15 mg/4.35 mg/11.8 mg hard capsules
tegafur/gimeracil/oteracil
What Teysuno is and what it is used for
Teysuno contains the active ingredients tegafur gimeracil and oteracil.
Teysuno belongs to the drug class fluoropyrimidines called “antineoplastic agents” that stop the growth of cancer cells.
Teysuno is prescribed by doctors for:
- treatment of adults with advanced gastric cancer and is taken together with cisplatin, which is another cancer medicine
- treatment of colon and rectal cancer that has spread (metastasized) and where it is not possible to continue with another fluoropyrimidine (cancer treatments with the same type of medicine as Teysuno) because of side effects on the skin of the hands or feet (hand-foot -syndrome) or the heart. In these patients, Teysuno is given alone or in combination with other cancer medicines.
What you need to know before taking Teysuno
Do not take Teysuno
– if you are allergic to tegafur, gimeracil, Interacial, or to any other ingredient in this medicine (listed in section 6).
– if you are taking other cancer medicines containing fluoropyrimidines, such as fluorouracil and capecitabine, or have had severe and unexpected reactions to fluoropyrimidines
– if you know that you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency)
– if you are pregnant or breastfeeding
– if you have a serious blood disorder
– if you have a kidney disease that requires dialysis
– if you are being treated or within the last 4 weeks have been treated with brivudine for the treatment of herpes zoster (chicken pox or shingles ).
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, and dehydration
– eye problems, such as “dry eyes” or increased tear production
– or have had hepatitis B virus infection of the liver, as the doctor may want to monitor you more closely
– a partial lack of activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
– a family member with partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
DPD deficiency: DPD deficiency is a genetic disorder that is not usually associated with health problems unless you receive certain medications. If you have DPD deficiency and take Teysuno, you have an increased risk of serious side effects (listed in section 4, Possible side effects ). It is recommended that you be tested for DPD deficiency before starting treatment. If you lack this enzyme activity, you should not take Teysuno. If you have a reduced enzyme activity ( partial deficiency), your doctor will perhaps prescribe a reduced dose. If you test negative for DPD deficiency, you can still have serious and life-threatening side effects.
Children and young people
Teysuno is not recommended for children under 18 years of age.
Other medicines and Teysuno
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
| You must not take brivudine (antiviral medicine used to treat shingles or chickenpox) while you are being treated with Teysuno (including during the rest period when you are not taking any Teysuno capsules). If you have taken brivudine, you must wait at least 4 weeks after stopping brivudine before starting treatment with Teysuno. See also the section “Do not take Teysuno “. |
|---|
You also need to be especially careful if you are taking any of the following:
– other fluoropyrimidine-based drugs, such as the antifungal flucytosine. Teysuno cannot be substituted for other fluoropyrimidine-based medicines taken by mouth.
– inhibitors of the enzyme CYP2A6 that activates Teysuno, such as tranylcypromine and methoxsalen
– folinic acid (often used in chemotherapy with methotrexate)
– blood-thinning medicines: anticoagulants containing coumarin derivatives, such as warfarin
– medicines to treat convulsions or tremors, such as phenytoin
– medicines for the treatment of gout, such as allopurinol
Teysuno with food and drink
Teysuno should be taken at least one hour before or one hour after a meal.
Pregnancy and breastfeeding
Before starting treatment, you must tell the doctor or pharmacist if you are pregnant or if you plan to become pregnant. You must not take Teysuno if you are pregnant or think you may be pregnant.
During and up to 6 months after treatment with Teysuno, you must use contraception. If you become pregnant during this time, you must tell the doctor.
You must not breastfeed if you are taking Teysuno.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Be careful when driving or using machines, as Teysuno can make you tired, nauseous, or have blurred vision. Talk to your doctor if you are unsure.
Teysuno contains lactose (a type of sugar). If you have an intolerance to certain sugars, you should consult a doctor before taking this medication.
