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ROBITUSSIN MUCUS COUGH AND CONGESTION RELIEF is a brand name for Pseudoephedrine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nasal decongestant and expectorant for the symptomatic relief of respiratory tract disorders.
Verbatim from this product's MHRA label. Tap a section to expand.
Oral Administration.
Adults, (including the elderly) and children aged 12 years and over:
One 10ml measure every 4-6 hours up to four times daily.
Children under 12 years:
Do not use. Do not exceed the stated dose. Do not use with other nasal decongestants or expectorants. Minimum dosing interval: 4 hours. Maximum duration of use without medical advice: 7 days. Maximum daily dose: 40 ml in any 24 hours (pseudoephedrine hydrochloride 240 mg, guaifenesin 800 mg).
4) Not known Cardiac Disorders Tachycardia, palpitations Rare Vascular Disorders Increased blood pressure1 Rare Immune System Disorders Hypersensitivity Not known Vomiting, dry mouth, nausea CommonGastrointestinal Disorders Ischaemic colitis Not known Skin and Subcutaneous Tissue Disorders Acute generalised exanthematous pustulosis (AGEP), allergic dermatitis2, rash Rare Renal and Urinary Disorders Dysuria, urinary retention3 Uncommon Eye Disorders Ischaemic optic neuropathy Not known 1Increases in systolic blood pressure have been observed.
At therapeutic doses, the effects of pseudoephedrine on blood pressure are not clinically significant. 2A variety of allergic skin reactions, with or without systemic features such as bronchospasm and angioedema have been reported following use of pseudoephedrine.
3Urinary retention is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy. Guaifenesin Post-Marketing Data System Organ Class Adverse Reaction Frequency Immune System Disorders Anaphylactic reactions, angioedema, hypersensitivity reactions Rare Respiratory, Thoracic and Mediastinal Disorders Dyspnoea4 Rare Gastrointestinal Disorders Vomiting, nausea, abdominal discomfort Rare Skin and subcutaneous Disorders Urticaria, rash Rare 4dyspnoea has been reported in association with other symptoms of hypersensitivity.
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.
Caution should be exercised in patients with arrhythmias and hyperthyroidism. Pseudoephedrine should be used with caution in those with moderate to severe renal impairment. 5).
Acute systemic vasoconstrictive events may occur: • Acute Coronary Syndrome (ACS):
Symptoms include sudden chest pain, tightness, heavy sweating and dyspnoea at rest. • There have been rare cases of posterior reversible encephalopathy (PRES)/reversible cerebral vasoconstriction syndrome (RCVS), symptoms reported include sudden onset of severe headache, nausea, vomiting, and visual disturbances.
Most cases improved or resolved within a few days following appropriate treatment. Pseudoephedrine should be discontinued immediately, and medical advice sought if any signs/symptoms or PRES/RCVS develop. 5). Patients suffering from a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema may require additional investigation and should seek medical advice to exclude underlying pathology.
Additional investigation may be required if symptoms of cough, nasal and sinus congestion do not improve within 7 days, worsen, or are accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
This product should not be taken with a cough suppressant. Acute perioperative hypertension may occur if volatile halogenated anaesthetics are used simultaneously with indirect sympathomimetic. When planning surgery, it is recommended that pseudoephedrine treatment is stopped several days before anaesthesia.
Pseudoephedrine contains an active substance that may result in a positive reaction during antidoping control tests. Use in caution in patients with occlusive vascular disease. Keep out of sight and reach of children. Severe Skin reactions Severe skin reaction such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products.
Prior hypersensitivity reaction to pseudoephedrine, guaifenesin or any of the excipients. Cardiovascular disease including hypertension, ischaemic heart disease, thyrotoxicosis, glaucoma, diabetes, enlargement of the prostate or urinary retention.
Do not use in patients with severe renal impairment. Concomitant use of other sympathomimetic decongestants. Patients taking a prescription monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI drug. 5). 5). Patients with phaeochromocytoma.
Use in children under 12 years of age. Patients with severe hypertension or uncontrolled hypertension. Patients with severe acute or chronic kidney disease/renal failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities.
Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Robitussin Chesty Cough with Congestion / Robitussin Mucus Cough and Congestion Relief should be discontinued and appropriate measures taken if needed.
Ischaemic optic neuropathy Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. Ischaemic colitis Some cases of ischaemic colitis have been reported with pseudoephedrine.
Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop. 8). 3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.
Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment. Stop use and ask your healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash or persistent headache.
Do not exceed recommended dose. Excipient warnings: - Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol. 4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
- This product contains Amaranth (E123), which may cause allergic reactions. 30% w/v). The amount in 10 ml of this medicine is equivalent to less than 6 ml beer or 3 ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.
2 mg/ml. 5 mg/ml. 4 mg/ml. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.