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Teysuno 15 mg. / 4.35 mg. / 11.8 mg. 126 capsules

Product Code: Teysuno 15 mg. / 4.35 mg. / 11.8 mg. 126 capsules
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Product viewed: 2735

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What is Teysuno and what is it used for?
Teysuno contains the active ingredients tegafur, gimeracil and oteracil.
Teysuno belongs to the fluoropyrimidine class of medicines known as "antineoplastic agents" that stop the growth of cancer cells.

Teysuno is prescribed by a doctor to treat adults with advanced stomach cancer and is taken with cisplatin, another anticancer medicine.

2. What do you need to know before taking 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);
- if you are taking other fluoropyrimidine anticancer medicines such as fluorouracil and capecitabine or have severe and unexpected reactions to fluoropyrimidines;
- if you have a known genetic deficit of the enzyme dihydropyrimidine dehydrogenase (DPD);
- if you are pregnant or breast-feeding
- if you have severe blood disorders;
- if you have kidney disease requiring dialysis;
- if you are currently being treated or treated over the last 4 weeks with sorivudine, brivudine or antiviral medicines of a similar class.

Warnings and precautions

Talk to your doctor before taking Teysuno if you have:
- blood disorders;
- kidney disease;
- stomach and / or intestinal problems such as pain, diarrhea, vomiting or dehydration;
- eye disorders such as "dry eye" or increased tearing;
- with a current or previous liver infection with hepatitis B virus, your doctor will monitor you more closely.

Children and adolescents
Teysuno is not recommended for use in children below 18 years of age.

Other medicines and Teysuno
Tell your doctor if you are taking, have recently taken or plan to take other medicines.

You should be particularly careful if you take any of the following:

other fluoropyrimidine drugs, such as antifungal flucytosine. Teysuno can not be a substitute for other fluoropyrimidines;
- antiviral medicines such as brivudine or sorivudine;
- inhibitors of the CYP2A6 enzyme that activates Teysuno, such as tranylcypromine and methoxlene;
- folinic acid (often used in methotrexate chemotherapy);
- blood-thinning drugs: coumarin derivatives of anticoagulants, such as warfarin;
- medicines to treat seizures or tremor, such as phenytoin;
- medicines that treat gout, such as allopurinol.

Teysuno with food and beverages
Teysuno should be taken at least one hour before or one hour after a meal.

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

You must use contraceptive measures during and up to 6 months after treatment with Teysuno. If you become pregnant during this time, you should tell your doctor.

You should not breast-feed 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 operating a machine as Teysuno may feel tired, have nausea or blurred vision. If you have any doubts, talk to your doctor.

Teysuno contains Lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Teysuno?
Always take Teysuno exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will tell you what dose you need to take, when to take it and how long you should take it. Your dose of Teysuno will be determined by your doctor based on your height and weight. Your doctor may reduce the dose if you have too severe side effects.

Teysuno capsules should be swallowed with water for at least 1 hour before or 1 hour after a meal. Teysuno should be taken twice a day (morning and evening).

Teysuno capsules are usually taken for 21 days, followed by a 7 day rest period (when capsules are not taken). This 28-day period is one treatment cycle. Cycles are repeated.

Teysuno will be given with another anticancer medicine called cisplatin. Cisplatin will be stopped after 6 cycles of treatment. Teysuno can be continued after stopping cisplatin.

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 and do not take a double dose to make up for the forgotten dose. Instead, continue with your regular schedule and contact your doctor.

