Abbreviated Prescribing Information: Clonidine hydrochloride 50mg/5ml Oral Solution.
Consult Summary of Product Characteristics before prescribing.
Presentation: A clear colourless solution containing 50mg/5ml clonidine hydrochloride. Therapeutic Indications: For prophylactic management of migraine or recurrent vascular headache. For management of vasomotor conditions commonly associated with the menopause and characterised by flushing. Posology: In adults: Initial dose of 5 ml (50 mcg) twice daily. If no improvement after 2 weeks, dose can be increase to 7.5 ml (75 mcg) twice daily. Patients should be informed that it may take 2-4 weeks until clonidine hydrochloride is fully effective. In elderly: No specific information on the use of this product nor any adverse reactions related to this age group have been reported. Paediatric population: Not recommended for use in children and adolescents under the age of 18 years. Patients with renal impairment: Careful monitoring of blood pressure is required. Method of administration: Oral. Contra-indications: Hypersensitivity to the active substance or to any of the excipients; clonidine hydrochloride should not be used in patients with severe bradyarrhythmia resulting from either sick-sinus syndrome or AV block of 2nd or 3rd degree. Special Warnings and Precautions for use: Clonidine hydrochloride should be used with caution in patients with cerebrovascular disease, coronary insufficiency, heart failure, occlusive peripheral vascular disorders (e.g. Raynaud’s disease), polyneuropathy, constipation, renal insufficiency and those with a history of depression. Caution should be observed where antihypertensive agents are being used as they may enhance hypotensive effects. Clonidine hydrochloride can cause bradycardia depending on the dose given. In patients with pre-existing cardiac conduction abnormalities, arrhythmias have been observed after high doses of Clonidine hydrochloride. Dose should be tapered over 2–4 days under physician guidance when discontinuing therapy with clonidine, as abrupt withdrawal of clonidine after long-term high-dose use may cause agitation, restlessness, palpitations, hypertension, nervousness, tremor, headache, or nausea. Patients using contact lenses should be advised that clonidine hydrochloride may cause decreased lacrimation. Caution should be observed when methylphenidate is concomitantly used with clonidine as serious adverse events, including sudden death, have been reported. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: Not applicable. A list of very common, common, and serious adverse reactions is presented below: Very Common: dizziness, sedation, orthostatic hypotension and dry mouth. Common: depression, sleep disorder, headache, constipation, nausea, salivary gland pain, vomiting, erectile dysfunction and fatigue. Serious adverse reactions: confusional state, delusional perception, hallucination, atrioventricular block, bradyarrhythmia, sinus bradycardia, Raynaud’s phenomenon and colonic pseudo-obstruction. Refer to the SmPC for full details of other adverse reactions. Legal Category: Prescription only medicine. Pack Size and NHS Price: 100ml – £251.67. Marketing Authorisation Number: PL 00427/0302 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [October-2025].