Contraindications
Concomitant use with other drugs containing diphenhydramine (including topical preparations) or MAOIs (or within 14 days of use). Lactation.
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Special Precautions
Patient with asthma, productive cough, chronic cough (associated with COPD or smoking), diabetes mellitus, CV disease (e.g. ischaemic heart disease, hypertension), genitourinary obstruction, prostatic hyperplasia, pyloroduodenal obstruction (e.g. stenotic peptic ulcer), thyroid dysfunction, increased intraocular pressure or angle-closure glaucoma. Treatment with a cough and cold medicine in children (especially under 12 years old) should be considered carefully due to potential risks and limited evidence on efficacy. Not recommended for use in children below 6 years of age. Pregnancy. Patient Counselling This drug may cause CNS depression (e.g. drowsiness), if affected, do not drive or operate machinery.
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Adverse Reactions
Significant: CNS depression (e.g. drowsiness); excitability in children.
Blood and lymphatic system disorders: Haemolytic anaemia, agranulocytosis, thrombocytopenia.
Cardiac disorders: Chest tightness, palpitations, tachycardia, extrasystoles.
Ear and labyrinth disorders: Tinnitus, labyrinthitis.
Eye disorders: Diplopia, blurred vision.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, xerostomia, dry mucous membranes, epigastric distress.
General disorders and administration site conditions: Fatigue.
Immune system disorders: Anaphylaxis.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Chills.
Nervous system disorders: Headache, ataxia, dizziness, neuritis, paraesthesia, restlessness, sedation, seizure, vertigo, tremor.
Psychiatric disorders: Insomnia, confusion, euphoria, irritability, nervousness.
Renal and urinary disorders: Dysuria, polyuria, early menses, urinary retention.
Respiratory, thoracic and mediastinal disorders: Constriction of the pharynx, thickening of bronchial secretions, wheezing.
Skin and subcutaneous tissue disorders: Diaphoresis, photosensitivity, rash, urticaria.
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Drug Interactions
CNS depressant effects may be potentiated by sedatives or tranquilisers.
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CIMS Class
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ATC Classification
R01AB01 - phenylephrine ; Belongs to the class of topical sympathomimetic combination preparations, excluding corticosteroids. Used as nasal decongestants.
C01CA06 - phenylephrine ; Belongs to the class of adrenergic and dopaminergic cardiac stimulants excluding glycosides. Used in the treatment of heart failure. D04AA32 - diphenhydramine ; Belongs to the class of topical antihistamines used in the treatment of pruritus. R06AA02 - diphenhydramine ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines. S01GA05 - phenylephrine ; Belongs to the class of sympathomimetics used as ophthalmologic decongestants. S01FB01 - phenylephrine ; Belongs to the class of sympathomimetics used as mydriatics and cycloplegics. R01BA03 - phenylephrine ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants. R01AA04 - phenylephrine ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants. |