If you stop taking Teysuno
There are no side effects caused by stopping treatment with Teysuno. If you are using blood thinning or anti-convulsant medicines,
Low red blood cell count leading to anemia
You may have symptoms like cold hands and feet, look pale, be dizzy, dropped, have a shortage of air.
If you get any of the above symptoms, do not overwork, relax and sleep more.
Low white blood cell counts lead to an increased risk of severe local (ie, mouth, lung, urine) or blood infection
You may have symptoms such as fever, chills, cough, sore throat.
If you have a temperature of 38.5 ° C or higher, stop taking Teysuno and contact your doctor immediately.
To prevent infection, stay away from crowded places, make gargle after home, wash your hands before eating and after using the toilet.
Low platelet counts lead to increased bleeding risk:
If you have bleeding from the skin, mouth (caused by toothbrushing), nose, respiratory tract, stomach, intestine, etc., stop taking Teysuno and contact your doctor immediately.
To prevent bleeding, avoid heavy work or heavy loads so as to prevent injuries and injuries. Wear wide clothing to protect the skin. Wash your teeth and blow your nose carefully.
Loss of appetite (anorexia) can lead to weight loss and dehydration
You can dehydrate if you do not eat and / or do not drink enough water.
If you are dehydrated, you may get symptoms such as dry mouth, weakness, dry skin, vertigo, stiffness.
Try to eat often and less. Avoid fatty and highly aromatic foods. Even if you do not feel hungry, keep on eating so much to maintain good nutrition.
If you feel tired and have a temperature with loss of appetite, contact your doctor immediately.
Nervous disorder: You may experience stiffness, numbness, pain, altered sensation, muscle weakness, trembling or movement difficulties.
Weakness and fatigue, which may be side effects caused by other medicines.
Common side effects (may affect 1 to 10 people in 100) include:
- Nervousness: headache, dizziness, drowsiness, taste changes;
- Eye problems, increased or reduced tedious discomfort, visual problems, serious blistering of the eyes, resulting in wear of the surface of the eye (erosion of the cornea);
- Ear: hearing problems;
- Blood vessels: high or low blood pressure, blood clots in the legs and lungs;
- Lung paths and nasal strokes: shortness of breath, cough;
- Chest and mouth: dry mouth, wounds in the mouth, throat and esophagus, hiccups, abdominal pain, indigestion, inflammation of the stomach or intestine, perforation of the stomach, small intestine or colon;
- Liver: yellowing of the eyes and skin, changes in blood tests that show the function of the liver;
- Skin: hair loss, itching, rash or dermatitis, skin reaction, dry skin, hand-foot reaction (pain, swelling and redness of the hands and / or feet), pigment skin stains;
- Kidney: decreased urine volume, changes in blood tests that show kidney function, renal impairment and kidney failure;
- Others: cold chills, weight loss, swelling in certain places and bone and muscle pain.

Uncommon side effects (may affect between 1 and 10 per 1,000 people) include:
- Psyche: seeing and hearing non-existent things, changes in personality, inability to sit calmly, confusion, feeling nervous, depression, impaired sexual function;
- Nervous disorders: voice disorders, inability to speak and understand words, memory problems, unsteady gait, balance problems, unilateral weakness, drowsiness, nerve inflammation, altered smell, impaired brain function, fainting, loss of consciousness, seizures;
- Eye: itchy and red eyes, allergic reactions in the eyes, falling eyelid;

- Ear: dizziness, ear plugging, ear discomfort;
- Heart: irregular or rapid heartbeat, chest pain, accumulation of excess fluid around the heart, heart attack, heart failure;
- Blood vessels: Venous inflammation, hot flushes;
- Pulmonary and nasal passages: runny nose, voice disturbances, nasal congestion, throat flushing, hay fever;
- Rash and mouth: fluid in the abdomen, gastroesophageal reflux disease, increased salivary secretion, excessive bleeding, oral inflammation, gastrointestinal disorder, mouth pain, abnormal oesophageal abdominal contractions, stomach and intestine obstruction, retroperitoneal fibrosis, teeth that crack or break easily, difficulty in swallowing, salivary gland disorders, hemorrhoids;
- Skin: loss of skin color, peeling skin, increased body hair, brittle nails, increased sweating;
- General: worsening of the general condition, weight gain, redness and swelling at the injection site, cancer pain and bleeding,
Rare side effects (affects 1 to 10 users in 10,000) and very rare side effects (affects less than 1 in 10,000 people) include:
- acute hepatic failure;
- pancreas infection;
- muscle breakdown;
- loss of sense of smell;
- sun allergy
- Generalized blood clotting and bleeding
- a disease affecting the white matter of the brain;
- serious blistering of the skin, mouth and genitals;
- Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B (hepatic infection) in the past.

If you get any of the side effects or if you notice any side effects not listed in this leaflet, please tell your doctor.

If any of the side effects gets serious, stop taking Teysuno and tell your doctor straight away.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system.

As you report side effects, you can contribute to getting more information on the safety of this medicine.

5. How do you store Teysuno?
- Keep out of the reach and sight of children.
- Do not use this medicine after the expiry date which is stated on the blister after "EXP" and the carton after "EXP". The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Teysuno contains:

- The active substances are tegafur, gimeracil and oteracil.
Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as monoclonal).

- The other ingredients are:

Capsule contents: lactose monohydrate, magnesium stearate;
Capsule formulation: 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.
What does Teysuno look like and contents of the pack
The hard capsules have a white body and an opaque brown cap printed with "TC448" in gray. They are available in blisters containing 14 capsules each.

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

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