Rinex Diffucaps, Rinex 5 ml Capsules

RINEX is indicated for:

• The symptomatic relief of nasal congestion due to the common cold and flu, hay fever, allergic rhinitis, other upper respiratory allergies, or associated with sinusitis.
• Relief of Eustachian tube congestion as an adjunct to treatment of middle ear infection.

DO NOT EXCEED THE RECOMMENDED DOSE.

RINEX DIFFUCAPS

Adults and children 12 years and older: One capsule every 8 to 12 hours. Do not chew the capsule or the content.

RINEX SYRUP

NOT FOR CHILDREN UNDER 6 YEARS OF AGE.

Adults and children 12 years and older: One medicine measure (5 ml) 3 to 4 times daily.

Children 6 to 12 years: Half a medicine measure (2.5 ml) 3 to 4 times daily.

RINEX PED syrup

NOT FOR CHILDREN UNDER 6 YEARS OF AGE.

Children 6 to 12 years: One medicine measure (5 ml) 3 to 4 times daily.

• Hypersensitivity to any of the active ingredients or excipients in RINEX (see COMPOSITION).
• During acute attacks of asthma.
• Patients on a monoamine oxidase inhibitor for depression (e.g. tranylcypromine) or within two weeks of stopping treatment.
• Safety in pregnancy and lactation has not been established (see HUMAN REPRODUCTION).
• Patients with hypertension, hyperthyroidism or cardiovascular disease, such as ischaemic heart disease.
• RINEX PED syrup and RINEX SYRUP are contraindicated in children under six years of age.
• RINEX DIFFUCAPS is contraindicated in children under twelve years of age.

RINEX should not be taken for more than seven days. After 5 to 7 days tachyphylaxis may occur and the product loses effect. If symptoms do not improve, or are accompanied by fever, consult a doctor.

Exceeding the recommended dosage may result in nervousness, dizziness, sleeplessness, tremulousness or cardiac dysrhythmia. This may also occur in sensitive individuals at small doses.

RINEX should be used with caution in patients with:

• Occlusive vascular disease including arteriosclerosis and aneurysms.
• Closed-angle glaucoma.
• Phaeochromocytoma.

Severe hypertensive episodes leading to intracranial haemorrhage have followed phenylpropanolamine ingestion. Patients should be informed of the dangers of exceeding the recommended dose; in particular the increased risk of serious adverse events such as hypertensive crisis and haemorrhagic stroke. Patients with cardiovascular disease, hypertension or hyperthyroidism should not use the RINEX products (see CONTRAINDICATIONS).

In addition, RINEX may aggravate conditions such as diabetes, glaucoma or prostatic enlargement. Patients on monoamine oxidase inhibitors (e.g. tranylcypromine) should not use RINEX (see CONTRAINDICATIONS).

RINEX should be used with care in conditions such as narrow angle glaucoma, urinary retention and prostatic hypertrophy. RINEX may also suppress positive skin results and should thus be stopped several days before the test.

RINEX should be used with caution in patients who may be hypersensitive to the effects of sympathomimetics, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease; dysrhythmias or tachycardia; occlusive vascular disorders, including arteriosclerosis, hypertension, or aneurysms. Reversal of action of many antihypertensive agents occurs in patients given sympathomimetics, and therefore special care is advisable in patients receiving antihypertensive therapy (see INTERACTIONS).

Alcohol: Potentiates sedation.

Antihypertensive agents including alpha- and beta-blockers: Reversal of action of antihypertensive agents.

Cardiac glycosides, quinidine or tricyclic antidepressants: Increased risk of dysrhythmias may occur in patients.

Halothane, or other halogenated anaesthetics: May induce ventricular fibrillation.

Hypnotics and anxiolytics: May cause potentiation of drowsiness.

Monoamine oxidase inhibitors, atropine and tricyclic antidepressants: Enhancement of antimuscarinic effects.

Phenytoin: Chlorphenamine, as contained in RINEX, inhibits phenytoin metabolism leading to phenytoin toxicity.

Central nervous system depressants, including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquilisers: Enhancement of sedative effects.

Interactions are possible with reserpine, tricyclic antidepressants, digoxin and alpha-methyldopa.

Safety in pregnancy and lactation has not been established. Phenylephrine hydrochloride is best avoided in pregnancy, because of the potential promotion of uterine contractility and peripheral vasoconstriction, with the possibility of foetal hypoxia.

