Zydelig

Patient Information Leaflet

Zydelig 100 mg film-coated tablets

idelalisib
Please read all of 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.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What Zydelig is and what it is used for

Zydelig is an anticancer medicine that contains the active substance idelalisib. It works by blocking the effects of an enzyme involved in the proliferation and survival of certain white blood cells called lymphocytes. Since this enzyme is overactive in certain malignant white blood cells, blocking it enables Zydelig to kill tumor cells and reduce their number.

Zydelig can be used to treat two different cancers in adults:

Chronic lymphocytic leukemia

Chronic lymphocytic leukemia (CLL) is a cancer of a type of white blood cells known as B-lymphocytes. In this disease, B-lymphocytes multiply too rapidly and live too long, resulting in excessive numbers circulating in the blood.

In CLL, Zydelig is used in combination with another medicine (rituximab) in patients who have certain high-risk factors or in patients whose cancer has not responded after at least one prior anticancer treatment.

Follicular lymphoma

Follicular lymphoma (FL) is a cancer of a type of white blood cells called B-lymphocytes. In this disease, B-lymphocytes multiply too rapidly and live too long, leading to an excessive accumulation in the lymph nodes.

In FL, Zydelig is used as monotherapy in patients whose cancer has not responded after two prior anticancer treatments.

2. What you should know before taking Zydelig

Do not take Zydelig

• if you are allergic to idelalisib or to any of the other ingredients of this medicine (listed in section 6). Consult your doctor if this condition applies to you.

Warnings and precautions
Talk to your doctor before taking Zydelig. Inform your doctor:

• if you have liver problems
• if you have other illnesses (especially infections or fever)

Severe and life-threatening infections have occurred in patients taking Zydelig.
While taking Zydelig, you will need to take an additional medicine prescribed by your doctor to
prevent a certain type of infection. Your doctor will monitor you for signs of infection.
Inform your doctor immediately if you become ill (especially with fever, cough, or difficulty
breathing) while taking Zydelig.
Contact your doctor immediately if you or someone else notices in you: memory loss, reasoning problems, difficulty walking, or loss of vision. These may be symptoms of a very rare and serious brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML).
Before and during treatment with Zydelig, regular blood tests will be performed. These tests are necessary to check whether you have an infection, to ensure your liver is functioning properly, and to monitor your blood cell counts (full blood count). If necessary, your doctor may decide to temporarily interrupt treatment before restarting it at the same or a lower dose. Your doctor may also decide to permanently discontinue treatment with Zydelig.
Zydelig can cause severe diarrhea. Inform your doctor immediately at the first sign of diarrhea.
Zydelig can cause inflammation of the lungs. Inform your doctor immediately:

• if you develop a cough or if your cough worsens
• if you experience shortness of breath or difficulty breathing

Severe skin disorders with blistering, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with idelalisib treatment. Stop taking idelalisib and contact your doctor immediately if you notice any of the symptoms described in section 4.
Inform your doctor immediately:

• if you develop redness and blistering of the skin
• if you experience swelling and blistering of the mucous membranes of the mouth, throat, nose, genitals, and/or eyes

Laboratory tests may show an increase in white blood cells (called "lymphocytes") during the first weeks of treatment. This effect is expected and may last for several months. Generally, this does not mean that your blood cancer is worsening. Your doctor will check your blood count before and during treatment with Zydelig and, in rare cases, may need to prescribe another medicine. Consult your doctor to understand the meaning of your blood test results.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Zydelig
Zydelig must not be used with other medicines unless your doctor has told you that it is safe to do so.
Inform your doctor if you are taking, have recently taken, or might take any other medicine. This is extremely important, as taking multiple medicines together may strengthen or weaken their effects.
Taking Zydelig together with certain medicines may prevent them from working properly or may worsen side effects. In particular, inform your doctor if you are taking any of the following medicines:

• alfuzosin, a medicine used to treat benign prostatic hyperplasia
• dabigatran, warfarin, medicines used to thin the blood
• amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
• dihydroergotamine, ergotamine, medicines used to treat migraine
• cisapride, a medicine used to relieve certain stomach disorders
• pimozide, a medicine used to treat abnormal thoughts or feelings
• midazolam, triazolam, taken orally to promote sleep and/or relieve anxiety
• quetiapine, a medicine used to treat schizophrenia, bipolar disorder, and major depressive disorders
• amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
• bosentan, a medicine used to treat pulmonary arterial hypertension
• sildenafil, tadalafil, medicines used to treat erectile dysfunction and pulmonary hypertension, a lung disease causing breathing difficulties
• budesonide, fluticasone, medicines used to treat hay fever and asthma, and salmeterol, used to treat asthma
• rifabutin, a medicine used to treat bacterial infections including tuberculosis
• itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections
• boceprevir, telaprevir, medicines used to treat hepatitis C
• carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
• rifampicin, a medicine used to prevent and treat tuberculosis and other infections
• St. John’s wort (Hypericum perforatum), a herbal product used for depression and anxiety
• alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used to relieve pain
• cyclosporine, sirolimus, tacrolimus, medicines used to control the body's immune response after transplantation
• colchicine, a medicine used to treat gout
• trazodone, a medicine used to treat depression
• buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
• dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer
• oral or implantable hormonal contraceptives, used to prevent pregnancy
• clarithromycin, telithromycin, medicines used to treat bacterial infections
• atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol

