Intended for UK healthcare professionals only .
Tiogiva ® is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease ( COPD ) in adults only . 1
WE ’ RE ASKING YOU TO PRESCRIBE TIOGIVA ® , A LLAMA FOR COPD
The extra ‘ L ’ is for Low cost .
tiotropium See COPD , think LLAMA
• is bioequivalent to Spiriva ® , but costs 42 % less 2-4
• delivers the same active substance as Braltus ® , but costs 25 % less 1-3 , 5
• has the same inhaler technique as other tiotropium capsule inhalers , so no need for patients to change technique 6-10
SEE COPD , THINK LLAMA , PRESCRIBE TIOGIVA
Scan to visit www . tiogiva . co . uk
Tiogiva ( tiotropium bromide ) 18 mcg inhalation powder Please refer to the Summary of Product Characteristics ( SmPC ) before prescribing . Presentation : Delivered dose : 10 mcg of tiotropium per capsule ( the dose that leaves the mouthpiece is 12.1 microgram tiotropium bromide ). Each capsule contains 21.7 mcg of tiotropium bromide , equivalent to 18 mcg of tiotropium . Indications : Maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease ( COPD ). Dosage and administration : For inhalation only . Must not be swallowed . Inhalation should be at the same time each day . Adults : Inhalation of the contents of one capsule once daily with the dry powder inhaler . To get a full daily dose , the patient must breathe out completely . The patient should also inhale a second time from the same capsule . See SmPC for administration and instructions for use . Children : Not to be used in children or adolescents < 18 years of age . Elderly : No special requirements . Renal Impairment : Mild ( creatinine clearance > 50 ml / min ): no special requirements . Moderate to severe ( creatinine clearance ≤50 ml / min ): Use only if expected benefit outweighs the potential risk . There is no long-term experience in patients with severe renal impairment . Hepatic Impairment : No special requirements . Contraindications : Hypersensitivity to the active substances or to any of the excipients , or to atropine or its derivatives , e . g . ipratropium or oxitropium . Precautions : Not to be used for the initial treatment of acute episodes of bronchospasm , i . e . rescue therapy . Immediate hypersensitivity reactions may occur . Use with caution in patients with narrow-angle glaucoma , prostatic hyperplasia or bladder-neck obstruction . Inhaled medicines may cause inhalationinduced bronchospasm . Use with caution in patients with recent myocardial infarction < 6 months ; unstable or life-threatening cardiac arrhythmia ; cardiac arrhythmia requiring intervention or a change in drug therapy in the past year ; hospitalisation for heart failure ( NYHA Class III or IV ) within past year . Avoid getting the powder into eyes ( may result in precipitation or worsening of narrow-angle glaucoma , eye pain or discomfort , temporary blurring of vision , visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema . Should any combination of these eye symptoms develop , patients should stop using Tiogiva and consult a specialist immediately ). Dry mouth , which has been observed with anti-cholinergic treatment , may in the long term be associated with dental caries . Tiogiva should not be used more frequently than once daily . Contains lactose ; patients with rare hereditary problems of galactose intolerance , total lactase deficiency or glucose-galactose malabsorption should not take this medicine . The excipient lactose monohydrate may contain small amounts of milk proteins which may cause allergic reactions . Interactions : No formal drug interaction studies have been performed . Co-administration with other anticholinergic drugs not recommended . Adverse reactions : Common : dry mouth . Uncommon : dizziness , headache , taste disorders , vision blurred , atrial fibrillation , pharyngitis , dysphonia , cough , gastro-oesophageal reflux disease , constipation , oropharyngeal candidiasis , rash , dysuria , urinary retention . Rare : insomnia , glaucoma , intraocular pressure increased , supraventricular tachycardia , tachycardia , palpitations , bronchospasm , epistaxis , laryngitis , sinusitis , intestinal obstruction , including ileus paralytic , gingivitis , glossitis , dysphagia , stomatitis , nausea , urticaria , pruritus , hypersensitivity ( including immediate reactions ), angioedema , urinary tract infection . Frequency not known : dehydration , dental caries , anaphylactic reaction , skin infection , skin ulcer , dry skin , joint swelling . Please consult the summary of product characteristics for further information . Marketing Authorisation Number : PL 25258 / 0370 . Marketing authorization Holder : Glenmark Pharmaceuticals Europe Limited Laxmi House , 2B Draycott Avenue , Kenton , Harrow , Middlesex , HA3 0BU , UK . Distributer : As above . Legal classification : POM . Price : 30 capsules + inhaler £ 19.99 , 30 capsules £ 19.20 , 60 capsules £ 38.40 . Job code : PP-UK-TIO-0055 . Date of preparation : September 2021
Adverse events should be reported . Reporting forms and information can be found at https :// yellowcard . mhra . gov . uk . Adverse events should also be reported to Glenmark Pharmaceuticals Europe Ltd medical _ information @ glenmarkpharma . com or call 0800 458 0383
References : 1 . Tiogiva Summary of Product Characteristics . 2 . BNF . July 2022 . ( See NHS indicative price ). 3 . Data on file TIO / 2022 / 06 / 003 . June 2022 . 4 . MHRA Public Assessment Report PL25258 / 0370 . 5 . Braltus ® Summary of Product Chracteristics . 6 . Tiogiva Patient Information Leaflet . 7 . Spiriva ® Patient Information Leaflet . Available at https :// www . medicines . org . uk / emc / product / 1693 / pil . 8 . Braltus ® Patient Information Leaflet . Available at https :// www . medicines . org . uk / emc / product / 4446 / pil . 9 . Acopair ® Patient Information Leaflet . Available at https :// www . medicines . org . uk / emc / product / 12673 / pil . 10 . Data on file TIO / 2022 / 02 / 001 . February 2022 .
PIP codes : Tiogiva dry powder inhaler and capsules 18 mcg ( 30 ) – 4178752 , Tiogiva inhalation powder , hard capsules 18 mcg ( 30 ) – 4178729 , Tiogiva inhalation powder , hard capsules 18 mcg ( 60 ) – 4178711 .
Tiogiva ® is a registered trademark of Glenmark Pharmaceuticals Europe Limited . Spiriva ® is a registered trademark of Boehringer Ingelheim International GmbH . Braltus ® is a registered trademark of Teva UK Ltd . Acopair ® is a registered trademark of Mylan EMEA SAS .
© 2022 Glenmark Pharmaceuticals Europe Ltd . All rights reserved . Date of preparation : August 2022 PP-UK-TIO-0131 V2