Prescribing Information
Trimbow 87/5/9 Pressurised Metered Dose Inhaler (pMDI) Prescribing Information Please refer to the full Summary of Product Characteristics (SPC) before prescribing. Presentation: Each Trimbow 87/5/9 pMDI delivered dose contains 87micrograms (mcg) of beclometasone dipropionate (BDP), 5mcg of formoterol fumarate dihydrate (formoterol) and 9mcg of glycopyrronium. This is equivalent to a metered dose of 100mcg BDP, 6mcg formoterol and 10mcg glycopyrronium. Indications: Maintenance treatment in adult patients with moderate to severe chronic
obstructive pulmonary disease (COPD) not
adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2
‑agonist (for effects on symptoms control and prevention of exacerbations see section 5.1 of SPC). Dosage and administration: For inhalation in adult patients (≥18 years). 2 inhalations twice daily (bd). Can be used with the AeroChamber Plus®
spacer device. BDP
in Trimbow is characterised by an extrafine particle size distribution which results in a more potent effect than formulations of BDP with a non‑extrafine particle size distribution (100mcg of BDP extrafine in Trimbow are equivalent to 250mcg of BDP in a non‑extrafine formulation). Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Not for acute use in treatment of acute episodes of bronchospasm or to treat COPD exacerbation. Discontinue immediately if hypersensitivity or paradoxical bronchospasm. Deterioration of disease: Trimbow should not be stopped abruptly. Cardiovascular effects: Use with caution in patients with cardiac arrhythmias, aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, occlusive vascular diseases, arterial hypertension and aneurysm. Caution should also be used when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females) either congenital or induced by medicinal products. Trimbow should not be administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias. Caution in patients with thyrotoxicosis, diabetes mellitus, phaeochromocytoma and untreated hypokalaemia. Increase in pneumonia and pneumonia hospitalisation in COPD patients receiving ICS observed. Clinical features of pneumonia may overlap with symptoms of COPD exacerbations. Systemic effects of ICS may occur, particularly at high doses for long periods, but are less likely than with oral steroids. These include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation, decrease in bone mineral density, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression and aggression. Use with caution in patients with pulmonary tuberculosis or fungal/viral airway infections. Potentially serious hypokalaemia may result from beta2
-agonist therapy. Formoterol may cause a
rise in blood glucose levels. Glycopyrronium should be used with caution in patients with narrow- angle glaucoma, prostatic hyperplasia or urinary retention. Use in patients with severe hepatic or renal impairment should only be considered if benefit outweighs the risk. Interactions: Since glycopyrronium is eliminated via renal route, potential drug interactions could occur with medicinal products affecting renal excretion mechanisms e.g. with cimetidine (an inhibitor of OCT2 and MATE1 transporters in the kidney) co‑administration, glycopyrronium showed a slight decrease in renal excretion (20%) and a limited increase in total systemic exposure (16%). Possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded and therefore caution and appropriate monitoring is advised. Related to formoterol: Non-cardioselective beta-blockers (including eye drops) should be avoided. Concomitant administration of other beta-adrenergic drugs may have potentially additive effects. Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants and phenothiazines can prolong the QTc interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2
-sympathomimetics. Hypertensive reactions
may increase the likelihood of arrhythmias in patients receiving digitalis glycosides. Related to glycopyrronium: Co-administration with other anticholinergic-containing medicinal products is not recommended. Excipients: Presence of ethanol may cause potential interaction in sensitive patients taking metronidazole or disulfram. Fertility, pregnancy and lactation: Should only be used during pregnancy if the expected benefits outweigh the potential risks. Children born to mothers receiving substantial doses should be observed for adrenal suppression. Glucocorticoids and metabolites are excreted in human milk. It is unknown whether formoterol or glycopyrronium (including their metabolites) pass into human breast-milk but they have been detected in the milk of lactating animals. Anticholinergic agents like glycopyrronium could suppress lactation. A risk/benefit decision should be taken to discontinue therapy in the mother or discontinue breastfeeding. