FRUZAQLA 1 mg Hard Capsule

Зміст інструкції

1. FRUZAQLA 1 mg hard capsules, 5 mg hard capsules
   1. What is FRUZAQLA and what is it used for
   2. What you need to know before you take FRUZAQLA
   3. How to take FRUZAQLA
   4. Possible side effects
   5. How to store FRUZAQLA
   6. Contents of the pack and other information

FRUZAQLA 1 mg hard capsules, 5 mg hard capsules

fruquintinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. 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 be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is FRUZAQLA and what is it used for

FRUZAQLA contains the active substance fruquintinib, a type of anticancer medicine called a
kinase inhibitor.
FRUZAQLA is used to treat adult patients with colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic). It is used in cases where other
treatments have not worked or are not suitable for you.

How FRUZAQLA works
Cancer cells need new blood vessels to grow. FRUZAQLA prevents
tumors from forming new blood vessels, thus slowing the growth and spread of cancer.
If you have any questions about how this medicine works or why it has been prescribed for you, please
ask your doctor, pharmacist or nurse.

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

• High blood pressure. Your doctor needs to make sure your blood pressure is under control before you start and during treatment with this medicine.
• Any bleeding problems. Tell your doctor if you have or have ever had bleeding problems, or if you are taking warfarin, acenocoumarol or other medicines to thin your blood and prevent blood clots.
• Serious stomach and intestinal problemscaused by a hole in the intestinal wall (known as gastrointestinal perforation). If you develop serious stomach and intestinal problems, see your doctor immediately.
• Kidney problems(indicated by the presence of protein in your urine).
• Any skin problems, which may include redness, pain, swelling or blisters on the palms of your hands or the soles of your feet.
• Recent headache, severe and persistent, vision disturbances, seizures or changes in yourmental state(such as confusion, memory loss or disorientation). If you notice any of these changes, or someone close to you notices them, see your doctor immediately.
• An unhealing wound or if you have recently had or are about to have surgery. FRUZAQLA may affect wound healing.
• Recent problems related to blood clotsin veins and arteries (types of blood vessels), including stroke, heart attack, embolism or thrombosis.

Your doctor may prescribe other medicines to prevent more serious complications and reduce the
symptoms. Your doctor may delay the next dose of FRUZAQLA or stop treatment with
FRUZAQLA.

Children and adolescents
FRUZAQLA is not intended for use in children and adolescents for the treatment of colon or rectal cancer that has spread to other parts of the body.

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 certain other infections, such as rifampicin.

Pregnancy
FRUZAQLA has not been studied in pregnant women. Given its mechanism of action,
FRUZAQLA should not be used during pregnancy unless absolutely necessary, as
it may cause harm to the fetus. If you are pregnant, suspect you are pregnant or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine. The doctor
will discuss with you the potential risks of taking this medicine during
pregnancy.

Contraception for women
Women of childbearing potential must use highly effective contraceptive methods during treatment
and for at least 2 weeks after the last dose of FRUZAQLA. Talk to your doctor about the
most suitable contraceptive methods for you.

Breast-feeding
Tell your doctor if you are breast-feeding or are planning to breast-feed. It is not known whether FRUZAQLA passes into
breast milk, therefore the risk to newborns/infants cannot be excluded. You should not breast-feed
during treatment with this medicine and for at least 2 weeks after the last dose. Talk to your
doctor to discuss the best way to feed your baby during this period.

Driving and operating machinery
FRUZAQLA slightly impairs the 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 ability to concentrate and react.

FRUZAQLA contains
Tartrazine (E102) and sunset yellow FCF/orange yellow S (E110) only in 1 mg capsules. These are
dyes that may cause allergic reactions.
Allura Red AC (E129) only in 5 mg capsules. This is a dye that may cause allergic
reactions.

3. How to take FRUZAQLA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Recommended dose
The recommended dose is 5 milligrams (mg), to be taken once a day at approximately the same time
each day, for 21 days, followed by 7 days of rest (no medicine). This is 1 treatment cycle.
Depending on your response to treatment and possible side effects, your doctor may
ask you to switch to a lower dose or to temporarily or permanently stop the
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 potential effects of taking a non-intact capsule are unknown.
• If you have or think you have difficulty swallowing the capsules whole, talk to your doctor before starting treatment.

