Teysuno 20 mg/5.8 mg/15.8 mg hard capsules

Teysuno belongs to the fluoropyrimidine class of medicine known as ?antineoplastic agents? which stop the growth of cancer cells.

Teysuno is prescribed by doctors for the treatment of adults with advanced stomach (gastric) cancer and is taken with cisplatin, another anti-cancer medicine.

Do not take Teysuno if you:

• are allergic (hypersensitive) to tegafur, gimeracil, oteracil or any of the other ingredients of Teysuno
• are taking other fluoropyrimidine anti-cancer medicine such as fluorouracil and capecitabine, or have had severe and unexpected reactions to fluoropyrimidines
• have known genetic deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
• are pregnant or breastfeeding
• have severe blood disorders
• have severe kidney problems
• are currently being treated or have been treated in the last 4 weeks with sorivudine, brivudine or a similar class of anti-viral medicines

Take special care with Teysuno

• Before treatment with Teysuno, tell your doctor if you have:
• blood disorders
• kidney disease
• stomach and/or bowel problems such as pain, diarrhoea, vomiting and dehydration
• eye disorders, such as ?dry eye? or increased tearing
• Teysuno is not recommended for children under 18 years of age.
• Teysuno cannot be substituted for other oral fluoropyrimidine medicine.

Taking other medicines
Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines. You need to be particularly careful if you are taking any of the following:

• other fluoropyrimidine based medicines such as the anti-fungal flucytosine
• antivirals such as brivudine or sorivudine
• inhibitors of the enzyme CYP2A6 which activates Teysuno such as tranylcypromine and methoxsalen
• folinic acid (often used in chemotherapy with methotrexate)
• blood-thinning medicines: coumarin-derivative anticoagulants such as warfarin
• medicines for the treatment of seizures or tremors such as phenytoin
• medicines that treat gout such as allopurinol

Taking 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 your doctor or pharmacist if you are pregnant, if you think you are pregnant, or if you intend to become pregnant. You must not take Teysuno if you are pregnant or think you might be.
During and up to 6 months after treatment with Teysuno, you must use contraceptive measures. If you become pregnant during this time, you must tell your doctor.
You must not breastfeed if you are taking Teysuno.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Use caution when driving or operating a machine, as Teysuno may make you tired, nauseous or have blurred vision. If you have any doubts talk to your doctor.

Important information about some of the ingredients of Teysuno

This medicine contains lactose (one 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.

Always take Teysuno exactly as your doctor has told you. You should check with your doctor if you are not sure.

Your doctor will tell you what dose you need to take, when to take it and for how long you need to 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 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).

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 one treatment cycle. The cycles are repeated.

Teysuno will be given with another anti-cancer medicine called cisplatin. Cisplatin will be stopped after 6 treatment cycles. 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 at all and do not double the next one. Instead, continue your regular dosing schedule and check with your doctor.

If you stop taking Teysuno

There are no side effects caused by stopping treatment with Teysuno. In case you are using blood thinning or anti-seizure medications, stopping Teysuno might require that your doctor adjusts the dose of your medications.

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

Like all medicines, Teysuno can cause side effects, although not everybody gets them. While some symptoms are easily identified as side effects by the patients themselves, a blood test is required to identify some other symptoms. Your doctor will discuss this with you and will explain the possible risks and benefits of the treatment.

If you are concerned about the side effects below, talk to your doctor.

Very common side effects (affect more than 1 user in 10) include:

• Diarrhoea, nausea, vomiting, constipation
• If you experience diarrhoea more than 4 times a day or in the middle of the night, or if you experience sore mouth accompanied by diarrhoea, stop taking Teysuno and contact your doctor immediately.
• If you experience diarrhoea, avoid high-fibre, fatty and spicy foods.
• Take plenty of liquids between meals to replace lost fluids and prevent dehydration, low blood volume, andimbalance of salts or chemicals in the blood.
• If you experience nausea and vomit a dose of medication, make sure you tell your doctor. Do not replace the dose that has been vomited.
• If you vomit more than two times in 24 hours, stop taking Teysuno and contact your doctor immediately.
• To help manage nausea and vomiting: - Lie down or take deep breaths when feeling nauseous - Avoid tight clothing
• Low red blood cell count leading to anaemia
• You may have symptoms such as cold hands and feet, looking pale, light-headedness, fatigue, breathlessness.
• If you experience any of the above-mentioned symptoms, try not to work too hard and get ample sleep and rest.
• Low white blood cell count leading to increased risk of severe local (e.g.,oral, lung, urine) or blood infections
• You may have symptoms such as fever, chills, coughing, sore throat. o If you have fever of 38.5 o C or higher, stop taking Teysuno and contact your doctor immediately.
• To prevent infection, keep away from crowded places, gargle upon returning home, and wash your hands before meals and before and after using the bathroom.
• Low platelet count leading to an increased chance of bleeding
• If you have bleeding of the skin, mouth (caused by brushing teeth), nose, respiratory tract, stomach, gut, etc. , stop taking Teysuno and contact your doctor immediately.
• To prevent bleeding, avoid hard work or strenuous sports so as to prevent injuries and bruises. Wear loose clothing to protect the skin. Brush your teeth and blow your nose gently.
• Loss of apetite (anorexia) can lead to weight loss and dehydration
• You may become dehydrated if you do not eat and/or drink enough water.
• If you become dehydrated you may have symptoms such as dry mouth, weakness, dry skin, dizziness, cramping
• Try to eat frequent small meals. Avoid fatty and strong-smelling food. Even if you do not feel hungry, continue to eat as much as you can to maintain good nutrition.
• If you feel tired and have fever together with loss of appetite, contact your doctor immediately.
• Nerve disorder: you may feel numbness, tingling, pain, abnormal sensation, weak muscle, shaking, or movement difficulties.
• Weakness and fatigue, which could be side effects caused by other medicines.

