Teysuno

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Teysuno
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Teysuno
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • Antineoplastic agents,
  • Żona terapewtika:
  • Stomach Neoplasms
  • Indikazzjonijiet terapewtiċi:
  • Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin.
  • Sommarju tal-prodott:
  • Revision: 15

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Authorised
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/001242
  • Data ta 'l-awtorizzazzjoni:
  • 13-03-2011
  • Kodiċi EMEA:
  • EMEA/H/C/001242
  • L-aħħar aġġornament:
  • 29-03-2019

Rapport ta 'Valutazzjoni Pubblika

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

EMA/20503/2012

EMEA/H/C/001242

EPAR summary for the public

Teysuno

tegafur/gimeracil/oteracil

This is a summary of the European public assessment report (EPAR) for Teysuno. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Teysuno.

What is Teysuno?

Teysuno is a medicine that contains the active substances tegafur, gimeracil and oteracil. It is available

as capsules containing 15 mg tegafur with 4.35 mg gimeracil and 11.8 mg oteracil, and as capsules

containing 20 mg tegafur with 5.8 mg gimeracil and 15.8 mg oteracil.

What is Teysuno used for?

Teysuno is used to treat adults with advanced gastric (stomach) cancer. It is used in combination with

cisplatin (another anticancer medicine).

The medicine can only be obtained with a prescription.

How is Teysuno used?

Teysuno should only be prescribed by a qualified doctor experienced in treating cancer patients with

anticancer medicines.

Teysuno is used together with cisplatin, in a 4-week cycle starting on the day of the cisplatin

administration. The dose to be taken is calculated based on the active substance tegafur and the

patient’s body surface area (calculated using the patient’s height and weight). The recommended dose

for one cycle of treatment is 25 mg/m

twice a day (in the morning and evening) for three weeks,

followed by a one-week rest period. The cycle is repeated every four weeks, including once cisplatin

administration is stopped after six cycles. Teysuno capsules are taken with water at least one hour

before or after a meal. For more information on the use of Teysuno, including how to use it with

cisplatin, see the summary of product characteristics (also part of the EPAR).

How does Teysuno work?

The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that

are dividing, such as cancer cells) that belongs to the ‘anti-metabolites’ group. Tegafur is a ‘prodrug’

that is converted in the body to a chemical called 5-fluorouracil (5-FU). 5-FU is similar to pyrimidine, a

substance found in the genetic material of cells (DNA and RNA). In the body, 5-FU takes the place of

pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it prevents the

growth of cancer cells and eventually kills them.

The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer

side effects: gimeracil by preventing the breakdown of 5-FU and oteracil by reducing the activity of 5-

FU in normal, non-cancerous tissue in the gut.

How has Teysuno been studied?

In the main study, Teysuno was compared with the anticancer medicine 5-FU given as an infusion in

1,053 adults with advanced gastric cancer. Both medicines were given with cisplatin. The main

measure of effectiveness was how long the patients lived.

What benefit has Teysuno shown during the studies?

Treatment with Teysuno capsules was as effective as treatment with 5-FU infusions. Patients receiving

Teysuno with cisplatin lived for an average of 8.6 months compared with 7.9 months for patients

receiving 5-FU with cisplatin.

What is the risk associated with Teysuno?

In patients treated with Teysuno in combination with cisplatin, the most common severe side effects

(seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood

cell), anaemia (low red blood cell counts) and fatigue (tiredness). For the full list of all side effects

reported with Teysuno, see the package leaflet.

Teysuno must not be used in people who are hypersensitive (allergic) to any of the active substances

or any of the other ingredients. It must also not be used in the following groups:

patients currently receiving another fluoropyrimidine (a group of anticancer medicines that includes

Teysuno) or who have had severe and unexpected reactions to fluoropyrimidines;

patients with a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) as well as

patients who, within the previous four weeks, have been treated with a medicine that inhibits this

enzyme;

pregnant or breast-feeding women;

patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or

platelets in the blood);

patients with severe kidney problems requiring dialysis;

patients who should not be receiving cisplatin.

