Pregabalin Teva 20mg/ml Oral Solution

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

pregabalin

Available from:

TEVA UK Limited

ATC code:

N03AX16

INN (International Name):

pregabalin

Dosage:

20mg/ml

Pharmaceutical form:

Oral Solution

Administration route:

Oral use

Units in package:

473 ml

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Teva Operations Poland Sp. z.o.o.

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:

2015-05-05

Patient Information leaflet

PREGABALIN TEVA 20 MG/ML
ORAL SOLUTION
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.
1. WHAT PREGABALIN TEVA IS AND WHAT IT IS USED  
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
PREGABALIN TEVA
3. HOW TO TAKE PREGABALIN TEVA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PREGABALIN TEVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT PREGABALIN TEVA IS AND WHAT IT 
IS USED FOR
Pregabalin Teva belongs to a group of 
medicines used to treat epilepsy and 
Generalised Anxiety Disorder (GAD) in adults.
EPILEPSY: Pregabalin Teva 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 Teva for you to help treat your 
epilepsy when your current treatment is not 
controlling your condition. You should take 
Pregabalin Teva in addition to your current 
treatment. Pregabalin Teva is not intended to 
be used alone but should always be used in 
combination with other anti-epileptic 
treatment.
GENERALISED ANXIETY DISORDER:  Pregabalin Teva 
is used to treat Generalised Anxiety Disorder 
(GAD). The symptoms of GAD are prolonged 
excessive anxiety and worry that are difficult 
to control. GAD can also cause restlessness 
or feeling keyed up or on edge, being easily 
fatigued (tired), having difficulty concentrating 
or mind going blank, feeling irritable, having 
muscle tension or sleep dist

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Pregabalin Teva 20 mg/ml Oral Solution 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml contains 20mg of pregabalin. 

Excipient(s) with known effect: 
Each ml contains 1.3 mg of methyl parahydroxybenzoate (E218) and
0.16 mg of 
propyl parahydroxybenzoate (E216) 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Oral solution. 
Clear colourless solution with strawberry odour. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
_Epilepsy _
Pregabalin Teva is indicated as adjunctive therapy in
adults with partial seizures with 
or without secondary generalisation. 

_Generalised Anxiety Disorder _
Pregabalin Teva 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. 
_ _
_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 and tolerability, the dose may be
increased to 300 mg (15 
ml) per day after 1 week. Following an additional week the dose
may be increased to 
450 mg (22.5 ml) per day. The maximum dose of 600 mg (30 ml)
per day may be 
achieved after an additio