Ventmax Sr 4mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventmax SR 4 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains salbutamol sulfate 4.80mg (equivalent to 4mg of salbutamol base).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Modified release capsules, hard
Size 4 capsules with opaque grey cap and opaque pale green body, containing creamy white spherical microgranules, with ‘4 mg’ printed in black ink
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Continuous symptomatic treatment of asthma and other types of reversible obstructive airways disease:
- in patients requiring daily administration of quick-acting beta-2 agonists with a short duration of action;
- and/or with nocturnal symptoms.
N.B. : In asthma, the treatment with Ventmax SR should be combined with an anti-inflammatory treatment, such as inhaled corticosteroids.
4.2. Posology and method of administration
Method of Administration Oral use
Posology
Twice-daily administration of Ventmax SR capsules procures a bronchodilator effect, which is maintained for about 12 hours after each dose.
Adults: The recommended dose is one 8mg capsule twice daily.
Older_people: It is not necessary to adjust the dose.
Paediatric_population: In children aged 3 to 12 years, the recommended dose is one 4mg capsule twice daily.
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1
4.4. Special warnings and precautions for use
Warnings:
Athletes should be advised that this product contains an active substance which may produce a positive dope test reaction.
Precautions for Use:
In asthma, Ventmax SR is a maintenance treatment reserved, like all long-acting beta2 agonists, for patients who are not completely controlled by the anti-inflammatory treatments with which it is prescribed concomitantly.
Ventmax SR can be combined on demand with other symptomatic treatments (bronchodilators). If paroxysmal dyspnoea should occur in spite of an adequately followed treatment, it is recommended that a short-acting beta2 agonist bronchodilator be used to treat such symptoms.
If a patient’s consumption of quick and short-acting beta2 agonists should increase rapidly within a few days, this may be indicative (especially if the peak flow values fall and/or become very irregular), of decompensation of the asthmatic disease, with a possibility of development of a status asthmaticus, and calls for a consultation to reevaluate the patient’s condition. Such decompensation should be treated preferably in a specialised centre. In such circumstances consideration should be given to increased anti-inflammatory therapy, for example, by increasing the patient’s dose of inhaled corticosteroids, or by a course of oral corticosteroids.
Ventmax should be given with caution to patients with hyperthyroidism/thyrotoxicosis, cardiovascular disease, arrhythmias and hypertension.
There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.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.
Potentially serious hypokalaemia may result from beta2 agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by hypoxia or by concomitant treatment with steroids, diuretics and xanthine derivatives such as theophylline. It is recommended that serum potassium levels are monitored in these circumstances.
In common with other beta2 agonists, salbutamol can cause an increase in blood glucose levels. In diabetic patients this may cause the development of ketoacidosis especially when beta2 agonists are administered intravenously. Therefore, salbutamol should be used with caution in patients with diabetes.
4.5. Interactions with other medicinal products and other forms of interaction
Potentially serious hypokalaemia may result from beta2 agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by hypoxia or by concomitant treatment with steroids, diuretics and xanthine derivatives such as theophylline. It is recommended that serum potassium levels are monitored in these circumstances.
Non-cardioselective beta-adrenoceptor blocking agents such as propranolol antagonise the effects of salbutamol.
The adverse metabolic effects of high doses of salbutamol, such as increased blood glucose levels, may be exacerbated by concomitant administration of high doses of corticosteroids.
Salbutamol should be cautiously used in subjects under therapy with monoamine oxidase inhibitors or tricyclic antidepressants due to the possible strengthened effects of salbutamol on the vascular system.
4.6. Fertility, pregnancy and lactation
Pregnancy: Ventmax SR capsules should not be used during pregnancy (especially during the first trimester), unless the benefit for the mother outweighs any possible risk to the foetus. Salbutamol has been used therapeutically for many years in human beings (including its use in the management of premature labour), with no evidence of harmful effects on foetuses or newborn infants. However, as for most drugs, few data have been published on the safety of salbutamol in the early stages of human pregnancy. Animal studies have shown that there are harmful effects on the foetus at very high doses.
Lactation: Since it is possible that salbutamol may be excreted in breast milk, it should not be used during lactation unless the benefit/risk ratio is favourable; it is not known whether salbutamol has harmful effects on newborn infants.
4.7. Effects on Ability to Drive and Use Machines
None known.