Zydelig may be prescribed in combination with other medicines for the treatment of CLL. It is very important that you also read the package leaflets provided with these medicines.
If you have any doubts about any of the medicines you are taking, consult your doctor.
Pregnancy and breastfeeding

• Zydelig must not be used during pregnancy. There is no information on the safety of this medicine in pregnant women.
• Use a reliable contraceptive method to avoid pregnancy while being treated with Zydelig and for 1 month after the last dose.
• Zydelig may reduce the effectiveness of oral contraceptives and implantable hormonal contraceptives. While taking Zydelig and for 1 month after the last dose, you must also use a barrier contraceptive method such as condoms or an intrauterine device (IUD).
• Inform your doctor immediately if you become pregnant.

You must not breastfeed while taking Zydelig. If you are currently breastfeeding, consult your doctor before starting treatment. It is not known whether the active ingredient in Zydelig passes into breast milk.
Driving and using machines
It is unlikely that Zydelig will affect your ability to drive or operate machinery.
Zydelig contains sunset yellow FCF (E110)
Inform your doctor if you are allergic to sunset yellow FCF (E110). Zydelig contains sunset yellow FCF, which may cause allergic reactions.
Zydelig contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Zydelig

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor.
The recommended dose is 150 mg taken orally twice daily. However, your doctor may reduce the dose to 100 mg twice daily if you experience certain side effects.
Zydelig may be taken with or without food.
Swallow the tablet whole. Do not chew or crush the tablet. Inform your doctor if you have difficulty swallowing tablets.

If you take more Zydelig than you should
If you accidentally take more Zydelig than recommended, you may be at an increased risk of side effects related to this medicine (see section 4, Possible side effects).
Seek immediate advice from your doctor or the nearest emergency department. Take the bottle and this leaflet with you so you can easily describe what you have taken.

If you forget to take Zydelig
Be careful not to miss any doses of Zydelig. If you forget to take a dose and remember within 6 hours of the scheduled time, take it immediately. Then take the next dose at the usual time. If you forget to take a dose and remember more than 6 hours after the scheduled time, wait and take the next dose at the usual time.

Do not stop treatment with Zydelig
Do not stop treatment with Zydelig unless your doctor tells you to do so.
If you have any doubts about how to use this medicine, talk to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
STOP treatment with Zydelig and contact your doctor immediately if you experience
any of the following side effects:

• reddish patches on the trunk, small localized changes in skin colour, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (a rare side effect – may affect up to 1 in 1,000 people)
• widespread rash, high fever and swollen lymph nodes (DRESS) (the frequency of this side effect is not known)

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

• diarrhoea/inflammation of the large intestine
• rash
• changes in white blood cell count
• infections
• fever

Blood tests may also show:

• increased liver enzymes in the blood
• increased levels of fats in the blood

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

• inflammation of the lungs
• liver damage

Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor. You can also report side effects directly via 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 Zydelig

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 vial and carton after
Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zydelig contains

• The active substance is idelalisib. Each film-coated tablet contains 100 mg of idelalisib.
• The other components are:
  Tablet core: Microcrystalline cellulose, hydroxypropylcellulose (E463), croscarmellose sodium, sodium starch glycolate, magnesium stearate.

Film coating:
Polyvinyl (alcohol) (E1203), macrogol (E1521), titanium dioxide (E171), talc (E553B),
sunset yellow FCF (E110) (see section 2, What you need to know before taking Zydelig).

Description of the appearance of Zydelig and contents of the pack
Zydelig 100 mg film-coated tablets are orange, oval-shaped tablets, embossed with "GSI" on one side and the number "100" on the other.

The following pack is available: outer packaging containing 1 plastic bottle with 60 film-coated tablets.

