Utefos 400 mg hard capsules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Utefos 400 mg Hard Capsules

Tegafur

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

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

Leaflet Contents:

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

1. What Utefos is and what it is used for

Utefos is a medication used to treat cancer. It belongs to a group of medicines that work by preventing the multiplication of tumor cells.

Utefos is indicated in adults for the treatment of patients with colorectal cancer and gastric cancer. It is also used for the treatment of patients with advanced gastrointestinal tumors (including those of the esophagus and pancreas) or when there are disease recurrences.

Treatment of patients with metastatic breast cancer.

Treatment of patients with advanced head and neck cancer or when the cancer has spread to other parts of the body (stages III and IV).

2. What you need to know before taking Utefos

Do not take Utefos

• If you are allergic to tegafur or to 5-fluorouracil (5-FU), or to any of the other ingredients of this medicine listed in section 6.
• If you are pregnant or breastfeeding.
• If you have bone marrow disorders (reduced white blood cells or platelets, which may be due to previous radiotherapy or anticancer chemotherapy).
• If you have severe liver disease.
• If you have a known problem metabolizing drugs in the liver (known deficiency of the hepatic enzyme CYP2A6).
• If you know you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency).
• If you are being treated or have been treated within the last 4 weeks with brivudine, as part of treatment for herpes zoster (shingles or herpes).
• This medicine must not be used in adolescents, children, or infants.

Warnings and precautions

During treatment, you will have periodic blood tests. If you develop significant blood or gastrointestinal disturbances, your doctor will stop administration of the product. Once symptoms have resolved, treatment may be restarted at a lower dose.

Consult your doctor or pharmacist before starting Utefos if:

• You have liver or kidney problems.
• You are an elderly patient.
• You have or have had heart problems (abnormal heart rhythm, chest pain).
• You have or have had problems metabolizing similar medicines (5-fluorouracil).
• You have been treated with other anticancer medicines or have received radiotherapy. Your doctor may need to adjust your dose.
• You are taking anticoagulants or phenytoin.
• You know you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD).
• You are a relative of someone with partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD).

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

You must inform your doctor if you experience any type of allergy or exaggerated reaction to Utefos, such as persistent diarrhea, as your doctor may need to adjust the dose or discontinue treatment.

You must not be vaccinated with vaccines containing live microorganisms while being treated with Utefos, as you could develop the disease the vaccine is intended to prevent.

Children and adolescents

This medicine is contraindicated in adolescents, children, and infants.

Taking Utefos with other medicines

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

It is especially important that you inform your doctor if you are taking any of the following medicines:

• Medicines that reduce liver metabolism, such as certain antifungal agents (miconazole, ketoconazole, clotrimazole), pigment stimulants (methoxsalen), or those that increase liver metabolism (phenobarbital, rifampicin).
• Medicines to reduce blood clotting (acenocoumarol, warfarin).
• Medicines for seizures or tremors (phenytoin).

Do not use any type of vaccine without first consulting your doctor. While you are taking Utefos, some vaccines may cause serious infections.

Taking Utefos with food and drink

Taking this medicine with food may alter its absorption. Therefore, it is recommended to take it on an empty stomach, at least one hour before or after a meal.

You should not take Utefos together with grapefruit juice, as it may reduce the activity of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take Utefos if you are pregnant or think you might be pregnant, as it may cause serious harm to your baby.

You must use reliable contraception, whether you are male or female of childbearing age, during treatment and for up to 3 months after stopping treatment. Consult your doctor.

You must not breastfeed while taking Utefos, as the baby may experience serious adverse effects.

If you wish to have a child during or after treatment, inform your doctor before starting treatment. You may wish to seek advice about sperm storage prior to starting treatment.

Driving and use of machines

Utefos may cause dizziness, nausea, or disorientation. Therefore, until you know how this medicine affects you, take special care when driving vehicles or operating machinery.

