SPC changes
Accessing SPCs
The summaries of product characteristics and patient
information leaflets for medicines licensed in the UK are available online |
Alimta
An indication for first-line treatment of patients with locally advanced
or metastatic non-small cell lung cancer other than with predominantly
squamous cell histology has been added to the summary of product characteristics
for Alimta (pemetrexed; Lilly).
Depo-Medrone
Warnings about potential psychiatric side effects reported with corticosteroids
and systemic steroids have been added to the summaries of product characteristics
for Depo-Medrone (methylprednisolone; Pharmacia) and Depo-Medrone with
Lidocaine (methlyprednisolone with lidocaine hydrochloride; Pharmacia).
Forsteo
The 18-month course of Forsteo (teriparatide; Lilly) should not be repeated
over a patient’s lifetime, the summary of product characteristics
now warns. In addition, increased alkaline phosphatase has been added
as an uncommon adverse effect.
Fucidin
The contraindications, excipients and storage conditions have been updated
in the summary of product characteristics for Fucidin (sodium fusidate;
LEO Pharma) tablets. The SPC now states that patients with rare hereditary
problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose
malabsorption should not take Fucidin.
Gelatin and polyvinylpyrrolidone
have been removed from the list of exicipients and all-rac-alpha-tocopherol
has been added. The SPC also now states that Fucidin does not require
any special storage conditions.
Humatrope
Information about use in elderly patients and patients requiring glucocorticoid
therapy has been updated in the summary of product characteristics
for Humatrope (somatropin; Lilly). The SPC now says that patients aged
65 years or over are more sensitive to the action of Humatrope and
may be more prone to develop adverse events, and that experience in
patients over 80 years of age is limited.
It also now says that if
glucocorticoid therapy is required, glucocorticoid dosage and compliance
should be monitored carefully to avoid either adrenal insufficiency
or inhibition of growth promoting effects and that, in patients treated
with somatropin, previously undiagnosed secondary hypoadrenalism
may be unmasked, requiring glucocorticoid replacement therapy.
Levitra
Sudden deafness has been added to the list of undesirable effects in
the summary of product characteristics for Levitra (vardenafil; Bayer).
The SPC also now says that sudden decrease or loss of hearing has been
reported in a small number of post-marketing and clinical trial cases
with use of PDE5 inhibitors.
Neoral
Additional warnings have been added to the summaries of product characteristics
for Neoral (ciclosporin; Novartis) soft gelatin capsules and oral solution.
These include additional information about treatment of psoriasis and
atopic dermatitis in elderly patients, children and adolescents and
treatment of atopic dermatitis in patients with benign lymphadenopathy.
The interactions sections of the SPCs have also been updated.
Nimotop
Information about dosing for aneurysmal subarachnoid haemorrhage has
been updated in the summaries of product characteristics for Nimotop
(nimodipine; Bayer) tablets and solution for infusion. Information
has been added about cytochrome P450, and the special warnings, interactions,
pregnancy and lactation, undesirable effects and overdose sections
have also been updated.
Prevenar
Information about immunisation schedules has been updated in the summary
of product characteristics for Prevenar (adsorbed pneumococcal polysaccharide
conjugate vaccine; Wyeth).
Additional information is also now included
in the pharmacodynamic properties section.
Somatuline Autogel
Information on self-injection has been added to the summary of product
characteristics for Somatuline Autogel (lanreotide; Ipsen). The SPC
now states that, for patients considered by their healthcare professional
to be stabilised on their treatment, the injection may be given by
an appropriately trained friend or relative of the patient, and
that patients may self-administer the product after appropriate training.
Back to Top
|
The
Pharmaceutical Journal