AXITINIB ACCORD 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Axitinib Accord 1 mg film-coated tablets

Axitinib Accord 3 mg film-coated tablets

Axitinib Accord 5 mg film-coated tablets

axitinib

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.

Contents of the pack

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

1. What is Axitinib Accord and what is it used for

Axitinib Accord is a medicine that contains the active substance axitinib. Axitinib reduces the blood supply to the tumor and reduces the growth of cancer.

Axitinib Accord is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when other medicines (called sunitinib or cytokines) are not able to slow down the progression of the disease.

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

2. What you need to know before you take Axitinib Accord

Do not take Axitinib Accord:

If you are allergic to axitinib or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, talk to your doctor.

Warnings and precautions

Talk to your doctor or nurse before taking Axitinib Accord:

• If you have high blood pressure.

Axitinib Accord may increase your blood pressure. It is important that you have your blood pressure checked before you start taking this medicine and from time to time during treatment. If you have high blood pressure (hypertension), you may be treated with medicines that lower your blood pressure. Your doctor should make sure that you have your blood pressure under control before you start taking Axitinib Accord and during treatment with this medicine.

• If you have thyroid problems.

Axitinib Accord may cause thyroid problems. Contact your doctor if you feel more tired than usual, feel colder than other people, or your voice becomes hoarser while taking this medicine. Before treatment with Axitinib Accord, your thyroid function should be checked and from time to time while you are taking it. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement before or during treatment with this medicine.

• If you have recently had any problems with blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.

Call the emergency service immediately and contact your doctor if you have symptoms such as chest pain or pressure, pain in your arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of your body, speech problems, headache, changes in vision, or dizziness while taking this medicine.

• If you have bleeding problems.

Axitinib Accord may increase the risk of bleeding. Tell your doctor if you have bleeding, cough up blood or bloody sputum while taking this medicine.

• If you have or have had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

• If you have severe stomach pain (abdominal pain) or stomach pain that does not go away while taking this medicine.

Axitinib Accord may increase the risk of developing a stomach ulcer or intestinal ulcer or the formation of fistulas (abnormal tube-like passage from one body cavity to another or to the skin). Contact your doctor if you have severe abdominal pain while taking this medicine.

• If you are going to have surgery or have an open wound.

Your doctor should stop Axitinib Accord at least 24 hours before surgery, as it may affect wound healing. Treatment with this medicine should be restarted when the wound is well healed.

• If you have symptoms such as headache, confusion, seizures (epileptic fits), or changes in vision with or without high blood pressure while taking this medicine.

Call the emergency service immediately and contact your doctor. This may be a rare neurological side effect known as reversible posterior leukoencephalopathy syndrome.

• If you have liver problems.

Your doctor should do blood tests to monitor your liver function before and during treatment with Axitinib Accord.

• If you have symptoms such as excessive tiredness, swelling of the abdomen, legs, or ankles, difficulty breathing, or protrusion of the neck veins while taking this medicine.

Axitinib Accord may increase the risk of heart failure events. Your doctor should monitor you for signs or symptoms of heart failure events from time to time throughout treatment with axitinib.

Use in children and adolescents

Axitinib Accord is not recommended for people under 18 years of age. This medicine has not been studied in children or adolescents.

Other medicines and Axitinib Accord

Some medicines may affect Axitinib Accord or be affected by it. Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription, vitamins, and herbal medicines. The medicines listed in this leaflet may not be the only ones that interact with Axitinib Accord.

The following medicines may increase the risk of side effects with Axitinib Accord:

• ketoconazole or itraconazole, used to treat fungal infections;
• clarithromycin, erythromycin, or telithromycin, antibiotics used to treat bacterial infections;
• atazanavir, indinavir, nelfinavir, ritonavir, or saquinavir, used to treat HIV/AIDS;
• nefazodone, used to treat depression.

The following medicines may decrease the effectiveness of Axitinib Accord:

• rifampicin, rifabutin, or rifapentine, used to treat tuberculosis (TB);
• dexamethasone, a steroid medicine prescribed for various diseases, some of which are serious;
• phenytoin, carbamazepine, or phenobarbital, antiepileptics used to prevent seizures or epileptic fits;
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression.

