Pregabalin Wockhardt 20 mg/ml oral solution

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Pregabalin

Prieinama:

Pinewood Laboratories Ltd

ATC kodas:

N03AX; N03AX16

INN (Tarptautinis Pavadinimas):

Pregabalin

Dozė:

20 milligram(s)/millilitre

Vaisto forma:

Oral solution

Gydymo sritis:

Other antiepileptics; pregabalin

Autorizacija statusas:

Not marketed

Leidimo data:

2018-03-16

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN WOCKHARDT 20 MG/ML ORAL SOLUTION
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.
The name of your medicine is Pregabalin Wockhardt 20mg/ml Oral
Solution. It is referred to
as Pregabalin Oral Solution throughout this leaflet.
WHAT IS IN THIS LEAFLET
1. What Pregabalin Oral Solution
is and what it is used for
2. What you need to know before you take Pregabalin Oral Solution
3. How to take Pregabalin Oral Solution
4. Possible side effects
5. How to store Pregabalin Oral Solution
6. Contents of the pack and other information
1. WHAT PREGABALIN ORAL SOLUTION IS AND WHAT IT IS USED FOR
Pregabalin Oral Solution
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 Oral Solution
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 Oral Solution
is used to treat a certain form of epilepsy (partial seizures
with or without secondary generalisation-epileptic fits starting on
one specifi

Prekės savybės

Health Products Regulatory Authority
30 September 2022
CRN00CZW7
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pregabalin Wockhardt 20 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg of pregabalin
Excipient(s) with known effect
Each ml contains 1.30 mg of methyl parahydroxybenzoate (E218) and
0.163 mg propyl parahydrobenzoate (E216)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Neuropathic pain
Pregabalin Oral Solution is indicated for the treatment of peripheral
and central neuropathic pain in adults.
Epilepsy
Pregabalin Oral Solution is indicated as adjunctive therapy in adults
with partial seizures with or without secondary
generalisation.
Generalised Anxiety Disorder
Pregabalin Oral Solution 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 (7.5 to 30 ml) per day given in either
two or three divided doses.
_Neuropathic pain_
Pregabalin treatment can be started at a dose of 150 mg (7.5 ml) per
day given as two or three divided doses. Based on
individual patient response and tolerability, the dose may be
increased to 300 mg (15 ml) per day after an interval of 3 to 7
days, and if needed, to a maximum dose of 600 mg (30 ml) per day after
an additional 7-day interval.
_Epilepsy_
Pregabalin treatment can be started with a dose of 150 mg (7.5 ml) per
day given as two or three divided doses. Based on
individual patient response and tolerability, the dose may be
increased to 300 mg (15 ml) per day after 1 week. The maximum
dose of 600 mg (30 ml) per day may be achieved after an additional
week.
_Generalised Anxiety Disorder_
The dose range is 150 to 600 mg (7.5 to 30 ml) 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