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SALAMOL CFC-FREE is a brand name for Albuterol (also known as Salbutamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The symptomatic treatment of asthma and other conditions with associated reversible airways obstruction. For relief of wheezing and shortness of breath, Salamol CFC- Free Inhaler should be used on an as required basis. Prevention of asthma attacks induced by exercise or exposure to allergens. Salamol CFC-Free Inhaler…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For optimum results in most patients Salamol CFC-Free Inhaler should be used as required. Adults (including the Elderly) Relief of acute asthma symptoms including bronchospasm One inhalation (100 micrograms) may be administered as a single minimum starting dose.
This may be increased to two inhalations (200 micrograms) if necessary. Prevention of allergen or exercise-induced bronchospasm Two inhalations (200 micrograms) should be taken 10-15 minutes before challenge. On demand use of Salamol CFC-Free Inhaler should not exceed 8 inhalations (800 micrograms) in any 24 hours.
Inhalations should not usually be repeated more often than every 4 hours. Reliance on such frequent supplementary use, or a sudden increase in dose indicates poorly controlled or deteriorating asthma. For all patients, four hours should be allowed between each dose.
Paediatric Population Relief of acute asthma symptoms including bronchospasm The usual dosage for children under the age of 12 years: one inhalation (100 micrograms). The dose may be increased to two inhalations (200 micrograms) if required.
Children aged 12 years and over:
Dose as per adult population. Prevention of allergen or exercise-induced bronchospasm The usual dosage for children under the age of 12 years: one inhalation (100 micrograms) before challenge or exertion. The dose may be increased to two inhalations (200 micrograms) if required.
Children aged 12 years and over:
Dose as per adult population. The usual dosage for children under the age of 12 years: up to two inhalations (200 micrograms) 4 times daily.
Children aged 12 years and over:
Dose as per adult population. Patients with Hepatic or Renal Impairment No need to adjust the dose. Method of administration For Inhalation Use. Salamol administration in children should be supervised by an adult. Children may need help to use their inhaler.
Parents can help by spraying the aerosol when the child begins to inhale. Patients should wait four hours between doses. Patients should sit or stand upright during inhalation. It is also important during inhalation that the inhaler be held in an upright position as the inhaler works correctly only in a vertical position.
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 (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000; including isolated reports), not known (cannot be estimated from the available data).
4) Vascular disorders Rare Peripheral vasodilatation Respiratory, thoracic and mediastinal disorders Very rare Paradoxical bronchospasm (with an immediate increase in wheezing after dosing) Gastrointestinal disorders Rare Mouth irritation, nausea, vomiting, dry mouth, sore mouth Skin and subcutaneous tissue disorders Very rare Pruritus Uncommon Myalgia, muscle cramps, mouth and throat irritation Rare Muscle cramps Musculoskeletal and connective tissue disorders Very rare Fine tremor (particularly of hands) As with other inhalation therapies, paradoxical bronchospasm may occur immediately after dosing.
Salamol CFC-Free Inhaler should be discontinued immediately, the patient reassessed and treated immediately with another presentation or a different fast-acting inhaled bronchodilator. 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.
Salbutamol should be administered cautiously to patients with thyrotoxicosis, coronary insufficiency, hypertrophic obstructive cardiomyopathy, arterial hypertension, known tachyarrhythmias, concomitant use of cardiac glycosides or diabetes mellitus.
Patients should be instructed in the proper use of the inhaler and their technique checked, to ensure that the active substance reaches the target areas within the lungs. The inhaler contains enough salbutamol for a total of 200 actuations (puffs).
After the 200 actuations (puffs) have been used, the inhaler can when actuated continue to release a spray of propellant which no longer contains the prescribed dose of salbutamol. Methods such as shaking, weighing or submerging inhalers are not accurate for determining that an inhaler is empty of the prescribed dose of salbutamol.
To avoid inadvertent use of an empty inhaler, maintaining a record of the number of actuations (puffs) administered to the patient should be considered. Keeping a back- up inhaler could also be considered. 6). , inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms decrease, and they do not require Salamol CFC-Free Inhaler.
The management of asthma should normally follow a stepwise programme, and the patient’s response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled bronchodilators, in particular ß2-agonists to control symptoms, indicates deterioration of asthma control, and patients should be warned to seek medical advice as soon as possible.
Under these conditions, the patient’s therapy plan should be reassessed. Asthamatic patients whose conditions deteriorates despite salbutamol therapy, or where a previously effective dose fails to give relief for at least three hours, should seek medical advice in order that any necessary additional steps may be taken.