For how long to take FRUZAQLA
Your doctor will perform regular check-ups. You may continue to take FRUZAQLA normally
as long as it remains effective and the side effects are acceptable.

If you take more FRUZAQLA than you should
Immediately inform your doctor if you have taken a higher dose than prescribed. Medical
assistance may be necessary and your doctor may tell you to stop taking
FRUZAQLA.

If you forget to take FRUZAQLA
If less than 12 hours remain until your next dose, skip the missed dose and take the next dose
as scheduled.
If more than 12 hours remain until your next dose, take the missed dose and then take the
next dose as scheduled.
If you vomit after taking FRUZAQLA, do not take a capsule to replace it. Continue the
treatment by taking the next dose at the usual time.

Before stopping treatment with FRUZAQLA
Do not stop taking the medicine unless your doctor tells you to do so. If you
have any doubts about using 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. With this medicine the following side effects may occur:

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

High blood pressure
Tell your doctor if you experience the following symptoms:

• severe headache
• mental confusion or dizziness
• confusion
• severe chest pain

Bleeding
FRUZAQLA can cause serious bleeding in the digestive system such as stomach, throat, rectum or
intestine. Seek immediate medical attention if you have the following symptoms:

• blood in the stool or black stools
• blood in the urine
• stomach pain
• cough/vomiting with blood

Serious problems with the stomach and intestines due to gastrointestinal perforation
Treatment with FRUZAQLA can lead to gastrointestinal perforation.
Seek immediate medical attention if you have the following symptoms:

• cough/vomiting with blood
• severe stomach (abdominal) pain or stomach pain that does not go away
• red or black stools

Reversible brain swelling (reversible posterior encephalopathy syndrome)
Seek immediate emergency medical attention and call your doctor if you have the following symptoms:

• headache
• confusion
• seizures
• vision changes

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

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

• decreased number of platelets (cells that help the blood to clot), detected in the blood test (thrombocytopenia), which can cause bruising or bleeding
• decreased thyroid gland activity (hypothyroidism), which can cause fatigue, weight gain and changes in skin and hair
• weight loss and decreased appetite (anorexia)
• high blood pressure (hypertension)
• changes in voice or hoarseness (dysphonia)
• frequent bowel movements or loose stools (diarrhea)
• painful or dry mouth, sores or ulcers in the mouth (stomatitis)
• increased liver enzymes in blood tests, including aspartate aminotransferase and alanine aminotransferase
• increased bilirubin in the blood (abnormal liver function test)
• redness, pain, blisters and swelling of the palms of the hands or soles of the feet (palmo-plantar erythrodysesthesia)
• pain in bones, muscles, chest or neck (musculoskeletal discomfort)
• joint pain (arthralgia)
• protein in the urine (proteinuria)
• weakness, lack of strength and energy, excessive fatigue (asthenia/fatigue)

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

• lung infection (pulmonary infection)
• infection of nose and throat (upper respiratory tract infection)
• bacterial infection
• decreased white blood cells in blood tests (leukopenia), which can increase the risk of infection
• decreased neutrophils (a type of white blood cells) in blood tests (neutropenia), which can increase the risk of infection
• decreased potassium levels in blood tests (hypokalaemia)
• nosebleed (epistaxis)
• sore throat
• bleeding in the digestive system such as stomach, rectum or intestine (gastrointestinal hemorrhage)
• hole in the stomach (gastrointestinal perforation)
• increased pancreatic enzymes in blood tests (which may be a sign of problems with the pancreas)
• tooth pain, gum or lip pain (oral pain)
• skin rashes
• ulcers in the mouth (mucosal inflammation)

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

• reversible brain swelling (reversible posterior encephalopathy syndrome)
• pain in the area of the stomach, nausea, vomiting and fever, which may be symptoms of inflammation of the pancreas (pancreatitis)
• severe pain in the upper right or central abdomen, nausea and vomiting, which may be symptoms of inflammation of the gallbladder (cholecystitis)
• delayed wound healing.

