New Licensed Version of Alimemazine 10mg/5ml Oral Sol. S/f

Don’t Forget to Sign Up for the Rebate Scheme!

A new strength of alimemazine oral solution sugar free 10mg/5mL is now available for dispensing. [This was previously only available via Special Order.]

In the NHSBSA Hints and Tips Dispensing Contractors Issue 44 (July 2021) the following information is given:

“Unlicensed medicines update 

The following Actual Medicinal Products (AMPs) are now licensed: 

Alimemazine 10mg/5ml oral solution sugar free (Lucis Pharma Ltd) with AMPP = 100ml 

Instead of using Alimemazine 10mg/5ml oral solution (Special Order), you may want to consider using the licensed option instead.”

Lucis Pharma have set up a rebate scheme for Dispensing Doctors to ensure that every pack you dispense will not lose you money, regardless of any wholesaler discount you may receive.

Please download the rebate sign up form here and once completed email it to:

rebates@lucispharma.co.uk

Now with NHS dm+d List Price: £182.00 for dispensing doctors and community pharmacy contractors. 

This New 10mg/5mL strength compliments existing Alimemazine 7.5mg/5mL and 30mg/5mL oral solutions with a convenient measure to help improve patient compliance.

‘Sugar-free preparations should be used whenever possible.’ – BNF Guidance on Prescribing

For the management of urticaria and pruritus – see the full SPC below:

ABBREVIATED PRESCRIBING INFORMATION

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard

Adverse events should also be reported to Lucis Pharma Ltd Tel: 0845 838 2842 enquiries@lucispharma.co.uk “

Please refer to the Summary of Product Characteristics (SmPC) for full details of Prescribing Information

Alimemazine tartrate 10mg/5ml oral solution, sugar-free

Presentation: Alimemazine tartrate 10mg/5ml oral solution.

Indications: Alimemazine has powerful antihistamine and anti-emetic actions and is used for the management of urticaria and pruritus.  

Dosage and administration: Alimemazine tartrate 10mg/5ml oral solution, sugar-free should be used for this indication in children. Alimemazine may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years but only Alimemazine tartrate 30mg/5ml oral solution, sugar-free should be used for this specific indication. Not recommended for children less than 2 years old. DO NOT exceed the recommended dose.

Urticaria and pruritus – For Oral Administration. Adults: 10 mg (5 ml) two or three times daily; up to 100 mg (50 ml) per day have been used in intractable cases. Elderly: Dose should be reduced to 10 mg (5 ml) once or twice daily. Children 2-5 years of age: 2.5mg (approx. 1.25 ml) three or four times daily. Children 5-12 years of age: 5mg (2.5 ml) three or four times daily.
Children over 12 years of age: 10mg (5 ml) two or three times daily.

As a sedative before anaesthesia

For the indication of sedation prior to anaesthesia, which requires a once only, high dose of alimemazine, the higher strength 30mg/5ml oral solution should be prescribed to limit propylene glycol (excipient) exposure.

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Precautions and warnings: Alimemazine is contraindicated in patients with: Known hypersensitivity to phenothiazines or to any of the excipients.(see full spc), Hepatic or renal dysfunction , Epilepsy, Parkinson’s disease, Hypothyroidism , Phaeochromocytoma, Myasthenia gravis, History of narrow angle glaucoma, History of agranulocytosis, Prostatic hypertrophy . Alimemazine is contraindicated for use in children less than 2 years of age.

Interactions: The sedative effects of phenothiazines may be intensified (additively) by alcohol (see section 4.4 of spc), anxiolytics & hypnotics, opiates, barbiturates, and other sedatives. There may be increased antimuscarinic and sedative effects of phenothiazines with tricyclic antidepressants and MAOI’s (including moclobemide). Respiratory depression may occur. (See full spc). The hypotensive effect of most antihypertensive drugs especially alpha- adrenoreceptor blocking agents may be exaggerated by phenothiazines.

Pregnancy and lactation: Alimemazine, like other drugs, should be avoided in pregnancy unless the physician considers it essential. Phenothiazines may be excreted in milk: breast feeding should be suspended during treatment.

Effects on ability to drive and use machines: Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery.

Adverse reactions: Very Common: Constipation, Dry Mouth, Nasal Congestion, Insomnia, Agitation. Consult the Summary of Product Characteristics in relation to other side effects.

Overdose: Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias, and hypothermia. Severe extra-pyramidal dyskinesias may occur. It is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary.

Price: 10mg/5ml s/f solution is £182.00 for 100ml.

Category: POM. Marketing Authorisation Number: PL 42176/0019

Marketing Authorisation Holder: Lucis Pharma Ltd
14 Aston Magna, Moreton in Marsh Gloucestershire GL56 9QQ United Kingdom

Job Code: UK/MED/21/0019.

Date of Preparation: 17th February 2021.