How to take Teysuno
Always take Teysuno as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The doctor will tell you what dose you must take, when to take it and how long you must take it. The dose of Teysuno is determined by the doctor based on your weight and height. The doctor can reduce the dose if you get side effects that are too severe.
Teysuno capsules should be swallowed with water at least 1 hour before or 1 hour after a meal. Teysuno must be taken twice daily (morning and evening).
Against stomach cancer:
Teysuno capsules are usually taken for 21 days followed by a 7-day rest period (when no capsules are taken). This 28-day period is a treatment cycle. The cycles repeat.
Teysuno is given together with another cancer medicine called cisplatin. Treatment with cisplatin is discontinued after 6 treatment cycles. Treatment with Teysuno can be continued after treatment with cisplatin has been discontinued.
For colon or rectal cancer that has spread:
Teysuno capsules are usually taken for 14 days followed by a rest period of 7 days (when no capsules are taken). This 21-day period is a treatment cycle. The cycles repeat.
Teysuno can be given together with other cancer medicines (cisplatin, oxaliplatin, irinotecan, or bevacizumab); it depends on the treatment you are receiving.
If you have taken too much Teysuno
Contact a doctor immediately if you have taken too many capsules.
If you forget to take Teysuno
Do not take the missed dose at all and do not take a double dose to make up for the missed dose. Instead, continue according to your usual dosage schedule and talk to the doctor.
If you stop taking Teysuno
There are no side effects when treatment with Teysuno is interrupted. If you use blood-thinning medicines or epilepsy medicines, stopping treatment with Teysuno may require your doctor to adjust the dose of one of your medicines.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Teysuno can cause side effects, although not everybody gets them. Although patients themselves can easily identify some symptoms as side effects, a blood test is required to identify certain other symptoms. The doctor will discuss this with you, as well as explain the possible risks and benefits of your treatment.
Very common side effects (which may affect more than 1 in 10 users) include:
- Diarrhea, nausea, vomiting, constipation
- If you have diarrhea more than 4 times a day or in the middle of the night, or if you have a sore mouth and diarrhea, stop taking Teysuno and contact your doctor immediately.
- If you get diarrhea, avoid fiber-rich, fatty, and spicy foods.
- Drink plenty of fluids between meals to replace lost fluids and prevent dehydration, low blood volume, and imbalance of salts or other substances in the blood.
- Make sure you tell the doctor if you feel nauseous and throw up a dose of medicine. Do not substitute a dose for one that has been vomited.
- If you vomit more than twice in 24 hours, stop taking Teysuno and contact your doctor immediately.
- To help manage nausea and vomiting:
- Lie down or take deep breaths when you feel nauseous
- Avoid tight clothing
- Low red blood cell count causing anemia:
- You may have symptoms such as cold hands and feet, paleness, dizziness, fatigue, and shortness of breath.
- If you get any of the above-mentioned symptoms, try not to work too hard and get plenty of sleep and rest.
- Low white blood cell count that increases the risk of severe local infections (e.g. in the mouth, lungs, urine) or blood infections:
- You may get symptoms such as fever, chills, cough, and sore throat.
- If you develop a fever of 38.5°C or higher, stop taking Teysuno and contact your doctor immediately.
- To prevent infection, avoid crowded places, gargle when you get home, and wash your hands before meals, as well as before and after going to the toilet.
- A low number of blood platelets which increases the risk of bleeding:
- If you have bleeding in the skin, mouth (caused by brushing your teeth), nose, respiratory tract, stomach, intestine, etc. stop taking Teysuno and contact your doctor immediately.
- To prevent bleeding, avoid hard work or strenuous activities to prevent injury and bruising. Wear loose clothing to protect the skin. Brush your teeth and wash carefully.
- Loss of appetite ( anorexia ) can lead to weight loss and dehydration
- You can become dehydrated if you don’t eat and/or drink enough water.
