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SPC changes: November 2013

23/30 November 2013


Imatinib and dronedarone have been added as moderate CYP3A4 inhibitors to the summary of product characteristics for Afinitor (everolimus; Novartis).


The updated summary of product characteristics for Ciproxin (ciprofloxacin hydrochloride; Bayer) states that the single dose of the medicine that may be used to treat uncomplicated cystitis in pre-menopausal women is expected to be associated with lower efficacy than the longer treatment duration.


Hepatocellular injury, hepatic failure and hepatocellular jaundice are now listed as adverse events of treatment with Danol (danazol; Sanofi) on the summary of product characteristics.


Haemophiliac patients with cardiovascular risk factors or diseases may be at the same risk  of developing cardiovascular events as non-haemophiliac patients when clotting has been normalised by treatment with FVIII, according to the updated summary of product characteristics for Kogenate (octocog alfa; Bayer). Patients should be evaluated and monitored for cardiac risk factors.


According to the updated summary of product characteristics for Perjeta (pertuzumab; Roche), men with female partners of childbearing potential no longer have to use contraception while receiving the medicine or for six months following the last dose of Perjeta.


Yervoy (ipilimumab; Bristol Myers-Squibb) is now indicated for the first-line treatment of adult patients with advanced (unresectable or metastatic) melanoma. Further changes to the summary of product characteristics reflect this addition.

16 November 2013


The updated summary of product characteristics for Amaryl (glimepiride; Zentiva) states that glimepiride should be administered at least four hours before colesevelam, to prevent colesevelam binding to glimepiride and reducing glimepiride absorption from the gastrointestinal tract.


Acquired haemophilia has been reported following use of clopidogrel (Zentiva). In cases of confirmed isolated activated partial thromboplastin time prolongation with or without bleeding, acquired haemophilia should be considered. Clopidogrel should be discontinued in patients with a confirmed diagnosis of acquired haemophilia.


The summaries of product characteristics for Cymbalta and Yentreve (both duloxetine hydrochloride; Eli Lilly) now advise caution when co-adminstering the products with drugs that affect the serotonergic neurotransmitter systems, because of the risk of developing serotonin syndrome.


Quetiapine is now contraindicated for concomitant use with Telzir (fosamprenavir; ViiV) and Prezista (darunvir; Janssen), according to the updated summaries of product characteristics.


Rabeprazole (Zentiva) is now indicated in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease. The summary of product characteristics recommends that rabeprazole 20mg, clarithromycin 500mg and amoxicillin 1g are all administered twice daily for seven days.


Sevelamer can reduce intestinal absorption of fat-soluble vitamins and therefore may impair intestinal absorption of calcitriol, according to the updated summary of product characteristics for Rocaltrol (calcitriol; Roche).


According to the updated summary of characteristics for Zydol (tramadol hydrochloride; Grunenthal), tramadol can induce convulsions and increase the potential for selective serotonin reuptake inhibitors, antipsychotics, tricyclic antidepressants and other

seizure threshold-lowering medicinal products to cause convulsions.

9 November 2013


The summary of product characteristics for Augmentin (amoxicillin/clavulanic acid; GlaxoSmithKline) now states that it may reduce the concentration of mycophenolate mofetil when the two are taken together. However, dose adjustment of mycophenolate mofetil is not normally necessary in the absence of evidence of graft dysfunction. Close clinical monitoring should be performed. Additonally, aseptic meningitis with unknown frequency has been added as an undesirable effect. 


Patients receiving Avastin (bevacizumab; Roche) plus chemotherapy, with a history of arterial thromboembolism, diabetes or age greater than 65 years have an increased risk of developing arterial thromboembolic reactions during therapy, according to the updated summary of product characteristics. Caution should be taken when treating these patients with Avastin.


Sexual adverse events associated with Avodart (dutasteride; GlaxoSmithKline) treatment may persist after the treatment has been discontinued, according to the updated summary of product characteristics.

Easyhaler Salbutamol

The summary of product characteristics for Easyhaler Salbutamol (salbutamol sulphate; Orion) has been updated with detailed instructions for use.


