Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gabapentin
Brown & Burk UK Ltd
N02BF01
Gabapentin
300mg
Oral capsule
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04080100; GTIN: 5060124640136
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 Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Noumed 300mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 300mg hard capsule contains 300mg of gabapentin. Excipient with known effect: Each 300mg hard capsule contains 50.50 mg of lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM ‘Capsule, hard’. Size ‘1’ yellow/yellow hard gelatin capsule marked ‘MG 300’ 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 generalisation in adults and adolescents aged 12 years and above. TREATMENT OF PERIPHERAL NEUROPATHIC PAIN Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section. TABLE 1: DOSING CHART - INITIAL TITRATION Day 1 Day 2 Day 3 300mg once a day 300mg two times a day 300mg three times a day Discontinuation of gabapentin: In accordance with current clinical practice, if gabapentin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication. Epilepsy: Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy. _Adults and adolescents:_ In clinical trials, the effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by titrating the dose as described in Table 1 or Đọc toàn bộ tài liệu