- If you become dehydrated, you may experience symptoms such as dry mouth, weakness, dry skin, dizziness, and cramps.
- Try to eat frequent and small meals. Avoid greasy and strong-smelling food. Even if you don’t feel hungry, keep eating as much as you can to maintain good nutrition.
- If you feel tired and have a fever with a loss of appetite, contact your doctor immediately.
- Nervous disorders
- You may experience numbness, tingling, pain, abnormal sensation, muscle weakness, tremors, or difficulty moving.
- Weakness and fatigue, can be side effects caused by other medicines.
Common side effects (may affect 1 to 10 users in 100) include:
- Nerves: headache, dizziness, drowsiness, taste changes
- Eyes: eye problems, discomfort from increased or decreased tear production, vision problems, serious impact on the surface of the eye (cornea) including superficial or deeper wounds (corneal erosion).
- Ears: hearing problems
- Blood vessels: high or low blood pressure, blood clots in the legs and lungs
- Lungs and nasal passages: shortness of breath, cough
- Intestine and mouth: dry mouth, ulcers in the mouth, throat, and esophagus, hiccups, abdominal pain, stomach upset, inflammation of the stomach or intestines, ulcers through the entire wall of the stomach, small intestine, and large intestine.
- Liver: yellow eyes and yellow skin, changes in blood tests showing the liver function
- Skin: hair loss, itching, rash or dermatitis, skin reaction, dry skin, hand and foot reaction (pain, swelling, and redness of hands and/or feet), pigmented skin spots
- Kidneys: decreased urine output, changes in blood tests showing kidney function, decreased kidney function, and kidney failure
- Other: frostbite, weight gain, swelling in specific areas, and pain in muscles and bones
Uncommon side effects (may affect 1 to 10 users in 1,000) include:
- Mental disorders: seeing and hearing things that are not there, personality change, inability to sit still, confusion, nervousness, depression, sexual dysfunction
- Nerves: voice disorders, inability to speak and understand words, memory problems, unsteady gait, balance problems, unilateral weakness of the body, drowsiness, nerve inflammation, distorted sense of smell, brain dysfunction, fainting, loss of consciousness, stroke, convulsions
- Eyes: itchy and red eyes, allergic reactions in the eyes, drooping upper eyelids
- Ears: dizziness, blocked ears, discomfort in the ears
- Heart: irregular or rapid heartbeat, chest pain, fluid accumulation around the heart, heart attack, heart failure
- Blood vessels: vein inflammation, blood spasms
- Lungs and nasal passages: runny nose, voice disturbances, stuffy nose, red throat, hay fever
- Gut and mouth: fluid in the abdomen, gastroesophageal reflux disease, increased salivation, abnormal belching, inflammation of the lips, gastrointestinal disturbances, pain in the mouth, abnormal muscle contractions in the esophagus, blockage of the stomach and intestines, peptic ulcer, retroperitoneal fibrosis, teeth that crack or move easily tears, difficulty swallowing, salivary gland disorders, hemorrhoids
- Skin: fading skin color, scaly skin, excessive body hair, nail shrinkage, profuse sweating
- General: worsening of general condition, weight gain, redness and swelling at the injection site, cancer pain and bleeding, multiple organ failure
- Changes in blood tests: high blood sugar, high blood fats, changes in blood clotting time, high blood cell count, low or high protein level
- Other: frequent urination, blood in the urine, neck pain, back pain, chest pain, tense muscles or muscle cramps, joint swelling, discomfort in arms and legs, muscle weakness, joint inflammation, and joint pain
Rare side effects (may affect 1 to 10 in 10,000 users) and very rare side effects (may affect less than 1 in 10,000 users) include:
- acute liver failure
- infection of the pancreas
- breakdown of muscles
- loss of the sense of smell
- sun allergy
- widespread blood clots and bleeding
- a disease that affects the white matter of the brain
- serious illness with blisters on the skin, in the mouth, and on the genitals
- recurrence (reactivation) of hepatitis B infection when you have previously had hepatitis B (a liver infection)
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor.