Marketing Authorization Holder
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

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

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

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

България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: +353 (0) 1 686 1888 Tél/Tel: +32 (0) 24 01 35 50

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

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

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

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

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

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

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

Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: +353 (0) 1 686 1888 Tel: +40 31 631 18 00

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

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

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

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

Latvija United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888 Tel: +44 (0) 8000 113700

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

Patient Information Leaflet

Zydelig 150 mg film-coated tablets

idelalisib
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

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

1. What Zydelig is and what it is used for

Zydelig is an anticancer medicine that contains the active substance idelalisib. It works by blocking
the effects of an enzyme involved in the multiplication and survival of certain white blood cells
called lymphocytes. Since this enzyme is overactive in some malignant white blood cells, blocking it
enables Zydelig to kill tumour cells and reduce their number.
Zydelig can be used to treat two different cancers in adults:
Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is a cancer of a type of white blood cells called B-lymphocytes. In
this disease, B-lymphocytes multiply too rapidly and live too long, resulting in too many circulating in the
blood.
In CLL, Zydelig is used in combination with another medicine (rituximab) in patients who have certain high-risk factors or in patients whose cancer has not responded after at least one prior anticancer treatment.
Follicular lymphoma
Follicular lymphoma (FL) is a cancer of a type of white blood cells called B-lymphocytes. In this
disease, B-lymphocytes multiply too rapidly and live too long, resulting in too many accumulating in the lymph nodes. In FL, Zydelig is used alone in patients whose cancer has not responded after two prior anticancer treatments.

2. What you need to know before taking Zydelig

Do not take Zydelig

• if you are allergic to idelalisib or to any of the other ingredients of this medicine (listed in section 6). Consult your doctor if this condition applies to you.

Warnings and precautions
Talk to your doctor before taking Zydelig. Inform your doctor:

• if you have liver problems
• if you have other illnesses (especially infections or fever)

Severe and life-threatening infections have occurred in patients taking Zydelig.
While taking Zydelig, you must take an additional medicine prescribed by your doctor to prevent a
certain type of infection. Your doctor will monitor you for signs of infection.
Contact your doctor immediately if you become ill (especially with fever, cough, or difficulty
breathing) while taking Zydelig.
Contact your doctor immediately if you or someone else notices in you: memory loss, reasoning problems,
difficulty walking, or loss of vision. These may be symptoms of a very rare and serious brain infection
that can be fatal (progressive multifocal leukoencephalopathy or PML).
Before and during treatment with Zydelig, regular blood tests will be performed. These tests are
to ensure you do not have an infection, to check that your liver is functioning properly, and that your
blood count (full blood count) is normal. If necessary, your doctor may decide to temporarily interrupt
treatment before restarting it at the same or a lower dose. Your doctor may also decide to permanently
discontinue treatment with Zydelig.
Zydelig can cause severe diarrhea. Contact your doctor immediately at the first sign of diarrhea.
Zydelig can cause inflammation of the lungs. Contact your doctor immediately:

• if you develop cough or if your cough worsens
• if you experience shortness of breath or difficulty breathing

Severe skin disorders with blistering, including Stevens-Johnson syndrome, toxic epidermal
necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported
in association with idelalisib treatment. Stop taking idelalisib and contact your doctor immediately if
you experience any of the symptoms described in section 4.
Contact your doctor immediately:

• if you develop redness and blistering of the skin
• if you develop swelling and blistering of the mucous membranes of the mouth, throat, nose, genitals, and/or eyes

Laboratory tests may show an increase in white blood cells (called "lymphocytes") in the blood during
the first weeks of treatment. This effect is expected and may last for several months. Generally, this
does not mean that your blood cancer is worsening. Your doctor will check your full blood count before
and during treatment with Zydelig and, in rare cases, may need to prescribe another medicine. Talk to
your doctor to understand the meaning of your blood test results.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as it has not been studied
in this age group.
Other medicines and Zydelig
Zydelig must not be used with other medicines unless your doctor has told you that it is safe to do so.
Tell your doctor if you are taking, have recently taken, or might take any other medicines. This is
extremely important, as taking several medicines together may increase or reduce their effects.
Taking Zydelig together with certain medicines may prevent them from working properly or may worsen
side effects. In particular, inform your doctor if you are taking any of the following medicines:

