Linefor 150 mg, harde capsules

Country: Netherlands

Language: Dutch

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

Active ingredient:

PREGABALINE 150 mg/stuk

Available from:

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

ATC code:

N03AX16

INN (International Name):

PREGABALINE 150 mg/stuk

Pharmaceutical form:

Capsule, hard

Composition:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MAÏSZETMEEL ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Administration route:

Oraal gebruik

Therapeutic area:

Pregabalin

Product summary:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MAÏSZETMEEL; PROPYLEENGLYCOL (E 1520); SCHELLAK GLAZE, GEDEELTELIJK VERESTERD; TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;

Authorization date:

2017-01-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Linefor 25 mg, harde capsules
Linefor 50 mg, harde capsules
Linefor 75 mg, harde capsules
Linefor 100 mg, harde capsules
Linefor 150 mg, harde capsules
Linefor 200 mg, harde capsules
Linefor 225 mg, harde capsules
Linefor 300 mg, harde capsules
_Pregabalin _
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 Linefor is and what it is used for
2.
What you need to know before you take Linefor
3.
How to take Linefor
4.
Possible side effects
5.
How to store Linefor
6.
Contents of the pack and other information
1.
WHAT LINEFOR IS AND WHAT IT IS USED FOR
Linefor belongs to a group of medicines used to treat epilepsy,
neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
•
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN
: Linefor 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
: Linefor is used to treat a certain form of epilepsy (partial
seizures with or without
secondary generalisation) in adults. Your doctor will prescribe
Linefor for you to help treat your
epilepsy when your curren

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Linefor 25 mg, harde capsules
Linefor 50 mg, harde capsules
Linefor 75 mg, harde capsules
Linefor 100 mg, harde capsules
Linefor 150 mg, harde capsules
Linefor 200 mg, harde capsules
Linefor 225 mg, harde capsules
Linefor 300 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Linefor 25 mg, harde capsules
Each capsules, hard contains 25 mg of pregabalin.
Excipient with known effect: lactose monohydrate.
_ _
Each capsules, hard contains 55 mg of lactose monohydrate.
Linefor 50 mg, harde capsules
Each capsules, hard contains 50 mg of pregabalin.
Excipient with known effect: lactose monohydrate.
Each capsules, hard contains 18 mg of lactose monohydrate.
Linefor 75 mg, harde capsules
Each capsules, hard contains 75 mg of pregabalin.
Excipient with known effect: lactose monohydrate.
Each capsules, hard contains 27 mg of lactose monohydrate.
Linefor 100 mg, harde capsules
Each capsules, hard contains 100 mg of pregabalin.
Excipient with known effect: lactose monohydrate.
Each capsules, hard contains 36 mg of lactose monohydrate.
Linefor 150 mg, harde capsules
Each capsules, hard contains 150 mg of pregabalin.
Excipient with known effect: lactose monohydrate.
Each capsules, hard contains 54 mg of lactose monohydrate.
Linefor 200 mg, harde capsules
Each capsules, hard contains 200 mg of pregabalin.
Excipient with known effect: lactose monohydrate.
Each capsules, hard contains 72 mg of lactose monohydrate.
Linefor 225 mg, harde capsules
Each capsules, hard contains 225 mg of pregabalin.
Excipient with known effect: lactose monohydrate.
Each capsules, hard contains 81 mg of lactose monohydrate.
Linefor 300 mg, harde capsules
Each capsules, hard contains 300 mg of pregabalin.
Excipient with known effect: lactose monohydrate.
Each capsules, hard contains 108 mg of lactose monohydrate.
2
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Linefor 25 mg:
White hard gelatin capsules overprinted with “25” on