IPRATROPIUM BROMIDE/SALBUTAMOL NEUTEC

Posology The recommended dose for adults (including elderly patients) and adolescents over 12 years: 1 single-dose container inhaled via nebuliser three or four times daily. Special patient groups Patients with hepatic or renal impairment Ipratropium bromide/salbutamol has not been studied in patients with hepatic or renal insufficiency and must therefore be administered with caution in these patient groups.

Paediatric population The safety and efficacy of ipratropium bromide/salbutamol in children under 12 years of age has not been established, therefore Ipratropium bromide/salbutamol Neutec is not intended for use in this group of patients.

If higher doses than those recommended are required to achieve a good effect, the patient’s overall treatment must be reviewed by a doctor. Method of administration Inhalation use. The use of Ipratropium bromide/salbutamol Neutec follows five simple steps, which are outlined below: 1.

The nebuliser is prepared for use according to the manufacturer’s instructions. 2. The pouch is opened and a single-dose container is separated from the strip. 3. The top is removed from the ampoule. 4. The contents of the ampoule is squeezed into the nebuliser chamber.

5. The patient inhales the nebulised solution through the mouthpiece/nebuliser mask with calm and even breaths. g. jet nebuliser after the single dose ampoule has been opened and its contents transferred to the nebuliser chamber. The use of the solution for nebulization is not only limited to the given examples, but can also be based on the experience of the clinical professional.

For full instructions on the use of the nebuliser the patient must be instructed to read the leaflet of the respective device carefully before starting the inhalation. 08 * PARI LC PLUS Nebuliser was used in in vitro studies No information is available in respect of pulmonary inhalation and deposition patterns across nebuliser systems that have not been studied.

The use of an alternative untested nebuliser system may alter the pulmonary deposition of the active substances, this in turn may alter the efficacy and safety of the product and dose adjustment may then become necessary. 4). g. in the hospital setting.

Home based treatment can be recommended in exceptional cases for experienced patients after consultation with a doctor provided that adequate treatment with a powder or spray inhaler is not possible. Since single-dose containers contain no preservatives, it is important that the contents are used immediately after opening and that a fresh container is used for each administration to avoid microbial contamination.

Summary of the safety profile Many of the listed undesirable effects can be assigned to the anticholinergic and beta- 2 sympathomimetic properties of the medicinal product. As with all inhalation therapy ipratropium bromide/salbutamol may show symptoms of local irritation.

Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during the post approval phase of this medicine. The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastrointestinal motility disorders (including constipation, diarrhoea and vomiting), nausea and dizziness.

Based on the MedDRA system organ class and frequencies, adverse reactions 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) Not known Nervousness UncommonPsychiatric disorders Mental disorder Rare Dizziness Uncommon Headache Uncommon Nervous system disorders Tremor Uncommon Accommodation disorder Rare Corneal oedema Rare Glaucoma Rare Eye pain Rare Intraocular pressure increased Rare Mydriasis Rare Vision blurred Rare Conjunctival hyperaemia Rare Eye disorders Halo vision Rare Palpitations Uncommon Tachycardia Uncommon Arrhythmia Rare Atrial fibrillation Rare Myocardial ischaemia Rare Cardiac disorders Supraventricular tachycardia Rare Respiratory, thoracic Cough Uncommon MedDRA system organ class Adverse reaction Frequency Dysphonia Uncommon Throat irritation Uncommon Bronchospasm Rare Bronchospasm paradoxical Rare Dry Throat Rare Laryngospasm Rare and mediastinal disorders Pharyngeal oedema Rare Dry mouth Uncommon Nausea Uncommon Gastrointestinal motility disorder Rare Diarrhoea Rare Constipation Rare Vomiting Rare Oedema mouth Rare Gastrointestinal disorders Stomatitis Rare Skin reaction Uncommon Hyperhidrosis Rare Rash Rare Urticaria Rare Skin and subcutaneous tissue disorders Pruritus Rare Muscle spasms Rare Muscular weakness Rare Musculoskeletal and connective tissue disorders Myalgia Rare Renal and urinary disorders Urinary retention Rare General disorders and administration site conditions Asthenia Rare Blood pressure systolic increased UncommonInvestigations Blood pressure diastolic decreased Rare Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Dyspnoea Patients must be advised to contact a doctor or the nearest hospital immediately in the event of acute or rapidly worsening dyspnoea (breathing difficulties), or if a reduced response to treatment becomes apparent. This could be a sign of a worsening of the patient’s chronic obstructive pulmonary disease, and other therapy may be required.

Hypersensitivity Immediate hypersensitivity reactions may occur after administration of ipratropium bromide/salbutamol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal oedema. Paradoxical bronchospasm As with other inhaled medicines, ipratropium bromide/salbutamol can cause paradoxical bronchospasm, which may be life-threating.

If paradoxical bronchospasm occurs, ipratropium bromide/salbutamol must be discontinued immediately, the patient has to be assessed and provided with an alternative therapy. e. mydriasis, blurring of vision, increased intraocular pressure, narrow-angle glaucoma and eye pain) have been reported when an ipratropium bromide aerosol alone or in combination with a beta-2 agonist has come into contact with the eyes.

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 any combination of these symptoms develops, treatment with miotic eye drops should be initiated and the patient must seek specialist advice immediately.

Patients must be instructed in the correct use of ipratropium bromide/salbutamol and warned not to allow the solution or mist to enter into the eyes. This is particularly important in patients who may be pre-disposed to glaucoma. Such patients must be warned specifically to protect their eyes.

To avoid inadvertent entry of this medicine into the eye, the nebulised ipratropium bromide/salbutamol solution for inhalation must be inhaled with the help of a mouthpiece. If this is not available and a nebuliser mask should be used instead, this must fit the patient.

Ipratropium bromide/salbutamol Neutec is contraindicated in: • Patients with hypertrophic obstructive cardiomyopathy. • Patients with tachyarrhythmia. 1.