Pregabalin STADA Arzneimittel AG 150 mg Kapsel, hård

Country: Շվեդիա

language: շվեդերեն

source: Läkemedelsverket (Medical Products Agency)

active_ingredient:

pregabalin

MAH:

STADA Arzneimittel AG

ATC_code:

N02BF02

INN:

pregabalin

dosage:

150 mg

pharmaceutical_form:

Kapsel, hård

composition:

mannitol Hjälpämne; pregabalin 150 mg Aktiv substans

class:

Apotek

prescription_type:

Receptbelagt

therapeutic_area:

Pregabalin

leaflet_short:

Förpacknings: Blister, 14 kapslar; Blister, 56 kapslar

authorization_status:

Avregistrerad

authorization_date:

2015-09-10

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pregabalin STADA Arzneimittel AG 25 mg capsules, hard
Pregabalin STADA Arzneimittel AG 50 mg capsules, hard
Pregabalin STADA Arzneimittel AG 75 mg capsules, hard
Pregabalin STADA Arzneimittel AG 100 mg capsules, hard
Pregabalin STADA Arzneimittel AG 150 mg capsules, hard
Pregabalin STADA Arzneimittel AG 200 mg capsules, hard
Pregabalin STADA Arzneimittel AG 300 mg capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 25 mg of pregabalin.
Each capsule, hard contains 50 mg of pregabalin.
Each capsule, hard contains 75 mg of pregabalin.
Each capsule, hard contains 100 mg of pregabalin.
Each capsule, hard contains 150 mg of pregabalin.
Each capsule, hard contains 200 mg of pregabalin.
Each capsule, hard contains 300 mg of pregabalin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard.
The 25 mg capsule is white, size 4 (14.5 mm), marked “PGB 25” on
the body with black ink.
The 50 mg capsule is white, size 3 (16 mm), marked “PGB 50” on the
body with black ink. The
body is also marked with a black circular line.
The 75 mg capsule is white and orange, size 4 (14.5 mm), marked “PGB
75” on the body with
black ink.
The 100 mg capsule is orange, size 3 (16 mm), marked “PGB 100” on
the body with black ink.
The 150 mg capsule is white, size 2 (18 mm), marked “PGB 150” on
the body with black ink.
The 200 mg capsule is light orange, size 1 (19.5 mm), marked “PGB
200” on the body with
black ink.
The 300 mg capsule is white and orange, size 0 (21.5 mm), marked
“PGB 300” on the body
with black ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Neuropathic pain
Pregabalin STADA Arzneimittel AG is indicated for the treatment of
peripheral and central
neuropathic pain in adults.
Epilepsy
Pregabalin STADA Arzneimittel AG is indicated as adjunctive therapy in
adults with partial
seizures with or without secondary generalisation.
Generalised Anxiety Disorder
Pregabalin