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Letters to the Editor
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SPCs
Is Paramol information incorrect?
From Mr G. Diamond, MRPharmS
Recently a customer enquired about advice on a patient information leaflet
for over-the-counter Paramol (paracetamol 500mg and dihydrocodeine tartrate
7.46mg) tablets. She asked if it was safe to continue to take Paramol
as she was on medication for hypothyroidism. The special warning and
precautions section on the summary of product characteristics highlights “reducing
doses in the elderly, hyperthyroidism and chronic hepatic disease”.
I decided to log this as a College of Pharmacy Practice intervention
as it seemed an interesting case.
I discovered from a textbook that the precaution for Paramol may be referring
to “hypothyroidism” and non-specifically to “narcotics”.
Furthermore, I confirmed with the manufacturer’s medical information
officer who confirmed “hypothyroidism” rather than “hyperthyroidism”.
For good measure I consulted the Royal Pharmaceutical Society’s
library information officer who said that the SPC did refer to “hyperthyroidism”.
The information officer kindly e-mailed me some further references.
I advised the patient to refrain from taking the tablets until she clarified
the matter with her own doctor. I understand that untreated cases of
severe hypothyroidism can precipitate a rare myxoedema coma along with
other drugs, including narcotics, which contribute to CNS suppression.
If anyone can give me further information regarding Paramol in relation
to contraindications in thyroid conditions I would be grateful. My guess
is that the SPC should read “hypothyroidism” instead of “hyperthyroidism”.
Gerry Diamond
Manchester
| |
CHRIS ROBINSON, regulatory affairs controller at
SSL International plc, responds:
Mr Diamond is indeed correct in his
conclusion that the summary
of product characteristics for Paramol caplets should read hypothyroidism
and not hyperthyroidism.
We are grateful to Mr Diamond for pointing out this inaccuracy, which,
it appears, was due to an administrative error. Steps are being taken
to correct this detail
as quickly as possible. |
|
The
Pharmaceutical Journal