Teysuno

EMA/20503/2012

Page 2/3

Teysuno

EMA/20503/2012

Page 3/3

Why has Teysuno been approved?

The CHMP decided that Teysuno’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

Other information about Teysuno

The European Commission granted a marketing authorisation valid throughout the European Union for

Teysuno on 14 March 2011.

The full EPAR for Teysuno can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Teysuno,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2012.

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B. 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. Do not pass it on to others. It may harm them, even

if their symptoms are the same as yours.

If you get any side effects, talk to your doctor. This includes any possible any side effects not

listed in this leaflet. See section 4.

What is in this leaflet:

What Teysuno is and what it is used for

What you need to know before you take Teysuno

How to take Teysuno

Possible side effects

How to store Teysuno

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 the fluoropyrimidine class of medicines 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.

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).

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 breast-feeding

have severe blood disorders

have kidney disease requiring dialysis

are currently being treated or have been treated in the last 4 weeks with sorivudine, brivudine or

a similar class of anti-viral medicines

Warnings and precautions

Talk to your doctor before taking Teysuno 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

a current or previous infection of the liver with the hepatitis B virus, since your doctor

may want to monitor you more closely

Children and adolescents

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 need to

be particularly careful if you are taking any of the following:

- other fluoropyrimidine based medicines such as the anti-fungal flucytosine.

Teysuno cannot be

substituted for other oral fluoropyrimidine medicine.

- 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

Teysuno with food and drink

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

Pregnancy and breast-feeding

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.

Teysuno 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.

3.

How to take Teysuno

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 take a double dose to make up for a forgotten dose.

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 medicines, stopping Teysuno might require that your doctor adjusts the dose

of your medicines.

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

4.

Possible side effects

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.

Very common side effects (may affect more than 1 in 10 people) 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, and imbalance 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.

If you have fever of 38.5

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 (may affect 1 to 10 in 100 people) include:

-

Nerve: headache, dizziness, sleeplessness, changes in taste

-

Eye

eye problems, increased or decreased tearing discomfort, vision problems, serious illness

with blistering of the eyes, wearing away of the surface “skin” of the eye (corneal erosion).

-

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 (may affect 1 to 10 in 1,000 people) 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 (may affect 1 to 10 in 10,000 people) and very rare side effects (may affect less

than 1 in 10,000 people) include:

acute liver failure

pancreas infection

muscle breakdown

loss of sense of smell

sun allergy

widespread blood clotting and bleeding

disease affecting the white matter of the brain

serious illness with blistering of the skin, mouth and genitals

recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver

infection)

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.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via 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.

How to store Teysuno

Keep out of the sight and reach of children.

Do not use this medicine 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

to throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other 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

monopotassium).

The other ingredients are:

Capsule contents: lactose monohydrate, magnesium stearate

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

talc

Ink: red iron oxide (E172), yellow iron oxide (E172), Indigo carmine (E132), carnauba wax,

bleached shellac, glyceryl monooleate

What Teysuno looks like and contents of the pack

The hard capsules have a white body and opaque brown cap imprinted "TC448" in grey. They are

provided in blisters containing 14 capsules each.

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

Marketing Authorisation Holder

Nordic Group BV

Siriusdreef 22

2132 WT Hoofddorp

The Netherlands

Manufacturer

Nordic Pharma

Tolweg 15

3741 LM Baarn

The Netherlands

QPharma AB

Agneslundsvagen 27

P.O. Box 590

SE-201 25 Malmo

Sweden

AndersonBrecon (UK) Limited

Wye Valley Business Park

Hay-on-Wye, Hereford

HR3 5PG

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Nordic Pharma

Tél/Tel: +32 (0)3 820 5224

info@nordicpharma.be

Lietuva

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

България

NORDIC Pharma, s.r.o.

Tel: +420 241 080 770

info@nordicpharma.cz

Luxembourg/Luxemburg

Nordic Pharma

Tél/Tel: +32 (0)3 820 5224

info@nordicpharma.be

Česká republika

NORDIC Pharma, s.r.o.

