Pregabalin Remedica 25 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

N03AX16

INN (International Name):

PREGABALIN 25 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

PREGABALIN 25 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Authorised

Authorization date:

2024-02-28

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREGABALIN REMEDICA 25 MG HARD CAPSULES
PREGABALIN REMEDICA 75 MG HARD CAPSULES
PREGABALIN REMEDICA 150 MG HARD CAPSULES
PREGABALIN REMEDICA 300 MG HARD CAPSULES
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.
WHAT IS IN THIS LEAFLET
1.
What Pregabalin Remedica is and what it is used for
2.
What you need to know before you take Pregabalin Remedica
3.
How to take Pregabalin Remedica
4.
Possible side effects
5.
How to store Pregabalin Remedica
6.
Contents of the pack and other information
1.
WHAT PREGABALIN REMEDICA IS AND WHAT IT IS USED FOR
Pregabalin Remedica contains the active substance called pregabalin.
It 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 Remedica 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 Remedica is used to treat a certain form of epilepsy
(partial
seizures with or without secondary generalisation) i

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Remedica 25 mg hard capsules
Pregabalin Remedica 75 mg hard capsules
Pregabalin Remedica 150 mg hard capsules
Pregabalin Remedica 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Remedica 25 mg hard capsules: Each hard capsule contains 25
mg of
pregabalin.
Pregabalin Remedica 75 mg hard capsules: Each hard capsule contains 75
mg of
pregabalin.
Pregabalin Remedica 150 mg hard capsules: Each hard capsule contains
150 mg of
pregabalin.
Pregabalin Remedica 300 mg hard capsules: Each hard capsule contains
300 mg of
pregabalin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
Pregabalin Remedica 25 mg hard capsules: White hard capsules printed
with ‘25’
marked on the body.
Pregabalin Remedica 75 mg hard capsules: White and orange hard
capsules printed
with ‘75’ marked on the body.
Pregabalin Remedica 150 mg hard capsules: White hard capsules printed
with ‘150’
marked on the body.
Pregabalin Remedica 300 mg hard capsules: White and orange hard
capsules printed
with ‘300’ marked on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neuropathic pain
Pregabalin Remedica is indicated for the treatment of peripheral and
central neuropathic
pain in adults.
Epilepsy
Pregabalin Remedica is indicated as adjunctive therapy in adults with
partial seizures
with or without secondary generalisation.
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Generalised anxiety disorder
Pregabalin Remedica 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