TEYSUNO 15 mg/4.35 mg/11.8 mg HARD CAPSULES

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the User

Teysuno 15 mg/4.35 mg/11.8 mg hard capsules

tegafur/gimeracil/oteracil

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 or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Teysuno and what is it used for

Teysuno contains the active substances tegafur, gimeracil, and oteracil.

Teysuno belongs to a group of medicines called fluoropyrimidines, known as "antineoplastic agents", which stop the growth of cancer cells.

Doctors prescribe Teysuno for:

• Treating adults with advanced stomach cancer (gastric cancer) and it is taken together with cisplatin, another anticancer medicine.
• Treating cancer in the large intestine and rectum that has spread (metastasized) and cannot be further treated with another fluoropyrimidine (anticancer treatments of the same class of medicines as Teysuno) due to side effects on the skin of the hands and feet (hand-foot syndrome) or the heart. In these patients, Teysuno is used alone or in combination with other anticancer medicines.

2. What you need to know before you take Teysuno

Do not take Teysuno if:

• you are allergic to tegafur, gimeracil, oteracil, or any of the other ingredients of this medicine (listed in section 6);
• you are taking another anticancer medicine from the group of fluoropyrimidines such as fluorouracil and capecitabine, or have had severe and unexpected reactions due to fluoropyrimidines;
• you know that you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency);
• you are pregnant or breastfeeding;
• you have severe blood disorders;
• you have kidney disease that requires dialysis;
• you are being treated or have been treated in the last 4 weeks with brivudine as part of the treatment for herpes zoster (chickenpox or shingles).

Warnings and precautions

Talk to your doctor before starting to take Teysuno if you have:

blood disorders;

• kidney disease;
• gastrointestinal problems such as pain, diarrhea, vomiting, or dehydration;
• eye disorders, such as "dry eye" or excessive tearing;
• a current or previous liver infection with hepatitis B virus, as your doctor may want to monitor you more closely;
• a partial deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD);
• if you are a relative of a person with a partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD).

DPD deficiency: DPD deficiency is a genetic condition that is not usually associated with health problems unless you are being treated with certain medicines. If you have a DPD deficiency and take Teysuno, you will have a higher risk of experiencing severe side effects (listed in section 4, Possible side effects). It is recommended that you have a test to detect DPD deficiency before starting treatment. If you have no enzyme activity, you should not take Teysuno. If you have reduced enzyme activity (partial deficiency), your doctor may prescribe a lower dose. Even if the test results for DPD deficiency are negative, you may still experience severe and potentially life-threatening side effects.

If you experience lack of energy, confusion, drowsiness, seizures, or loss of consciousness, contact your doctor immediately.

Children and adolescents

Teysuno is not recommended for use in children under 18 years of age.

Using Teysuno with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

You also need to be careful if you are taking any of the following medicines:

• other fluoropyrimidines such as flucytosine, an antifungal medicine. Teysuno cannot be replaced by other fluoropyrimidines given by mouth;
• inhibitors of the enzyme CYP2A6, which activates Teysuno, such as tranycypromine or methoxsalen;
• folinic acid (often used in chemotherapy with methotrexate);
• anticoagulant medicines derived from coumarin such as warfarin

• anticonvulsant medicines to prevent seizures or tremors, such as phenytoin;
• medicines for the treatment of gout, such as allopurinol.

Using Teysuno with food and drink

Teysuno should be taken at least one hour before or one hour after meals.

Pregnancy and breastfeeding

Before starting treatment, you must tell your doctor or pharmacist if you are pregnant, think you may be pregnant, or plan to become pregnant. You should not take Teysuno if you are pregnant or think you may be pregnant.

Men should use contraceptive measures during treatment and for 3 months after finishing treatment with Teysuno.

Women should use contraceptive measures during treatment and for 6 months after finishing treatment with Teysuno.

If you become pregnant during this period, you should inform your doctor.

You should not breastfeed if you are taking Teysuno.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Be careful when driving or using machines, as Teysuno may make you feel tired, nauseous, or have blurred vision. If you are unsure, talk to your doctor.

Teysuno contains

Lactose(a type of sugar). If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

3. How to take Teysuno

Follow the instructions for taking Teysuno exactly as your doctor has told you. If you are unsure, talk to your doctor.

Your doctor will tell you what dose you need to take, when, and for how long. Your doctor will determine your dose of Teysuno based on your weight and height. Your doctor may reduce the dose if you experience severe side effects.

