Zydelig 100 mg film-coated tablets

2. What you need to know before you take Zydelig

Do not take Zydelig

• if you are allergicto idelalisib or any of the other ingredients of this medicine (listed in section 6).

→ Consult your doctorif this applies to you.

Warnings and precautions

Talk to your doctor before you start taking Zydelig. Tell your doctor:

• if you have liver problems
• if you have any other illness or condition (especially an infection or fever)

Severe and fatal infections have occurred in patients treated with Zydelig. You will need to take an additional medicine that your doctor will provide while you are taking Zydelig to prevent a type of infection. Your doctor will monitor you for signs of infection. Tell your doctor immediately if you become unwell (especially if you have a fever, cough or difficulty breathing) while taking Zydelig.

Tell your doctor immediately if you or someone else notices: memory loss, confusion, difficulty walking or loss of vision – these could be due to a rare but serious brain infection (progressive multifocal leukoencephalopathy or PML) that can be fatal.

You will need to have regular blood testsbefore and during treatment with Zydelig. This is to check that you do not have an infection, that your liver is working properly and that your blood counts are normal. If necessary, your doctor may decide to stop treatment for a while, before starting it again at the same dose or at a lower dose. Your doctor may also decide to stop treatment with Zydelig altogether.

Zydelig can cause severe diarrhoea. Tell your doctor immediately at the first sign of diarrhoea.

Zydelig can cause inflammation of the lungs. Tell your doctor immediately:

• if you have a new cough or worsening cough
• if you have shortness of breath or difficulty breathing

Severe blistering skin conditions have been reported in some people treated with Zydelig while also receiving other medicines that are known to cause these potentially fatal conditions. Blistering can also affect the lining of the mouth, genitals and/or eyes. Skin peeling can cause serious infection. Tell your doctor immediately:

• if you have redness and blistering of the skin
• if you have swelling and blistering of the lining of the mouth, genitals and/or eyes

Lab tests may show an increase in white blood cells (called "lymphocytes") in the blood in the first few weeks of treatment. This is expected and may last for a few months, and usually does not mean that your blood cancer is getting worse. Your doctor will check your blood counts before treatment or during treatment with Zydelig and in rare cases may need to give you another medicine. Talk to your doctor about what the test results mean.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because 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 it is safe to do so.

Tell your doctor if you are taking, have recently taken or might take any other medicines.This is especially important because using more than one medicine at the same time can increase or decrease their effects.

Taking Zydelig with certain medicines may make them not work properly or may make their side effects worse. In particular, tell your doctor if you are taking any of the following:

• alfuzosin, a medicine used to treat enlarged prostate
• 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 migraines
• cisapride, a medicine used to relieve certain stomach problems
• pimozide, a medicine used to treat abnormal thoughts or feelings
• midazolam, triazolam, when taken by mouth to help sleep and/or relieve anxiety
• quetiapine, a medicine used to treat schizophrenia, bipolar disorder and major depression
• 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 impotence and pulmonary hypertension, a lung disease that makes it difficult to breathe
• budesonide, fluticasone, medicines used to treat pollen allergy 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 remedy used to treat depression and anxiety
• alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used to relieve pain
• ciclosporin, sirolimus, tacrolimus, medicines used to control the body's immune response after a transplant
• colchicine, a medicine used to treat gout
• trazodone, a medicine used to treat depression
• buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
• dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer
• hormonal contraceptives taken by mouth or implanted, 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 supplied with these medicines.

Ask your doctor if you have any questions about your medicines.

Pregnancy and breast-feeding

• 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 contraceptionto prevent pregnancy while you are being treated with Zydelig and for the month after your last treatment.
• Zydelig may make the "pill" and hormonal contraceptives implanted less effective.You should also use a barrier method of contraception such as condoms or an IUD while you are taking Zydelig and for the month after your last treatment.
• Tell your doctor immediately if you become pregnant.

Do not breast-feed while you are taking Zydelig.If you are currently breast-feeding, consult your doctor before you start treatment. It is not known if the active substance of Zydelig passes into breast milk.

Driving and using machines

It is unlikely that Zydelig will affect your ability to drive or use machines.

Zydelig contains orange yellow FCF (E110)

Tell your doctor if you are allergic to orange yellow FCF (E110). Zydelig contains orange yellow FCF, which may cause allergic reactions.

3. How to take Zydelig

Always take this medicine exactly as your doctor has told you.

If you are not sure, check with your doctor.

The recommended doseis 150 mg by mouth twice a day. However, your doctor may reduce this dose to 100 mg twice a day if you experience certain side effects.

Zydelig can be taken with or without food.

Swallow the tablet whole.Do not chew or crush the tablet. Tell your doctor if you have problems swallowing the tablets.

If you take more Zydelig than you should

If you accidentally take a larger dose of Zydelig than recommended, you may have a higher risk of side effects with this medicine (see section 4, Possible side effects).

Contact your doctor or the nearest emergency department immediately for advice. Take the bottle and this leaflet with you so that you can easily describe what you have taken.

If you forget to take Zydelig

Try to avoid missing any dose of Zydelig. If you miss a dose and it has been less than 6 hours, take the missed dose immediately. Then take the next dose as usual. If you miss a dose and it has been more than 6 hours, wait and take the next dose at the usual time.

Do not stop taking Zydelig

Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions on the use of 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 could be serious.

STOP taking Zydelig and seek medical help immediately if you have any of the following symptoms:

• redness and blistering of the skin
• swelling and blistering of the lining of the mouth, genitals and/or eyes

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:

• increase in blood levels of liver enzymes

Common side effects

(may affect up to 1 in 10 people)

• inflammation of the lungs
• liver damage

Blood tests may also show:

• increase in blood levels of fats

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 bottle and carton after {EXP}. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Zydelig Composition

• The active ingredient isidelalisib. Each film-coated tablet contains 100 mg of idelalisib.

• The othercomponents are:Tablet core:

Microcrystalline cellulose, hydroxypropylcellulose (E463), sodium croscarmellose, sodium starch glycolate, magnesium stearate.

Film coating:

Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), orange yellow FCF (E110) (see section 2. What you need to know before you start takingZydelig).

Appearance and Package Contents

The film-coated tablets are orange, oval-shaped tablets with "GSI" engraved on one side and "100" on the other.

The following pack size is available: outer carton with 1 plastic bottle of 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet

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