If any side effects become serious, stop taking Teysuno and contact a doctor immediately.
How to store Teysuno
– Store out of the sight and reach of children.
– Use before the expiry date stated on the carton (after EXP or EXP) and the blister (after EXP). The expiration date is the last day of the specified month.
– No special storage instructions.
– Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
– The active substances are tegafur, gimeracil and oteracil.
Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil, and 11.8 mg Interacial (as monopotassium).
– 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, glyceryl monooleate
Appearance and package sizes of the medicine
The hard capsules have a white body and an opaque brown body marked with “TC448” in gray. They are supplied in blisters containing 14 capsules each.
Each pack contains either 42 capsules, 84 capsules, or 126 capsules.
Marketing Authorisation Holder
Nordic Group BV
Siriusdreef 41
2132 WT Hoofddorp
Netherlands
Manufacturer
Nordic Pharma BV
Siriusdreef 41
2132 WT Hoofddorp
Netherlands
Millmount Healthcare Limited
Block 7, City North
Business Campus, Stamullen
Co. Meath, K32 YD60
Ireland
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienNordic PharmaTel/Tel: +32 (0)3 820 5224info@nordicpharma.be | LithuaniaNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com |
| BulgariaAMRING FARMA SRL,Tel. : +40 31 620 1204RO.OfficeRomania@nordicpharma.com | Luxembourg/LuxembourgNordic PharmaTel/Tel: +32 (0)3 820 5224info@nordicpharma.be |
| Czech RepublicNORDIC Pharma, s.r.oPhone: +420 241 080 770info@nordicpharma.cz | MagyarországNORDIC Pharma, s.r.oPhone: +420 241 080 770info@nordicpharma.cz |
| DenmarkNordic DrugsTel: +46 (0)40 36 66 00info@nordicdrugs.se | MaltaNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com |
| DeutschlandNordic PharmaPhone: +49 (0)89 889 690 680info@nordicpharma.de | The NetherlandsNordic Pharma BVPhone: +31 (0)85 48 35 871info-nl@nordicpharma.com |
| EstoniaNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com | NorwayNordic DrugsPhone: +46 40 36 66 00info@nordicdrugs.no |
| GreeceAenorasis SAPhone: +30 210 6136332info@aenorasis.gr | AustriaNordic PharmaPhone: +49 (0)89 889 690 680info@nordicpharma.de |
| SpainNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com | PolishAMRING FARMA SRL,Tel. : +40 31 620 1204RO.OfficeRomania@nordicpharma.com |
| FranceNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com | PortugalNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com |
| HrvatskaNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com | RomaniaAMRING FARMA SRL,Tel. : +40 31 620 1204RO.OfficeRomania@nordicpharma.com |
| IrelandNordic Pharma IrelandPhone: +353 (0)1 400 4141info@nordicpharma.ie | SlovenijaNORDIC Pharma, s.r.oTel.: +420 241 080 770info@nordicpharma.cz |
| IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is | Slovenian RepublicNORDIC Pharma, s.r.oTel.: +420 241 080 770info@nordicpharma.cz |
| ItalyNordic PharmaPhone: +39 (0)2 241 26710/26711info@nordicpharma.it | Finland/FinlandNordic DrugsPh: +358 (0)10 231 1040info@nordicdrugs.fi |
| CyprusNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com | SwedenNordic Drugs ABPhone: +46 (0)40 36 66 00info@nordicdrugs.se |
| LatviaNordic Pharma (France)Tel/Τηλ/Tel/Tel.: +33 (0)1 70 37 28 00info@nordicpharma.com | United Kingdom (Northern Ireland)Nordic Pharma IrelandPhone: +353 (0)1 400 4141info@nordicpharma.ie |