and/or serum creatinine in the blood

Rare side effects

(may affect up to 1 in 1,000 people)

• Stevens-Johnson Syndrome (SJS) is a serious and potentially life-threatening condition that usually begins with flu-like symptoms. After a few days, other symptoms appear, including:
• painful red or purple skin that looks burned and peels off
• blisters on skin, mouth, nose and genitals
• eyes that are watery, red and painful
• If you develop any of these symptoms, stop taking the medicine immediately and tell your doctor right away.
• If any of the 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 (the frequency cannot be estimated based on
available data).

• Bone problems.Some patients taking combination antiretroviral medicines such as Biktarvy 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
• aching and pains in the joints (especially in the hip, knees and shoulders)
• difficulty moving
• If you notice any of these symptoms, tell your doctor.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Biktarvy

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 outer packaging and on the
bottle or on the blisters after {Scad.}. The expiry date refers to the last day of that month.

Bottle
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly
closed. Do not use if the seal on the bottle opening is broken or missing.

Blisters
Store in the original packaging to protect the medicine from moisture. Do not use if the foil
on the blister is torn or punctured.
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 Biktarvy contains
The active ingredients arebictegravir, emtricitabine and tenofovir alafenamide. Each Biktarvy tablet
50 mg/200 mg/25 mg contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of
emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.

Other ingredients are

Tablet core
Microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E470b).

Film coating
Polyvinyl alcohol (E203), titanium dioxide (E171), macrogol (E1521), talc (E553b), red iron oxide
(E172), black iron oxide (E172).

Description of Biktarvy and contents of the pack
Biktarvy 50 mg/200 mg/25 mg film-coated tablets are brown-purple, capsule-shaped, film-coated and
with “GSI” imprinted on one side and “9883” on the other side of the tablet.
The tablets may be supplied in a bottle or in a blister pack. Not all pack sizes may be marketed.

Bottle
Biktarvy is supplied in bottles of 30 tablets and in packs of 3 bottles, each containing
30 tablets. Each bottle also contains a desiccant, silica gel, which must remain in the
bottle to protect the tablets. The silica gel is contained in a separate sachet or jar and must not be swallowed.

Blister
Biktarvy 50 mg/200 mg/25 mg tablets are also supplied in blister packs of 30 tablets and in
multipacks containing 3 boxes, each containing 30 tablets. Each individual pack
contains 4 blisters containing 7 tablets and 1 blister containing 2 tablets. Each blister cavity contains a desiccant which must not be removed or swallowed.

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
Tél/Tel: + 32 (0) 24 01 35 50

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 (0) 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 (0) 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 (0) 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 (0) 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 (0) 22 262 8702

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

Portugal
Gilead Sciences, Lda.
Tel: + 351 (0) 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 (0) 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 (0) 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 medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu.