Gabapentin 400mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Arrow Generics Ltd

ATC code:

N02BF01

INN (International Name):

Gabapentin

Dosage:

400mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5060034832447

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 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
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 Gabapentin Milpharm is and what it is
used for
2.
What you need to know before you take
Gabapentin Milpharm
3.
How to take Gabapentin Milpharm
4.
Possible side effects
5.
How to store Gabapentin Milpharm capsules
6.
Contents of the pack and other information
1. WHAT GABAPENTIN MILPHARM IS AND WHAT
IT IS USED FOR
Gabapentin Milpharm belongs to a group of
medicines used to treat epilepsy and peripheral
neuropathic pain (long lasting pain caused by
damage to the nerves).
The active substance in Gabapentin Milpharm
is gabapentin.
Gabapentin Milpharm is used to treat:
Various forms of epilepsy (seizures that are
initially limited to certain parts of the brain,
whether the seizure spreads to other parts of
the brain or not).
Your doctor will prescribe Gabapentin Milpharm
for you to help treat your epilepsy when your
current treatment is not fully controlling your
condition. You should take Gabapentin
Milpharm in addition to your current treatment
unless told otherwise. Gabapentin Milpharm
can also be used on its own to treat adults and
children over 12 years of age.
Peripheral neuropathic pain (long lasting pain
caused by damage to the nerves). A variety of
different diseases can cause peripheral
neuropathic pain (primarily occurring in the legs
and/or arms), such as diabetes or shingles.
Pain sensations may be described as hot,
burning, throbbing, shooting, stabbing, sharp,
cramping, aching, tingling, numbness, pins and
needles etc.
2. WHAT YOU NEED TO KNO

Summary of Product characteristics

OBJECT 1
GABAPENTIN 400MG CAPSULES
Summary of Product Characteristics Updated 31-Jul-2019 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Gabapentin Milpharm 400 mg capsules, hard
2. Qualitative and quantitative composition
Each 400 mg hard capsule contains 400 mg gabapentin.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Capsule, hard
Gabapentin 400 mg capsules, hard, imprinted with 'D' on orange cap and
'04' on orange body, containing
white to off-white crystalline powder.
4. Clinical particulars
4.1 Therapeutic indications
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of
partial seizures with and without secondary
generalization in adults and children aged 6 years and above (see
section 5.1).
Gabapentin is indicated as monotherapy in the treatment of partial
seizures with and without secondary
generalization in adults and adolescents aged 12 years and above.
Treatment of peripheral n