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Tagrisso (osimertinib mesylate) – Package leaflet - L01XE

Updated on site: 10-Oct-2017

Medication nameTagrisso
ATC CodeL01XE
Substanceosimertinib mesylate
ManufacturerAstraZeneca AB

Package leaflet: Information for the patient

TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets osimertinib

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What TAGRISSO is and what it is used for

2.What you need to know before you take TAGRISSO

3.How to take TAGRISSO

4.Possible side effects

5.How to store TAGRISSO

6.Contents of the pack and other information

1.What TAGRISSO is and what it is used for

TAGRISSO contains the active substance osimertinib which belongs to the protein kinase inhibitor class of anticancer medicines. TAGRISSO is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer.’ It is used when:

You test positive for a ‘T790M mutation’ – see ‘How TAGRISSO works.’

Your cancer is advanced and is worsening despite previous treatments, which may have included a medicine which worked to block ‘EGFR’ (epidermal growth factor receptor).

How TAGRISSO works

A test has shown that your cancer is linked to a specific change in the EGFR gene called ‘T790M.’ This is known as a T790M mutation.

Because of this T790M mutation, medicines that block EGFR may no longer work.

TAGRISSO affects T790M and may help to slow or stop your lung cancer growing. It may also help to shrink the tumour.

If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take TAGRISSO

Do not take TAGRISSO if:

you are allergic (hypersensitive) to osimertinib or any of the other ingredients of this medicine (listed in section 6).

you are taking St. John’s Wort (Hypericum perforatum).

If you are not sure, talk to your doctor, pharmacist or nurse before taking TAGRISSO.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking TAGRISSO if:

you have suffered from inflamation of your lungs (a condition called ‘interstitial lung disease’).

you have ever had heart problems – your doctor may want to keep a close eye on you.

you have a history of eye problems.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.

Tell your doctor straight away while taking this medicine if:

you have sudden difficulty in breathing together with a cough or fever. See ‘Serious side effects’ in section 4 for more information.

Children and adolescents

TAGRISSO has not been studied in children or adolescents. Do not give this medicine to children or adolescents under the age of 18 years.

Other medicines and TAGRISSO

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription. This is because TAGRISSO can affect the way some other medicines work. Also some other medicines can affect the way TAGRISSO works.

Tell your doctor before taking TAGRISSO if you are taking any of the following medicines:

The following medicines may reduce how well TAGRISSO works:

Phenytoin, carbamazepine or phenobarbital – used for seizures or fits.

Rifabutin or rifampicin – used for tuberculosis (TB).

St. John’s Wort (Hypericum perforatum) – an herbal medicine used for depression.

TAGRISSO may affect how well the following medicine works and/or increase side effects of these medicines:

Warfarin – used for blood clots.

Phenytoin and S-mephenytoin – used for seizures or fits.

Alfentanil, fentanyl and other painkillers used for operations.

Rosuvastatin – used to lower cholesterol.

Oral hormonal contraceptive pill– used to prevent pregnancy.

Bosentan – used for high blood pressure in the lungs.

Efavirenz and etravirine – used to treat HIV infections/AIDS.

Modafinil – used for sleep disorders.

If you are taking any of the medicines listed above, tell your doctor before taking TAGRISSO.

Your doctor will discuss appropriate treatment options with you.

Pregnancy information for women

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do become pregnant during treatment, tell your doctor straight away. Your doctor will decide with you whether you should carry on taking TAGRISSO.

You should not become pregnant while taking this medicine. If you are able to become pregnant, you must use effective contraception. See ‘Contraception - information for women and men’ below.

If you plan to become pregnant after taking the last dose of this medicine, ask your doctor for advice. This is because some medicine may remain in your body, (see advice on contraception below).

Pregnancy information for men

If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away.

Contraception information for women and men

You must use effective contraception during treatment.

TAGRISSO may interfere with how well oral hormonal contraceptives work. Discuss with your doctor the most appropriate methods of contraception.

TAGRISSO may pass into semen. Therefore, it is important that men also use effective contraception.

You must also do this after completing treatment with TAGRISSO:

Women – keep using contraception for 2 months after.

Men – keep using contraception for 4 months after.

Breast-feeding

Do not breast-feed while taking this medicine. This is because it is not known if there is a risk to your baby.

Driving and using machines

TAGRISSO has no or no marked influence on the ability to drive and use machines.

3.How to take TAGRISSO

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The recommended dose is one 80 mg tablet each day.

If necessary, your doctor may reduce your dose to one 40 mg tablet each day.

How to take

TAGRISSO is taken by mouth. Swallow the tablet whole with water. Do not crush, split or chew the tablet.

Take TAGRISSO every day at the same time.

You can take this medicine with or without food.

If you have trouble swallowing the tablet, you can mix it in water:

Put the tablet in a glass.

Add 50 mL (about two-thirds of a tumblerful) of still (non-fizzy) water – do not use any other liquids.

Stir the water until the tablet breaks up into very small pieces - the tablet will not completely dissolve.

Drink the liquid straight away.

