PREGABALIN BASICS 20 mg/ml oral solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Pregabalin

Disponible depuis:

Basics GmbH

Code ATC:

N03AX16

DCI (Dénomination commune internationale):

Pregabalin

forme pharmaceutique:

Oral solution

Domaine thérapeutique:

pregabalin

Statut de autorisation:

Not marketed

Date de l'autorisation:

2022-01-28

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN BASICS 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, pharmacist or
nurse
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What PREGABALIN BASICS is and what it is used for
2.
What you need to know before you take PREGABALIN BASICS?
3.
How to take PREGABALIN BASICS?
4.
Possible side effects
5.
How to store PREGABALIN BASICS?
6.
Contents of the pack and other information
1.
WHAT PREGABALIN BASICS IS AND WHAT IT IS USED FOR
PREGABALIN BASICS 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 BASICS 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 BASICS is used to treat a certain form of epilepsy (partial
seizures
with or without secondary generalisation-epileptic fits starting on
one specific part of the brain)
in adults. Your doctor will prescribe PREGABALIN BASICS for you to
help treat your
epilepsy when your current treatment is not controlling your
condition. You should

Résumé des caractéristiques du produit

Health Products Regulatory Authority
15 March 2024
CRN00F28H
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PREGABALIN BASICS 20 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg of pregabalin.
Excipients with known effect:
Each ml contains 2.0 mg of methyl parahydroxybenzoate (E218).
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 BASICS is indicated for the treatment of peripheral and
central neuropathic pain in adults.
Epilepsy
PREGABALIN BASICS is indicated as adjunctive therapy in adults with
partial seizures with or without secondary generalisation.
Generalised Anxiety Disorder
PREGABALIN BASICS 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 150 mg (7.5 ml) per
day. Based on individual patient response an