Zydelig 150 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 ill (especially if you have a fever, cough, or difficulty breathing) while taking Zydelig.

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

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 permanently.

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

Zydelig may 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 taking other medicines that are known to cause these potentially fatal conditions. Blistering may also affect the lining of the mouth, genitals, and/or eyes. Skin peeling may 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

Laboratory 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 review 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 old 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 extremely 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 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 hard 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 contraceptive methodto avoid becoming pregnant while 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 contraceptive method such as condoms or an IUD while taking Zydelig and for the month after your last treatment.
• Tell your doctor immediately if you become pregnant.

Do not breast-feed while taking Zydelig.If you are currently breast-feeding, consult your doctor before starting 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.

3. How to take Zydelig

Take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor again.

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 is 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. Container contents and additional information

Zydelig composition

• The active ingredient isidelalisib. Each film-coated tablet contains 150 mg of idelalisib.

• The other ingredients 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), red iron oxide (E172).

Appearance and packaging of the product

The film-coated tablets are pink, oval-shaped tablets, with "GSI" engraved on one side and "150" 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 last revision of this leaflet

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