To make sure you have taken all of the medicine, rinse the glass thoroughly with another 50 mL of water and drink it.

If you take more TAGRISSO than you should

If you take more than your normal dose, contact your doctor or nearest hospital straight away.

If you forget to take TAGRISSO

If you forget a dose, take it as soon as you remember it. However, if it is less than 12 hours until your next dose is due, skip the missed dose. Take your next normal dose at its scheduled time.

If you stop taking TAGRISSO

Do not stop taking this medicine - talk to your doctor first. It is important to take this medicine every day, for as long as your doctor prescribes it for you.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.Possible side effects

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

Serious side effects

Tell your doctor straight away if you notice the following serious side effects:

Sudden difficulty in breathing together with a cough or fever - this may be a sign of inflamed lungs (a condition called ‘interstitial lung disease’) and can be fatal in some cases. Your doctor may wish to stop TAGRISSO if you get this side effect. This side effect is common: it may affect up to 1 in 10 people.

If you develop watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. This side effect is uncommon: it may affect up to 1 in 100 people.

Tell your doctor straight away if you notice the serious side effects listed above.

Other side effects

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

Diarrhoea - this may come and go during treatment. Tell your doctor if your diarrhoea does not go away or becomes severe.

Skin and nail problems - signs may include itching, dry skin, rash, redness around the fingernails. This is more likely in areas exposed to the sun. Using moisturisers regularly on your skin and nails can help with this. Tell your doctor if your skin or nail problems get worse.

Stomatitis - inflammation of the inner lining of the mouth.

Reduction in the number of white blood cells (leukocytes or neutrophils).

Reduction in the number of platelets in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects 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.How to store TAGRISSO

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

Do not use this medicine after the expiry date (EXP) which is stated on the blister foil and carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What TAGRISSO contains

The active substance is osimertinib (as mesylate). Each 40 mg film-coated tablet contains 40 mg of osimertinib. Each 80 mg film-coated tablet contains 80 mg of osimertinib.

The other ingredient(s) are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, black iron oxide.

What TAGRISSO looks like and contents of the pack

TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with “AZ” and “40” on one side, and plain on the other.

TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with “AZ” and “80” on one side, and plain on the other.

TAGRISSO is supplied in blisters containing 30 x 1 film-coated tablets, packed in cartons containing 3 blisters of 10 tablets each.

TAGRISSO is supplied in blisters containing 28 x 1 film-coated tablets, packed in cartons containing 4 blisters of 7 tablets each.

Marketing Authorisation Holder and Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

AstraZeneca S.A./N.V.

UAB AstraZeneca Lietuva

Tel: +32 2 370 48 11

Tel: +370 5 2660550

България

Luxembourg/Luxemburg

АстраЗенека България ЕООД

AstraZeneca S.A./N.V.

Тел.: +359 24455000

Tél/Tel: +32 2 370 48 11

Česká republika

Magyarország

AstraZeneca Czech Republic s.r.o.

AstraZeneca Kft.

Tel: +420 222 807 111

Tel.: +36 1 883 6500

Danmark

Malta

AstraZeneca A/S

Associated Drug Co. Ltd

Tlf: +45 43 66 64 62

Tel: +356 2277 8000

Deutschland

Nederland

AstraZeneca GmbH

AstraZeneca BV

Tel: +49 41 03 7080

Tel: +31 79 363 2222

Eesti

Norge

AstraZeneca

AstraZeneca AS

Tel: +372 6549 600

Tlf: +47 21 00 64 00

Ελλάδα

Österreich

AstraZeneca A.E.

AstraZeneca Österreich GmbH

Τηλ: +30 210 6871500

Tel: +43 1 711 31 0

España

Polska

AstraZeneca Farmacéutica Spain, S.A.

AstraZeneca Pharma Poland Sp. z o.o.

Tel: +34 91 301 91 00

Tel.: +48 22 245 73 00

France

Portugal

AstraZeneca

AstraZeneca Produtos Farmacêuticos, Lda.

Tél: +33 1 41 29 40 00

Tel: +351 21 434 61 00

Hrvatska

România

AstraZeneca d.o.o.

AstraZeneca Pharma SRL

Tel: +385 1 4628 000

Tel: +40 21 317 60 41

Ireland

Slovenija

AstraZeneca Pharmaceuticals (Ireland) Ltd

AstraZeneca UK Limited

Tel: +353 1609 7100

Tel: +386 1 51 35 600

Ísland

Slovenská republika

Vistor hf.

AstraZeneca AB, o.z.

Sími: +354 535 7000

Tel: +421 2 5737 7777

Italia

Suomi/Finland

AstraZeneca S.p.A.

AstraZeneca Oy

Tel: +39 02 9801 1

Puh/Tel: +358 10 23 010

Κύπρος

Sverige

Αλέκτωρ Φαρµακευτική Λτδ

AstraZeneca AB

Τηλ: +357 22490305

Tel: +46 8 553 26 000

Latvija

United Kingdom

SIA AstraZeneca Latvija

AstraZeneca UK Ltd

Tel: +371 67377100

Tel: +44 1582 836 836

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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