SAPHIRA

Posology Treatment to be given: • under close medical supervision • at the lowest effective dose • for the shortest possible duration (not exceeding 4 weeks) Doses should be individualised. Extension of use should not take place without further clinical evaluation.

4). When treatment is started the patient should be informed that: • treatment will be of limited duration • the dosage will be progressively decreased • there is a possibility of rebound phenomena. 4). Treatment should be initiated at the lowest available dose and given for the shortest possible duration.

If this medicine is being used for the treatment of epilepsy, it should be used for as long as the prescriber considers necessary. 25 mg, 3 to 4 times per day. May be increased if needed until a clinical response is achieved up to 4 mg total daily dose.

25 mg as a single dose before retiring, increased as required until a clinical response is achieved; up to 2 mg. Pre-medication before operative dentistry or general surgery: 2-3 mg the night before operation, 2-4 mg one to two hours before the procedure.

4). 5mg according to weight, not less than one hour before operation. 4). 6). Method of administration For oral use.

4 Special warnings and precautions). Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.

These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.

Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants.

Injury, poisoning and procedural complications Not known:

Fall Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

9 Overdose Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur. In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy. In more serious cases, and especially when other CNS-depressant drugs or alcohol are ingested, symptoms may include ataxia, hypotension, hypotonia, respiratory depression, coma, and very rarely, death.

6)) • Myasthenia gravis • Benzodiazepines should not be used alone in depression or anxiety with depression (may precipitate suicide). 4 Special warnings and precautions for use Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.

Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.

, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.

These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.