Pregabaline Apotex 150 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PREGABALINE

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

N03AX16

INN (Algemene Internationale Benaming):

PREGABALIN

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Pregabalin

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); LACTOSE 1-WATER; MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;

Autorisatie datum:

2017-05-22

Bijsluiter

PREGABALINE APOTEX 25 MG, 75 MG, 150 MG AND 300 MG, HARDE
CAPSULES – RVG 120020-4-6-5
MODULE 1.3
Product Information
Version: 2020-01
MODULE 1.3.1
Package Leaflet
Replaces: 2019-08
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREGABALINE APOTEX 25 MG, HARDE CAPSULES
PREGABALINE APOTEX 75 MG, HARDE CAPSULES
PREGABALINE APOTEX 150 MG, HARDE CAPSULES
PREGABALINE APOTEX 300 MG, HARDE CAPSULES
PREGABALINE
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 Pregabaline Apotex is and what it is used for
2.
What you need to know before you take Pregabaline Apotex
3.
How to take Pregabaline Apotex
4.
Possible side effects
5.
How to store Pregabaline Apotex
6.
Contents of the pack and other information
1.
WHAT PREGABALINE APOTEX IS AND WHAT IT IS USED FOR
Pregabalin belongs to a group of medicines used to treat epilepsy,
neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN:
Pregabalin is used to treat long lasting pain caused by
damage to the nerves. A variety of diseases can cause peripheral
neuropathic pain, such as diabetes or
shingles. Pain sensations may be described as hot, burning, throbbing,
shooting, stabbing, sharp,
cramping, aching, tingling, numbness, pins and needles. Peripheral and
central neuropathic pain may
also be associated with mood changes, sleep disturbance, fatigue
(tiredness), and can have an impact
on physical and social functioning and overall quality of life.
EPILEPSY:
Pregabalin is used to treat a certain form of epilepsy (par

Productkenmerken

PREGABALINE APOTEX 25 MG, 75 MG, 150 MG AND 300 MG, HARDE
CAPSULES – RVG 120020-4-6-5
MODULE 1.3
Product Information
Version: 2020-01
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2019-08
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pregabaline Apotex 25 mg, harde capsules
Pregabaline Apotex 75 mg, harde capsules
Pregabaline Apotex 150 mg, harde capsules
Pregabaline Apotex 300 mg, harde capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 25mg, 75 mg,150 mg or 300 mg of Pregabalin
Excipients with known effect
_: _
25 mg: Each hard capsule also contains 9 mg lactose monohydrate.
75 mg: Each hard capsule also contains 27 mg lactose monohydrate.
150 mg: Each hard capsule also contains 54 mg lactose monohydrate.
300 mg: Each hard capsule also contains 108 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard
25mg: Hard gelatin capsules, size no. 4, cap: opaque white colour,
body: opaque white colour,
Content of capsules: White powder.
Imprinted APO P25 in black ink.
75mg: Hard gelatin capsules, size no. 4, cap: opaque orange colour,
body: opaque white colour,
Content of capsules: White powder.
Imprinted APO P75 in black ink.
150 mg: Hard gelatin capsules, size no. 2, cap: opaque white colour,
body: opaque white colour,
Content of capsules: White powder.
Imprinted APO P150 in black ink.
300mg: Hard gelatin capsules, size no. 0, cap: opaque orange colour,
body: opaque white colour,
Content of capsules: White powder.
Imprinted APO P300 in black ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ _
Neuropathic pain
Pregabalin is indicated for the treatment of peripheral and central
neuropathic pain in adults.
PREGABALINE APOTEX 25 MG, 75 MG, 150 MG AND 300 MG, HARDE
CAPSULES – RVG 120020-4-6-5
MODULE 1.3
Product Information
Version: 2020-01
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2019-08
_ _
Epilepsy
Pregabalin is indicated as adjunctive therapy in adults with partial
seizure