Common side effects (affect 1 to 10 users in 100) include:

• Nerve: headache, dizziness, sleeplessness, changes in taste
• Eye: eye problems, increased or decreased tearing discomfort, vision problems
• Ear: hearing problems
• Blood vessels: high or low blood pressure, blood clots in the leg and lung
• Lung and nasal passages: shortness of breath, cough
• Gut and mouth: dry mouth, sores in mouth, throat, and oesophagus, hiccups, abdominal pain, indigestion, stomach or bowel inflammation, perforation of the stomach, small intestine, and large bowel.
• Liver: yellow eyes and skin, changes in blood tests which show the way the liver is working,
• Skin: hair loss, itchiness, rash or dermatitis, skin reaction, dry skin, hand-and-foot reaction (pain, swelling and redness of hands and/or feet), pigmented skin patches
• Kidney: decreased urine volume, changes in blood tests which show the way the kidney is working, kidney impairment and failure
• Other: chills, weight decrease, swelling in specific areas and muscle bone pain

Uncommon side effects (affect 1 to 10 users in 1,000) include:

- Mental: seeing and hearing some things that are not there, personality change, unable to sit still, confusion, feeling of nervousness, depression, sexual dysfunction

• Nerve:, voice disorder, inability to speak and understand words, memory problem, unsteady gait, balance problems, one sided body weakness, sleepiness, nerve inflammation, distorted sense of smell, brain dysfunction, fainting, loss of consciousness, stroke, seizures
• Eye: itchy and red eyes, allergic reactions in eyes, drooping upper eyelid
• Ear: vertigo, ear clogging, ear discomfort
• Heart: irregular or fast heart beat, chest pain, accumulation of excess fluid around the heart, heart attack, heart failure
• Blood vessels: inflammation of a vein, hot flush
• Lung and nasal passages: runny nose, voice disorder,nasal clogging, pharyngeal erythema, hay fever
• Gut and mouth: fluid in the abdomen, gastroesophageal reflux disease, increased salivary secretion, excessive burping and belching, lip inflammation, gastrointestinal disorder, oral pain, abnormal contractions of muscles of the oesophagus, blockage in the stomach and intestine, stomach ulcer, retroperitoneal fibrosis, teeth that crack or break easily, swallowing difficulty, disorder of the salivary gland, haemorrhoids
• Skin: loss of skin colour, peeling skin, excessive body hair, nail shrinkage, excessive sweating,
• General: general condition worsening, weight increase, redness and swelling at the injection site, cancer pain and bleeding, multiple organ failure
• Changes in blood tests: high blood sugar, high blood lipids, changes in blood clotting time, high blood cell counts, low or high protein level
• Other: frequent urination, blood in urine, neck pain, back pain, breast pain, muscle tightness or cramps, joint swelling, limb discomfort, muscle weakness, arthritis inflammation and pain

Rare side effects (affect 1 to 10 users in 10,000) and very rare side effects (affect less than 1 user in 10,000) include:

• acute liver failure
• pancreas infection
• muscle breakdown
• loss of sense of smell
• sun allergy
• loss of a portion of the surface ?skin? of the eye (corneal erosion)
• widespread blood clotting and bleeding
• disease affecting the white matter of the brain
• serious illness with blistering of the skin, mouth, eyes, and genitals

If you experience 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 get serious, stop taking Teysuno and tell your doctor immediately.

• Keep out of the reach and sight of children.
• Do not use Teysuno after the expiry date which is stated on the outer carton and blister after EXP. The expiry date refers to the last day of the month.
• This medicine does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Teysuno contains

• The active substances are tegafur, gimeracil and oteracil. Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil, and 19.6 mg oteracil monopotassium corresponding to 15.8 mg oteracil.
• The other ingredients are:

Capsule contents: lactose monohydrate, magnesium stearate
Capsule shells: gelatin, titanium dioxide (E171), sodium lauryl sulphate,
talc
Ink: red iron oxide (E172), yellow iron oxide (E172), FD&C Blue No. 2 aluminium lake (E132), carnauba wax, bleached shellac, glyceryl monooleate

What Teysuno looks like and contents of the pack

The hard capsules have a white body and white cap imprinted "TC442" in grey.

Each pack contains either 42 capsules (3 blisters of 14 capsules each) or
84 capsules (6 blisters of 14 capsules each)

Marketing Authorisation Holder

Taiho Pharma Europe, Limited
55 Colmore Row, Birmingham
West Midlands, B3 2AS
United Kingdom

Manufacturer

Brecon Pharmaceuticals Ltd.
Wye Valley Business Park
Hay-on-Wye
Hereford, HR3 5PG
United Kingdom

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