Prospect: information for the patient

Lynparza 100 mg film-coated tablets

Lynparza 150 mg film-coated tablets

olaparib

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

What is Lynparza and how it works

Lynparza contains the active ingredient olaparib. Olaparib is a type of cancer medicine, called a PARP inhibitor (poly (adenosine diphosphate-ribose) polymerase inhibitor).

PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. These specific cancer cells can be identified:

• by their response to platinum-based chemotherapy, or
• by looking for defective DNA repair genes, such as the BRCA (BReast CAncer) genes.

When Lynparza is used in combination with abiraterone (an androgen receptor signaling inhibitor), the combination may help improve the anticancer effect on prostate cancer cells with or without defective DNA repair genes (e.g., BRCA genes).

What is Lynparza used for

Lynparza is used to treat

• a type of ovarian cancer (with BRCA mutation) that has responded to the first standard platinum-based chemotherapy treatment.

• It is used with a test to know if you have ovarian cancer with a BRCA mutation.

• ovarian cancer that has recurred (reappeared). It can be used after the tumor has responded to previous treatment with standard platinum-based chemotherapy.

• a type of ovarian cancer (HRD positive defined by a BRCA mutation or genomic instability) that has responded to the first standard platinum-based chemotherapy and bevacizumab treatment.Lynparza is used with bevacizumab.

• a type of breast cancer (BRCA-mutated, HER2-negative) when the cancer has not spread to other parts of the body and the treatment is to be administered after surgery (adjuvant treatment). You should have received chemotherapy before or after surgery. If your cancer is hormone receptor-positive, your doctor may also prescribe hormone therapy.

• It is used with a test to know if you have breast cancer with a BRCA mutation.

• a type of breast cancer (BRCA-mutated, HER2-negative) that has spread beyond the original tumor.You must receive chemotherapy, either before or after the cancer has spread.

• It is used with a test to know if you have cancer with a BRCA mutation.

• a type of pancreatic cancer (BRCA-mutated) that has responded to the first standard platinum-based chemotherapy treatment.

• It is used with a test to know if you have pancreatic cancer with a BRCA mutation.

• a type of prostate cancer (with BRCA mutations) that has spread beyond the original tumor and no longer responds to medical or surgical treatment to reduce testosterone levels.You should have received certain hormone therapies, such as enzalutamide or abiraterone acetate.

• It is used with a test to know if you have prostate cancer with a BRCA mutation.

• a type of prostate cancer that has spread to other parts of the body (metastatic) beyond the original tumor and no longer responds to medical or surgical treatment that reduces testosterone levels.Lynparza is used in combination with another cancer medicine called abiraterone, along with the steroid prednisone or prednisolone.

• a type of endometrial cancer (endometrial cancer MMR proficient) that has spread beyond the original tumor or has recurred (reappeared).Lynparza is used with durvalumab if the cancer has not progressed after initial treatment with chemotherapy (carboplatin and paclitaxel) in combination with durvalumab.
• • It is used with a test to determine if you have endometrial cancer MMR proficient.

When Lynparza is administered in combination with other cancer medicines, it is essential to read also the prospectuses of these other medicines. If you have any questions about these medicines, consult your doctor.

Do not take Lynparza

• if you are allergic to olaparib or any of the other ingredients in this medicine (listed in section 6)
• if you are breastfeeding (see section 2 of this leaflet for more information)

Do not take Lynparza if any of the above applies to you. If you are unsure, consult your doctor, pharmacist or nurse before taking Lynparza.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take or during treatment with Lynparza

• if you have a low blood count in the blood tests. These may be low counts of red blood cells or white blood cells, or low platelet count. See section 4 for more information about these side effects, including the signs and symptoms you need to be aware of (for example, fever or infection, bruises or bleeding). Rarely, these may be a sign of a more serious bone marrow problem such as “Myelodysplastic Syndrome” (MDS) or “Acute Myeloid Leukaemia” (AML).When Lynparza is used in combination with another cancer medicine (durvalumab), a low blood count may be a sign of “Pure Red Cell Aplasia” (PRCA), a condition in which red blood cells are not produced, or “Autoimmune Haemolytic Anaemia” (AIHA), a condition in which red blood cells are destroyed in excess.

• if you notice any new symptoms or worsening difficulty breathing, cough or wheezing (a high-pitched sound that occurs when breathing). A small number of patients treated with Lynparza reported inflammation of the lungs (pneumonitis). Pneumonitis is a serious disease that often requires hospital treatment.

• if you experience any new symptoms or worsening of pain or swelling in a limb, difficulty breathing, chest pain, rapid breathing or irregular heartbeats. A small number of patients treated with Lynparza developed a blood clot in a deep vein, usually in the leg (deep vein thrombosis), or a blood clot in the lungs (pulmonary embolism).

