NETIN 300MG CAPSULE,HARD

Country: Կիպրոս

language: հունարեն

source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

PIL PIL (PIL)
19-01-2023
SPC SPC (SPC)
16-03-2018

active_ingredient:

GABAPENTIN

MAH:

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

ATC_code:

N02BF01

INN:

GABAPENTIN

dosage:

300MG

pharmaceutical_form:

CAPSULE,HARD

composition:

GABAPENTIN (0060142963) 300MG

administration_route:

ORAL USE

prescription_type:

Εθνική Διαδικασία

therapeutic_area:

GABAPENTIN

leaflet_short:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 CAPS IN BLISTER(S) (300036202) 30 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 50 CAPS IN BLISTER(S) (300036203) 50 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

PIL

                                COMPARATIVE TABLE ENGLISH VS GREEK PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
NETIN 100 MG CAPSULES
NETIN 300 MG CAPSULES
NETIN 400 MG CAPSULES
Gabapentin
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 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Netin is and what it is used for
2.
What you need to know before you take Netin
3.
How to take Netin
4.
Possible side effects
5.
How to store Netin
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΧΡΉΣΤΗ
NETIN 100 MG ΚΑΨΆΚΙΑ
NETIN 300 MG ΚΑΨΆΚΙΑ
NETIN 400 MG ΚΑΨΆΚΙΑ
Γκαμπαπεντίνη
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 περαιτέρω απορίες, ρωτήστε
τον γιατρό ή τον φαρμακοποιό
σας.

Η συνταγή για αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για σας. Δεν
πρέπει να δώσετε το φάρμακο σε άλλους.
Μπορεί να τους προκαλέσει
βλάβη, ακόμα και όταν τα συμπτώματα
της ασθένειάς τους είναι ίδια με
τα δικά σας.

Εάν παρατ
                                
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SPC

                                1.
NAME OF THE MEDICINAL PRODUCT
Netin 100 mg Capsules
Netin 300 mg Capsules
Netin 400 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg capsule contains 100 mg gabapentin.
Each 300 mg capsule contains 300 mg gabapentin.
Each 400 mg capsule contains 400 mg gabapentin.
Excipient(s) with known effect:
Each 100 mg capsule contains 22.50 mg lactose anhydrous.
Each 300 mg capsule contains 67.50 mg lactose anhydrous.
Each 400 mg capsule contains 90.00 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules
For 100 mg strength:
Hard gelatin capsules size 3 coni-snap, with white opaque body and
cap, filled with white
powder.
For 300 mg strength:
Hard gelatin capsules size 1 coni-snap, with yellow opaque body and
cap, filled with white
powder.
For 400 mg strength:
Hard gelatin capsules size 0 coni-snap, with orange opaque body and
cap, filled with white
powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1
SUMMARY OF PRODUCT CHARACTERISTICS
Epilepsy
Netin is indicated as adjunctive therapy in the treatment of partial
seizures with and without
secondary generalization in adults and children aged 6 years and above
(see section 5.1).
Netin is indicated as monotherapy in the treatment of partial seizures
with and without secondary
generalization in adults and adolescents aged 12 years and above.
Treatment of peripheral neuropathic pain
Netin is indicated for the treatment of peripheral neuropathic pain
such as painful diabetic
neuropathy and post-herpetic neuralgia in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all indications a titration scheme for the initiation of therapy
is described in Table 1, which is
recommended for adults and adolescents aged 12 years and above. Dosing
instructions for
children under 12 years of age are provided under a separate
sub-heading later in this section.
Table 1
DOSING CHART- INITIAL TITRATION
Day 1
Day 2
Day 3
300 mg once a day
300 mg two times a day
300 mg three times a day
Discontinuation of gabap
                                
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documents_in_other_languages

PIL PIL անգլերեն 16-03-2018
SPC SPC անգլերեն 19-01-2023