Gabapentin 300mg capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download Bijsluiter (PIL)
20-04-2020
Download Productkenmerken (SPC)
17-07-2019

Werkstoffen:

Gabapentin

Beschikbaar vanaf:

DE Pharmaceuticals

ATC-code:

N02BF01

INN (Algemene Internationale Benaming):

Gabapentin

Dosering:

300mg

farmaceutische vorm:

Oral capsule

Toedieningsweg:

Oral

klasse:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04080100

Bijsluiter

                                OTHER MEDICINES AND GABAPENTIN
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. In particular, tell your
doctor (or pharmacist) if you are taking or have been recently taking
any medicines for convulsions, sleeping disorders,
depression, anxiety, or any other neurological or psychiatric
problems.
Medicines containing opioids such as morphine
If you are taking any medicines containing opioids (such as morphine),
please tell your doctor or pharmacist as opioids may
increase the effect of Gabapentin. In addition, combination of
Gabapentin with opioids may cause symptoms like sleepiness
and/or decrease in breathing.
Antacids for indigestion
If Gabapentin and antacids containing aluminum and magnesium are taken
at the same time, absorption of Gabapentin from the
stomach may be reduced. It is therefore recommended that Gabapentin is
taken at the earliest two hours after taking an antacid.
GABAPENTIN:
•
Is not expected to interact with other antiepileptic drugs or the oral
contraceptive pill.
•
May interfere with some laboratory tests, if you require a urine test
tell your doctor or hospital what you are taking.
GABAPENTIN CAPSULES WITH FOOD
Gabapentin can be taken with or without food.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
PREGNANCY
Gabapentin should not be taken during pregnancy, unless you are told
otherwise by your doctor. Effective contraception must
be used by women of child-bearing potential.
There have been no studies specifically looking at the use of
gabapentin in pregnant women, but other medications used to
treat seizures have reported an increased risk of harm to the
developing baby, particularly when more than one seizure medica-
tion is taken at the same time. Therefore, whenever possible, you
should try to take only one seizure medication during
pregnancy and only under the advic
                                
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Productkenmerken

                                OBJECT 1
GABAPENTIN 300MG CAPSULES
Summary of Product Characteristics Updated 26-Jul-2019 | Accord-UK 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 Accord-UK 300mg capsules
2. Qualitative and quantitative composition
Each capsule contains 300mg of gabapentin
Excipients with known effect:
Each 300 mg hard capsule contains 50.5mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules,hard
Size 1, yellow-yellow, hard gelatin capsules printed with C and GK.
4. Clinical particulars
4.1 Therapeutic indications
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of
partial seizures with and without
secondary generalisation 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
generalisation in adults and adolescents aged 12 years and above.
Treatment of peripheral neuropathic p
                                
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