IPRAMOL STERI-NEB

In situations of acute dyspnea (difficulty breathing) or rapid worsening of dyspnea, patients should be advised to immediately consult a doctor or the nearest hospital if additional inhalations of Ipramol Steri-Neb do not produce adequate improvement.

Posology Adults (including elderly patients and children over 12 years):

The content of one ampoule three or four times daily. Ipramol Steri-Neb has not been studied in patients with liver or kidney failure and should be used with caution in these patient populations. Paediatric population The safety and efficacy of Ipramol Steri-Neb in children aged below 12 years have not been established.

Method of administration Inhalation use. Ipramol Steri-Neb may be administered from a suitable nebuliser or an intermittent positive pressure ventilator after the single dose ampoule has been opened and its contents transferred to the nebuliser chamber.

Administration should be in accordance with the manufacturer’s instructions for the devices. The solution in the single dose ampoules is intended for inhalation use only and should not be taken orally or administered parenterally. i.

Prepare the nebuliser by following the manufacturer’s instructions and the advice of your doctor. ii. Carefully separate a new ampoule from the strip. Never use an ampoule that has been opened already. iii. Open the ampoule by simply twisting off the top always taking care to hold it in an upright position.

iv. Unless otherwise instructed by your doctor, squeeze all the contents of the plastic ampoule into the nebuliser chamber. v. Assemble the nebuliser and use it as directed by your doctor. The duration of treatment for the inhalation of a complete dose is usually between five and 15 minutes.

vi. After nebulisation clean the nebuliser according to the manufacturer’s instructions. It is important that the nebuliser is kept clean. As the single dose units contain no preservatives it is important that the contents are used immediately after opening and a fresh ampoule is used for each administration to avoid microbial contamination.

Partly used, opened or damaged single dose units should be discarded. Any solution remaining in the nebuliser chamber should be discarded. It is strongly recommended that Ipramol Steri-Neb should not be mixed with other drugs in the same nebuliser

Many of the undesirable effects described can be attributed to the anticholinergic and beta-2 sympathomimetic properties of Ipratropium/Salbutamol. As with all inhalation therapies, Ipramol Steri-Neb may cause symptoms of local irritation.

Adverse reactions were identified from data obtained through clinical trials and pharmacovigilance activities in the post- approval phase of the drug. The most frequently reported undesirable effects in the clinical trials were headache, throat irritation, cough, dry mouth, gastrointestinal motility disturbances (including constipation, diarrhoea and vomiting), nausea and dizziness.

Based on the MedDRA system organ class and frequencies, adverse events are listed in the table below. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

4) Psychiatric disorders Uncommon Rare Restlessness Memory disorders, mental disorders, anxiety, hyperactivity in children Uncommon Headache, Dizziness, TremorNervous system disorders Rare Sleep disturbances Eye disorders Rare Accommodation disorders Corneal edema Pain in the eye Mydriasis Increased intraocular pressure Glaucoma Blurred vision Conjunctival hyperemia Visual halos Cardiac disorders Uncommon Rare Palpitations, tachycardia Arrhythmias Peripheral vasodilatation Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) and coronary ischaemic disease.

, inhalation-induced bronchospasm) Pharyngeal edema Gastrointestinal disorders Uncommon Rare Dry mouth Nausea Throat irritations Diarrhoea Vomiting Obstipation Motility disturbances Edema of the mouth Stomatitis Skin and subcutaneous tissue disorders Rare RashUrticaria, Pruritus Hyperhidrosis Angioedema Musculoskeletal, connective tissue and bone disorders Rare Myalgia Muscle cramps Muscle weakness Renal and urinary disorders Rare Urinary retention General disorders and administration site conditions Rare Asthenia Investigations Uncommon Rare Systolic blood pressure increased Diastolic blood pressure decreased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

2). Patients should be instructed to consult a doctor immediately in the event of acute, rapidly worsening dyspnoea or if a reduced response to treatment becomes apparent. Immediate hypersensitivity reactions may occur after administration as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.

There are also rare reports of a number of ocular complications when aerosolised ipratropium bromide, either alone or in combination with a beta2-adrenergic agonist, has been inadvertently sprayed into the eye. Patients must therefore be instructed in the correct use of Ipramol Steri-Neb with their nebuliser and must be warned not to allow the solution or mist to enter the eyes.

To avoid inadvertent entry of drug into the eye, it is preferable to administer the nebulised suspension using a mouthpiece rather than a face mask. Such ocular complications may include acute angle glaucoma, mydriasis, blurring of vision, increased intraocular pressure, eye pain and narrow-angle glaucoma.

Patients who may be susceptible to glaucoma should be warned specifically about the need for ocular protection. Antiglaucoma therapy is effective in the prevention of acute narrow-angle glaucoma in susceptible individuals. Eye pain or discomfort, blurred vision, visual halos or coloured spots together with red eyes from conjunctival congestion or corneal oedema may be manifestations of acute narrow-angle glaucoma.

If a combination of these symptoms develops, treatment with miotic eye drops should be initiated and the patient should seek specialist advice immediately. In the following conditions Ipramol Steri-Neb should only be used after careful assessment of risk/benefit: inadequately controlled diabetes mellitus, recent myocardial infarction and/or severe organic heart or vascular disorders, hyperthyroidism, phaeochromocytoma, intestinal obstruction, prostatic hypertrophy, bladder outflow obstruction and risk of narrow-angle glaucoma.

Caution should be exercised when Ipramol Steri-Neb is used by patients with cardiac disease (severe heart disease, ischaemic disease, arrhythmias). Patients should be advised if they experience chest pain and or dyspnoea that they should contact their emergency services.

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta-agonists.

g. ischaemic heart disease, arrhythmias or severe heart failure) who are receiving salbutamol for respiratory disease should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.

Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be either respiratory or cardiac in origin. Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is advised in severe airway obstruction, as this effect may be potentiated by concomitant treatment with xanthine derivatives, diuretics and steroids.

Hypokalaemia can bring about increased sensitivity to arrhythmias in patients being treated with digoxin. Additionally, hypoxia may aggravate the effects of hypokalaemia on cardiac rhythm. It is recommended that serum levels of potassium are monitored in such situations.

Patients with cystic fibrosis may be more prone to disturbances in gastrointestinal motility and therefore ipratropium bromide, as with other anticholinergics, should be used with caution in these patients. As with other inhalation therapy there is a risk of inhalation-induced bronchoconstriction or paradoxical bronchospasm.

If this occurs the patient will experience an immediate increase in wheezing and shortness of breath after dosing, which should be treated straightaway with an alternative presentation or different fast- acting inhaled bronchodilator.

Ipramol Steri-Neb should be discontinued immediately, the patient should be assessed and, if necessary, alternative therapy instituted. If it is necessary to use higher doses than recommended to control the symptoms of bronchoconstriction (or bronchospasm) the patient’s treatment plan should be reassessed.

9). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short- acting beta-agonist treatment.

It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting. g. in the context of athletic performance enhancement (doping). 2).

1. • Hypertrophic obstructive cardiomyopathy • Tachyarrhythmia.