INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FLEMEZE BRONCHODILATORY SYRUP
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FLEMEZE BRONCHODILATORY SYRUP
(Liquid)

COMPOSITION:
Each 5 mL liquid contains:
Orciprenaline sulphate         5 mg
Bromhexine hydrochloride         4 mg
Preservatives:        
Methylparaben         0,05% m/v
Propylparaben         0,01% m/v

PHARMACOLOGICAL CLASSIFICATION:
A: 10.1 Antitussives and expectorants.

PHARMACOLOGICAL ACTION:
Flemeze Bronchodilatory Syrup has mucolytic and bronchodilatory properties.

INDICATIONS:
Flemeze Bronchodilatory Syrup is indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).

CONTRA-INDICATIONS:
Flemeze Bronchodilatory Syrup is contra-indicated in patients with known hypersensitivity to sympathomimetic amines, hypertrophic obstructive cardiomyopathy and tachyarrhythmia.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: 10 –20 mL three times daily
Children 3 to 12 years: 5 –10 mL three times daily
Children under 3 years: 2,5 –5 mL three times daily
Do not exceed the recommended dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Orciprenaline Sulphate
Central effects of orciprenaline sulphate include: fear, anxiety, restlessness, tremor, insomnia, confusion, irritability and psychotic states. Cardiovascular symptoms include hypertension, tachycardia, cardiac arrhythmias, anginal pain, palpitations and cardiac arrest. Hypotension with dizziness, fainting and flushing may occur.
Other effects that may occur include difficulty in micturition and urinary retention, dyspnoea, cough, weakness, altered glucose metabolism and hypersalivation. Headache is also common.
Some patients have experienced a feeling of tightness in the chest or asthma exacerbation. Paradoxical bronchoconstriction has been reported. Cases of irritation of allergic reactions have occurred, primarily in hypersensitive patients.
The concomitant use of other sympathomimetic agents should be carefully controlled as cardiovascular effects may be additive. Anticholinergic bronchodilators may however, be inhaled at the same time.
Orciprenaline should be used with caution in patients with hyperthyroidism, cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension and aneurysms. Anginal pain may be precipitated in patients with angina pectoris. Potentially serious hypokalaemia may result from beta2-agonist therapy. Overdosage may cause cardiac effects.
High dosages may increase the risk of serious side-effects, including cardiac dysrhythmias. This risk is further aggravated if administered concomitantly with other medicines that cause hypokalaemia and cardiac dysrhythmias (e.g. xanthine derivatives, steroids and diuretics), or in the presence of hypoxia and acidosis. It is recommended that serum potassium levels are monitored in such situations. The maximum dose should not be exceeded.
In the case of acute, rapidly worsening dyspnoea, a doctor should be consulted immediately.
If bronchial obstruction deteriorates, it is inappropriate and possibly hazardous to simply increase the use of beta-agonists such as Flemeze Bronchodilatory Syrup beyond the recommended dose over extended periods of time. The use of high amounts of beta-agonists like Flemeze Bronchodilatory Syrup on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. In this situation, the patient's therapy plan and in particular the adequacy of anti-inflammatory therapy should be reviewed to prevent potentially life-threatening deterioration of disease control.
On-demand treatment (symptom orientated) may be preferable to regular use in patients on long-term treatment. In addition, these patients should be re-evaluated for the addition or the increase of anti-inflammatory therapy (e.g. inhaled corticosteroids) to control airway inflammation and to prevent long-term damage.
Care is required when sympathomimetic agents such as orciprenaline are given to patients with insufficiently controlled diabetes mellitis or closed-angle glaucoma. Orciprenaline should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as it may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if sympathomimetic agents are given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Orciprenaline should not be given to patients receiving treatment with monoamine oxidase inhibitors or within 14 days of its termination.
Special care is advisable in patients receiving antihypertensive therapy.
Bromhexine Hydrochloride
Bromhexine should be used with care in patients with a history of peptic ulceration. Gastro-intestinal side-effects may occur occasionally with bromhexine and a transient rise in serum aminotransferase values has been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and special precautions. The administration of a beta-blocker will effectively antagonise the action of orciprenaline, however, the use of beta-blockers is dangerous in asthmatic patients as they may precipitate or increase bronchial obstruction.
Further treatment should be symptomatic and supportive.

IDENTIFICATION:
A clear liquid with a caramel-menthol taste and odour.

PRESENTATION:
Bottles of 100 mL and 200 mL.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C).
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
29/10.1/0289

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 December 1995

Zimbabwe details:
2000/22.2.5/3772        P

Updated on this site: May 2003
Source: Pharmaceutical Industry

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