Trazodon HCl Sandoz 100 mg, tabletten

Negara: Belanda

Bahasa: Belanda

Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Bahan aktif:

TRAZODONHYDROCHLORIDE 100 mg/stuk SAMENSTELLING overeenkomend met ; TRAZODON 91,1 mg/stuk

Tersedia dari:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kode ATC:

N06AX05

INN (Nama Internasional):

TRAZODONHYDROCHLORIDE 100 mg/stuk SAMENSTELLING overeenkomend met ; TRAZODON 91,1 mg/stuk

Bentuk farmasi:

Tablet

Komposisi:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201),

Rute administrasi :

Oraal gebruik

Area terapi:

Trazodone

Ringkasan produk:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201);

Tanggal Otorisasi:

1900-01-01

Selebaran informasi

Sandoz B.V.
Page 1/14
Trazodon HCl Sandoz 100 mg, tabletten
RVG 111061
1311-v3
1.3.1.3 Bijsluiter
March 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRAZODON HCL SANDOZ 100 MG, TABLETTEN
trazodone hydrochloride
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 or 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 the leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] is one of a group of medicines called anti
– depressants. It is used to
treat depressive disorders (major depressive episodes).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
-
if you are allergic to trazodone hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
Sandoz B.V.
Page 2/14
Trazodon HCl Sandoz 100 mg, tabletten
RVG 111061
1311-v3
1.3.1.3 Bijsluiter
March 2020
-
Alcohol intoxication and intoxication with hypnotics (if you are
drunk, or under the influence of
hypnotic drugs)
-
if you have recently had a heart attack
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using [nationally completed
name].
Carefull use and regular medical checks are advisable if any of the
following applies to you:
-
you have epilepsy. Abrupt increase or decrease of dosage sho

Karakteristik produk

Sandoz B.V.
Page 1/19
Trazodon HCl Sandoz 100 mg, tabletten
RVG 111061
1311-v4
1.3.1.1 Samenvatting van de
Productkenmerken
March 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trazodon HCl Sandoz 100 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of trazodone hydrochloride.
Excipient with known effect
Each tablet contains 160.75 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Oblong off-white tablets, with three scorelines. The tablet is about
18.5 mm long and about 6.7
mm wide.
The tablet can be divided into equal doses if broken in the middle,
into a threequarter and a
quarter tablet, if broken at an end scoreline, or into equal quarters
if broken at all three scorelines.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for major depressive episode.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Sandoz B.V.
Page 2/19
Trazodon HCl Sandoz 100 mg, tabletten
RVG 111061
1311-v4
1.3.1.1 Samenvatting van de
Productkenmerken
March 2020
_Adults: _
The optimum dosage should be individually determined for each patient.
The initial dose is 150 mg a day, administered in divided doses after
food, or as a single dose
upon retiring.
The dose will be increased every 3 to 4 days by 50 mg a day
(preferably upon retiring) until an
optimal therapeutic effect is achieved.
This may be increased up to a dose of 400 mg a day, administered in
divided doses after food, or
as a single dose upon retiring. In administering divided doses the
major part of the divided dose
should be taken upon retiring.
In hospitalised patients, the maximum daily dose may be incrementally
increased to a maximum
of 600 mg per day, administered as divided doses.
After reaching an effective dosage, clinical response is usually
evident within two to four weeks.
In the case of non – responders the dosage may be increased to the
maximimum recommended.
If, following this, there is no