- 1. What has happened to change advice given about the supply of some
cough and cold medicines in children under 6 years?
The Medicines and Healthcare products Regulatory Authority (MHRA) has reviewed over
the counter (OTC) products used for treating coughs and colds in children and advised
that certain medicines should no longer be used in children under the age of six.
The change in guidance affects Medised for Children. However, no serious safety
concerns have been reported relating to Medised for Children. All medicines, whether
for children or adults, should always be used as per the dosage instructions on
the pack.
This is a precautionary measure only and the pharmaceutical industry has voluntarily
agreed to change the labels on products to remove the dosage instructions for children
under six by March 2010.
- 2. Are some OTC children’s cough & cold medicines being withdrawn from
shelves?
They are not being withdrawn from shelves. The MHRA has reviewed OTC products used
for treating coughs and colds in children and has advised that packs should be changed
by March 2010 on certain medicines to indicate they should no longer be used in
children under the age of six.
- 3. Are these medicines harmful for under sixes?
The MHRA has issued new best practice advice stating that medicines containing the
ingredients listed below should not be used to treat coughs and colds in children
under the age of 6. As there are no specific safety concerns with these medicines,
companies will be allowed to sell through the affected products. Newly labelled
packs reflecting the new advice will start to be available later in 2009 and the
changeover will be completed by March 2010.
Remember:
- Always read the medicine label and follow the advice
- Stick to the recommended dose
- Do not use more than one product containing the same active ingredient
- Consult your GP or pharmacist if you have any worries about a product
- 4. Which ingredients are affected by the new guidance?
These products are not harmful if administered in accordance with the directions
on the label. The review did not identify any new safety concerns and this is a
precautionary measure only.
Non-prescription cough and cold medicines that contain the following active ingredients
should not be used in children younger than six years under the new advice:
- Bromphreniramine, chlorphenamine, diphenhydramine, doxylamine, promethazine and
triprolidine (antihistamines)
- Dextrometorphan and pholcodine (antitussives)
- Guaifenesin and ipecacuanha (expectorants)
- Phenylephrine, pseudoephedrine, ephedrine, oxymetazoline and xylometazoline (decongestants)
Medinol Under 6 contains paracetamol only so is not affected by this advice and
is suitable to be given to children from three months old (or 2 months on the advice
of a doctor).
- 5. Does this new advice affect the complete Medi range; Medised for
Children, Medinol Under 6 and Medinol Over 6?
The only product in the Medi range affected by the changes is Medised for Children
because it contains diphenhydramine as well as paracetamol. The new advice means
that from March 2010 Medised will no longer be available for the treatment of cold
symptoms in children under 6 years. Only Medinol Under 6 will be suitable for relief
of symptoms of colds in children under 6 years. Medinol Under 6 contains paracetamol
and is suitable for infants over 3 months (or 2 months on the advice of a doctor).
- 6. When will the Medised packaging be changed from over 2 years to 6
years?
Medised packaging will be changed as soon as possible (the changes have to be approved
by the MHRA before the packs can be updated) in time to meet the March 2010 deadline.
Keep visiting Medimums.co.uk to receive updates on the packaging changes.
- 7. Has my child been put at risk if I have been administering these
types of products from a very early age?
No, these products are not harmful if administered in accordance with the directions
on the label. The changes are a precautionary measure only, reflecting the change
in guidance for treating coughs and colds in under sixes.. If you are concerned
about your child’s health or about the correct medicine to use, then you should
speak to your pharmacist, health visitor or other healthcare professional.
- 8. What is the new advice for treating coughs and colds in children
under 6 years?
According to the MHRA, parents and carers are being advised that children under
six suffering from a cough or cold should be treated with paracetamol or ibuprofen
to lower the child’s temperature. If they have a cough, they are being advised to
use a simple cough syrup, such as glycerol, honey or lemon. Baby Meltus Cough Linctus
is not affected by the new advice, and you can continue to use this product to relieve
the symptoms of coughs in babies and infants from 3 months (contains dilute acetic
acid, always read the label).
For young babies who are having difficulty feeding, nasal saline drops are recommended
to help thin and clear nasal secretions. Vapour rubs and inhalant decongestants,
which can be applied to a child’s clothing, can also be used to provide relief from
a blocked nose.
However, while the changes are made, all medicines continue to be suitable for use
as instructed on the label.
Note that Medinol Under 6 which contains paracetamol only, is not affected by this
advice and is suitable to be given to children from three months old.
- 9. What advice can medimums.co.uk give to parents who are concerned
about the health of their children?
If concerned about your child’s health or about the correct medicine to use, then
you should speak to your pharmacist, health visitor or other healthcare professional.
In addition, you can call the SSL customer care line on 0800 915 4435.
- 10. Is there a list of products which are affected?
Yes. This is available from the MHRA, who have issued this advice. For further information,
the MHRA can be contacted at www.mhra.gov.uk
Always read the label and the in pack leaflet