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SPC changes: October 2013

26 October 2013


Allopurinol (Aurobindo) should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs because this could result in more serious hypersensitivity reactions, according to the updated summary of product characteristics. Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions.

In the early stages of allopurinol treatment, prophylaxis for gouty arthritis should be given in the form of a suitable anti-inflammatory agent or colchicine for at least one month.


Two of the influenza strains in Fluvirin (influenza vaccine, [surface antigen, inactivated]; Novartis) have been changed, according to the updated summary of product characteristics.


The tip cap composition of the prefilled syringe for Granocyte (lenograstim; Chugai) contains latex rubber which may cause severe allergic reactions in predisposed patients, according to the updated summary of product characteristics.


Chemoprophylaxis with Lariam (mefloquine hydrochloride; Roche) should be started 10 days before departure, with the second intake three days before departure, according to the updated summary of product characteristics. Subsequent doses should be taken once a week on a fixed day.

In addition to the existing neuropsychiatric adverse reactions listed, cases of suicide, suicidal thoughts and self-endangering behaviour such as attempted suicide have been reported. Also, patients should be advised to consult a doctor if signs of arrhythmia or palpitations occur during chemoprophylaxis with mefloquine, because these symptoms might precede severe cardiologic effects in rare cases. Concomitant use of mefloquine and anticonvulsants may reduce seizure control by lowering the plasma levels of anticonvulsants. Concomitant administration of mefloquine and drugs known to lower the epigenetic threshold — including tricyclic antidepressants, selective serotonin reuptake inhibitors, buproprion, antipsychotics, tramodol, chloroquine and some antibiotics — may increase the risk of convulsions.

Mefloquine should be stopped in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness and weakness, to prevent the development of an irreversible condition.


According to the updated summary of product characteristics for Nexium (esomeprazole magnesium trihydrate; AstraZeneca), increased chromogranin A levels may interfere with investigations for neuroendocrine tumours. To prevent this, esomeprazole treatment should be stopped five days before CgA measurement.

Nicorette Quickmist

Dizziness, presyncopal symptoms, constipation and gingival bleeding have been added as cessation-associated symptoms to the summary of product characteristics for Nicorette Quickmist (nicotine; McNeil).


Pancreatitis or a history of pancreatitis if associated with severe hypertriglyceridaemia has been removed as a contraindication on the updated summary of product characteristics for Yasmin (ethinylestradiol/drospirenone; Bayer).

 19 October 2013


Revolade (eltrombopag olamine; GlaxoSmithKline) is now indicated for adults with chronic hepatitis C infection who have thrombocytopenia. The summary of product characteristics now states that it is not recommended for women of childbearing potential not using contraception.


Zonegran (zonisamide; Eisai) is now indicated as adjunctive therapy for partial seizures in children aged six years and above.

12 October 2013


According to the updated summary of product characteristics for Eliquis (apixaban; Bristol-Myers Squibb), the use of Eliquis is not recommended for patients with prosthetic heart valves, with or without atrial fibrillation, because the safety and efficacy of the drug has not been studied in this group. In addition, haemodialysis is unlikely to be an effective means of managing apixaban overdose.


The upper age limit for Humira (adalimumab; AbbVie) treatment for polyarticular juvenile idiopathic arthritis and paediatric Crohn’s disease has been removed on the updated summary of product characteristics.

5 October 2013


The summary of product characteristics for Dobutamine (dobutamine hydrochloride; Hameln) has been updated, following the outcome of the EU paediatric work-sharing procedure for Dobutamine, to specifically clarify use in the paediatric population.


Florinef (fludrocortisone acetate; Bristol-Myers Squibb) should be stored in a refrigerator (2–8°C) with the bottle tightly closed, according to the updated summary of product characteristics. Excursions to room temperature (25°C) are permitted for up to 30 days, but after this time unused tablets should be disposed of.


The summary of product characteristics no longer recommends that male patients with female partners must use effective contraception while receiving Perjeta (pertuzumab; Roche) and also for six months following the last dose of Perjeta.


Stelara (ustekinumab; Janssen-Cilag) is now indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug therapy has been inadequate, according to the updated summary of product characteristics.


The summary of product characteristics for Votubia (everolimus; Novartis) has been updated to include imatinib and dronedarone as moderate CYP3A4/PgP inhibitors, which can increase everolimus concentrations.


According to the updated summary of product characteristics for Zytiga (abiraterone acetate; Janssen-Cilag), strong inducers of CYP3A4 during treatment should be avoided unless there is no therapeutic alternative, owing to risk of decreased exposure to Zytiga.



Citation: The Pharmaceutical Journal URI: 20065401

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