• alfuzosin, a medicine used to treat benign prostatic hyperplasia
• dabigatran, warfarin, medicines used to thin the blood
• amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
• dihydroergotamine, ergotamine, medicines used to treat migraine
• cisapride, a medicine used to relieve certain stomach disorders
• pimozide, a medicine used to treat abnormal thoughts or feelings
• midazolam, triazolam, taken orally to promote sleep and/or relieve anxiety
• quetiapine, a medicine used to treat schizophrenia, bipolar disorder, and major depressive disorders
• amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
• bosentan, a medicine used to treat pulmonary arterial hypertension
• sildenafil, tadalafil, medicines used to treat erectile dysfunction and pulmonary hypertension, a lung disease causing breathing difficulties
• budesonide, fluticasone, medicines used to treat hay fever and asthma, and salmeterol, used to treat asthma
• rifabutin, a medicine used to treat bacterial infections including tuberculosis
• itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections
• boceprevir, telaprevir, medicines used to treat hepatitis C
• carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
• rifampicin, a medicine used to prevent and treat tuberculosis and other infections
• St. John’s wort (Hypericum perforatum), a herbal product used for depression and anxiety
• alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used to relieve pain
• cyclosporine, sirolimus, tacrolimus, medicines used to control the body's immune response after transplantation
• colchicine, a medicine used to treat gout
• trazodone, a medicine used to treat depression
• buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
• dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer
• oral or implantable hormonal contraceptives, used to prevent pregnancy
• clarithromycin, telithromycin, medicines used to treat bacterial infections
• atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol

Zydelig may be prescribed in combination with other medicines for the treatment of CLL. It is very
important that you also read the package leaflets provided with these medicines.
If you have any doubts about any of the medicines you are taking, ask your doctor.
Pregnancy and breastfeeding

• Zydelig must not be used during pregnancy. There is no information on the safety of this medicine in pregnant women.
• Use a reliable method of contraception to prevent pregnancy while being treated with Zydelig and for 1 month after the last dose.
• Zydelig may reduce the effectiveness of oral contraceptives and implantable hormonal contraceptives. While taking Zydelig and for 1 month after the last dose, you must also use a barrier method of contraception such as condoms or an intrauterine device (IUD).
• Contact your doctor immediately if you become pregnant.

You must not breastfeed while taking Zydelig. If you are currently breastfeeding, consult your doctor
before starting treatment. It is not known whether the active substance in Zydelig passes into breast
milk.
Driving and using machines
It is unlikely that Zydelig will affect your ability to drive or use machinery.
Zydelig contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Zydelig

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
The recommended dose is 150 mg taken orally twice daily. However, your doctor may reduce the dose to 100 mg twice daily if you experience certain side effects.
Zydelig may be taken with or without food.
Swallow the tablet whole. Do not chew or crush the tablet. Inform your doctor if you have difficulty swallowing tablets.
If you take more Zydelig than you should
If you accidentally take more Zydelig than recommended, you may be at an increased risk of experiencing side effects related to this medicine (see section 4, Possible side effects).
Seek immediate advice from your doctor or the nearest emergency department. Take the bottle and this patient information leaflet with you so that you can easily describe what you have taken.
If you forget to take Zydelig
Be careful not to miss any doses of Zydelig. If you forget to take a dose and you remember within 6 hours of when you should have taken it, take it immediately. Then take your next dose at the usual time. If you forget to take a dose and you remember more than 6 hours after you should have taken it, wait and take the next dose at your regular scheduled time.
Do not stop treatment with Zydelig
Do not stop treatment with Zydelig unless your doctor tells you to do so.
If you have any questions about how to use this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
STOP treatment with Zydelig and contact your doctor immediately if you experience
any of the following side effects:

• reddish patches on the trunk, small localized changes in skin colour, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (a rare adverse reaction - may affect up to 1 in 1,000 people)
• widespread rash, high fever and swollen lymph nodes (DRESS) (the frequency of this adverse reaction is unknown)

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

• diarrhoea/inflammation of the large intestine
• rash
• changes in white blood cell count
• infections
• fever

Blood tests may also show:

• increased liver enzyme levels in the blood
• increased blood fat levels

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

• inflammation of the lungs
• liver damage

Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor. You can also report side effects directly via 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 Zydelig

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zydelig contains

• The active substance is idelalisib. Each film-coated tablet contains 150 mg of idelalisib.
• The other components are:
  Tablet core: Microcrystalline cellulose, hydroxypropylcellulose (E463), sodium croscarmellose, sodium starch glycolate, magnesium stearate.

Film coating:
Polyvinyl (alcohol) (E1203), macrogol (E1521), titanium dioxide (E171), talc (E553B), iron oxide red (E172).

Description of the appearance of Zydelig and contents of the pack
Zydelig 150 mg film-coated tablets are pink, oval-shaped tablets, marked with “GSI” on one side and the number “150” on the other.

The following pack is available: outer packaging containing 1 plastic bottle with 60 film-coated tablets.

Marketing Authorization Holder
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50

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

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

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

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

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

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

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

Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: + 40 31 631 18 00

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

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

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

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

Latvija United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888 Tel: + 44 (0) 8000 113700

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