INLYTA 1 mg FILM-COATED TABLETS

2. What you need to know before you take Inlyta

Do not take Inlyta:

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 Inlyta:

• If you have high blood pressure.

Inlyta may increase blood pressure. It is important that you have your blood pressure checked before starting to take this medicine and periodically during treatment. If you have high blood pressure (hypertension), you may be treated with medicines that lower blood pressure. Your doctor should make sure that you have your blood pressure under control before starting treatment with Inlyta and during treatment with this medicine.

• If you have thyroid problems.Inlyta may cause thyroid problems. Contact your doctor if you feel tired more easily, feel colder than other people, or your voice becomes deeper while taking this medicine. Before treatment with Inlyta, your thyroid function should be checked and periodically while 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 blood clots in 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 the arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, speech problems, headache, changes in vision, or dizziness while taking this medicine.

• If you have bleeding problems.

Inlyta 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.

Inlyta 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). Talk to 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 Inlyta 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 posterior reversible leukoencephalopathy syndrome.

• If you have liver problems.

Your doctor should perform blood tests to monitor liver function before and during treatment with Inlyta.

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

Inlyta may increase the risk of heart failure events. Your doctor should monitor the appearance of signs or symptoms of heart failure events periodically throughout treatment with axitinib.

Use in children and adolescents

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

Taking Inlyta with other medicines

Some medicines may affect Inlyta 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 Inlyta.

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

• 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 Inlyta:

• rifampicin, rifabutin, or rifapentine, used to treat tuberculosis (TB);
• dexamethasone, a steroid medicine prescribed for the treatment of 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 Inlyta. 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 Inlyta, or change to another medicine.

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

Taking Inlyta 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, consult your doctor, pharmacist, or nurse before using this medicine.

• Inlyta may harm the fetus or breastfed baby.

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

• During treatment with Inlyta and up to 1 week after the last dose of this medicine, use a reliable contraceptive method to avoid pregnancy.

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

Driving and using machines

If you experience dizziness and/or feel tired while taking Inlyta, be careful when driving or using machines.

Inlytacontains lactose

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

Inlyta 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 Inlyta

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

The recommended dose is 5 mg twice a day. Your doctor may then increase or decrease your dose depending on how you tolerate treatment with Inlyta.

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

If you take more Inlyta 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 package or this leaflet. You may need medical attention.

If you forget to take Inlyta

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 Inlyta

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

If you stop taking Inlyta

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 Inlyta"):}

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

• Blood clots in 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 the arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, speech problems, headache, changes in vision, or dizziness.

• Bleeding.Tell your doctor if you have any of these symptoms or have a bleeding problem while taking Inlyta: black or tarry stools, coughing up blood or bloody sputum, or changes in mental status.

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

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

• Reversible brain disorder (posterior reversible leukoencephalopathy syndrome).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 Inlyta 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.
• Overactive thyroid (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 communication in the form of a tube from one body cavity to another or to the skin).
• 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 it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Inlyta

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 on the blister or bottle after "EXP". The expiry date is the last day of the month stated.

No special storage conditions are required.

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

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

Inlyta Composition

• The active ingredient is axitinib. Inlyta tablets are available in different concentrations.

Inlyta 1 mg: each tablet contains 1 mg of axitinib.

Inlyta 3 mg: each tablet contains 3 mg of axitinib.

Inlyta 5 mg: each tablet contains 5 mg of axitinib.

Inlyta 7 mg: each tablet contains 7 mg of axitinib.

• The other components are microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, hypromellose 2910 (15 mPa·s), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172) (see section 2 Inlyta contains lactose).

Product Appearance and Package Contents

Inlyta 1 mg film-coated tablets are oval, red, and engraved with "Pfizer" on one side and "1 XNB" on the other. Inlyta 1 mg is available in bottles of 180 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets.

Inlyta 3 mg film-coated tablets are round, red, and engraved with "Pfizer" on one side and "3 XNB" on the other. Inlyta 3 mg is available in bottles of 60 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets.

Inlyta 5 mg film-coated tablets are triangular, red, and engraved with "Pfizer" on one side and "5 XNB" on the other. Inlyta 5 mg is available in bottles of 60 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets.

Inlyta 7 mg film-coated tablets are diamond-shaped, red, and engraved with "Pfizer" on one side and "7 XNB" on the other. Inlyta 7 mg is available in bottles of 60 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

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

Date of 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/.