SUNLENCA 300 mg Фильм-Coated Таблетки

Содержание инструкции

1. Sunlenca 464 mg injectable solution
   1. What is Sunlenca and what is it used for
   2. What you need to know before you are given Sunlenca
   3. How Sunlenca is administered
   4. Possible side effects
   5. How to store Sunlenca
   6. Contents of the pack and other information
2. Sunlenca 300 mg film-coated tablets
   1. What is Sunlenca and what is it used for
   2. What you need to know before taking Sunlenca
   3. How to take Sunlenca
   4. Possible side effects
   5. How to store Sunlenca
   6. Contents of the pack and other information

Sunlenca 464 mg injectable solution

lenacapavir

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start to use 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.
• 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 Sunlenca is and what it is used for
• 2. What you need to know before Sunlenca is given to you
• 3. How Sunlenca is given
• 4. Possible side effects
• 5. How to store Sunlenca
• 6. Contents of the pack and other information

1. What is Sunlenca and what is it used for

Sunlenca contains the active substance lenacapavir. It is a medicine called an antiretroviral
capsid inhibitor.
Sunlenca is a prolonged-release medicine used in combination with other antiretroviral
medicinesfor the treatment of human immunodeficiency virus (HIV) type 1, the virus that
causes acquired immunodeficiency syndrome (AIDS).
It is used for the treatment of HIV infection in adults with limited treatment options
(for example, when other antiretroviral medicines are not sufficiently effective or are not
suitable).
Treatment with Sunlenca in combination with other antiretrovirals reduces the amount of HIV in the body.
This improves the function of the immune system (the body's natural defenses) and reduces the
risk of developing diseases related to HIV infection.

2. What you need to know before you are given Sunlenca

Do not be given Sunlenca

• If you are allergic to lenacapavir or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
• rifampicin,used to treat some bacterial infections, such as tuberculosis
• carbamazepine, phenytoin, used to prevent seizures
• St John's wort(Hypericum perforatum), a herbal remedy used against depression and anxiety.
• If any of these conditions apply to you, do not be given Sunlenca and tell your doctor immediately.

Warnings and precautions
Talk to your doctor before using Sunlenca

• Talk to your doctor or pharmacist if you suffer from or have ever suffered from severe liver disease orif tests have shown you have liver problems.Your doctor will carefully assess whether to treat you with Sunlenca.

While you are using Sunlenca
When you start using Sunlenca, pay attention to:

• signs of inflammationor infection.
• If you notice any of these symptoms, tell your doctor immediately.For more information see section 4, Possible side effects.
• Reactions at the injection site of Sunlenca.
• A hardened mass or nodule may form at the injection site. In some cases, these nodules persist for more than a year and in some cases may not disappear. If the problem does not go away at the time of the next injection, tell your doctor. For more information, see section 4, Possible side effects.

Regular appointments are important
It is important that you attend all scheduled appointmentsto receive Sunlenca injections, to monitor your HIV infection and to prevent the disease from getting worse. Talk to your doctor
if you are thinking of stopping treatment. If a Sunlenca injection is given to you
late or if you stop treatment with Sunlenca, you will need to take other medicines to treat your
HIV infection and reduce the risk of developing viral resistance.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. The use of Sunlenca in
patients under 18 years of age has not yet been studied; therefore, the safety and efficacy of
the medicine in this age group are unknown.

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

Medicines that must never be taken with Sunlenca:

• rifampicin,used to treat some bacterial infections, such as tuberculosis
• carbamazepine, phenytoin,used to prevent seizures
• St John's wort (Hypericum perforatum), a herbal remedy used against depression and anxiety.
• If you are taking any of these medicines, do not be given Sunlencainjectable and tell your doctor immediately.

Talk to your doctor particularly if you are taking:

• antibiotics containing:
• rifabutin
• anticonvulsants used to treat epilepsy and prevent seizures, containing:
• oxcarbazepine or phenobarbital
• medicines used to treat HIV, containing:
• atazanavir/cobicistat, efavirenz, nevirapine, tipranavir/ritonavir or etravirine
• medicines used to treat migraine headaches, containing:
• dihydroergotamine or ergotamine
• medicines used to treat impotence and pulmonary hypertension, containing:
• sildenafil or tadalafil
• medicines used to treat impotence, containing:
• vardenafil
• corticosteroids (also known as “steroids”) taken orally or given by injection used to treat allergies, inflammatory bowel disease and various other diseases that cause inflammation, containing:
• dexamethasone or hydrocortisone/cortisone
• medicines used to lower cholesterol ,containing:
• lovastatin or simvastatin
• antiarrhythmics used to treat heart problems, containing:
• digoxin
• medicines used to help you sleep, containing:
• midazolam or triazolam
• anticoagulants used to prevent and treat blood clots, containing:
• rivaroxaban, dabigatran or edoxaban.
• Tell your doctor if you are taking any of these medicinesor if you start taking them during treatment with Sunlenca. Do not stop treatment without contacting your doctor.