Adverse events are listed below by system class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and <1/100), rare (>1/10,000 and < 1/1,000), very rare (<1/10,000), unknown (frequency cannot be estimated from the available data).
|
System/organ/Class |
Adverse Reaction |
Frequency |
|
Immune System Disorders |
Hypersensitivity (including angioedema, urticaria, bronchospasm, hypotension, and collapse) |
Very Rare |
|
Metabolism & Nutrition Disorders |
Hypokalaemia |
Rare |
|
Psychiatric disorders |
Hyperactivity (in children) |
Rare |
|
Nervousness |
Unknown | |
|
Nervous System Disorders |
Headache Dizziness |
Unknown Unknown |
|
Tachycardia (with or without peripheral vasodilation) |
Rare | |
|
Cardiac Disorders |
Cardiac arrhythmia (including atrial flutter, supraventricular tachycardia and extrasystole |
Very rare |
|
Palpitation |
Uncommon | |
|
Myocardial Ischaemia (see section 4.4) |
Unknown | |
|
Gastrointestinal Disorders |
Nausea, vomiting |
Unknown |
|
Vascular Disorders |
Peripheral vasodilation |
Rare |
|
Musculoskeletal & Connective tissue disorders |
Muscle tremor, predominantly of extremities, possibly with associated tenseness |
Common |
|
Muscle cramps |
Very rare |
Potentially serious hypokalaemia may result from beta2 agonist therapy. This effect may be potentiated by hypoxia. Particular caution is advised in severe asthma, with monitoring of serum potassium levels.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms
Intensified tremor, tachycardia, changes in blood pressure, sedation, nervousness.
Management
In the event of serious poisoning, the stomach should be emptied and, if necessary, a cardioselective beta-blocker administered in hospital, with the appropriate caution in patients subject to bronchospasm. Hypokalaemia may follow overdose, and patients’ serum potassium levels should be monitored.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Pharmacotherapeutic group: selective beta-2-adrenoceptor agonists; ATC
code: R03C
C02.
Salbutamol is a beta-adrenergic receptor agonist, with a selective action focused much more on the beta-2 receptors (of the bronchi, uterus and blood vessels in particular) than on the cardiac beta-i receptors. Because of this selectivity, cardiac effects are moderate at usual therapeutic doses.
5.2 Pharmacokinetic properties
After oral administration, the absolute bioavailability of salbutamol, which varies from one subject to another, is about 40%, owing in particular to a hepatic first-pass effect.
After administration of Ventmax SR, maximum plasma concentrations are reached in 4 to 5 hours. Administering Ventmax SR during a meal does not alter the global bioavailability of the drug, but delays and slightly lowers the peak plasma concentration.
The principal metabolite, a conjugated sulfate, has no effect on the beta receptors.
The apparent elimination half-life is about 12 hours.
The product is eliminated, essentially in the urine (75% to 80%), partly in unchanged form and partly as inactive metabolites.
5.3. Preclinical safety data
Carcinogenic and mutagenic potential, impairment of fertility: Salbutamol sulfate has been found to cause a dose-related increase in the incidence of benign leiomyomas of the mesovarium in the rat at oral doses corresponding to 3, 16 and 78 times the maximum oral dose for a 50kg human. The relevance of these findings to humans is not known. A study in mice, and a lifetime oral study in hamsters, showed no evidence of an oncogenic potential.
In-vitro studies have shown no evidence of mutagenicity.
Oral reproduction studies in rats have shown no evidence of impaired fertility.
Pregnancy - Teratogenic effects: Salbutamol has been shown to be teratogenic in mice when given subcutaneously in doses corresponding to 0.4 times the maximum human oral dose.
There are no adequate and well-controlled studies in pregnant women. A relationship between use of salbutamol and congenital anomalies has not been established
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Sucrose Maize starch
Colloidal anhydrous silica
Methacrylic copolymer
Ethylcellulose
Dibutyl sebacate
Talc
Gelatin
Titanium dioxide Black iron oxide Yellow iron oxide Erythrosine Patent blue V.
Black marking ink (Shellac, Ethyl Alcohol, Isopropyl Alcohol, n-Butyl Alcohol, Propylene Glycol, Water - Filtered, Ammonium Hydroxide, Potassium Hydroxide, Black Iron Oxide)
6.2. Incompatibilities
Not applicable.
3 years.
6.4. Special Precautions for Storage
Do not store above 30°C.
6.5. Nature and Contents of Container
Blister packs (250pm PVC / 20pm aluminium) packed in cardboard boxes containing 28, 30, 56 or 60 capsules. Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Not applicable
7. MARKETING AUTHORISATION HOLDER
Chiesi Limited 333 Styal Road Manchester M22 5LG United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 08829/0095
9. DATE OF FIRST AUTHORISATION / RENEWAL THE OF AUTHORISATION
22nd August 1997
10 DATE OF REVISION OF THE TEXT
12/10/2015