Pregabalin Milpharm 75mg capsules, hard

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Pregabalin

Available from:

Milpharm Limited

ATC code:

N03AX16

INN (International Name):

Pregabalin

Dosage:

75mg

Pharmaceutical form:

Capsule, hard

Administration route:

Oral use

Units in package:

Blister packs: 14, 21, 30, 56, 60, 84, 90, 100, 112 and 200 capsules; Bottle packs: 30, 200, 250 and 500 capsules

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

APL Swift Services (Malta) Limited

Therapeutic group:

Antiepileptics, other antiepileptics

Therapeutic indications:

It is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation and for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Authorization status:

Authorised

Authorization date:

2015-07-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN MILPHARM 25 MG CAPSULES, HARD
PREGABALIN MILPHARM 50 MG CAPSULES, HARD
PREGABALIN MILPHARM 75 MG CAPSULES, HARD
PREGABALIN MILPHARM 100 MG CAPSULES, HARD
PREGABALIN MILPHARM 150 MG CAPSULES, HARD
PREGABALIN MILPHARM 200 MG CAPSULES, HARD
PREGABALIN MILPHARM 225 MG CAPSULES, HARD
PREGABALIN MILPHARM 300 MG CAPSULES, HARD
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 your
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 Pregabalin Milpharm is and what it is used for
2.   What you need to know before you take Pregabalin Milpharm
3.  How to take Pregabalin Milpharm
4.  Possible side effects
5.   How to store Pregabalin Milpharm
6.  Contents of the pack and other information

1.  WHAT PREGABALIN MILPHARM IS AND WHAT IT IS USED FOR
Pregabalin Milpharm belongs to a group of medicines used to treat
epilepsy and 
Generalised Anxiety Disorder (GAD) in adults.
EPILEPSY: Pregabalin Milpharm is used to treat a certain form of
epilepsy (partial 
seizures with or without secondary generalisation) in adults. Your
doctor will 
prescribe Pregabalin Milpharm for you tohelp treat your epilepsy
when your 
current treatment is not controlling your condition. You should
take Pregabalin 
Milpharm in addition to yourcurrent treatment. Pregabalin
Milpharm is not 
intended to be used alone, but should always be used in
combination with other 
anti-epileptic treatment.
GENERALISED ANXIETY DISORDER: Pregabalin Milp

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Pregabalin Milpharm 75 mg capsules, hard 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each capsule, hard contains 75 mg of pregabalin. 
_ _
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Capsule, hard. 

Orange cap/white body, size “4” hard gelatin
capsule shells, imprinted with ‘Z’ on 
cap and ‘12’ on body with black ink contains
white to off-white granular powder.  

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
_Epilepsy _
Pregabalin Milpharm is indicated as adjunctive therapy in adults
with partial seizures 
with or without secondary generalisation. 
_ _
_Generalised Anxiety Disorder _
Pregabalin Milpharm is indicated for the treatment
of Generalised Anxiety Disorder 
(GAD) in adults. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 
The dose range is 150 to 600 mg per day given in either two
or three divided doses. 

_Epilepsy _
Pregabalin treatment can be started with a dose of 150 mg per
day given as two or 
three divided doses. Based on individual patient response and
tolerability, the dose 
may be increased to 300 mg per day after 1 week.
The maximum dose of 600 mg per 
day may be achieved after an additional week. 

_Generalised Anxiety Disorder _
The dose range is 150 to 600 mg per day given as two or three
divided doses. The 
need for treatment should be reassessed regularly. 

Pregabalin treatment can be started with a dose of 150 mg per
day. Based on 
individual patient response and tolerability, the dose may be
increased to 300 mg per 
day after 1 week. Following an additional week the dose may be
increased to 450 mg 
per day. The maximum dose of 600 mg per day may be achieved
after an additional 
week. 

_Discontinuation of pregabalin _
In accordance with current clinical practice,