Answers the call to sleep®
INTRODUCING ADAFLEX
Bringing melatonin and sleep together to support the lives of children with ADHD.
For many sufferers, the impacts of childhood ADHD are exacerbated by sleep disruption2.
Research recognises that this frequently results in a significant range of developmental issues, from family difficulties to compromised educational progress, often with wider implications3.
Previously, UK healthcare providers haven't had a licensed melatonin product specifically for sleep disorders in children with ADHD as part of their treatment armoury.
Until now, prescribers have had to consider off-label adult-indicated alternatives. For many this was far from ideal, whilst for others it was a difficult professional choice to make, creating friction between professionals as they try to develop shared care agreements for these patients4.
Adaflex from AGB Pharma answers this treatment dilemma. It introduces prescribing clarity with a range of 5 different strengths of indication-specific melatonin dedicated to sleep disruption associated with childhood ADHD1.
Adaflex also uses a non-modified standard tablet to help influence circadian rhythm without delay, allowing Adaflex to be used 30 - 60 minutes before bedtime1.
This clear, simplified and expanded treatment choice aims to enhance the ability of prescribers to respond to the issues experienced, supporting parents and tailoring care closer to the needs of the individual child.
WHO IS ADAFLEX FOR?
Adaflex is indicated for Insomnia in children aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient*1. Research indicates that as many as 5% of children suffer from ADHD5.
In the UK that's approaching 395,000 6-17-year-olds7, with up to 50% of them suffering from sleep disruption6.
Adaflex aims to help ease this complex and continuing care situation with a unique range of 1mg to 5mg melatonin specifically indicated for healthcare professional prescription use, to address the problem of sleep disruption in children with ADHD.
This builds on positive NICE data, the findings of which recognise that 87.8% of parents who treat their child with melatonin consider it an effective therapy, particularly with sleep onset8.
*Adaflex is also indicated for the short-term treatment of jet lag in adults1.
PRICING & ORDERING
Adaflex is available in 1mg - 5mg dose strengths. All in packs of 30 tablets. The range of strengths and pricing structure has been developed to help healthcare professionals move up and down the strengths to find the best fit for their patient.
Adaflex is available to order via the major UK wholesalers AHH, Alliance and Phoenix Numark.
For additional information please contact info@agb-pharma.com
| Trade Price (NHS Price) | PIP code | Pack Size | Unit EAN | |
|---|---|---|---|---|
| Adaflex 1 mg Tablets | £13.30 | 4192332 | 30 tablets | 7350116410440 |
| Adaflex 2 mg Tablets | £15.30 | 4192340 | 30 tablets | 7350116410457 |
| Adaflex 3 mg Tablets | £17.60 | 4192316 | 30 tablets | 7350116410464 |
| Adaflex 4 mg Tablets | £20.23 | 4192324 | 30 tablets | 7350116410471 |
| Adaflex 5 mg Tablets | £23.27 | 4192357 | 30 tablets | 7350116410488 |
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 AGB-Pharma AB at uk.med.info@agb-pharma.com.
UK ABBREVIATED PRESCRIBING INFORMATION
Please refer to Summary of Product Characteristics (SmPC) for specific information before prescribing.
ADAFLEX 1MG, 2MG, 3MG, 4MG AND 5MG TABLETS
ACTIVE INGREDIENT: Each tablet contains melatonin 1mg, 2mg, 3mg, 4mg or 5mg.
INDICATIONS: Short term treatment of jet lag in adults; insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient.
DOSAGE AND ADMINISTRATION:
Dose: Adults with jet lag: The recommended dose is 1-5 mg for a maximum of 5 days. A maximum of 16 treatment cycles may occur per year. Insomnia in children aged 6 years or older and adolescents with ADHD: The recommended starting dose is 1-2 mg; the dose can be increased by 1 mg every week until effect up to a maximum 5 mg per day, independent of age; the lowest effective dose should be sought. After at least 3 months of treatment, the treatment effect should be evaluated and stopping treatment considered if no clinically relevant effect seen. The patient should be monitored at regular intervals to check that Adaflex is still the most appropriate treatment. During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should be made regularly. If the sleep disorder has started during treatment with medicinal products for ADHD, dose adjustment or switching to another product should be considered.
