Buccolam

5 mg Purple 10 years to adults 10 mg Orange Carers should only administer a single dose of midazolam. If the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought and the empty syringe given to the healthcare professional to provide information on the dose received by the patient.

2). For patients at increased risk of respiratory depression from benzodiazepines, administration of BUCCOLAM under healthcare professional supervision should be considered prior to starting treatment with BUCCOLAM. This administration may be performed in the absence of a seizure.

Special populations Renal impairment No dose adjustment is required, however, BUCCOLAM should be used with caution in patients with chronic renal failure as elimination of midazolam may be delayed and the effects prolonged. 4) Hepatic impairment Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal half- life.

4). 3). Paediatric population The safety and efficacy of midazolam in children aged 0 to 3 months has not been established. No data are available. Elderly The elderly are more sensitive to the effects of benzodiazepines. In patients from 60 years and in elderly patients BUCCOLAM should be used with caution.

Method of administration 4 BUCCOLAM is for oromucosal use. The full amount of solution should be inserted slowly into the space between the gum and the cheek. Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution.

If necessary (for larger volumes and/or smaller patients), approximately half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side. 6. Precautions to be taken before handling or administering the medicinal product No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.

BUCCOLAM is not for intravenous use. The oral syringe cap should be removed before use to avoid risk of choking.

Summary of the safety profile Published clinical studies show that oromucosal midazolam was administered to approximately 443 children and 224 adults with seizures. Respiratory depression occurs at a rate of up to 5%, although this is a known complication of convulsive seizures as well as being related to midazolam use.

One episode of pruritus was possibly attributed to the use of buccal midazolam. Tabulated list of adverse reactions The table below lists the adverse reactions reported to occur when oromucosal midazolam was administered in clinical studies and postmarketing experience.

The frequency of adverse reactions is classified as follows:

Common: ≥ 1/100 to < 1/10 Uncommon: ≥ 1/1,000 to < 1/100 Very rare: < 1/10,000 Not known: cannot be estimated from the available data Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness: System Organ Class Frequency: Adverse Drug Reaction Psychiatric disorders Very rare: Aggression**, agitation**, anger**, confusional state**, euphoric mood**, hallucination**, hostility**, movement disorder**, physical assault** Nervous system disorders Common: Sedation, somnolence, depressed levels of consciousness Respiratory depression Very rare: Anterograde amnesia**, ataxia**, dizziness**, headache**, seizure**, paradoxical reactions** Cardiac disorders Very rare: Bradycardia**, cardiac arrest**, hypotension**, vasodilatation** Respiratory, thoracic and mediastinal disorders Very rare: Apnoea**, dyspnea**, laryngospasm**, respiratory arrest** Gastrointestinal disorders Common: Nausea and vomiting Very rare: Constipation**, dry mouth** Skin and subcutaneous tissue disorders Uncommon: Pruritus, rash and urticarial Not known: Angioedema* 9 General disorders and administration site conditions Very rare: Fatigue**, hiccups** Immune system disorders Not known: Anaphylactic reaction* **These adverse reactions have been reported to occur when midazolam is injected in children and/or adults, which may be of relevance to oromucosal administration.

g. • patients with chronic respiratory insufficiency • patients with chronic renal failure, impaired hepatic function or with impaired cardiac function • paediatric patients with cardiovascular instability. These high-risk patients may require lower dosages.

Respiratory insufficiency Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration. Paediatric patients aged 3 to 6 months Given the higher metabolite to parent drug ratio in younger children, a delayed respiratory depression as a result of high active metabolite concentrations in the 3-6 months age group cannot be excluded.

Therefore, the use of BUCCOLAM in the 3-6 month age group should be limited for use only under the supervision of a health care professional where resuscitation equipment is available and where respiratory function can be monitored and equipment for respiratory assistance, if needed, is available.

Altered elimination of midazolam Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.

Concomitant use with other benzodiazepines 5 Debilitated patients are more prone to the central nervous system (CNS) effects of benzodiazepines and, therefore, lower doses may be required. Medical history of alcohol or drug abuse Midazolam should be avoided in patients with a medical history of alcohol or drug abuse.

Amnesia Midazolam may cause anterograde amnesia. Excipients Sodium This medicine contains less than 1 mmol sodium (23 mg) per oral syringe, that is to say essentially ‘sodium-free’.

1 Myasthenia gravis Severe respiratory insufficiency Sleep apnoea syndrome Severe hepatic impairment