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MHRA advises on use of children's medicines

The MHRA has published guidance on the safer use of OTC medicines in children under the age of 12

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the safer use of OTC medicines in children under the age of 12.

The announcement follows extensive risk/benefit analysis and has been published following advice from the Commission on Human Medicines (CHM). The review did not highlight any immediate risks, such as those found in the under two age group in March 2008, however, the review found no evidence that the medicines, which can cause side effects, actually work.
MHRA director of vigilance and risk management of medicines, Dr June Raine said: "Over-the-counter medicines used to treat coughs and colds have been used for many years. However they came into use when clinical trials were not required to demonstrate that they worked in children. This means they were not specially designed for children."

Parents and carers of children under six are advised to follow the Department of Health guidance 'Birth to Five', published in 2007. For children aged six to 12, medicines will continue to be available, but will be obtainable only from pharmacies.

The lists below show the products affected by this review.

Products parents can still use to treat coughs and colds in children under six years of age:
For pain and to lower temperature:
Calpol Infant Suspension
Calpol Sugar-free Infant Suspension (2+ months)
Calpol Sugar-free Infant Suspension sachets (2+ months)
Calprofen (3+ months)
Calprofen Sachets (3+ months)
Cuprofen Suspension for Children
Disprol Paracetamol Suspension (from 3 months)
Disprol Soluble Paracetamol Tablets (from 3 months)
Medinol Under 6 Paracetamol Oral Suspension
Nurofen for Children Strawberry 3 months to 12 years
Nurofen for Children Orange 3 months to 12 years
Nurofen for Children Strawberry Baby (from 3 months)
Nurofen for Children Orange Baby (from 3 months)
Simple cough mixtures:
Baby Meltus Cough Linctus
Beechams Veno's Honey and Lemon (Under 1 year: not to be given)
Benylin Children's Tickly Coughs (3 months +)
Benylin Tickly Coughs (Non drowsy) (Under 1 year: not to be given)
CalCough Tickly
Care Glycerin Lemon & Honey with Glucose (Under 1 year: not recommended)
Lemsip Cough Dry
Tixylix Baby Syrup (Not recommended under 3 months)

Products that currently have doses for under six and are changing their labelling to remove these doses (they can still be used to treat children over six years old):
Beechams Veno's Expectorant
Beechams Veno's Honey & Lemon
Benilyn Childrens Chesty Coughs/
Calcough Chesty
Benilyn Childrens Coughs and Colds
Benilyn Childrens Night Coughs
Benylin Children's Dry Cough
Calpol Night
Care Glycerin lemon & honey with Ipecac
Cofsed Linctus
Family Meltus Chesty Coughs Honey and Lemon Flavour
Galenphol Linctus
Galenphol Paediatric Linctus
Galpseud linctus
Junior Meltus Chesty Coughs with Catarrh
Junior Meltus Dry Coughs with Congestion
Junior Meltus Dry Coughs with Congestion
Lemsip Cough and Cold Chesty Cough Medicine
Lemsip Cough Chesty
Medised for Children
Multi-Action Actifed
Multi-Action Actifed Chesty Coughs
Mutli-Action Actifed Dry Coughs
Non- Drowsy Sudafed Childrens
Non Drowsy Sudafed Expectorant
Non Drowsy Sudafed Linctus
Otrivine Childrens Nasal Drops
Robitussin Chesty Cough Medicine
Robitussin Chesty Cough with Congestion
Tixilix Cough and Cold
Tixylix Chesty Cough
Tixylix Night Cough
Vicks Cough Syrup for Chesty Coughs
Vicks Cough Syrup for Dry Coughs

Children's cough and cold products that already only have dosages for children six years and over:
Afrazine Nasal
Allens Pine and Honey Balsam
Beechams Decongestant Plus with Paracetamol
Beechams Flu Plu
Beechams Powders Capsules
Benilyn Chesty Coughs (Non Drowsy)
Benilyn Chesty Coughs (Original)
Benilyn Dry Coughs (Non Drowsy)
Benilyn Dry Coughs (Original)
Benylin 4 Flu
Benylin 4 Flu
Benylin Cold & Flu Max strength
Benylin Cough and Congestion
Benylin Dual Action Night Cough & Congestion
Care Pholcodine linctus
Covonia Original Bronchial Balsam
Day Nurse
Day Nurse
Fenox Nasal
Fenox Nasal
Lemsip Max Cold & Flu
Lemsip Max Day & Night Cold & Flu relief
Lemsip Max Daytime Cold & Flu relief
Lemsip Max Sinus Capsules
Non- Drowsy Sinutab
Non-Drowsy Sudafed Congestion & Headache Capsules
Non-Drowsy Sudafed Congestion Cold and Flu
Non-Drowsy Sudafed Dual Relief
Otrivine Antistin Eye Drops
Otrivine Mucron
Robitussin Dry Cough Medicine
Tixylix Dry Cough
Vicks Cold & Flu Care Daymed Capsules
Vicks Cold & Flu care Medinite Complete Syrup
Vicks Cold & Flu care Medinite Complete Syrup
Vicks Sinex Decongestant Nasal
Vicks Sinex Micromist
Vicks Sinex Soother

2nd March 2009


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