Escitalopram Polpharma 10 mg orodispergeerbare tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

ESCITALOPRAMOXALAAT 12,8 mg/stuk SAMENSTELLING overeenkomend met ; ESCITALOPRAM 10 mg/stuk

Available from:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAMOXALAAT 12,8 mg/stuk SAMENSTELLING overeenkomend met ; ESCITALOPRAM 10 mg/stuk

Pharmaceutical form:

Orodispergeerbare tablet

Composition:

ACESULFAAM KALIUM (E 950) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NEOHESPERIDINEDIHYDROCHALCON ; PEPERMUNTOLIE ; PEPERMUNTSMAAKSTOF ; POLACRILINE KALIUM ; ZOUTZUUR (E 507),

Administration route:

Oraal gebruik

Therapeutic area:

Escitalopram

Product summary:

Hulpstoffen: ACESULFAAM KALIUM (E 950); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450); MALTODEXTRINE; NEOHESPERIDINEDIHYDROCHALCON; PEPERMUNTOLIE; PEPERMUNTSMAAKSTOF; POLACRILINE KALIUM; ZOUTZUUR (E 507);

Authorization date:

2013-05-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESCITALOPRAM POLPHARMA 5 MG ORODISPERGEERBARE TABLETTEN
ESCITALOPRAM POLPHARMA 10 MG ORODISPERGEERBARE TABLETTEN
ESCITALOPRAM POLPHARMA 15 MG ORODISPERGEERBARE TABLETTEN
ESCITALOPRAM POLPHARMA 20 MG ORODISPERGEERBARE TABLETTEN
Escitalopram
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 Escitalopram Polpharma is and what it is used for
2.
What you need to know before you take Escitalopram Polpharma
3.
How to take Escitalopram Polpharma
4.
Possible side effects
5.
How to store Escitalopram Polpharma
6.
Contents of the pack and other information
1.
WHAT ESCITALOPRAM POLPHARMA IS AND WHAT IT IS USED FOR
Escitalopram Polpharma belongs to a group of antidepressants called
selective serotonin reuptake
inhibitors (SSRIs). These medicines act on the serotonin-system in the
brain by increasing the
serotonin level. Disturbances in the serotonin-system are considered
an important factor in the
development of depression and related diseases.
Escitalopram Polpharma contains escitalopram and is used to treat
depression (major depressive
episodes) and anxiety disorders (such as panic disorder with or
without agoraphobia, social anxiety
disorder, generalised anxiety disorder and obsessive-compulsive
disorder).
It may take a couple of weeks before you start to feel better.
Continue to take Escitalopram Polpharma
even if it takes some time before you feel any improvement in your
condition.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
W

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Escitalopram Polpharma 5 mg orodispergeerbare tabletten
Escitalopram Polpharma 10 mg orodispergeerbare tabletten
Escitalopram Polpharma 15 mg orodispergeerbare tabletten
Escitalopram Polpharma 20 mg orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Escitalopram Polpharma 5 mg: Each tablet contains 5 mg escitalopram,
equivalent to 6.3875 mg
escitalopram oxalate.
Escitalopram Polpharma 10 mg: Each tablet contains 10 mg escitalopram,
equivalent to 12.775 mg
escitalopram oxalate.
Escitalopram Polpharma 15 mg: Each tablet contains 15 mg escitalopram,
equivalent to 19.1625 mg
escitalopram oxalate.
Escitalopram Polpharma 20 mg: Each tablet contains 20 mg escitalopram,
equivalent to 25.55 mg
escitalopram oxalate.
Excipient(s) with known effect: lactose monohydrate and sodium.
Each 5 mg tablet contains 58.935 mg lactose monohydrate.
Each 10 mg tablet contains 117.87 mg lactose monohydrate.
Each 15 mg tablet contains 176.805 mg lactose monohydrate.
Each 20 mg tablet contains 235.74 mg lactose monohydrate.
Each 5 mg, 10 mg, 15 mg, 20 mg tablet contains less than 1 mmol sodium
(23 mg) per tablet, that is to
say essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Escitalopram Polpharma 5 mg: white to off-white round, flat tablets
with beveled edges, a diameter of
7 mm and engraved with “5” on one side.
Escitalopram Polpharma 10 mg: white to off-white round, flat tablets
with beveled edges, a diameter
of 9 mm and engraved with “10” on one side.
Escitalopram Polpharma 15 mg: white to off-white round, flat tablets
with beveled edges, a diameter
of 11 mm and engraved with “15” on one side.
Escitalopram Polpharma 20 mg: white to off-white round, flat tablets
with beveled edges, a diameter
of 12 mm and engraved with “20” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Treatment of panic disorder