Patient Information Leaflet

FRUZAQLA 1mg Hard Capsules

FRUZAQLA 5mg Hard Capsules

fruquintinib

This medicine is subject to additional monitoring, which will speed up the detection of any new safety information. You can contribute by reporting any side effects you may experience. The final part of section 4 includes information on how to report these side effects.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What FRUZAQLA is and what it is used for

2.What you need to know before you start taking FRUZAQLA

3.How to take FRUZAQLA

4.Possible side effects

5.Storage of FRUZAQLA

6.Contents of the pack and additional information

FRUZAQLA contains the active ingredient fruquintinib, a cancer medication called a kinase inhibitor.

FRUZAQLA is used for the treatment of adult patients with colorectal cancer (colon or rectal cancer) that has spread to other parts of the body (metastatic). It is used when other treatments have not worked or are not suitable for a person.

How FRUZAQLA works

Cancer cells need new blood vessels to grow. FRUZAQLA prevents tumors from generating new blood vessels, which slows down the growth and spread of cancer.

If you have any questions about how this medication works or why you have been prescribed it, consult your doctor, pharmacist, or nurse.

Do not take FRUZAQLA

-if you are allergic to fruquintinib or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take FRUZAQLA, or at any time during treatment, if you have any of the conditions listed below:

• High blood pressure. Your doctor will ensure that your blood pressure is controlled before starting this medication and during treatment.
• Anybleeding problem. Inform your doctor if you have or have had any bleeding problems or if you are taking warfarin, acenocoumarol, or other medications that thin the blood to prevent blood clots.
• Severe gastrointestinal problemscaused by a hole in the intestinal wall (known as gastrointestinal perforation). If you experience severe gastrointestinal problems, consult your doctor immediately.
• Kidney problems(indicated by the presence of protein in the urine).
• Anyskin problem, including redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet.
• Intense and persistent headache, visual disturbances, seizures, or altered mental staterecently (such as confusion, memory loss, or disorientation). If you or those around you notice any of these changes, consult your doctor immediately.
• Unhealed wound or if you have recently undergone, or are about to undergo, surgery, as FRUZAQLA may affect wound healing.
• Recent blood clotting problemsin veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.

Your doctor may provide you with other medications to prevent more serious complications and reduce your symptoms. Your doctor may delay the next dose of FRUZAQLA or stop your treatment with FRUZAQLA.

Children and adolescents

FRUZAQLA should not be administered to children and adolescents for the treatment of cancer that has spread to other parts of the body.

Other medications and FRUZAQLA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. In particular, inform your doctor or pharmacist if you are taking medications used to treat tuberculosis or other infections, such as rifampicin.

Pregnancy

FRUZAQLA has not been studied in pregnant women. Based on how it works, FRUZAQLA should not be used during pregnancy unless clearly necessary, as it may cause harm to the fetus. If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will discuss the risks of taking this medication during pregnancy with you.

Contraception for women

Women who may become pregnant should use highly effective contraceptive methods during treatment with FRUZAQLA and for at least 2weeks after the last dose of the medication. Consult your doctor about the most suitable contraceptive methods for you.

Breastfeeding

Inform your doctor if you are breastfeeding or intend to breastfeed. It is unknown whether FRUZAQLA passes into breast milk, and the risk cannot be ruled out in newborns/infants. Do not breastfeed during treatment with this medication or for at least 2weeks after the last dose of FRUZAQLA. Consult your doctor about the best way to feed your baby during this period.

Driving and operating machinery

FRUZAQLA has a minimal effect on your ability to drive and operate machinery. You may feel tired after taking FRUZAQLA. Do not drive or use tools or machinery if you experience symptoms that affect your concentration and reaction time.

FRUZAQLA contains

Tartrazine (E102) and yellow-orange colorant (E110) only in 1mg capsules. These are colorants that may cause allergic reactions.

Red Allura AC (E129) only in 5mg capsules. This is a colorant that may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Recommended Dose

The recommended dose is 5 milligrams (mg) taken once a day, approximately at the same time each day for 21 days, followed by 7 days of rest (without taking the medication). This is considered a treatment cycle.

Depending on your response to treatment and possible side effects, your doctor may ask you to change to a lower dose or temporarily or permanently discontinue treatment.

How to Take FRUZAQLA

• Take FRUZAQLA with or without food.
• Swallow the capsule whole with water or another beverage.
• Do not chew, dissolve, or open the capsules, as the effects of not taking the entire capsule are unknown.
• Consult your doctor before starting treatment if you have difficulty or think you may have difficulty swallowing the entire capsules.

For How Long to Take FRUZAQLA

Your doctor will check on you regularly. You will continue to take FRUZAQLA normally as long as it continues to be effective and side effects are acceptable.

If You Take More FRUZAQLA Than You Should

Inform your doctor immediately if you take a dose higher than prescribed. You may require medical attention and your doctor may ask you to stop taking FRUZAQLA.

If You Forget to Take FRUZAQLA

If there are less than 12 hours until your next dose, omit the missed dose and take the next one as scheduled.

If there are more than 12 hours until your next dose, take the missed dose and then take the next one as scheduled.

If you vomit after taking FRUZAQLA, do not take another capsule as a substitute. Take the next dose at the usual time.

Before Discontinuing Treatment with FRUZAQLA

Do not stop taking the medication unless your doctor tells you to. 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. With this medicine, the following side effects may be observed.

