SPC changes: December 2013
21/28 December 2013
Dizziness, vertigo, joint swelling, asthenia and pruritis are now listed as common adverse reactions in the summary of product characteristics for alendronic acid (Zentiva). Musculoskeletal pain, which is sometimes severe, is now listed as a very common adverse reaction. There have also been rare reports of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Amias (candesartan cilexetil; Takeda) is now indicated for the treatment of hypertension in children and adolescents aged six to <18 years. Extensive changes to the summary of product characteristics reflect this.
Camcolit (lithium; Norgine) may prolong the effects of neuromuscular blocking agents. It also crosses the placenta and is excreted in breast milk according to the updated summary of product characteristics.
Cimzia (certolizumab pegol; UCB), in combination with methotrexate, is now indicated for the treatment of active psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Concurrent therapy with quetiapine is now contraindicated in the summary of product characteristics for Invirase (saquinavir mesilate; Roche).
Naropin (ropivacaine; AstraZeneca) solution for infusion 2mg/ml is now indicated for peripheral nerve block in infants from one year old and children up to and including 12 years old. Further changes to the summary of product characteristics reflect this.
The summaries of product characteristics for Tamiflu (oseltamivir phosphate; Roche) have been extensively updated with changes to information on pharmacy compounding and dosing. The shelf life for the storage of pharmacy compounded suspension of Tamiflu capsules has been reduced from three weeks to 10 days.
Severe renal impairment and known hypersensivity to atenolol and chlortalidone are now contraindicated in the summary of product characteristics for Tenoret (atenolol, chlortalidone; AstraZeneca). Tenoret should only be administered after alfa-receptor blockade in patients with phaeochromocytoma and caution must be exercised if anaesthetics are used with Tenoret.
07/14 December 2013
Lactic acidosis has been added as a side effect with unknown frequency to the summary of product characteristics of Bricanyl (terbutaline; AstraZeneca) solution for injection or infusion and Bricanyl Respoules.
Arachis oil (peanut oil) has been added as an excipient of Colpermin (peppermint oil; McNeil) in the summary of product characteristics.
Pregnancy and breastfeeding is no longer a contraindication for the use of Curanail (amorolfine hydrochloride; Galderma) in the summary of product characteristics. Warning against using Curanail in children and against using cosmetic nail varnish or artificial nails during treatment have been added.
The summary of product characteristics of Efient (prasugrel hydrochloride; Eli Lilly and Company) now states that Efient is contraindicated in patients with severe hepatic impairment.
Voriconazole, a potent inhibitor of CYP3A4, has been added to the list of medicines that should not be used concomitantly with Inegy (ezetimibe and simvastatin; MSD), according to Inegy’s updated summary of product characteristics. Information on the risks associated with concomitant administration with fusidic acid have also been added to the SPC.
Concomitant use of yellow fever vaccine is contraindicated with irinotecan hydrochloride concentrate for solution for infusion (Hospira), according to the updated summary of product characteristics. Live or live attenuated vaccines should not be administered while the patient is receiving irinotecan hydrochloride. Additionally, patients with respiratory or cardiac risk factors should be closely monitored while receiving irinotecan.
Men receiving Perjeta (pertuzumab; Roche) who have female partners of childbearing potential are no longer required to use contraception while receiving treatment or for six months following the final dose, according to the updated summary of product characteristics.
Hypersensitivity reactions of the tongue and throat have been added to the list of undesirable effects of Propecia (finasteride; MSD) in the summary of product characteristics.
Advice on the dosage of Tegretol (carbamazepine; Novartis) has been updated in the summary of product characteristics.
Transvasin Heat Rub cream (hexyl nicotinate, ethyl nicotinate, tetrahydrofurfuryl salicylate; Thornton & Ross) is contraindicated where there is known hypersensitivity to aspirin, other salicylates or non-steroidal anti-inflammatories, especially when associated with a history of asthma, according to the updated summary of product characteristics. Additionally, methylhydroxybenzoate may cause allergic reactions (possibly delayed) and cetostearyl alcohol may cause local skin reactions (eg, contact dermatitis). Additionally, it is warned that topical salicylates may potentiate the effects of warfarin.
The summary of product characteristics for Valdoxan (agomelatine; Servier) now states that it is contraindicated in people with transaminase levels three times the upper limit of normal. Decisions on dose increases should be balanced against risk of transaminase elevation. Liver injury has been reported in agomelatine-treated people, including hepatic failure leading to death or liver transplantation in people with hepatic risk factors.
Voriconazole, a potent CYP3A4 inhibitor, has been added to the list of medications contraindicated for use with Zocor (simvastatin; MSD) in Zocor’s summary of product characteristics.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.20065398
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