Tel: +420 241 080 770

info@nordicpharma.cz

Magyarország

NORDIC Pharma, s.r.o.

Tel: +420 241 080 770

info@nordicpharma.cz

Danmark

Nordic Drugs

Tlf: +45 70 20 08 40

info@nordicdrugs.dk

Malta

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Deutschland

Nordic Pharma

Tel: +49 (0)89 889 690 680

info@nordicpharma.de

Nederland

Nordic Pharma BV

Tel: +31 (0)35 54 80 580

info@nordicpharma.nl

Eesti

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Norge

Nordic Drugs

Tlf: +46 40-36 66 00

info@nordicdrugs.no

Ελλάδα

Aenorasis S.A.

Τηλ: +30 210 6136332

info@aenorasis.gr

Österreich

Nordic Pharma

Tel: +49 (0)89 889 690 680

info@nordicpharma.de

España

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Polska

NORDIC Pharma, s.r.o.

Tel: +420 241 080 770

info@nordicpharma.cz

France

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Portugal

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Hrvatska

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Ireland

Nordic Pharma Ireland

Tel: +353 (0)1 400 4141

info@nordicpharma.ie

România

NORDIC Pharma, s.r.o.

Tel.: +420 241 080 770

info@nordicpharma.cz

Slovenija

NORDIC Pharma, s.r.o.

Tel.: +420 241 080 770

info@nordicpharma.cz

Ísland

Vistor hf.

Sími: +354 535 7000

vistor@vistor.is

Slovenská republika

NORDIC Pharma, s.r.o.

Tel.: +420 241 080 770

info@nordicpharma.cz

Italia

Nordic Pharma

Tel: +39 (0)2 241 26710/26711

info@nordicpharma.it

Suomi/Finland

Nordic Drugs

Puh/Tel: +358 (0)10 231 1040

info@nordicdrugs.fi

Κύπρος

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Sverige

Nordic Drugs AB

Tel: +46 (0)40 36 66 00

info@nordicdrugs.se

Latvija

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

United Kingdom

Nordic Pharma

Tel: +44 (0) 118 207 916

info@nordicpharma.co.uk

This leaflet was last revised in

Other sources of information

Detailed information this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu .

Package leaflet: Information for the user

Teysuno 20 mg/5.8 mg/15.8 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. Do not pass it on to others. It may harm them, even

if their symptoms are the same as yours.

If you get any side effects, talk to your doctor . This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet:

What Teysuno is and what it is used for

What you need to know before you take Teysuno

How to take Teysuno

Possible side effects

How to store Teysuno

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 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.

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).

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 breast-feeding

have severe blood disorders

have kidney disease requiring dialysis

are currently being treated or have been treated in the last 4 weeks with sorivudine, brivudine or

a similar class of anti-viral medicines

Warnings and precautionsTalk to your doctor before taking teysuno 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

a current or previous infection of the liver with the hepatitis B virus, since your doctor

may want to monitor you more closely

Children and adolescents

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 need to

be particularly careful if you are taking any of the following:

- other fluoropyrimidine based medicines such as the anti-fungal flucytosine.

Teysuno cannot be

substituted for other oral fluoropyrimidine medicine.

- 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

Teysuno with food and drink

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

Pregnancy and breast-feeding

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.

Teysuno 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.

3.

How to take Teysuno

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 take a double dose to make up for a forgotten dose.

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 medicines, stopping Teysuno might require that your doctor adjusts the dose

of your ines.

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

4.

Possible side effects

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.

Very common side effects (may affect more than 1 in 10people) 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, and imbalance 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.

