Teysuno 20mg5.8mg15.8mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Tegafur; Gimeracil; Oteracil potassium

Διαθέσιμο από:

Nordic Pharma Ltd

Φαρμακολογική κατηγορία (ATC):

L01BC53

INN (Διεθνής Όνομα):

Tegafur; Gimeracil; Oteracil potassium

Δοσολογία:

20mg ; 5.8mg ; 15.8mg

Φαρμακοτεχνική μορφή:

Capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Never Valid To Prescribe As A VMP

Περίληψη προϊόντος:

BNF: 08010300

Φύλλο οδηγιών χρήσης

2
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.
-
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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Teysuno is and what it is used for
2.
Before you take Teysuno
3.
How to take Teysuno
4.
Possible side effects
5.
How to store Teysuno
6.
Further information
1.
WHAT TEYSUNO IS AND WHAT IT IS USED FOR
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.
BEFORE YOU TAKE TEYSUNO
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 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
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

Αρχείο Π.Χ.Π.

OBJECT 1
TEYSUNO 20MG/5.8MG/15.8MG HARD CAPSULES
Summary of Product Characteristics Updated 31-May-2018 | Nordic Pharma
Limited
1. Name of the medicinal product
Teysuno 20 mg/5.8 mg/15.8 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil and 15.8 mg
oteracil (as monopotassium).
Excipient with known effect
Each hard capsule contains 93.6 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule (capsule).
The capsule has an opaque white body and opaque white cap imprinted
“TC442” in grey.
4. Clinical particulars
4.1 Therapeutic indications
Teysuno is indicated in adults for the treatment of advanced gastric
cancer when given in combination
with cisplatin (see section 5.1).
4.2 Posology and method of administration
Teysuno should only be prescribed by a qualified physician experienced
in treating cancer patients with
anti-neoplastic medicinal products.
Posology
The recommended standard dose of Teysuno when administered in
combination with cisplatin is 25
mg/m
2
(expressed as tegafur content) twice daily, morning and evening, for
21 consecutive days followed
by 7 days rest (1 treatment cycle). This treatment cycle is repeated
every 4 weeks.
The standard and reduced Teysuno and cisplatin doses and calculations
according to body surface area
(BSA) for doses of Teysuno given in combination with cisplatin are
provided in Table 1 and Table 2,
respectively. The patient's BSA must be recalculated and the Teysuno
dose adjusted accordingly if a
patient's weight increases or decreases by ≥10% from the one used
for the previous calculation of BSA
and the change is clearly not related to fluid retention.
The recommended dose of cisplatin with this regimen is 75 mg/m
2
by intravenous infusion administered
once every 4 weeks. Cisplatin should be discontinued after 6 cycles
without withdrawal of Teysuno. If
cisplatin is discontinued before 6 cycles, Teysuno treatment alone can
be resumed when the criteria