SALIPRANEB

For inhalation use.

The recommended dose is:

Adults (including elderly patients and children over 12 years): 1 ampoule three or four times daily.

Children under 12 years:

There is no experience of the use of Salipraneb in children under 12 years.

Administration:

Salipraneb 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 device.

The solution in the single dose ampoules is intended for inhalation use only and should not be taken orally or administered parenterally. 1. Prepare the nebuliser by following the manufacturer's instructions and the advice of your doctor.

2. Carefully separate a new ampoule from the strip. Never use an ampoule that has been opened already. 3. Open the ampoule by simply twisting off the top, always taking care to hold it in an upright position. 4. Unless otherwise instructed by your doctor, squeeze all the contents of the plastic ampoule into the nebuliser chamber.

5. Assemble the nebuliser and use it as directed by your doctor. 6. 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 Salipraneb should not be mixed with other medicines in the same nebuliser.

g. restlessness, memory disorders, anxiety, depression, hyperactivity in children Nervous system disorders Sleep disturbances Eye disorders Accommodation disorders Pain in the eyes, mydriasis, increased intraocular pressure, closed-angle glaucoma.

e. inhalation-induced bronchoconstriction) Gastrointestinal disorders Dryness of mouth, nausea Vomiting Mouth and throat irritation, motility disorders Dental caries Skin and subcutaneous tissue disorders Rash, itching, urticaria, angioedema of the tongue, lips and face Musculoskeletal, connective tissue and bone disorders Tremor Myalgia, muscular cramp, muscular weakness Renal and urinary disorders Urinary retention General disorders and administration site conditions Headache Dizziness Anaphylactic reaction, sweating * reported spontaneously in post-marketing data therefore frequency regarded as unknown 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.

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.

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.

Salipraneb should be discontinued immediately, the patient should be assessed and, if necessary, alternative therapy instituted. 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. 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 Salipraneb with their nebuliser and must be warned not to allow the solution or mist to enter the eyes. 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 Salipraneb should only be used after careful risk/benefit assessment: inadequately controlled diabetes mellitus, recent myocardial infarction and/or severe organic heart or vascular disorders, hyperthyroidism, phaeochromocytoma, prostatic hypertrophy, bladder outflow obstruction and risk of narrow-angle glaucoma.

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. 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.

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 salbutamol. g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol 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 of either respiratory or cardiac origin. There have been reports of dental caries with the use of Salbutamol. Good oral hygiene and regular dental inspections are recommended, particularly in children.

Patients with hypertrophic obstructive cardiomyopathy or tachyarrhythmia. 1.