Important information about some of the components of Utefos

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Utefos

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Your doctor will calculate the dose of Utefos based on your body surface area and the type of cancer to be treated. The usual daily dose ranges between 500 and 1,000 mg per square meter of body surface area, divided into 2 or 3 doses per day (every 8 or 12 hours), for 3 to 6 weeks, followed by a one-week rest period.

Your height and weight will be measured to calculate your body surface area. Your doctor will determine the dose you should take. This dose may be adjusted or changed during treatment and may be temporarily suspended if your general condition changes.

Utefos may be used alone, but it may also be used in combination with other antitumor medicines.

Your doctor may recommend administering Utefos together with folinic acid. Your doctor will indicate the dose of this medicine and the days you should take it.

It is very important that you follow exactly the instructions for administration of Utefos given by your doctor. Your doctor will tell you what dose you need, when and how to take it, and for how long. In addition, your doctor will recommend periodic check-ups and laboratory tests to monitor your general condition.

Recommended dose in special populations:

Use in patients over 65 years of age:

Frequent monitoring is advisable in elderly patients receiving tegafur who have kidney and/or heart problems, as well as in those patients taking other medicines that may interact with tegafur.

Patients with kidney problems:

Patients with kidney problems should be monitored frequently to detect the onset of toxic effects or any possible worsening of kidney function.

Patients with liver problems:

The effect of tegafur in patients with liver problems on drug elimination has not been evaluated. Patients with severe liver disease must not take this medicine.

Method of administration:

This medicine is taken orally.

It is recommended to take the capsules on an empty stomach, at least one hour before or after a meal.

Do not take the capsules with grapefruit juice (see Taking Utefos with food and drinks).

Use in children and adolescents

Children and adolescents must not take Utefos due to lack of efficacy and safety data.

If you take more Utefos than you should

Symptoms or signs that may occur in case of overdose include: loss of appetite (anorexia), nausea, vomiting, inflammation of the mucous membrane of the mouth, diarrhea, and, in more severe cases, gastrointestinal ulceration and bleeding. Anemia may also occur, as well as possible skin or nervous system toxicity. Some of these adverse effects may have serious consequences.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Utefos

Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time and consult your doctor.

If you stop taking Utefos

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

Discontinuation of treatment with Utefos does not produce adverse effects.

However, if you are taking coumarin anticoagulants (e.g., Sintrom) or phenytoin, discontinuation of Utefos treatment may require your doctor to adjust your doses.

4. Possible adverse effects

Like all medicines, Utefos may cause adverse effects, although not everyone experiences them.

Contact your doctor if you experience any of the following adverse effects:

• Persistent diarrhoea: if you have 4 or more bowel movements per day or experience nocturnal diarrhoea.
• Vomiting: if you vomit more than once a day.
• Mucositis: if you have pain, redness, swelling, or sores in your mouth.
• Very dark stools or blood in your vomit.
• Skin reaction in the hands and feet: if you have pain, swelling, or redness in your hands and/or feet.
• Fever or infection: if you have a temperature of 38°C or higher, or other signs of infection.
• Easy bruising.

Possible adverse effects:

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

• Diarrhoea.
• Vomiting.
• Inflammation or ulceration of the oral mucosa.
• Hair loss.
• Dizziness.
• Headache.
• Weakness.
• Loss of coordination of movements.
• Loss of appetite.

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

• Blood disorders (reduction in the number of white blood cells, red blood cells, and/or platelets).
• Allergic reactions.
• Skin rashes, including hand-foot syndrome (numbness, pain, swelling, or redness in the hands and feet).
• Gastritis.
• Duodenal ulcer, gastrointestinal bleeding.

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

• Disorientation.
• Drowsiness.
• Euphoria.
• Changes in blood tests indicating liver function (bilirubin, alkaline phosphatase).
• Chest pain.
• Thrombosis in arteries or veins.
• Infection due to decreased immunity.
• Double vision.
• Involuntary and uncontrolled eye movements.
• Light sensitivity.
• Changes in blood tests indicating blood coagulation function.