Sunlenca is a prolonged-release medicine. If, after talking to your doctor, you decide to
stop treatment or switch to another treatment, you should know that low levels of
lenacapavir (the active ingredient in Sunlenca) can remain in your body for many
months after the last injection. These remaining low levels should not affect other antiretroviral medicines
taken later to treat HIV infection. However, other medicines
may be affected by the low levels of lenacapavir in your body if you take them within
9 months after the last Sunlenca injection. You should ask your doctor if these medicines can be
taken safely after stopping treatment with Sunlenca.

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.
As a precaution, it is preferable to avoid the use of Sunlenca during pregnancy unless
your doctor tells you otherwise.
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 considering breastfeeding you should
talk to your doctor as soon as possible.

Driving and using machines
Sunlenca should not affect your ability to drive and operate machinery.

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

3. How Sunlenca is administered

Sunlenca is used in combination with other antiretroviral medicationsto treat HIV infection.
Your doctor will tell you which other medications you need to take to treat HIV infection and when you should
take them.
Treatment with Sunlenca starts with tablets to be taken by mouth, followed by injections
administered by the doctor or nurse, as described below.

Talk to your doctor before taking the tablets.You will be told when to start
taking the tablets and when your appointment for the first injections will be scheduled.

Day 1 of treatment:

• two tablets to be taken by mouth. These can be taken with or without food.

Day 2 of treatment:

• two tablets to be taken by mouth. These can be taken with or without food.

Day 8 of treatment:

• one tablet to be taken by mouth. This can be taken with or without food.

Day 15 of treatment:

• two injections in the abdomen (stomach) administered at the same time by the doctor or nurse.

Every 6 months:

• two injections in the abdomen administered at the same time by the doctor or nurse.

If you are given too much Sunlenca
This medication will be administered by the doctor or nurse; therefore, it is unlikely that you will be
given an excessive amount. If you have any doubts, contact your doctor or nurse.

If you miss a Sunlenca injection

• It is important that you attend all scheduled appointments every 6 monthsto receive Sunlenca injections. This will help control the HIV infection and prevent the disease from worsening.
• If you cannot attend an injection appointment, inform your doctor as soon as possible to discuss your treatment options.

If you stop taking Sunlenca
Do not stop taking Sunlenca without talking to your doctor. Continue to receive
Sunlenca injections for the period prescribed by your doctor. Stopping treatment may have
serious consequences on the effectiveness of your future HIV treatments.

• Talk to your doctor if you no longer want to receive Sunlenca injections.

4. Possible side effects

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

Possible side effects: inform 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 anti-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.
• When you start taking medicines for HIV infection, autoimmune diseasesmay also develop, in which the immune system attacks healthy tissue in the body. 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 towards the torso
• palpitations, tremor or hyperactivity.
• If you notice these or any other symptoms of inflammation or infection , inform your doctorimmediately.

Very common side effects

(may affect more than 1 in 10 people)

• Reactions at the Sunlenca injection site.Symptoms may include:
• pain and discomfort
• a hardened mass or nodule, which may take longer to disappear than other injection site reactions or may not disappear
• inflammatory reaction such as redness, itching and swelling
• open wound on the skin

Common side effects

(may affect up to 1 in 10 people)

• Nausea

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 Sunlenca

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 label of the vial and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original package to protect the medicine from light.

6. Contents of the pack and other information

What Sunlenca contains
The active ingredient is lenacapavir. Each single-dose vial contains 463.5 mg of lenacapavir.
The other ingredients are
Macrogol (E1521), water for injections.

Description of Sunlenca and contents of the pack
The Sunlenca injectable solution (injection) is a clear solution, from yellow to
brown in colour, and free from visible particles. Sunlenca is supplied in two glass vials, each containing
1.5 mL of injectable solution. The vials are inside a delivery kit which also contains
2 vial access devices (devices used by the doctor or nurse to
withdraw Sunlenca from the vial), 2 single-use syringes and 2 injection needles.

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: + 420 910 871 986

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

------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:

Instructions for use - Sunlenca 464 mg injectable solution
The pack contains

2 vials	a c
2 vial access devices	m
2 syringes	r
2 injection needles 22G, 13 mm	F a

All components are for single use only.
Two injections of1.5 mLare required for a complete dose. The vial
access device must be used.
Check that:

• The vial and prepared syringe contain a solution from yellow to brown and free fromparticulate matter
• The contents are not damaged
• The product is not expired

1. Prepare the vial
a l i a	Remove the cap.
a I t	Clean the vial stopper with an alcohol wipe.
2. Prepare the vial access device
n z i	Press.
A g e	Unscrew.

3., 4. Connect and fill the syringe
	Connect the syringe and inject 1.5 mL of o air into the vial. Turn over and withdraw all the c contents. a m r a F l e
d 5. Connect the 22G injection needle to the syringe, expel air bubbles and prepare the delivery of 1.5 mL
a n Grey fitting a i l
a 6. Clean an injection site on the patient's abdomen
t Options for injection sites (at least 5 cm from the navel) a i z	Options for injection sites (at least 5 cm away from the navel).
7. Inject 1.5 mL of Sunlenca subcutaneously
n e Insert completely at 90° preferable A 45° acceptable

8. Administer the second injection
Repeat the steps for the 2nd injection at least 5 cm from the site of the first injection	a c o

Sunlenca 300 mg film-coated tablets

lenacapavir

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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; it could be harmful, even if their symptoms are the same as yours.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Sunlenca and what is it used for

Sunlenca contains the active substance lenacapavir. It is an antiretroviral medicine known as a
capsid inhibitor.
Sunlenca is used in combination with other antiretroviral medicinesfor the treatment of human
immunodeficiency virus (HIV) type 1, the virus that causes acquired immunodeficiency syndrome
(AIDS).
It is used for the treatment of HIV infection in adults with limited treatment options
(for example, when other antiretroviral medicines are not sufficiently effective or are not
suitable).
Treatment with Sunlenca in combination with other antiretrovirals reduces the amount of HIV in the body.
In this way, it improves the function of the immune system (the body's natural defenses) and reduces the
risk of developing diseases related to HIV infection.
Your doctor will tell you to take the Sunlenca tablets before you are given the Sunlenca injections
for the first time.

2. What you need to know before taking Sunlenca

Do not take Sunlenca

• If you are allergic to lenacapavir or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
• rifampicin,used to treat some bacterial infections, such as tuberculosis
• carbamazepine, phenytoin, used to prevent seizures
• St John's wort( Hypericum perforatum), a herbal remedy used to treat depression and anxiety.
• If any of these conditions apply to you, do not take Sunlenca and tell your doctor immediately.

Warnings and precautions
Talk to your doctor before taking Sunlenca

• Talk to your doctor or pharmacist if you suffer from or have ever suffered from severe liver disease orif tests have shown liver problems. Your doctor will carefully assess whether to treat you with Sunlenca.

While using Sunlenca
When you start using Sunlenca, pay attention to:

• signs of inflammation or infection.
• If you notice any of these symptoms, tell your doctor immediately. For more information see section 4, Possible side effects.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. The use of Sunlenca in
patients under 18 years of age has not yet been studied; therefore, the safety and efficacy of
the medicine in this age group are unknown.

Other medicines and Sunlenca
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Sunlenca can interact with other medicines. This may prevent Sunlenca or
other 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 Sunlenca:

• rifampicin,used to treat some bacterial infections, such as tuberculosis
• carbamazepine, phenytoin,used to prevent seizures
• St John's wort (Hypericum perforatum), a herbal remedy used to treat depression and anxiety.
• If you are taking any of these medicines, do not take Sunlenca and tell your doctor immediately.

