国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clobazam
Thame Laboratories Ltd
N05BA09
Clobazam
2mg/1ml
Oral suspension
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04080100; GTIN: 5055935100481
Package Leaflet: Information for the user CLOBAZAM THAME 5MG/5ML ORAL SUSPENSION CLOBAZAM THAME 10MG/5ML ORAL SUSPENSION (clobazam) TURN OVER 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. Medicines for epilepsy (such as phenytoin, carbamazepine, stiripentol or valproic acid). Medicines for depression (Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine and isocarboxazid or tricyclic anti-depressants - such as trazodone) or Selective Serotonin Re-uptake Inhibitors (SSRIs) such as fluvoxamine or paroxetine. Medicines for severe mental illness called ‘antipsychotics’ (such as chlorpromazine, haloperidol, clozapine and pimozide). Painkillers (such as medicines containing codeine, dihydrocodeine or morphine). Sleeping tablets (such as zolpidem). Tranquilisers (such as diazepam, temazepam or lorazepam). Muscle relaxants (such as baclofen). Antihistamines that make you sleepy (such as chlorphenamine, promethazine or diphenenhydramine). Lithium - used for a mental illness called ‘manic-depressive illness’ (mood changes between a state of high excitability or exaggerated emotions and depression). Cimetidine - used to treat ulcers and heartburn. Omeprazole – used to treat the symptoms of acid reflux such as heartburn or acid regurgitation. Ticlopidine – an antiplatelet medication used in patients with an increased risk of stroke. Fluconazole – used in the treatment of fungal conditions. Dextromethorphan – used to relieve dry, irritating cou 完全なドキュメントを読む
OBJECT 1 CLOBAZAM THAME 10MG/5ML ORAL SUSPENSION Summary of Product Characteristics Updated 20-Jun-2018 | Thame Laboratories 1. Name of the medicinal product Clobazam Thame 10mg/5ml Oral Suspension 2. Qualitative and quantitative composition The active substance is clobazam. Each 5ml of oral suspension contains 10mg clobazam. _Excipients with known effect: _ Each 5ml of oral suspension contains 7.5mg of methyl parahydroxybenzoate (E218), 10mg sucralose (E955) and 2.24mg of sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Suspension White to off-white viscous suspension. 4. Clinical particulars 4.1 Therapeutic indications Clobazam is a 1,5-benzodiazepine indicated for the short-term relief (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short term psychosomatic, organic or psychotic illness. The use of clobazam to treat short-term “mild” anxiety is inappropriate and unsuitable. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment. Indeed, in patients with anxiety associated with depression, clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepine (such as clobazam) alone, can precipitate suicide in such patients. In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment. Clobazam may be used as adjunctive therapy in epilepsy. 4.2 Posology and method of administration Posology Treatment of anxiety The usual anxiolytic dose for adults is 20-30mg daily in divided doses or as a single dose given at night. Doses up to 60mg daily have been used in the treatment of adult in-patients with severe anxiety. The lowest dose that can control symptoms should be used. After improvement of the sympto 完全なドキュメントを読む