Administration: Oral; the tablet can be crushed and mixed with water directly before administration; it is recommended that food is not consumed 2 h before and 2 h after intake. Adults with jet lag: At the time of destination bedtime for journeys of 5 time zones or longer, especially when traveling in an easterly direction, and not before 20:00 hr or after 04:00 hr at destination. Insomnia in children aged 6 years or older and adolescents with ADHD: 30-60 minutes before bedtime.
CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Caution should be used in the elderly and individual dosage is recommended. Use caution in patients with renal impairment. Not recommended in patients with moderate or severe hepatic impairment. Not recommended for children below 6 years with ADHD. Melatonin may cause drowsiness, use with caution if this effect is likely to be associated with a risk to patient safety. Not recommended in patients with autoimmune diseases. Caution should be exercised in patients with epilepsy. Melatonin tablets should be taken ideally at least 3 hours after a meal by patients with significantly impaired glucose tolerance or diabetes.
INTERACTIONS: Concomitant use with the CYP1A2 inhibitor fluvoxamine, alcohol, warfarin and other vitamin K antagonists and benzodiazepine-related hypnotics, should be avoided. Use with caution with the CYP1A2 inhibitors ciprofloxacin, norfloxacin and verapamil, combined hormonal contraceptives containing ethinylestradiol and gestagen, 5- or 8-methoxypsoralen, cimetidine, caffeine, the CYP1A2 inducers carbamazepine, phenytoin, rifampicin, omeprazole and smoking, nifedipine and other calcium antagonists, NSAIDs and beta-blockers.
FERTILITY, PREGNANCY, LACTATION: Not recommended during pregnancy or in women of child-bearing potential not using contraceptives, or breastfeeding. High doses and use for longer periods than indicated may compromise fertility in humans; no adequate data are available.
DRIVING AND USE OF MACHINES: Moderate influence on the ability to drive and use machines.
UNDESIRABLE EFFECTS: Very common: None. Common: Headache, somnolence. Consult SmPC in relation to other adverse reactions. Serious: Hypersensitivity reaction, angioedema, oedema of mouth, tongue oedema, leukopenia, thrombocytopenia, hyperbilirubinemia, angina pectoris.
LEGAL CATEGORY: POM.
MARKETING AUTHORISATION HOLDER: AGB-Pharma AB, Medicon Village, 223 81 Lund, Sweden.
Marketed in the UK by AGB-Pharma AB; Tel: +44 808 189 2048; Email: uk.med.info@agb-pharma.com.
| Product | NHS List Price | Pack Size | UK Marketing Authorisation Number |
|---|---|---|---|
| Adaflex 1 mg Tablets | £13.30 | 30 tablets | PL 52497/0001 |
| Adaflex 2 mg Tablets | £15.30 | 30 tablets | PL 52497/0002 |
| Adaflex 3 mg Tablets | £17.60 | 30 tablets | PL 52497/0003 |
| Adaflex 4 mg Tablets | £20.23 | 30 tablets | PL 52497/0004 |
| Adaflex 5 mg Tablets | £23.27 | 30 tablets | PL 52497/0005 |
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 AGB-Pharma AB at uk.med.info@agb-pharma.com.
DATE OF REVISION OF THE TEXT: November 2021
References
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- AGB Pharma (2021) Summary of Product Characteristics. Nov 2021.
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- AGB Pharma, PM Consultancy UK Research 2021, Data On File
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- NHS (2018) Delivering Effective Services for Children and Young People with ADHD. Available from https://www.england.nhs.uk/north-west/wp-content/uploads/sites/48/2019/03/GM-wide-ADHD-guidance.pdf accessed 10th Dec 20
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- Wajszilber D et al 2018, Sleep disorders in patients with ADHD: impact and management, Nature and science of sleep 2018:10 453 - 480
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- Calculated using population by age figures from Age groups - GOV.UK Ethnicity facts and figures (ethnicity-facts-figures.service.gov.uk)
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- ADHD: Sleep disorders in children and young people with attention deficit hyperactivity disorder: melatonin. NICE Evidence Summary ESUOM2. Published 4th Jan 2013
© 2021 AGB-Pharma AB. Date of revision of the text: April 2022