1. Salbutamol inhalation is contraindicated in treatment of threatened abortion or premature labour.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The aerosol spray is inhaled through the mouth into the lungs. The inhaler should be tested by firing two shots into the air before first use, and if the inhaler has not been used for a period of five days or longer. Use of the Inhaler Salamol inhaler may be used with a Volumatic® spacer device by patients who find it difficult to synchronise aerosol actuation with inspiration of breath.
Patients should refer to the instruction leaflet for the Volumatic spacer device for further information. Patients not using a Volumatic spacer should be advised to ignore the steps specifically marked for Patients using a Volumatic spacer and continue to the next step.
Patients using a Volumatic spacer should be advised to follow all the steps below including the ones for Patients using a Volumatic spacer. 1. Patients should remove the cap from the inhaler mouthpiece and make sure the mouthpiece is clean and clear.
Patients using a Volumatic spacer should fit the two halves of the spacer together and then press them firmly together. 2. The inhaler must be held in a vertical position, with the thumb on the base and the index finger on the top of the canister*.
Then, patients should shake the inhaler vigorously up and down. Patients using a Volumatic spacer should fit the inhaler firmly into the end of the spacer, opposite the mouthpiece. Patients should be advised to make sure the mouthpiece is clean.
3. Patients should exhale normally, and place the mouthpiece in their mouth with their lips closed around it. 4. Patients should inhale slowly and deeply and press the canister at the same time to release the spray. Patients using a Volumatic spacer should press down with their finger(s) on the top of the inhaler to release one puff of medicine.
Then, they should take one deep steady breath or 5 normal breaths to make sure that the medicine goes into their lungs. Patients should be advised they do not need to take the Volumatic out of their mouth to exhale. They should hear the mouthpiece valve ‘click’ or rattle as they breathe through it.
Otherwise, they should be advised to tilt the Volumatic up slightly and to try again. 5. Patients should remove the inhaler from their mouth and hold their breath for 10 seconds, and then exhale slowly. Patients using a Volumatic spacer should remove it from their mouth and their finger(s) from the top of the inhaler, and continue to hold their breath for a few seconds, then exhale slowly.
6. If more than one puff is needed, it is important to advise the patient to wait about one minute and start again from step 2. Then, put the cap back on the inhaler. Patient should be advised to clean the inhaler once a week, especially in the mouthpiece to prevent deposits from the aerosol building up.
Patients should be advised not to rush Steps 3 and 4. It is important that the patient starts to breathe in as slowly as possible just before using the inhaler. If ‘mist’ is coming from the top of the inhaler or the sides of the mouth of the patient, they should be advised to start again from step 2.
*Note: Children and people with weak hands should be advised they may find it easier by holding the inhaler with both hands. As with most inhaled medicinal products in pressurised containers, the therapeutic effect of this medicinal product may decrease when the container is cold.
The container should not be punctured, broken or burnt, even when apparently empty. The metal container must not be put into water. Full instructions for use of the inhaler and Volumatic spacer are given in the Patient Information Leaflet which should be read carefully by the patient before use.
Cleaning of the Inhaler Patient must clean the inhaler once a week. A Remove the mouthpiece cap B Remove the canister from the plastic mouthpiece. Patient should […]
Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality. , daytime symptoms, night-time awakening, and activity limitation due to asthma) for proper treatment adjustment as these patients are at risk for overuse of salbutamol.
The dosage or frequency of administration should only be increased on medical advice. Patients requiring long term management with Salamol CFC-Free Inhaler should be kept under regular surveillance. Care should be taken when treating acute asthma attacks or exacerbation of severe asthma as increased serum lactate levels, and rarely, lactic acidosis have been reported after the use of high doses of salbutamol have been used in emergency situations this is reversible on reducing the dose of salbutamol.
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, arrhythmias 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 either respiratory or cardiac in origin. Potentially serious hypokalaemia may result from ß2-agonist therapy mainly from parenteral and nebulised administration.
Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
In common with other beta-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported.
Concurrent administration of glucocorticoids can exaggerate this effect. As with other inhalation therapies, the potential for paradoxical bronchospasm should be considered. If it occurs the preparation should be discontinued immediately and alternative therapy given.
Solutions which are not of neutral pH may rarely cause paradoxical bronchospasm in some patients. Salbutamol and non-selective beta blocking drugs such as propranolol should not usually be prescribed together. Excipient(s) Ethanol The small amount of alcohol in this medicine will not have any noticeable effects.