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy. Effects on driving and operating machinery: None or negligible. Side effects: Common: pneumonia (in COPD patients), pharyngitis, oral candidiasis, urinary tract infection, nasopharyngitis, headache, dysphonia. Uncommon: influenza, oral fungal infection, oropharyngeal candidiasis, oesophageal candidiasis, sinusitis, rhinitis, gastroenteritis, vulvovaginal candidiasis, granulocytopenia, dermatitis allergic, hypokalaemia, hyperglycaemia, restlessness, tremor, dizziness, dysgeusia, hypoaesthesia, otosalpingitis, atrial fibrillation, electrocardiogram QT prolonged, tachycardia, tachyarrhythmia, palpitations, hyperaemia, flushing, cough, productive cough, throat irritation, epistaxis, diarrhoea, dry mouth, dysphagia, nausea, dyspepsia, burning sensation of the lips, dental caries, rash, urticaria, pruritus, hyperhidrosis, muscle spasms, myalgia, pain in extremity, musculoskeletal chest pain, dysuria, urinary retention, fatigue, asthenia, C-reactive protein increased, platelet count increased, free fatty acids increased, blood insulin increased, blood ketone body increased, blood cortisol decreased. Rare: Lower respiratory tract infection (fungal), hypersensitivity reactions, including erythema, lips, face, eyes and pharyngeal oedema, decreased appetite, insomnia, hypersomnia, angina pectoris (stable and unstable), ventricular extrasystoles, nodal rhythm, sinus bradycardia, blood extravasation, hypertension, paradoxical bronchospasm, oropharyngeal pain, angioedema, nephritis, blood pressure increased, blood pressure decreased. Very rare: thrombocytopenia, adrenal suppression, glaucoma, cataract, dyspnoea, growth retardation, peripheral oedema, bone density decreased. Unknown frequency: psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (Refer to SPC for full list of side effects). Legal category: POM Packs and price: £44.50 1x120 actuations. Marketing authorisation No: EU/1/17/1208/002 UK Distributor: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG. Date of preparation: Jun 2017. AeroChamber Plus® Medical International.
may occur following co‑administration with MAOIs including drugs with similar properties (e.g. furazolidone, procarbazine). Risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. Concomitant treatment with xanthine derivatives, steroids or diuretics may potentiate a possible hypokalaemic effect of beta2
-agonists. Hypokalaemia
He said doctors couldn’t get in to ‘quite a few villages’ and, in many places, the pharmacy was the only resource available.
is a registered trademark of Trudell
‘We extensively used the urgent supply PGDs, trimethoprim PGDs and minor ailment service extensively across all our shops particularly as a large number of surgeries were without GPs or closed,’ he said. ‘Thank goodness for the Scottish contract that allows community pharmacists to swing into action and effectively become people’s only NHS touch point locally. We must have taken a massive strain off NHS 24. I personally have taken urgent supply medicines to people from as far away at Stranraer.’
New NPA Chief Executive
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Chiesi Limited on 0800 0092329 (GB), 1800 817459 (IE).
Mark Lyonette is to join the National Pharmacy Association as chief executive from June 2018. Mark is currently chief executive of the Association of British Credit Unions. He brings with him a great deal of experience of running trade
beclometasone/formoterol/ glycopyrronium (87/5/9 mcg)
Janice Oman
Scotland Representation Manager
The snow can sometimes bring most of the country’s workforce to a standstill but recently we saw pharmacy teams across Scotland making deliveries on-foot to ensure sick and vulnerable people get vital medicines in time. The ‘Beast from the East’ caused chaos on the roads but we witnessed yet another reminder of the value the community pharmacy network brings to patients and society at large, going the extra mile to keep people well.
Right Medicine Pharmacy managing director Noel Wicks was one of many pharmacists braving the sub-zero temperatures to help his patients.
associations, membership bodies and leading a complex, regulated sector through change. We look forward to his arrival in June.
Medicines in pregnancy and patient safety
The NPA has developed a suite of patient safety resources, intended to raise the awareness of the risks of valproate and other medicines used during pregnancy amongst the pharmacy team and patients – the new resources include:
• ’Valproate dispensing guidance and checklist’ - A step-by-step
guide to follow and top tips for dispensing valproate products
• ’Reducing harm from medicines in pregnancy’ - A short factsheet
for pharmacy teams, including a list of medicines which carry risk when handled/used in pregnancy.
• Medicines in pregnancy poster - A poster to be displayed to
patients designed to encourage patients to ask the pharmacist before taking any medicines during pregnancy or if they are planning to conceive.
Go to
www.npa.co.uk to access them.
Guidance on cannabis oil and cannabidiol-containing products
Community pharmacy teams have seen a signifi cant increase in requests for cannabis oil and cannabidiol (CBD)-containing products from members of the public in recent months. The NPA has guidance on its website which is intended to assist you and your team in dealing with requests for cannabis oil/CBD-containing products and provide appropriate advice to your customers.
NPA IN FOCUS
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