• if you observe yellow discoloration of the skin or the white of the eyes, abnormally dark urine (brown color), abdominal pain on the right side, fatigue, decreased appetite or unexplained nausea and vomiting, contact your doctor immediately, as this may indicate liver problems.

If you think any of this might apply to you, consult your doctor, pharmacist or nurse before during treatment with Lynparza.

Tests and monitoring

Your doctor will make blood tests before and during treatment with Lynparza.

You will have a blood test

• before starting treatment
• every month, during the first year of treatment
• at regular intervals, decided by your doctor, after the first year of treatment.

If your blood count falls to a low level, you may need a blood transfusion (in which you will be given new blood or haemoderivatives from a donor).

Other medicines and Lynparza

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medicine, including those bought without a prescription and herbal medicines. This is because Lynparza may affect the way some medicines work and some medicines may affect Lynparza.

Inform your doctor, pharmacist or nurse if you are taking or have taken any of the following medicines

• any other cancer medicine
• a vaccine or a medicine that suppresses the immune system, as you may need to be closely monitored
• itraconazole, fluconazole - used for fungal infections
• telithromycin, clarithromycin, erythromycin - used for bacterial infections
• protease inhibitors potentiated with ritonavir or cobicistat, boceprevir, telaprevir, nevirapine, efavirenz - used for viral infections, including HIV
• rifampicin, rifapentine, rifabutin - used for bacterial infections, including tuberculosis (TB)
• phenytoin, carbamazepine, phenobarbital - used as sedatives or to treat seizures and epilepsy
• herbal remedies containing St. John's Wort (Hypericum perforatum) - used mainly for depression

• digoxin, diltiazem, furosemide, verapamil, valsartan – used to treat heart disease or high blood pressure
• bosentan – used to treat pulmonary arterial hypertension
• statins, for example simvastatin, pravastatin, rosuvastatin – used to lower cholesterol levels in the blood
• dabigatran – used to thin the blood
• glibenclamide, metformin, repaglinide – used to treat diabetes
• ergot alkaloids – used to treat migraines and headaches
• fentanyl – used to treat cancer pain
• pimozide, quetiapine – used to treat mental health problems
• cisapride – used to treat stomach problems
• colchicine – used to treat gout
• ciclosporin, sirolimus, tacrolimus – used to suppress the immune system
• methotrexate – used to treat cancer, rheumatoid arthritis and psoriasis

Inform your doctor, pharmacist or nurse if you are taking any of the above medicines or any other medicine. The medicines listed above may not be the only ones that could affect Lynparza.

Taking Lynparza with drinks

Do not drink grapefruit juice while taking Lynparza. This may affect how the medicine works.

Contraception, pregnancy and breastfeeding

Female patients

• Do not take Lynparza if you are pregnant or think you might be pregnant, as it may harm the foetus.
• Do not become pregnant while taking this medicine. If you have sex, use two effective contraceptive methods while taking this medicine and for 6 months after taking the last dose of Lynparza. It is not known whether Lynparza may affect the efficacy of some hormonal contraceptives. Inform your doctor if you are taking a hormonal contraceptive, as your doctor may recommend adding a non-hormonal contraceptive method.
• A pregnancy test should be done before starting treatment with Lynparza and at regular intervals during treatment and for 6 months after taking the last dose of Lynparza. If you become pregnant during this period, consult your doctor immediately.
• It is not known whether Lynparza passes into breast milk. Do not breastfeed while taking Lynparza, or for 1 month after taking the last dose of this medicine. If you plan to breastfeed, inform your doctor.

Male patients

• Use a condom when having sex with a female partner, even if she is pregnant, while taking Lynparza and for 3 months after taking the last dose. It is not known whether Lynparza passes into semen.
• Your female partner should also use an effective contraceptive method.
• Do not donate sperm while taking Lynparza or for 3 months after taking the last dose.

Driving and using machines

Lynparza may affect your ability to drive and use machines. If you feel dizzy, weak or tired while taking Lynparza, do not drive or use tools or machines.

Information about other ingredients present in this medicine

This medicine contains less than 1 mmol of sodium (23 mg) per 100 mg or 150 mg tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

How to Take

• Swallow Lynparza tablets whole, with or without food.
• Take Lynparza once in the morning and once at night.
• Do not chew, crush, dissolve, or divide the tablets as this may affect the speed at which the medication enters your body.

How Much to Take

• Your doctor will tell you how many Lynparza tablets to take. It is essential to take the total recommended dose each day. Continue to do so while your doctor, pharmacist, or nurse instructs you to.
• The usual recommended dose is 300 mg (2 tablets of 150 mg) twice a day - a total of 4 tablets per day.