Talk to your doctor particularly if you are taking:

• antibiotics containing:
• rifabutin
• anticonvulsants used to treat epilepsy and prevent seizures, containing:
• oxcarbazepine or phenobarbital
• medicines used to treat HIV, containing :
• atazanavir/cobicistat, efavirenz, nevirapine, tipranavir/ritonavir or etravirine
• medicines used to treat migraine headaches, containing:
• dihydroergotamine or ergotamine
• medicines used to treat impotence and pulmonary hypertension ,containing:
• sildenafil or tadalafil
• medicines used to treat impotence, containing:
• vardenafil
• corticosteroids (also known as “steroids”) taken orally or given by injection used to treat allergies, inflammatory bowel disease and various other diseases that cause inflammation, containing:
• dexamethasone or hydrocortisone/cortisone
• medicines used to lower cholesterol ,containing:
• lovastatin or simvastatin
• antiarrhythmics used to treat heart problems, containing:
• digoxin
• medicines used to help you sleep, containing:
• midazolam or triazolam
• anticoagulants used to prevent and treat blood clots, containing:
• rivaroxaban, dabigatran or edoxaban.
• Tell your doctor if you are taking any of these medicinesor if you start taking them during treatment with Sunlenca .Do not stop treatment without contacting your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
As a precaution, it is preferable to avoid the use of Sunlenca during pregnancy unless
your doctor tells you to.
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 of
breastfeeding you should talk to your doctor as soon as possible.
Driving and using machines
Sunlenca should not affect your ability to drive and operate machines.

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

3. How to take Sunlenca

Sunlenca is used in combination with other antiretroviral medicinesto treat HIV infection.
Your doctor will tell you which other medicines you need to take to treat your HIV infection and when you should
take them.
Treatment with Sunlenca starts with tablets to be taken by mouth, followed by injections
given by your doctor or nurse, as described below.

Talk to your doctor before taking the tablets.You will be told when to start
taking the tablets and when your appointment for the first injections will be scheduled.

Day 1 of treatment:

• two tablets to be taken by mouth. These can be taken with or without food.

Day 2 of treatment:

• two tablets to be taken by mouth. These can be taken with or without food.

Day 8 of treatment:

• one tablet to be taken by mouth. This can be taken with or without food.

Day 15 of treatment:

• two injections in the abdomen (stomach) given at the same time by your doctor or nurse.

Every 6 months:

• two injections in the abdomen given at the same time by your doctor or nurse.

If you take more Sunlenca than you should
Contact your doctor or pharmacist immediately. If you take a dose of Sunlenca higher than
recommended, you may have a greater risk of experiencing the possible side effects of
this medicine (see section 4, Possible side effects).

It is important that you do not miss any dose of Sunlenca tablets.

If you forget to take the tablets, inform your doctor or pharmacist immediately.

If you vomitwithin 3 hours of taking Sunlenca tablets, contact your doctor immediately and take
two more tablets. If you vomit more than 3 hours after taking Sunlenca, you do not need to
take two more Sunlenca tablets until your next scheduled dose or injection.

If you miss a Sunlenca injection

• It is important that you attend all scheduled appointments every 6 monthsto receive Sunlenca injections. This will help to control your HIV infection and prevent the disease from getting worse.
• If you cannot attend an injection appointment, inform your doctor as soon as possible to discuss your treatment options.

Do not stop taking Sunlenca
Do not stop taking Sunlenca tablets without talking to your doctor.
Stopping treatment may have serious consequences on the effectiveness of your future anti-HIV
treatments.

4. Possible side effects

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

Possible side effects: inform 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 anti-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.
• When you start taking medicines for HIV infection, autoimmune diseasesmay also develop, in which the immune system attacks healthy tissue in the body. 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 towards the torso
• palpitations, tremor or hyperactivity.
• If you notice these or any other symptoms of inflammation or infection , inform your doctorimmediately.

Common side effects

(may affect up to 1 in 10 people)

• Nausea

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 Sunlenca

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 box and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from humidity.
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 Sunlenca contains
The active ingredient is lenacapavir. Each tablet contains lenacapavir sodium equivalent to 300 mg of
lenacapavir.
The other ingredients are

Tablet core
Mannitol (E421), microcrystalline cellulose (E460), sodium croscarmellose (E468), copovidone,
magnesium stearate (E572), poloxamer (see section 2, Sunlenca contains sodium).

Film coating
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide
yellow (E172), iron oxide black (E172), iron oxide red (E172).

Description of the appearance of Sunlenca and contents of the pack
Sunlenca film-coated tablets are beige, capsule-shaped, film-coated and with
imprinted “GSI” on one side and “62L” on the other side. Sunlenca is supplied in a blister pack of 5 tablets
contained in a blister cardboard. The blister is inside an aluminium pouch. The aluminium
pouch contains a desiccant silica gel which must be left in the aluminium pouch
to help protect the tablets. The silica gel is contained in a separate bag or container
and must not be ingested.

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: + 420 910 871 986

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