Gabapentin 400mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Milpharm 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: 8901175006496

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
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 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
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). The doctor treating you or your child 6
years of age and older will prescribe Gabapentin Milpharm for
you to help treat epilepsy when the current treatment is not fully
controlling the condition. You or your child 6 years of age and
older should take Gabapentin Milpharm in addition to the 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

Summary of Product characteristics

OBJECT 1
GABAPENTIN 400MG CAPSULES
Summary of Product Characteristics Updated 23-Nov-2022 | 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