Teysuno capsules should be swallowed with water at least one hour before or one hour after meals. Teysuno should be taken twice a day (in the morning and at night).

For stomach cancer:

Teysuno capsules are usually given for 21 days, followed by a 7-day rest period (during which no capsules are taken). This 28-day period is a treatment cycle. The cycles are repeated.

Teysuno will be given with another anticancer medicine called cisplatin. Cisplatin is stopped after 6 cycles of treatment. Although you have stopped cisplatin, you may continue with Teysuno.

For cancer of the large intestine or rectum that has spread:

Teysuno capsules are usually given for 14 days, followed by a 7-day rest period (during which no capsules are taken). This 21-day period is a treatment cycle. The cycles are repeated.

Teysuno may be given with other anticancer medicines (cisplatin, oxaliplatin, irinotecan, or bevacizumab), depending on the treatment you are receiving.

If you take more Teysuno than you should

If you take more capsules than you should, contact your doctor immediately.

If you forget to take Teysuno

Do not take the missed dose or a double dose to make up for the missed dose. Instead, continue your normal dosing schedule and talk to your doctor.

If you stop taking Teysuno

Stopping treatment with Teysuno does not cause side effects. If you are taking anticoagulant or anticonvulsant medicines and stop taking Teysuno, your doctor may need to adjust the dose of these medicines.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Teysuno can cause side effects, although not everybody gets them. Some symptoms are easy to recognize as side effects by patients themselves, while for others, a blood test is needed. Your doctor will discuss these with you and explain the possible risks and benefits of your treatment.

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

• Diarrhea, nausea, vomiting, constipation.

• If you experience diarrhea more than 4 times a day or at night, or if you have ulcers or sores in the mouth accompanied by diarrhea, stop taking Teysuno and contact your doctor immediately.
• If you experience diarrhea, avoid foods high in fiber, fat, or spicy foods.
• Take plenty of fluids between meals to replace lost fluids and prevent dehydration, low blood volume, and electrolyte imbalance.
• If you experience nausea and vomit a dose of the medicine, make sure to inform your doctor.
• Do not replace the dose that you have vomited.
• If you vomit more than twice in 24 hours, stop taking Teysuno and contact your doctor immediately.
• To help you with nausea and vomiting:

• Lie down or breathe deeply when you feel nauseous.
• Avoid tight clothing.

• Decreased number of red blood cells, which can lead to anemia.

• You may experience symptoms such as cold hands and feet, paleness, mild dizziness, fatigue, difficulty breathing.

• If you experience any of these symptoms, avoid exerting yourself, try to rest, and sleep well.

• Decreased number of white blood cells, which can lead to an increased risk of severe local infections (e.g., oral, pulmonary, urinary) or blood infection.

• You may experience symptoms such as fever, chills, cough, and sore throat.
• If you have a fever of 38.5°C or higher, stop taking Teysuno and contact your doctor immediately.
• To avoid infections, avoid crowds, gargle when you get home, wash your hands before meals, and before and after using the bathroom.

• Decreased number of platelets, which can lead to an increased risk of bleeding.

• If you experience small bleeding in the skin, mouth (when brushing your teeth), nose, respiratory tract, stomach, intestine, etc., stop taking Teysuno and contact your doctor immediately.
• To prevent bleeding, avoid strenuous physical activity or demanding sports to prevent injuries and bruising. Wear loose clothing to protect your skin. Brush your teeth and blow your nose carefully.

• Lack of appetite (anorexia), which can lead to weight loss and dehydration.

• If you do not eat or drink enough water, you may become dehydrated.
• If you become dehydrated, you may experience symptoms such as dry mouth, fatigue, dry skin, dizziness, or cramps.
• Try to eat small, frequent meals. Avoid fatty or strongly flavored foods. Even if you do not feel hungry, try to eat as much as you can to maintain good nutrition.
• If you feel tired and have a fever, along with a lack of appetite, contact your doctor immediately.

• Nervous system disorders.

• You may experience numbness, tingling, pain, abnormal sensation, muscle weakness, tremors, or difficulty moving.

• Weakness and fatigue, which may be side effects caused by other medicines.