Do nottake these medicines during treatment with Axitinib Accord. If you are taking any of them, tell your doctor, pharmacist, or nurse. Your doctor may change the dose of these medicines, change the dose of Axitinib Accord, or change to another medicine.

Axitinib Accord may increase the side effects associated with theophylline, used to treat asthma or other lung diseases.

Taking Axitinib Accord with food and drinks

Do not take this medicine with grapefruit or grapefruit juice, as it may increase the risk of side effects.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor, pharmacist, or nurse for advice before taking this medicine.

• Axitinib Accord may harm the unborn baby or breastfed child.

• Do not take this medicine during pregnancy. If you are pregnant or think you may be pregnant, ask your doctor before taking it.

• During treatment with Axitinib Accord and for 1 week after the last dose of this medicine, use a reliable method of contraception to prevent pregnancy.

• Do not breastfeed during treatment with Axitinib Accord. If you are breastfeeding, your doctor will tell you whether to stop breastfeeding or stop taking Axitinib Accord.

Driving and using machines

If you feel dizzy or tired while taking Axitinib Accord, be careful when driving or using machines.

Axitinib Accord contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Axitinib Accord contains sodium

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

3. How to take Axitinib Accord

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, ask your doctor, pharmacist, or nurse again.

The recommended dose is 5 mg twice a day. Afterward, your doctor may increase or decrease your dose depending on how well you tolerate treatment with Axitinib Accord. There are other products available for the higher dose of 7 mg.

Swallow the tablets whole with a little water, with or without food. Take the doses of Axitinib Accord approximately every 12 hours.

If you take more Axitinib Accord than you should

If you accidentally take more tablets or a higher dose than you need, contact your doctor immediately for advice. If possible, show your doctor the pack or this leaflet. You may need medical attention.

If you forget to take Axitinib Accord

Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you vomit while taking Axitinib Accord

If you vomit, do not take an additional dose. Take the next dose at the usual time.

If you stop taking Axitinib Accord

If you are not able to take this medicine as your doctor has prescribed, or if you think you no longer need it, contact your doctor immediately.

If you have any other questions about 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.

Some side effects can be serious. You should contact your doctor immediately if you experience any of the following serious side effects (see also section 2 “What you need to know before you take Axitinib Accord”):

• Heart failure events. Contact your doctor if you feel excessively tired, swelling of the abdomen, legs, or ankles, difficulty breathing, or protrusion of the neck veins.

• Blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.Call the emergency service immediately and contact your doctor if you have symptoms such as chest pain or pressure, pain in your arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of your body, speech problems, headache, changes in vision, or dizziness.

• Bleeding. Tell your doctor if you have bleeding, cough up blood or bloody sputum, or have a change in mental status while taking this medicine.

• Stomach ulcer or intestinal ulcer or formation of fistulas (abnormal tube-like passage from one body cavity to another or to the skin). Contact your doctor if you have severe abdominal pain.

• Severe increase in blood pressure (hypertensive crisis). Contact your doctor if you have very high blood pressure, severe headache, or severe chest pain.

• Reversible posterior leukoencephalopathy syndrome (a rare neurological side effect). Call the emergency service immediately and contact your doctor if you experience symptoms such as headache, confusion, seizures (epileptic fits), or changes in vision with or without high blood pressure.

Other side effects with Axitinib Accord may include:

Very common: may affect more than 1 in 10 people

• High blood pressure or increases in blood pressure.
• Diarrhea, nausea, or vomiting, stomach pain, indigestion, irritation of the mouth, tongue, or throat, constipation.
• Shortness of breath, cough, hoarseness.
• Lack of energy, feeling weak or tired.
• Low thyroid activity (may be seen in blood tests).
• Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome), skin rash, dry skin.
• Pain in the joints, pain in the hands or feet.
• Lack of appetite.
• Protein in the urine (may be seen in urine tests).
• Weight loss.
• Headache, altered taste, or loss of taste.