Severe side effects

Inform your doctor immediatelyif you notice any of the following severe side effects.

High blood pressure

Inform your doctor if you notice the following symptoms:

• Intense headache.
• Dizziness or dizziness.
• Confusion.
• Intense chest pain.

Bleeding

FRUZAQLA may cause severe bleeding in the digestive system, such as in the stomach, throat, rectum, or intestines. Seek medical attention immediately if you experience the following symptoms:

• Blood in the stool or black stools.
• Blood in the urine.
• Abdominal pain.
• Coughing or vomiting blood.

Severe gastrointestinal problems due to gastrointestinal perforation

The treatment with FRUZAQLA may cause gastrointestinal perforation.

Seek medical attention immediately if you experience the following symptoms:

• Coughing or vomiting blood.
• Intense or persistent abdominal pain.
• Black or red stools.

Reversible inflammation of the brain (posterior reversible encephalopathy syndrome)

Seek urgent medical attention immediately and call your doctor if you experience the following symptoms:

• Headache.
• Confusion
• Seizures.
• Changes in vision.

Other side effects

Inform your doctor, pharmacist, or nurse if you notice any of the following side effects:

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

• Reduction in the number of platelets (cells that contribute to blood clotting) observed in blood tests (thrombocytopenia), which may cause bruising and bleeding more easily.
• Reduction in thyroid gland activity (hypothyroidism), which may cause fatigue, weight gain, and changes in skin and hair color.
• Weight loss and decreased appetite (anorexia).
• High blood pressure (hypertension).
• Changes in voice or hoarseness (dysphonia).
• Frequent or loose stools (diarrhea).
• Dry mouth or pain, sores, or ulcers in the mouth (stomatitis).
• Elevation of liver enzyme levels in blood tests, such as aspartate aminotransferase and alanine aminotransferase.
• Elevation of bilirubin levels in the blood (abnormality in liver function tests).
• Redness, pain, blisters, and swelling in the palms of the hands or soles of the feet (palmar-plantar erythrodysesthesia syndrome).
• Pain in the bones, muscles, chest, or neck (musculoskeletal pain).
• Pain in the joints (arthritis).
• Protein in the urine (proteinuria).
• Weakness, lack of strength, and energy, excessive fatigue (asthenia/ fatigue).

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

• Pneumonia (lung infection).
• Upper respiratory tract infection (throat and nasal infection).
• Bacterial infection.
• Reduction in the number of white blood cells (leucopenia) in blood tests, which may increase the risk of infection.
• Reduction in the number of neutrophils (a type of white blood cell) in blood tests (neutropenia), which may increase the risk of infection.
• Low potassium levels as observed in blood tests (hypokalemia).
• Nosebleeds (epistaxis).
• Sore throat.
• Bleeding in the digestive system, such as in the stomach, rectum, or intestines (gastrointestinal hemorrhage).
• Formation of a hole in the stomach (gastrointestinal perforation).
• Elevation of pancreatic enzyme levels in blood tests (which may be a sign of pancreatic problems).
• Pain in the teeth, gums, or lips (oral pain).
• Rash.
• Sores in the mouth (mucosal inflammation).

Uncommon (may affect up to 1 in 100 people):

• Reversible inflammation of the brain (posterior reversible encephalopathy syndrome).
• Pain in the abdominal area, nausea, vomiting, and fever, which may be symptoms of pancreatitis (inflammation of the pancreas).
• Pain in the upper right or central abdomen, nausea, and vomiting, which may be symptoms of gallbladder inflammation (cholecystitis).
• Delayed wound healing.

Frequency not known (cannot be estimated from available data):

• Sudden and intense pain in the abdominal, chest, or back area, which may be a symptom of aortic dissection (aortic dissection).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 theAppendixV. 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 box and on the bottle label after CAD. 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.

Keep the bottle perfectly closed.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of FRUZAQLA

FRUZAQLA 1mg hard capsules

• The active ingredient is fruquintinib. Each hard capsule contains 1mg of fruquintinib.
• The other components are:

• Filler of the capsule: maize starch, microcrystalline cellulose (E460), talc (E553b).
• Capsule coating: gelatin, titanium dioxide (E171), tartrazine (E102), yellow-orange colouring agent (E110).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium dioxide, iron oxide black (E172).

FRUZAQLA 5mg hard capsules

• The active ingredient is fruquintinib. Each hard capsule contains 5mg of fruquintinib.
• The other components are:

• Filler of the capsule: maize starch, microcrystalline cellulose (E460), talc (E553b).
• Capsule coating: gelatin, titanium dioxide (E171), allura red AC (E129), brilliant blue colouring agent (E133).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium dioxide, iron oxide black (E172).

Appearance of the product and contents of the pack

FRUZAQLA 1mg hard capsules (approximate length of 16mm) are white capsules with a yellow coating that have "HM013" printed on "1mg".

FRUZAQLA 5mg hard capsules (approximate length of 19mm) are white capsules with a red coating that have "HM013" printed on "5mg".

Each bottle contains 21hard capsules and a desiccant. The desiccant is a material that absorbs moisture and is located in a small container. Its purpose is to protect the capsules from moisture.

Keep the desiccant in the bottle. Do not ingest the desiccant.

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50‑58 Baggot Street Lower

Dublín 2

D02 HW68

Irlanda

Responsible for manufacturing

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

A98 CD36

Irlanda

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

Last update of the summary of product characteristics:

Other sources of information

Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.