CLONIDINE HYDROCHLORIDE

Adults:

Initially 5ml (50micrograms) twice daily. 5ml (75micrograms) twice daily. The duration of treatment depends upon the severity of the condition. If symptoms continue to occur the patient should be informed that it may take 2-4 weeks until Clonidine hydrochloride is fully effective.

Elderly:

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

Paediatric Population:

There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years. Patients with renal impairment Clonidine hydrochloride should be used with caution in patients with renal insufficiency.

Careful monitoring of blood pressure is required.

Most adverse effects are mild and tend to diminish with continued therapy. Adverse events have been ranked under headings of frequency using the following convention: Very common > 1/10 Common > 1/100, <1/10 Uncommon >1/1000, <1/100 Rare >1/10000, <1/1000 Very rare <1/10000 Not known Cannot be estimated from the available data Endocrine disorders: Gynaecomastia rare Psychiatric disorders: confusional state not known delusional perception uncommon depression common hallucination uncommon libido decreased not known nightmare uncommon sleep disorder common Nervous system disorders: dizziness very common headache common paraesthesia uncommon sedation very common Eye disorder: accommodation disorder not known lacrimation decreased rare Cardiac disorders: atrioventricular block rare bradyarrhythmia not known sinus bradycardia uncommon Vascular disorders: orthostatic hypotension very common Raynaud's phenomenon uncommon Respiratory, thoracic and mediastinal disorders: nasal dryness rare Gastrointestinal disorders: colonic pseudo-obstruction rare constipation common dry mouth very common nausea common salivary gland pain common vomiting common Skin and subcutaneous tissue disorders: Alopecia rare Pruritus uncommon Rash uncommon Urticaria uncommon Reproductive system and breast disorders: erectile dysfunction common General disorders and administration site conditions: Fatigue common Malaise uncommon Investigations: blood glucose increased rare Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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Clonidine hydrochloride should be used with caution in patients with cerebrovascular disease, coronary insufficiency, heart failure, occlusive peripheral vascular disorders, such as Raynaud's disease, polyneuropathy, constipation or those with a history of depression.

At doses higher than those recommended above, clonidine is an effective antihypertensive agent. Caution should therefore be observed where antihypertensive agents are being used, as potentiation of the hypotensive effect may occur. Provided the recommended Clonidine hydrochloride dosage regimen is followed, no difficulty with hypotension should arise during the routine management of patients with either migraine or menopausal flushing.

Depending on the dose given, Clonidine hydrochloride can cause bradycardia. In patients with pre-existing cardiac conduction abnormalities, arrhythmias have been observed after high doses of Clonidine hydrochloride. 2). Patients should be instructed not to discontinue therapy without consulting their physician.

Following sudden discontinuation of Clonidine hydrochloride after prolonged treatment with high doses, agitation, restlessness, palpitations, rapid rise in blood pressure, nervousness, tremor, headache or nausea have been reported.

When discontinuing therapy with Clonidine hydrochloride, the physician should reduce the dose gradually over 2-4 days. Patients who wear contact lenses should be warned that treatment with Clonidine hydrochloride may cause decreased lacrimation.

The use and the safety of clonidine in children and adolescents has little supporting evidence in randomized controlled trials and therefore cannot be recommended for use in this population. Serious adverse events, including sudden death, have been reported in concomitant use with methylphenidate.

The safety of using methylphenidate in combination with clonidine has not been systematically evaluated. Excipients warnings This product contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).

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