FRUZAQLA 1 mg HARD CAPSULES

2. What you need to know before you take FRUZAQLA

Do not take FRUZAQLA

• if you are allergic to fruquintinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking FRUZAQLA, or at any time during treatment, if you have any of the following conditions:

• High blood pressure. Your doctor will make sure your blood pressure is under control before you start taking this medicine and during treatment.
• Any bleeding problems. Tell your doctor if you have or have had bleeding problems or if you are taking warfarin, acenocoumarol, or other medicines that thin the blood to prevent blood clots.
• Severe stomach and intestinal problemscaused by a hole in the intestinal wall (known as gastrointestinal perforation). If you have severe stomach and intestinal problems, tell your doctor immediately.
• Kidney problems(indicated by protein in the urine).
• Any skin problems, including redness, pain, swelling, or blisters on the palms of the hands or soles of the feet.
• Severe headache, changes in vision, seizures, or altered mental statusrecently (such as confusion, memory loss, or disorientation). If you or those close to you notice any of these changes, tell 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 clot formation problemsin veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.

Your doctor may give you other medicines 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 given to children and adolescents for the treatment of colorectal cancer that has spread to other parts of the body, as it is not appropriate.

Other medicines and FRUZAQLA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking medicines 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 harm the fetus. If you are pregnant, think you may be pregnant, or plan to become pregnant, tell your doctor or pharmacist before using this medicine. Your doctor will discuss the risks and benefits of taking this medicine during pregnancy.

Contraception for women

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

Breast-feeding

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if FRUZAQLA passes into breast milk, and it cannot be excluded that it may harm newborns/infants. You should not breast-feed during treatment with this medicine and for at least 2 weeks after the last dose of FRUZAQLA. Talk to your doctor about the best way to feed your baby during this time.

Driving and using machines

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

FRUZAQLA contains

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

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

3. How to take FRUZAQLA

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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 medicine). 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 interrupt treatment temporarily or permanently.

How to take FRUZAQLA

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

How long to take FRUZAQLA

Your doctor will regularly check how you are doing. You will continue to take FRUZAQLA as usual while it is working and the side effects are acceptable.

If you take more FRUZAQLA than you should

Tell your doctor immediately if you take a higher dose than prescribed. You may need 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, skip the missed dose and take the next one as planned.

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

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

Before stopping treatment with FRUZAQLA

Do not stop taking the medicine unless your doctor tells you to. 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. The following side effects may occur with this medicine.

Serious side effects

Tell your doctor immediatelyif you notice any of the following serious side effects.

High blood pressure

Tell your doctor if you notice the following symptoms:

• Severe headache.
• Dizziness or dizziness.
• Confusion.
• Chest pain.

Bleeding

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

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

Severe stomach and intestinal problems due to gastrointestinal perforation

Treatment with FRUZAQLA may cause gastrointestinal perforation.

Seek medical attention immediately if you have the following symptoms:

• Coughing or vomiting blood.
• Severe stomach (abdominal) pain or pain that does not go away.
• Red or black stool.

Reversible brain inflammation (posterior reversible encephalopathy syndrome)

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

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

Other side effects

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

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

• Reduced number of platelets (cells that help blood clot) seen in blood tests (thrombocytopenia), which may cause bruising and bleeding more easily.
• Reduced thyroid activity (hypothyroidism), which may cause tiredness, 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 mouth pain, sores, or ulcers (stomatitis).
• Increased levels of liver enzymes in blood tests, such as aspartate aminotransferase and alanine aminotransferase.
• Increased levels of bilirubin in the blood (abnormal liver function tests).
• Redness, pain, blisters, and swelling on the palms of the hands or soles of the feet (palmar-plantar erythrodysesthesia syndrome).
• Pain in the bones, muscles, chest, or neck (musculoskeletal disorders).
• Pain in the joints (arthralgia).
• Protein in the urine (proteinuria).
• Weakness, lack of strength and energy, excessive tiredness (asthenia/fatigue).

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

• Lung infection (pneumonia).
• Infection of the throat and nose (upper respiratory tract).
• Bacterial infection.
• Reduced number of white blood cells (leukocytes) in blood tests (leukopenia), which may increase the risk of infection.
• Reduced number of neutrophils (a type of white blood cell) in blood tests (neutropenia), which may increase the risk of infection.
• Low potassium levels seen in blood tests (hypokalemia).
• Nosebleeds (epistaxis).
• Sore throat.
• Bleeding in the digestive system, such as in the stomach, rectum, or intestine (gastrointestinal hemorrhage).
• Formation of a hole in the stomach (gastrointestinal perforation).
• Increased levels of pancreatic enzymes 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 brain inflammation (posterior reversible encephalopathy syndrome).
• Pain in the stomach area, nausea, vomiting, and fever, which may be symptoms of pancreatitis (inflammation of the pancreas).
• Severe 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 the available data):

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

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 FRUZAQLA

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 label of the bottle after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Keep the bottle in the original package to protect it from moisture.

Keep the bottle tightly closed.

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. Container Content and Additional Information

Composition of FRUZAQLA

FRUZAQLA 1mg hard capsules

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

• Capsule filling: corn starch, microcrystalline cellulose (E460), talc (E553b).
• Capsule shell: gelatin, titanium dioxide (E171), tartrazine (E102), orange yellow colorant (E110).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium dioxide, black iron oxide (E172).

FRUZAQLA 5mg hard capsules

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

• Capsule filling: corn starch, microcrystalline cellulose (E460), talc (E553b).
• Capsule shell: gelatin, titanium dioxide (E171), allura red AC (E129), brilliant blue colorant (E133).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium dioxide, black iron oxide (E172).

Appearance and Container Content of the Product

FRUZAQLA 1 mg hard capsules (approximate length of 16 mm) are white capsules with a yellow shell, printed with «HM013» over «1mg».

FRUZAQLA 5 mg hard capsules (approximate length of 19 mm) are white capsules with a red shell, printed with «HM013» over «5mg».

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

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

Marketing Authorization Holder

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Manufacturer

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

A98 CD36

Ireland

You can request more information about this medicinal product 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 medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.