The use of RINEX may cause drowsiness and impaired concentration, which is aggravated by the simultaneous intake of alcohol and other central nervous system depressants; patients affected should not drive or operate machinery.

Chlorphenamine

Blood and the lymphatic system disorders

Less frequent: Agranulocytosis, leucopenia and haemolytic anaemia

Psychiatric disorders

Less frequent: Depression, nightmares, irritability

Frequency unknown: Euphoria

Nervous system disorders

Frequent: Sedation varying from slight drowsiness to deep sleep, and including lassitude, dizziness

Less frequent: Incoordination, headache, impaired concentration

Eye disorders

Less frequent: Blurred vision

Ear and labyrinth disorders

Less frequent: Tinnitus

Cardiac disorders

Less frequent: Palpitation, tachycardia, dysrhythmia

Vascular disorders

Less frequent: Hypotension

Respiratory, thoracic and mediastinal disorders

Less frequent: Increased viscosity of bronchial secretions

Gastrointestinal disorders

Less frequent: Nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite, abdominal pain, dyspepsia, dryness of the mouth and epigastric pain

Hepato-biliary disorders

Less frequent: Hepatitis, jaundice

Skin and subcutaneous tissue disorders

Less frequent: Allergic reactions including exfoliative dermatitis and cross-sensitivity to related medicines may occur, photosensitivity and skin reactions such as urticaria

Musculoskeletal, connective tissue and bone disorders

Less frequent: Muscular weakness, twitching

Renal and urinary disorders

Less frequent: Urinary retention

Frequency unknown: Difficulty in micturition, dysuria

General disorders and administrative site conditions

Less frequent: Tightness of the chest

Paradoxical central nervous system stimulation may occur, especially in children, with insomnia, nervousness, tachycardia, tremors and convulsions

Phenylpropanolamine

Psychiatric disorders

Frequency unknown: Fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states

Gastrointestinal disorders

Frequency unknown: Nausea, vomiting, appetite may be reduced, hypersalivation

Metabolism and nutritional disorders

Frequency unknown: Altered metabolism including disturbances of glucose metabolism

Phenylephrine

Psychiatric disorders

Frequent: Nervousness, irritability, restlessness, and excitability

Frequency unknown: Fear, anxiety, tremor, insomnia, confusion, weakness and psychotic states

Nervous system disorders

Frequent: Headache, dizziness, insomnia

Eye disorders

Frequency unknown: Mydriasis, acute angle closure glaucoma

Cardiac disorders

Frequency unknown: Tachycardia or bradycardia, cardiac dysrhythmias, angina pain, palpitations, cardiac arrest

Vascular disorders

Frequent: Increased blood pressure

Frequency unknown: Hypotension with dizziness, fainting and flushing may occur, haemorrhagic stroke, flushing, sweating, vasoconstriction

Respiratory, thoracic and mediastinal disorders

Frequency unknown: Dyspnoea

Gastrointestinal disorders

Frequent: Nausea, vomiting, diarrhoea

Frequency unknown: Appetite may be reduced, hypersalivation

Metabolism and nutritional disorders

Frequency unknown: Altered metabolism including disturbances of glucose metabolism

Skin and subcutaneous tissue disorders

Frequency unknown: Allergic reactions such as rash, urticaria, allergic dermatitis, hypersensitivity reactions, including cross-sensitivity with other sympathomimetics

Renal and urinary disorders

Frequency unknown: Difficulty in micturition, urinary retention, dysuria.

Chlorphenamine

The main symptoms of overdosage with chlorphenamine in infants and children include ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults, the usual symptoms are drowsiness, coma and convulsions. Hypertension may also occur. Elderly patients are more susceptible to these central nervous system depressant and hypotensive effects even at therapeutic doses.

Phenylpropanolamine

Overdosage with phenylpropanolamine may cause giddiness, headache, nausea, vomiting, sweating, thirst, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. Overdosage may also cause psychoses, hallucinations and cardiorespiratory collapse. Severe increase in blood pressure may occur. Treatment with alpha-adrenergic blocking agents to reduce blood pressure should be instituted if myocardial ischaemia or encephalopathy is provoked.

Phenylephrine

Overdosage with phenylephrine may cause headache, hypertension, palpitations and vomiting. Severe increase in blood pressure may occur. Treatment with alpha-adrenergic blocking agents to reduce blood pressure should be instituted if myocardial ischaemia or encephalopathy is provoked. Unless contraindications exist, the stomach should be emptied by gastric lavage. Further treatment is symptomatic and supportive.