Pregabalin Wockhardt 150 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pregabalin

Available from:

Wockhardt UK Limited

ATC code:

N03A

INN (International Name):

Pregabalin

Dosage:

150 milligram(s)

Pharmaceutical form:

Capsule, hard

Administration route:

oral use

Units in package:

10, 14, 20, 21, 28, 30, 56, 60, 84, 90, 100

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic group:

Anti-epileptics, other anti-epileptics

Therapeutic area:

ANTIEPILEPTICS

Therapeutic indications:

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

Authorization status:

Not marketed

Authorization date:

2015-10-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN WOCKHARDT 25 MG HARD CAPSULES
PREGABALIN WOCKHARDT 50 MG HARD CAPSULES
PREGABALIN WOCKHARDT 75 MG HARD CAPSULES
PREGABALIN WOCKHARDT 100 MG HARD CAPSULES
PREGABALIN WOCKHARDT 150 MG HARD CAPSULES
PREGABALIN WOCKHARDT 200 MG HARD CAPSULES
PREGABALIN WOCKHARDT 225 MG HARD CAPSULES
PREGABALIN WOCKHARDT 300 MG HARD CAPSULES
Pregabalin
READ ALL 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 pregabalin is and what it is used for
2. What you need to know before you take pregabalin
3. How to take pregabalin
4. Possible side effects
5. How to store Pregabalin Wockhardt Hard Capsules
6. Contents of the pack and other information
1.
WHAT PREGABALIN 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 (partial
seizures with or
without secondary

Summary of Product characteristics

Health Products Regulatory Authority
14 May 2020
CRN009PZJ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pregabalin Wockhardt 150 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg of pregabalin.
_Excipients with known effect:_
Each hard capsule also contains 16.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard.
Hard capsules, size 2, with a white cap and a white body, with
“150” printed in black ink on the body. The capsules contain a
white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Neuropathic pain_
Pregabalin is indicated for the treatment of peripheral and central
neuropathic pain in adults.
_Epilepsy_
Pregabalin is indicated as adjunctive therapy in adults with partial
seizures with or without secondary generalisation.
_Generalised Anxiety Disorder_
Pregabalin 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.
_Neuropathic pain_
Pregabalin treatment can be started at 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 an interval of 3 to 7 days, and if needed,
to a maximum dose of 600 mg per day after an additional 7 day
interval.
_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 i