Edurant (rilpivirine; Janssen) is no longer contraindicated with rifabutin. The medicines can be taken concomitantly, according to the updated summary of product characteristics.


The shelf life for Jakavi (ruxolitinib; Novartis) tablets in blister packs has been increased to two years from the date of manufacture.


Malarone (atovaquone/proguanil hydrochloride; GlaxoSmithKline) paediatric tablets are recommended for malaria prophylaxis in persons weighing less than 40kg, according to the updated summary of product characteristics.


Mimpara (cinacalcet; Amgen) is not recommended for use in the paediatric population; a fatal outcome was reported in a paediatric clinical trial patient with severe hypocalcaemia.  The summary of product characteristics of Mimpara has been updated to include information on the potential for fatal and life-threatening events in adults and children.


Increased blood creatinine has changed from an uncommon to a common adverse reaction of Stribild (elvitegravir/cobicistat/ tenofovir disoproxil; Gilead) according to the updated summary of product characteristics.


The updated summary of product characteristics for Valdoxan (agomelatine; Servier) states that the decision to increase the dose has to be balanced with a higher risk of transaminases elevation. Any dose increase to 50mg should be made on an individual patient benefit/risk basis and with strict respect to liver function test monitoring.


The summary of product characteristics for Viread (tenofovir; Gilead) tablets 245mg and Viread granules has been updated to allow dose adjustment for adults with moderate to severe renal impairment.

2 November 2013


For patients with breast cancer, ovarian cancer or multiple myeloma, the initial dose of Caelyx (pegylated liposomal doxorubin; Janssen) is administered at a rate no greater than 1mg/minute to reduce the risk of an infusion reaction, according to the updated summary of product characteristics. If no infusion reaction is observed, subsequent Caelyx infusions may be administered over 60 minutes.

For patients with AIDS-related Kaposi’s sarcoma, the dose of Caelyx is diluted in glucose solution for infusion 5% 250ml and administered over 30 minutes.


Cimzia (certolizumab pegol; UCB) is now indicated for the treatment of severe active axial spondyloarthritis comprising severe active ankylosing spondylitis and severe active axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adult patients.

Coversyl Arginine

According to the updated summary of product characteristics for Coversyl Arginine (perindopril arginine; Servier), concomitant use with aliskiren in patients with diabetes mellitus or renal impairment is now contraindicated.


Hypophosphataemia and hypertension are now listed as common adverse reactions on the summary of product characteristics for Ferinject (ferric carboxymaltose; Vifor).

The updated SPC also warns that parenterally administered iron preparations can cause hypersensitivity reactions, including potentially fatal anaphylactic or anaphylactoid reactions. The risk is increased for patients with known allergies,  those with a history of severe asthma, eczema or other atopic allergy, and for those with immune or inflammatory conditions. Ferinject should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available, and where full resuscitation facilities can be assured.


Concomitant treatment with quetiapine is now contraindicated, according to the updated summary of product characteristics for Incivo (telaprevir; Janssen-Cilag).


Librium (chlordiazepoxide hydrochloride; Meda) is now contraindicated for patients with myasthenia gravis, severe hepatic insufficiency or sleep apnoea syndrome. Also, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Librium.

The updated summary of product characteristics also states that tolerance to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. Rebound insomnia and anxiety can occur on withdrawal of treatment, so it is recommended that the dosage is decreased gradually.

Additionally, benzodiazepines may induce anterograde amnesia. To reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of seven to eight hours.

The SPC also indicates that benzodiazepines are not recommended for the primary treatment of psychotic illness.


Concomitant rifabutin treatment is no longer contraindicated with Edurant (rilpivirine hydrochloride; Janssen-Cilag) or Eviplera (emtricitabine/rilpivirine HCl/ tenofovir disoproxil fumarate; Gilead). However, for the duration of rifabutin treatment, the dose of Edurant should be increased to 50mg once daily, and patients taking Eviplera should take an additonal rilpivirine tablet 25mg per day.


Citation: The Pharmaceutical Journal URI: 20065399

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