Rewisca 75 mg hard capsules

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

PREGABALIN

Διαθέσιμο από:

PAHANG PHARMACY SDN. BHD.

INN (Διεθνής Όνομα):

PREGABALIN

Μονάδες σε πακέτο:

60capsule Capsules

Κατασκευάζεται από:

KRKA, d.d., Novo mesto

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REWISCA HARD CAPSULES
Pregabalin (50 mg, 75 mg, 150 mg)
1
WHAT IS IN THIS LEAFLET
1.
What _Rewisca _is used for
2.
How _Rewisca_ works
3.
Before you use _Rewisca_
4.
How to use _Rewisca_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Rewisca_
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT _REWISCA_ IS USED FOR
_Rewisca_ belongs to a group of
medicines used to treat epilepsy,
neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC
PAIN: _Rewisca_ 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: _Rewisca_ is used to treat a
certain form of epilepsy (partial
seizures with or without secondary
generalisation) in adults. Your doctor
will prescribe _Rewisca_ for you to help
treat your epilepsy when your current
treatment is not controlling your
condition. You should take _Rewisca_ in
addition to your current treatment.
_Rewisca_ is not intended to be used
alone, but should always be used in
combination with other anti-epileptic
treatment.
GENERALISED ANXIETY DISORDER:
_Rewisca_ 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, and
having muscle tension or sleep
disturbance. This is different to the
stresses and strains of everyday life

Αρχείο Π.Χ.Π.

1.3.1
Pregabalin
SPC, Labeling and Package Leaflet
MY
SmPCPIL133311_3
03.06.2019 – Updated: 08.07.2019
Page 1 of 11
REWISCA
_Pregabalin_
NAME OF THE MEDICINAL PRODUCT
Rewisca 50 mg hard capsules
Rewisca 75 mg hard capsules
Rewisca 150 mg hard capsules
COMPOSITION
Each hard capsule contains 50 mg, 75 mg or 150 mg pregabalin.
For the full list of excipients, see section List of excipients.
PRODUCT DESCRIPTION
50 mg hard capsules (capsules): The body of the capsule is white
colour, the cap of the capsule is
bright yellow colour. Capsule cap is imprinted with black mark P50.
The content of the capsule is
white to off white powder. Capsule size No. 3.
75 mg hard capsules: The body of the capsule is brownish yellow
colour, the cap of the capsule is
brownish yellow colour. Capsule cap is imprinted with black mark P75.
The content of the capsule is
white to off white powder. Capsule size No. 4.
150 mg hard capsules: The body of the capsule is white colour, the cap
of the capsule is yellowish
brown colour. Capsule cap is imprinted with black mark P150. The
content of the capsule is white to
off white powder. Capsule size No. 2.
THERAPEUTIC INDICATIONS
_Neuropathic pain_
Pregabalin is indicated for the treatment of peripheral and central
neuropathic pain in adults.
_Epilepsy_
Pregabalin is indicated as adjunctive therapy in adults with partial
seizures with or without secondary
generalisation.
_Generalised Anxiety Disorder_
Pregabalin is indicated for the treatment of Generalised Anxiety
Disorder (GAD) in adults.
_Fibromyalgia_
Pregabalin is indicated for the treatment of fibromyalgia.
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. Based
on individual patient response
1.3.1
Pregabalin
SPC, Labeling and Package Leaflet
MY
SmPCPIL133311_3
03.06.2019 – Updated: 08.07.2019
Page 2 of 11
and tolerability, the dose may be increased to 300 mg per day after an
in