Your Doctor May Prescribe a Different Dose If

• You have kidney problems. You will be instructed to take 200 mg (2 tablets of 100 mg) twice a day - a total of 4 tablets per day.
• You are taking certain medications that may affect Lynparza (see section 2).
• You experience certain side effects while taking Lynparza (see section 4). Your doctor may reduce your dose or discontinue treatment, either temporarily or permanently.

If You Take More Lynparza Than You Should

If you take more Lynparza than your usual dose, consult a doctor or go to the hospital immediately.

If You Forget to Take Lynparza

If you forget to take Lynparza, take the next dose at the usual time. Do not take a double dose (two doses at the same time) to make up for the missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you notice any of the following

Side effects reported in clinical trials with patients receiving Lynparza only:

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

• shortness of breath, feeling very tired, pale skin, or rapid heartbeat - these may be symptoms of a decrease in red blood cell count (anemia).

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (e.g., urticaria, difficulty breathing or swallowing, dizziness, which are signs and symptoms of hypersensitivity reactions).
• skin rash with itching on swollen and red skin (dermatitis).
• severe bone marrow problems (myelodysplastic syndrome or acute myeloid leukemia). See section 2.

Other side effects include

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

• nausea
• vomiting
• feeling tired or weak (fatigue)
• indigestion or heartburn (dyspepsia)
• loss of appetite
• headache
• changes in the taste of food (dysgeusia)
• feeling dizzy
• cough
• difficulty breathing (dyspnea)
• diarrhea - if it becomes severe, inform your doctor immediately.

Side effectsvery commonthat may be found in blood test results

• low white blood cell count (leucopenia or neutropenia) that may decrease your ability to fight infections and may be accompanied by fever.

Common(may affect up to 1 in 10 people)

• skin rash
• mouth pain (stomatitis)
• pain in the lower abdominal area under the ribs (upper abdominal pain).
• blood clot in a deep vein, usually in the leg (deep vein thrombosis) that may cause symptoms such as pain or swelling in the legs, or a blood clot in the lungs (pulmonary embolism) that may cause symptoms such as difficulty breathing, chest pain, rapid breathing, or rapid heart rate.

Side effectscommonthat may be found in blood test results

• low white blood cell count (lymphopenia) that may decrease your ability to fight infections and may be accompanied by fever
• low platelet count in the blood (thrombocytopenia) - you may notice the following symptoms

• bruising or bleeding for longer than normal if you are injured

• increased creatinine in the blood - this test is used to check the function of the kidneys.
• abnormal liver function tests

Side effectsuncommonthat may be found in blood test results

• increase in the size of red blood cells (not associated with any symptoms).

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

• swelling of the face (angioedema).
• inflammatory painful fat tissue under the skin (erythema nodosum).

Frequency not known(cannot be estimated from available data)

• signs of liver problems, such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdominal area, dark urine (brown color), decreased appetite, fatigue

Side effects reported in a clinical trial with patients who received Lynparza and durvalumab after initial treatment with chemotherapy (carboplatin and paclitaxel) with durvalumab, which occurred more frequently than in patients who received Lynparza only:

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

• low platelet count in the blood (thrombocytopenia) - you may notice the following symptoms
• • bruising or bleeding for longer than normal if you are injured
• skin rash

Side effectscommon(may affect up to 1 in 10 people) when using Lynparza with durvalumab

• allergic reactions (e.g., urticaria, difficulty breathing or swallowing, dizziness, which are signs and symptoms of hypersensitivity reactions).

In addition, the following side effects were reported in patients who received Lynparza with durvalumab:

Common(may affect up to 1 in 10 people):

• pure red cell aplasia, which may be associated with symptoms of difficulty breathing, fatigue, pale skin, or rapid heartbeat.

Your doctor will perform a blood test every month for the first year of treatment and at regular intervals thereafter. Your doctor will indicate if there is any change in your blood test that may require treatment.

If you notice any side effect not mentioned in this leaflet, contact your doctor immediately.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Lynparza

The active ingredient is olaparib.

• Each film-coated tablet of Lynparza 100 mg contains 100 mg of olaparib.
• Each film-coated tablet of Lynparza 150 mg contains 150 mg of olaparib.

The other components (excipients) are

• Tablet content: copovidone, anhydrous colloidal silica, mannitol, sodium stearate fumarate.
• Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172) (only in 150 mg tablets).

See Section 2 “Information on other ingredients present in this medicinal product”

Appearance of the product and contents of the pack

Lynparza 100 mg tablets are yellow to dark yellow, oval, biconvex, marked with "OP100" on one side and smooth on the other.

Lynparza 150 mg tablets are green to greenish-grey, oval, biconvex, marked with "OP150" on one side and smooth on the other.

Lynparza is available in packs containing 56 film-coated tablets (7 blisters of 8 tablets each) or multiple packs containing 112 (2 packs of 56) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

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