In addition to the adverse reactions listed above, the following adverse reactions have been reported for tegafur in combination with uracil:

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

• Reduction in the number of red blood cells, white blood cells, or platelets (anaemia, thrombocytopenia, leucopenia, neutropenia), bone marrow suppression leading to reduced blood cells. These adverse effects may cause weakness, increase susceptibility to infections, or increase the risk of bleeding or bruising. If you experience symptoms like these, speak to your doctor. They will advise whether you should temporarily stop treatment or adjust your dose.
• Nausea, mouth sores, anorexia, and abdominal pain.
• Feeling of weakness.
• Increased blood levels of certain liver enzymes (ALT, AST).

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

• Fungal infection.
• Difficulty breathing, increased cough, and throat inflammation.
• Dehydration and malnutrition.
• Insomnia, depression, and confusion.
• Altered or loss of taste sensation, tingling or numbness in the hands or feet.
• Tearing, eye inflammation (conjunctivitis).
• Constipation, flatulence, indigestion, dry mouth, belching, intestinal obstruction.
• Skin peeling, skin discoloration, itching, sweating, dry skin, and nail abnormalities.
• Muscle pain, back pain, joint pain.
• Fever, swelling, malaise, chills, and pain.
• Weight loss.

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

• Infection, sepsis.
• Problems with blood coagulation.
• Irregular heartbeat, heart failure, heart attack, and cardiac arrest.
• Circulatory collapse.
• Pulmonary embolism (blood clot in the veins inside and around the lungs).
• Intestinal inflammation, intestinal perforation.
• Liver inflammation, jaundice, and liver failure.
• Abnormal kidney function, urinary retention, and blood in the urine.
• Impotence.
• Chest pain.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Changes in the "white matter of the brain" (leukoencephalopathy).
• Altered or loss of sense of smell (anosmia, parosmia).
• Interstitial pneumonia.
• Fatigue.

Very rare adverse effects (may affect fewer than 1 in 10,000 people):

• Pneumonia.
• Various blood cell disorders (haemolytic anaemia, agranulocytosis, myelodysplastic syndrome, acute myeloid leukaemia, acute leukaemia), and disseminated intravascular coagulation.
• Memory loss, speech disturbances, abnormally reduced sensitivity to touch (hypoesthesia).
• Pancreatitis, stomach or intestinal ulcer, inactivity of the large intestine (paralytic ileus), fluid in the abdomen (ascites), inflammation of the large intestine (ischaemic colitis).
• Liver cirrhosis, severe rapidly progressing liver inflammation (fulminant hepatitis).
• Skin changes resembling systemic lupus erythematosus, other skin changes including blisters, hives with lumps, severe skin reaction with blisters (Stevens-Johnson syndrome).
• Acute kidney failure, nephrotic syndrome (kidney disease), urinary incontinence, and multi-organ failure.

Some of these adverse effects may be serious; therefore, always contact your doctor immediately if you begin to experience any adverse effect. Your doctor may advise reducing the dose and/or temporarily stopping Utefos. They may recommend resuming treatment at a lower dose. This will help reduce the likelihood of the adverse effect continuing or becoming severe.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Utefos

Store below 30°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP or CAD. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Utefos

The active substance is tegafur. Each hard capsule contains 400 mg of tegafur.

The other components (excipients) are: magnesium stearate, corn starch, anhydrous lactose and colloidal silicon dioxide.

Components of the capsule shell are: titanium dioxide (E-171), indigotine (E-132), gelatin.

Appearance of the product and contents of the pack

Utefos is presented as white and blue hard capsules.

Packs containing 20 or 60 hard capsules.

Marketing Authorization Holder

Mylan Pharmaceuticals, S.L.

C/Plom 2-4, 5th floor

08038 – Barcelona

Spain

Manufacturer

Prasfarma, S.L.

C/ Sant Joan, 11-15

08560 - Manlleu (Barcelona)

Spain

Date of the most recent review of this summary: September 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/