LYRICA 150 mg CAPSULES

Země: Jihoafrická republika

Jazyk: angličtina

Zdroj: South African Health Products Regulatory Authority (SAHPRA)

Dostupné s:

Viatris Healthcare (Pty) Ltd

Dávkování:

See ingredients

Léková forma:

CAPSULES

Složení:

EACH CAPSULE CONTAINS PREGABALIN 150,0 mg

Stav Autorizace:

Registered

Datum autorizace:

2009-06-11

Informace pro uživatele

Viatris Healthcare (Pty) Ltd
Page 1 of 5
Lyrica 25 mg, 75 mg, 150 mg capsule
Final approved PIL – 21 December 2022
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S5
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
LYRICA
® 25 MG CAPSULE
LYRICA
® 75 MG CAPSULE
LYRICA
® 150 MG CAPSULE
READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE LYRICA
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
LYRICA has been prescribed for you personally and you should not share
your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
1. WHAT LYRICA CONTAINS:
The active substance of LYRICA is pregabalin. Each capsule contains 25
mg, 75 mg or 150 mg of
pregabalin active substance.
The other ingredients that make up the capsule core are lactose
monohydrate, maize starch and talc.
2. WHAT LYRICA IS USED FOR:
LYRICA is used in adults to treat long lasting pain caused by damage
to the nerves, as in diabetes
mellitus and shingles (Herpes zoster). Pain from damaged nerves is
called neuropathic pain. Pain
sensations may be described as hot, burning, throbbing, shooting,
stabbing, sharp, cramping, aching,
tingling, numbness, pins and needles etc. If you have diabetes, the
pain can be in your arms, hands,
fingers, legs, feet or toes. If you have shingles, the pain is in the
area of the rash.
3. BEFORE YOU TAKE LYRICA:
BEFORE BEING TREATED WITH LYRICA, TELL YOUR DOCTOR IF:
Viatris Healthcare (Pty) Ltd
Page 2 of 5
Lyrica 25 mg, 75 mg, 150 mg capsule
Final approved PIL – 21 December 2022
•
You have had any allergic reaction to other medicines of this type
(e.g. gabapentin or Neurontin)
•
You are pregnant, trying to become pregnant or breastfeeding
•
You are suffering from or have ever suffered from any kidney
conditions. If so, your doctor may
prescribe a lower dose of LYRICA
•
You have any family problems of galactose intolerance
•
You have heart problems including heart failure
HAVE YOU EVER HAD AN ALLER

Charakteristika produktu

Viatris Healthcare (Pty) Ltd
Page 1 of 13
Lyrica 25 mg, 75 mg, 150 mg capsule
Final approved PI – 21 December 2022
SCHEDULING STATUS: S5
PROPRIETARY NAME AND DOSAGE FORM:
LYRICA
® 25 MG CAPSULE
LYRICA
® 75 MG CAPSULE
LYRICA
® 150 MG CAPSULE
COMPOSITION:
Each hard capsule contains 25 mg, 75 mg or 150 mg of pregabalin.
Excipients: Lactose monohydrate, maize starch, talc.
PHARMACOLOGICAL CLASSIFICATION:
A 2.5 Central nervous system depressants – Anticonvulsants,
including anti-epileptics
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
The
active
substance,
pregabalin,
is
a
gamma-aminobutyric
acid
(GABA)
analogue
((S)-3-
(aminomethyl)-5-methylhexanoic acid).
_Mechanism of action: _
_In vitro_ studies show that pregabalin binds to an auxiliary subunit
(

2
-

protein) of voltage-gated
calcium channels in the central nervous system, potently displacing [
3
H]-gabapentin. Two lines of
evidence indicate that binding of pregabalin to the

2
-

site is required for analgesic activity in animal
models: (1) Studies with the inactive R-enantiomer and other
structural derivatives of pregabalin and
(2) Studies of pregabalin in mutant mice with defective drug binding
to the

2
-

protein. In addition,
pregabalin reduces the release of several neurotransmitters, including
glutamate, noradrenaline, and
substance P. The significance of these effects for the clinical
pharmacology of pregabalin is not
known.
Pregabalin does not interact with either GABA
A
or GABA
B
receptors; it is not converted metabolically
into GABA or a GABA agonist; it is not an inhibitor of GABA uptake or
degradation.
Viatris Healthcare (Pty) Ltd
Page 2 of 13
Lyrica 25 mg, 75 mg, 150 mg capsule
Final approved PI – 21 December 2022
Pregabalin prevents pain-related behaviours in animal models of
neuropathic and post-surgical pain,
including hyperalgesia and allodynia.
_Clinical experience: _
_Neuropathic pain: _
The effectiveness of pregabalin for the management of neuropathic pain
was investigated in 10
double-blind, placebo-contro