If you have fever of 38.5

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 (may affect 1 to 10 in 100 people) include:

-

Nerve: headache, dizziness, sleeplessness, changes in taste

-

Eye

eye problems, increased or decreased tearing discomfort, vision problems, serious illness

with blistering of the eyes, wearing away of the surface “skin” of the eye (corneal erosion)

-

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 (may affect 1 to 10 in 1,000 people) 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 (may affect 1 to 10 in 10,000 people) and very rare side effects (may affect less

than 1 in 10,000 people) include:

acute liver failure

pancreas infection

muscle breakdown

loss of sense of smell

sun allergy

widespread blood clotting and bleeding

disease affecting the white matter of the brain

serious illness with blistering of the skin, mouth and genitals

recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver

infection)

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.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via 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.

How to store Teysuno

Keep out of the sight and reach 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

to throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Teysuno contains

The active substances are tegafur, gimeracil and oteracil.

Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil, and 15.8 mg oteracil (as

monopotassium).

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), Indigo carmine (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. They are provided in

blisters containing 14 capsules each.

Each pack contains 42 capsules or

84 capsules.

Marketing Authorisation Holder

Nordic Group BV

Siriusdreef 22

2132 WT Hoofddorp

The Netherlands

Manufacturer

Nordic Pharma

Tolweg 15

3741 LM Baarn

The Netherlands

QPharma AB

Agneslundsvagen 27

P.O. Box 590

SE-201 25 Malmo

Sweden

AndersonBrecon (UK) Limited

Wye Valley Business Park

Hay-on-Wye, Hereford

HR3 5PG

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Nordic Pharma

Tél/Tel: +32 (0)3 820 5224

info@nordicpharma.be

Lietuva

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

България

NORDIC Pharma, s.r.o.

Tel: +420 241 080 770

info@nordicpharma.cz

Luxembourg/Luxemburg

Nordic Pharma

Tél/Tel: +32 (0)3 820 5224

info@nordicpharma.be

Česká republika

NORDIC Pharma, s.r.o.

Tel: +420 241 080 770

info@nordicpharma.cz

Magyarország

NORDIC Pharma, s.r.o.

Tel: +420 241 080 770

info@nordicpharma.cz

Danmark

Nordic Drugs

Tlf: +45 70 20 08 40

info@nordicdrugs.dk

Malta

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Deutschland

Nordic Pharma

Tel: +49 (0)89 889 690 680

info@nordicpharma.de

Nederland

Nordic Pharma BV

Tel: +31 (0)35 54 80 580

info@nordicpharma.nl

Eesti

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Norge

Nordic Drugs

Tlf: +46 40-36 66 00

info@nordicdrugs.no

Ελλάδα

Aenorasis S.A.

Τηλ: +30 210 6136332

info@aenorasis.gr

Österreich

Nordic Pharma

Tel: +49 (0)89 889 690 680

info@nordicpharma.de

España

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Polska

NORDIC Pharma, s.r.o.

Tel: +420 241 080 770

info@nordicpharma.cz

France

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Portugal

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Hrvatska

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

Ireland

Nordic Pharma Ireland

Tel: +353 (0)1 400 4141

info@nordicpharma.ie

România

NORDIC Pharma, s.r.o.

Tel.: +420 241 080 770

info@nordicpharma.cz

Slovenija

NORDIC Pharma, s.r.o.

Tel.: +420 241 080 770

info@nordicpharma.cz

Ísland

Vistor hf.

Sími: +354 535 7000

vistor@vistor.is

Slovenská republika

NORDIC Pharma, s.r.o.

Tel.: +420 241 080 770

info@nordicpharma.cz

Italia

Nordic Pharma

Tel: +39 (0)2 241 26710/26711

info@nordicpharma.it

Suomi/Finland

Nordic Drugs

Puh/Tel: +358 (0)10 231 1040

info@nordicdrugs.fi

Κύπρος

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

Sverige

Nordic Drugs AB

Tel: +46 (0)40 36 66 00

info@nordicpharma.com

info@nordicdrugs.se

Latvija

Nordic Pharma (France)

Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00

info@nordicpharma.com

United Kingdom

Nordic Pharma

Tel: +44 (0) 118 207 9160

info@nordicpharma.co.uk

This leaflet was last revisedin

Other sources of information

Detailed information this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu .