Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
ATROVENT UDVs are contraindicated in patients with known hypersensitivity to atropine or its derivatives (such as the active substance ipratropium bromide) or to any other component of the product.
Use of the nebuliser solution should be subject to close medical supervision during initial dosing.
Immediate hypersensitivity reactions following the use of ATROVENT have been demonstrated by cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
As with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. ATROVENT UDVs should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted.
Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma.
There have been isolated reports of ocular complications (i.e. mydriasis, increased intra-ocular pressure, narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide, either alone or in combination with an adrenergic beta2-agonist, has come into contact with the eyes during nebuliser therapy.
Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Patients must be instructed in the correct administration of ATROVENT UDVs. Care must be taken not to allow the solution or mist to enter the eyes. It is recommended that the nebulised solution is administered via a mouthpiece. If this is not available and a nebuliser mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
ATROVENT UDVs should be used with caution in patients with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-outflow obstruction).
As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, ATROVENT, as with other anticholinergics, should be used with caution in these patients.
The chronic co-administration of ATROVENT inhalation with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of ATROVENT with other anticholinergic drugs is not recommended.
There is evidence that the administration of ATROVENT with beta-adrenergic drugs and xanthine preparations may produce an additive bronchodilatory effect.
The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see section Special warnings and precautions for use) may be increased when nebulised ipratropium bromide and beta2-agonists are administered simultaneously.
The safety of ATROVENT during human pregnancy has not been established. The benefits of using ATROVENT during a confirmed or suspected pregnancy must be weighed against the possible hazards to the unborn child. Nonclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.
It is not known whether ipratropium bromide is excreted into breast milk. It is unlikely that ipratropium bromide would reach the infant to an important extent, however caution should be exercised when ATROVENT is administered to nursing mothers.
Clinical data on fertility are not available for ipratropium bromide. Nonclinical studies performed with ipratropium bromide showed no adverse effect on fertility (see section 5.3).
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, accommodation disorder, mydriasis and blurred vision during treatment with ATROVENT. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of ATROVENT. As with all inhalation therapy ATROVENT may show symptoms of local irritation. Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during post approval use of the drug.
The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.
Frequencies: Very common ≥1/10, Common ≥1/100 <1/10, Uncommon ≥1/1,000 <1/100, Rare ≥1/10,000 <1/1,000, Very rare <1/10,000
Uncommon: Hypersensitivity, Anaphylactic reaction, Angioedema of tongue, lips & face
Common: Headache, Dizziness
Uncommon: Blurred vision, Mydriasis1, Intraocular pressure increased1, Glaucoma1, Eye pain1, Halo vision, Conjunctival hyperaemia, Corneal oedema
Rare: Accommodation disorder
Uncommon: Palpitations, Supraventricular tachycardia
Rare: Atrial fibrillation, Heart rate increased
Common: Throat irritation, Cough
Uncommon: Bronchospasm, Paradoxical bronchospasm2, Laryngospasm, Pharyngeal oedema, Dry throat
Common: Dry mouth, Nausea, Gastro-intestinal motility disorder
Uncommon: e.g. Diarrhoea, Constipation, Vomiting, Stomatitis
Uncommon: Rash, Pruritus
Rare: Urticaria
Uncommon: Urinary retention3
1 ocular complications have been reported when aerolised ipratropium bromide, either alone or in combination with an adrenergic beta2-agonist, has come into contact with the eyes – see section 4.4.
2 As with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. ATROVENT UDVs should be discontinued immediately, the patient assessed and, if necessary, alterative treatment instituted.
3 the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction.
Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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