Pregabalin 100mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Pregabalin

Διαθέσιμο από:

Wockhardt UK Ltd

Φαρμακολογική κατηγορία (ATC):

N03AX16

INN (Διεθνής Όνομα):

Pregabalin

Δοσολογία:

100mg

Φαρμακοτεχνική μορφή:

Capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04080100; GTIN: 5012727912349

Φύλλο οδηγιών χρήσης

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
MARCHESINI 6
560X150
READ ALL 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 is and what it is used for
2. What you need to know before you take
pregabalin
3. How to take pregabalin
4. Possible side effects
5. How to store pregabalin
6. Contents of the pack and other information
1. WHAT PREGABALIN IS AND WHAT IT IS USED FOR
Pregabalin 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 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 is used to treat a certain
form of epilepsy (partial seizures with or
without secondary generalisation) in adults.
Your doctor will prescribe pregabalin for you to
help treat your epilepsy when your current
treatment is not controlling your condition.
You should take pregabalin in addition to your
current treatment. pregabalin is not int

Αρχείο Π.Χ.Π.

OBJECT 1
PREGABALIN WOCKHARDT 100MG HARD CAPSULES
Summary of Product Characteristics Updated 22-Feb-2018 | Wockhardt UK
Ltd
1. Name of the medicinal product
Pregabalin Wockhardt 100mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 100 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule also contains 11 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
Hard capsules, size 3, with a brownish-red cap and a brownish-red
body, with “100” printed in black ink
on the body. The capsules contain a white to off-white powder.
4. Clinical particulars
4.1 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.
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 to 300 mg per day after
an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg
per day after an additional 7day
interval.
_Epilepsy _
Pregabalin treatment can be started with 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 to 300 mg per day after 1
week. The maximum dose of 600 mg per day may be achieved after an
additional week.
_Generalised Anxiety Disorder _
The dose range is 150 to 600 mg per day given as two or three divided
doses. The need for treatment
should be reassessed regularly.
Pregabalin treatment can be started wit