Common side effects (may affect between 1 and 10 in 100 people):

• nervous system:headache, dizziness, insomnia, taste disturbances;
• eye:eye disorders, increased or decreased tearing, eye discomfort, severe disease with blisters on the eyes and wear of the "skin" surface of the eyes (corneal erosion).
• ear:hearing problems;
• circulatory:increased or decreased blood pressure, blood clots or thrombi in the leg or lung;
• respiratory:difficulty breathing;
• digestive:sores or ulcers in the mouth, throat, or esophagus, hiccups, abdominal pain, indigestion, gastritis or colitis, perforation of the stomach, small intestine, or large intestine;
• liver:yellowing of the eyes and skin, changes in blood tests that show how the liver is working;
• skin:hair loss, itching, skin rash (or dermatitis, skin reactions), dry skin, hand-foot syndrome (pain, swelling, and redness of hands or feet), colored skin spots;
• kidney:decreased urine output, changes in blood tests that show how the kidneys are working, kidney disorders, and kidney failure;
• other:swelling of specific areas and bone and muscle pain.

Uncommon side effects (may affect between 1 and 10 in 1,000 people):

• mental:seeing or hearing things that are not there (hallucinations), changes in personality, inability to stay still, confusion, nervousness, depression, impotence;
• nervous system:speech disorders, inability to say or understand words, memory problems, unsteady gait, balance problems, weakness on one side of the body, drowsiness, nerve inflammation, altered sense of smell, brain abnormalities, dizziness, loss of consciousness, stroke, seizures;
• eye:irritation and redness of the eyes, allergic reactions in the eyes, drooping eyelids;
• ear:vertigo, blockage, ear discomfort;
• heart:irregular or rapid heartbeat, chest pain, accumulation of excess fluid around the heart, heart attack, heart failure;
• circulatory:inflammation of a vein, hot flashes;
• respiratory:runny nose, speech disorders, nasal congestion, throat redness, pollen allergy;
• digestive:gastroesophageal reflux disease, increased salivation, frequent belching, lip inflammation, gastrointestinal disorders, mouth pain, abnormal muscle contractions of the esophagus, gastric or intestinal obstruction, stomach ulcers, retroperitoneal fibrosis, fragile teeth that break easily, difficulty swallowing, disorders of the salivary glands;
• skin:loss of skin color, peeling, excessive hair growth, reduced nails, excessive sweating;
• general:general worsening, weight gain, redness and swelling at the injection site, pain and bleeding associated with cancer, multi-organ failure;
• blood test changes:high blood sugar, high lipid levels, altered coagulation time, increased blood cell count, altered protein levels;
• other:increased frequency of urination, blood in the urine, neck pain, back pain, breast pain, muscle stiffness or cramps, joint swelling, discomfort, inflammation, pain, and arthritis in the limbs.

Rare side effects (may affect between 1 and 10 in 10,000 people) and very rare side effects (may affect less than 1 in 10,000 people):

• acute liver failure;
• pancreatitis;
• muscle breakdown;
• loss of smell;
• allergy to sunlight;
• widespread blood clots and bleeding;
• diseases affecting the white matter of the brain;
• severe diseases with blisters on the skin, mouth, and genitals;
• recurrence (reactivation) of hepatitis B virus infection in case of past hepatitis B infection (a liver infection).
• High levels of ammonia in the blood

Tell your doctor if you experience any of the side effects listed or if you notice any side effect not listed in this leaflet.

If any of the side effects become serious, stop taking Teysuno and contact your doctor immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 Teysuno

• 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 blister and the carton, after EXP/CAD. The expiry date is the last day of the month indicated.

• No special storage conditions are required.

• 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

Composition of Teysuno

• The active substances are tegafur, gimeracil, and oteracil.

Each capsule contains 15 mg of tegafur, 4.35 mg of gimeracil, and 11.8 mg of oteracil (as monopotassium salt).

• The other ingredients are:

Capsule content: lactose monohydrate, magnesium stearate.

Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, talc.

Ink: red iron oxide (E172), yellow iron oxide (E172), Indigo Carmine (E132), carnauba wax, bleached shellac, glycerol monooleate.

Appearance of the Product and Package Contents

Hard capsules with a white body and a brown opaque cap with the inscription "TC448" in gray, arranged in blisters of 14 capsules each.

Each package contains 42 capsules, 84 capsules, or 126 capsules.

Marketing Authorization Holder

Nordic Group B.V.

Siriusdreef 41

2132 WT Hoofddorp

Netherlands

Manufacturer

Nordic Pharma B.V.

Siriusdreef 41

2132 WT Hoofddorp

Netherlands

Millmount Healthcare Limited

Block 7, City North

Business Campus, Stamullen

Co. Meath, K32 YD60

Ireland

Date of the Last Revision of this Leaflet:

Other Sources of Information:

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