Common: may affect up to 1 in 10 people

• Dehydration (loss of body fluids).
• Kidney failure.
• Flatulence (gas), hemorrhoids, bleeding gums, rectal bleeding, burning or tingling sensation in the mouth.
• Hyperthyroidism (may be seen in blood tests).
• Sore throat or irritation of the nose and throat.
• Muscle pain.
• Nosebleeds.
• Itching of the skin, redness of the skin, hair loss.
• Ringing or other sounds in the ears (tinnitus).
• Decreased red blood cell count (may be seen in blood tests).
• Decreased platelet count (cells that help blood clot) (may be seen in blood tests).
• Presence of red blood cells in the urine (may be seen in urine tests).
• Changes in the levels of different substances/enzymes in the blood (may be seen in blood tests).
• Increased red blood cell count (may be seen in blood tests).
• Swelling of the abdomen, legs, or ankles, protrusion of the neck veins, excessive tiredness, difficulty breathing (signs of heart failure events).
• Fistula (abnormal connection between two body parts).
• Dizziness.
• Inflammation of the gallbladder.

Uncommon: may affect up to 1 in 100 people

• Decreased white blood cell count (may be seen in blood tests).

Frequency not known: cannot be estimated from the available data

• Enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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 Axitinib Accord

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 carton and blister or bottle after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

OPA/aluminum/PVC/aluminum blister:

Store in the original package to protect from moisture.

HDPE bottle:

Keep the bottle tightly closed to protect from moisture.

Do not use this medicine if it is damaged or shows signs of tampering.

Bottle:

After the first opening of the bottle:

1mg: use within 45 days.

3mg and 5mg: use within 30 days.

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. Packaging Contents and Additional Information

Axitinib Accord Composition

• The active ingredient is axitinib. Axitinib Accord tablets are available in different doses.

Axitinib Accord 1 mg: each tablet contains 1 mg of axitinib.

Axitinib Accord 3 mg: each tablet contains 3 mg of axitinib.

Axitinib Accord 5 mg: each tablet contains 5 mg of axitinib.

• The other components are lactose, microcrystalline cellulose (E460), anhydrous colloidal silica, hydroxypropylcellulose (300–600 mPa*s), sodium croscarmellose (E468), talc, magnesium stearate (E470b), hypromellose 2910 (15 mPas) (E464), lactose monohydrate, titanium dioxide (E171), triacetin, and red iron oxide (E172) (see section 2 Axitinib Accord contains lactose).

Product Appearance and Packaging Contents

Axitinib Accord 1 mg film-coated tablets are film-coated tablets, modified capsule-shaped, biconvex, and red in color, engraved with 'S14' on one side and smooth on the other. The tablet size is approximately 9.1 ± 0.2 mm X 4.6 ± 0.2 mm. Axitinib Accord 1 mg is available in bottles of 180 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets or perforated unit-dose blisters of 28 x 1 or 56 x 1 tablets.

Axitinib Accord 3 mg film-coated tablets are film-coated tablets, round, biconvex, and red in color, engraved with 'S95' on one side and smooth on the other. The tablet size is approximately 5.3 ± 0.3 mm X 2.6 ± 0.3 mm. Axitinib Accord 3 mg is available in bottles of 60 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets or perforated unit-dose blisters of 28 x 1 or 56 x 1 tablets.

Axitinib Accord 5 mg film-coated tablets are film-coated tablets, triangular, biconvex, and red in color, engraved with 'S15' on one side and smooth on the other. The tablet size is approximately 6.4 ± 0.3 mm X 6.3 ± 0.3 mm. Axitinib Accord 5 mg is available in bottles of 60 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets or perforated unit-dose blisters of 28 x 1 or 56 x 1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6a Planta

08039 Barcelona

Spain

Manufacturer

APIS Labor GmbH

Resslstraße 9

9065 Ebenthal in Kärnten,

Austria

Accord Healthcare Polska Sp.z.o.o

ul Lutomierska 50,95-200

Pabianice

Poland

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

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT /NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel.: +34 93 301 00 64

EL

Win Medica Α.Ε.

Tel: +30 210 74 88 821

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: https://www.ema.europa.eu/.