Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gabapentin
DE Pharmaceuticals
N02BF01
Gabapentin
300mg
Oral capsule
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04080100
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 Lees het volledige document
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 Lees het volledige document