Pregabalin 75mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pregabalin

Available from:

Milpharm Ltd

ATC code:

N03AX16

INN (International Name):

Pregabalin

Dosage:

75mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100

Patient Information leaflet

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 your 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 Milpharm is and what it is used for
2.
What you need to know before you take Pregabalin
Milpharm
3.
How to take Pregabalin Milpharm
4.
Possible side effects
5.
How to store Pregabalin Milpharm
6.
Contents of the pack and other information
1.
WHAT PREGABALIN MILPHARM IS AND WHAT IT IS
USED FOR
Pregabalin Milpharm 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
Milpharm 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 Milpharm is used to treat a
certain form of epilepsy (partial seizures with or without
secondary generalisation) in adults. Your doctor will
prescribe Pregabalin Milpharm for you to help treat
your epilepsy when your current treatment is not
controlling your condition. You should take Pregabalin
Milpharm in addition to your current treatment.
Pregabalin Milpharm is not intended to be used alone,
but should always be used in

Summary of Product characteristics

OBJECT 1
PREGABALIN MILPHARM 75 MG CAPSULES, HARD
Summary of Product Characteristics Updated 07-Nov-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Pregabalin Milpharm 75 mg capsules, hard
2. Qualitative and quantitative composition
Each capsule, hard contains 75 mg of pregabalin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
Orange cap/white body, size “4” hard gelatin capsule shells,
imprinted with 'Z' on cap and '12' on body
with black ink contains white to off-white granular powder.
4. Clinical particulars
4.1 Therapeutic indications
_Neuropathic pain _
Pregabalin Milpharm is indicated for the treatment of peripheral and
central neuropathic pain in adults.
_Epilepsy _
Pregabalin Milpharm is indicated as adjunctive therapy in adults with
partial seizures with or without
secondary generalisation.
_Generalised Anxiety Disorder _
Pregabalin Milpharm 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 7-day
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 with a dose of 150 mg per day.
Based on individual pat