ADVECIT 100MG CAPSULE,HARD

Country: Կիպրոս

language: հունարեն

source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

active_ingredient:

TEMOZOLOMIDE

MAH:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

ATC_code:

L01AX03

INN:

TEMOZOLOMIDE

dosage:

100MG

pharmaceutical_form:

CAPSULE,HARD

composition:

TEMOZOLOMIDE (0085622931) 100MG

administration_route:

ORAL USE

prescription_type:

Εθνική Διαδικασία

therapeutic_area:

TEMOZOLOMIDE

leaflet_short:

Νομικό καθεστώς: Με Ιατρική Συνταγή; BOTTLE WITH 5 CAPS (310005901) 5 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; BOTTLE WITH 20 CAPS (310005902) 20 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 5 CAPS IN SACHETS (310005903) 5 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή

PIL

COMPARATIVE TABLE PIL-EN VS PIL-GR
Package leaflet: Information for the user
Advecit 5 mg Ηard gelatin capsules
Advecit 20 mg Ηard gelatin capsules
Advecit 100 mg Ηard gelatin capsules
Advecit 140 mg Ηard gelatin capsules
Advecit 180 mg Ηard gelatin capsules
Advecit 250 mg Ηard gelatin capsules
temozolomide
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, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1.
What Advecit is and what it is used for
2.
What you need to know before you take Advecit
3.
How to take Advecit
4.
Possible side effects
5.
How to store Advecit
6.
Contents of the pack and other information
Φύλλο οδηγιών χρήσης: Πληροφορίες για
τον χρήστη
Advecit 5 mg Σκληρά καψάκια ζελατίνης
Advecit 20 mg Σκληρά καψάκια ζελατίνης
Advecit 100 mg Σκληρά καψάκια ζελατίνης
Advecit 140 mg Σκληρά καψάκια ζελατίνης
Advecit 180 mg Σκληρά καψάκια ζελατίνης
Advecit 250 mg Σκληρά καψάκια ζελατίνης
τεμοζολομίδη
Διαβάστε προσεκτικά ολόκληρο το φύλλο
οδηγιών χρήσης πριν αρχίσετε
να
παίρνετε
αυτό
το
φάρμακο,
διότι
περιλαμβάνει
σημαντικές
πληροφορίες για σας.

Φυλάξτε αυτό το φύλλο οδηγιών χρήσης.
Ίσως χρειαστεί να το διαβάσετε
ξανά.

Εάν έχετε περαιτέ�

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Advecit 5 mg Ηard gelatin capsules
Advecit 20 mg Ηard gelatin capsules
Advecit 100 mg Ηard gelatin capsules
Advecit 140 mg Ηard gelatin capsules
Advecit 180 mg Ηard gelatin capsules
Advecit 250 mg Ηard gelatin capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 5 mg temozolomide.
Excipient(s) with known effect: Each hard capsule contains 87.3 mg of
anhydrous lactose.
Each hard gelatin capsule contains 20 mg temozolomide.
Excipient(s) with known effect: Each hard capsule contains 72.3 mg of
anhydrous lactose.
Each hard gelatin capsule contains 100 mg temozolomide.
Excipient(s) with known effect: Each hard capsule contains 83.6 mg of
anhydrous lactose.
Each hard gelatin capsule contains 140 mg temozolomide.
Excipient(s) with known effect: Each hard capsule contains 117.04 mg
of anhydrous lactose.
Each hard gelatin capsule contains 180 mg temozolomide.
Excipient(s) with known effect: Each hard capsule contains 150.48 mg
of anhydrous lactose.
Each hard gelatin capsule contains 250 mg temozolomide.
Excipient(s) with known effect: Each hard capsule contains 209.0 mg of
anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatin capsule.
FOR 5 MG STRENGTH
White opaque hard gelatin capsules, size 3, with two stripes in green
ink on the cap and with “T 5
mg” in green ink on the body, containing a white to light tan/light
pink powder.
FOR 20 MG STRENGTH
White opaque hard gelatin capsule, size 2, with two stripes in orange
ink on the cap and with “T 20
mg” in orange ink on the body, containing a white to light tan/light
pink powder.
FOR 100 MG STRENGTH
White opaque hard gelatin capsule, size 1, with two stripes in pink
ink on the cap and with “T 100
mg” in pink ink on the body, containing a white to light tan/light
pink powder.
FOR 140 MG STRENGTH
White opaque hard gelatin capsule, size 0, with two stripes in blue
ink on the cap and with “T 140
mg” in blue