HYCAMTIN 0.25 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

TOPOTECAN AS HYDROCHLORIDE

Commercializzato da:

NOVARTIS ISRAEL LTD

Codice ATC:

L01XX17

Forma farmaceutica:

HARD GELATIN CAPSULES

Composizione:

TOPOTECAN AS HYDROCHLORIDE 0.25 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

GLAXO SMITH KLINE MANUFACTURING S.P.A., ITALY

Gruppo terapeutico:

TOPOTECAN

Area terapeutica:

TOPOTECAN

Indicazioni terapeutiche:

Indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

Data dell'autorizzazione:

2014-07-31

Foglio illustrativo

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed according to a
physician’s prescription only
HYCAMTIN
® 0.25 MG
HYCAMTIN
® 1 MG
Hard gelatin capsules
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each Hycamtin 0.25 mg capsule contains
0.25 mg Topotecan (as Hydrochloride).
Each Hycamtin 1 mg capsule contains 1 mg
Topotecan (as Hydrochloride).
List of the additional ingredients detailed in
section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE
USING THE MEDICINE. This leaflet contains
concise information about the medicine. If you
have any other questions, refer to the physician
or the pharmacist.
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them even
if it seems to you that their medical condition
is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
HYCAMTIN IS USED TO TREAT:
patients with relapsed small cell lung cancer
(SCLC) for whom retreatment with the first-line
regimen is not considered appropriate.
Your physician will decide with you whether
Hycamtin therapy is better than further
treatment with your initial chemotherapy.
THERAPEUTIC GROUP
Antineoplastic agent
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
∙ IF YOU ARE SENSITIVE (ALLERGIC) to topotecan
or to any of the additional ingredients
contained in the medicine (listed in Section
6).
∙ Do not use the medicine if you are BREAST-
FEEDING.
∙ IF YOUR BLOOD CELL COUNTS ARE TOO LOW.
Your physician will tell you whether this is
the case, based on the results of your last
blood test.
TELL YOUR PHYSICIAN if any of these applies
to you.
SPECIAL WARNINGS REGARDING THE USE OF THE
MEDICINE
BEFORE THE TREATMENT WITH HYCAMTIN, TELL
THE PHYSICIAN IF:
∙ YOU HAVE ANY KIDNEY OR LIVER PROBLEMS.
Your dose of Hycamtin may need to be
adjusted.
∙ YOU ARE PREGNANT OR ARE PLANNING TO
BECOME PREGNANT (see "Pregnancy and
breast-feeding" section).
∙ YOU PLAN TO FATHER A CHILD (see "Pregnancy
and breast-feeding" section).
TELL YOUR PHYSICIAN if any of these applie

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