Not known (frequency cannot be estimated from the available data):

• severe and sudden pain in the abdomen, chest or back, which may be a symptom of a tear in the wall of the aorta (aortic dissection).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. 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. How to store 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
vial after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from moisture.
Keep the vial tightly closed.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FRUZAQLA contains
FRUZAQLA 1 mg hard capsules

• The active ingredient is fruquintinib. Each hard capsule contains 1 mg of fruquintinib.
• The other ingredients are:
• Capsule contents: corn starch, microcrystalline cellulose (E460), talc (E553b)
• Capsule shell: gelatin, titanium dioxide (E171), tartrazine (E102), sunset yellow FCF/orange yellow S (E110)
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide (E172).

FRUZAQLA 5 mg hard capsules

• The active ingredient is fruquintinib. Each hard capsule contains 5 mg of fruquintinib.
• The other ingredients are:
• Capsule contents: corn starch, microcrystalline cellulose (E460), talc (E553b)
• Capsule shell: gelatin, titanium dioxide (E171), allura red AC (E129), brilliant blue FCF (E133)
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide (E172).

Description of the appearance of FRUZAQLA and contents of the pack
FRUZAQLA 1 mg hard capsules (length approximately 16 mm) are white with a
yellow cap imprinted with “HM013” above “1mg”.
FRUZAQLA 5 mg hard capsules (length approximately 19 mm) are white with a
red cap imprinted with “HM013” above “5mg”.
Each bottle contains 21 hard capsules and a desiccant. The desiccant is a material that absorbs
moisture, inserted in a small container to protect the capsules from humidity.
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
Dublin 2
D02 HW68
Ireland

Manufacturer
Takeda Ireland Limited
Bray Business Park
Kilruddery
Co. Wicklow
A98 CD36
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Lietuva
Takeda, UAB
Tel: +370 521 09 070
[email protected]

България
Такеда България ЕООД
Тел.: +359 2 958 27 36
[email protected]

Luxembourg/Luxemburg
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Česká republika
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
[email protected]

Magyarország
Takeda Pharma Kft.
Tel.: +36 1 270 7030
[email protected]

Danmark
Takeda Pharma A/S
Tlf.: +45 46 77 10 10
[email protected]

Malta
Drugsales Ltd
Tel: +356 21419070
[email protected]

Deutschland
Takeda GmbH
Tel: +49 (0)800 825 3325
[email protected]

Nederland
Takeda Nederland B.V.
Tel: +31 20 203 5492
[email protected]

Eesti
Takeda Pharma OÜ
Tel: +372 6177 669
[email protected]

Norge
Takeda AS
Tlf: +47 800 800 30
[email protected]

Ελλάδα
Τakeda ΕΛΛΑΣ Α.Ε.
Tηλ: +30 210 6387800
[email protected]

Österreich
Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50
[email protected]

España
Takeda Farmacéutica España, S.A.
Tel: +34 917 90 42 22
[email protected]

Polska
Takeda Pharma Sp. z o.o.
Tel.: +48223062447
[email protected]

France
Takeda France SAS
Tél: + 33 1 40 67 33 00
[email protected]

Portugal
Takeda Farmacêuticos Portugal, Lda.
Tel: + 351 21 120 1457
[email protected]

Hrvatska
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
[email protected]

România
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
[email protected]

Ireland
Takeda Products Ireland Ltd
Tel: 1800 937 970
[email protected]

Slovenija
Takeda Pharmaceuticals farmacevtska družba
d.o.o.
Tel: + 386 (0) 59 082 480
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600
[email protected]

Italia
Takeda Italia S.p.A.
Tel: +39 06 502601
[email protected]

Suomi/Finland
Takeda Oy
Puh/Tel: 0800 774 051
[email protected]

Κύπρος
A.POTAMITIS MEDICARE LTD
Τηλ: +357 22583333

Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected] [email protected]

Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]

United Kingdom (Northern Ireland)
Takeda UK Ltd
Tel: +44 (0) 3333 000 181
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .