CLONIDINE HYDROCHLORIDE

Posology Clonidine 100 microgram Tablets are for oral administration only.

Adults:

Oral treatment should commence with 50 - 100 micrograms three times daily. This dose should be increased gradually every second or third day until control is achieved. Most patients will be controlled on divided daily doses of 300 - 1200 micrograms.

,1800 micrograms or more. Clonidine 100 microgram Tablets may be added to an existing antihypertensive regimen where blood pressure control has not been satisfactorily achieved. If side-effects with existing therapy are troublesome the concomitant use of Clonidine 100 microgram Tablets may allow a lower dose of the established regimen to be employed.

Patients changing treatment should have their existing therapy reduced gradually whilst Clonidine 100 microgram Tablets is added to their regimen. v. administration according to individual circumstances. 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. 4) according to the degree of renal impairment.

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 disorders: 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 There are occasional reports of fluid retention during initial stages of oral treatment.

This is usually transitory and can be corrected by the addition of a diuretic. Occasional reports of abnormal liver function tests and two cases of hepatitis have also been reported. 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.

) the use of the product is contraindicated. 4 Special warnings and precautions for use Caution should be exercised in patients with Raynaud's disease or other peripheral vascular disease. As with all drugs used in hypertension Clonidine 100 microgram Tablets should be used with caution in patients with cerebrovascular or coronary insufficiency.

Clonidine 100 microgram Tablets should also be used with caution in patients with mild to moderate bradyarrhythmia such as low sinus rhythm, and with polyneuropathy or constipation. Patients with a known history of depression should be carefully supervised while under long-term treatment with Clonidine 100 microgram Tablets as there have been occasional reports of further depressive episodes during oral treatment in such patients.

As with other antihypertensive drugs, treatment with Clonidine 100 microgram Tablets should be monitored particularly carefully in patients with heart failure. In hypertension caused by phaeochromocytoma no therapeutic effect of Clonidine 100 microgram Tablets can be expected.

Clonidine, the active ingredient of Clonidine 100 microgram Tablets, and its metabolites are extensively excreted in the urine. 2); careful monitoring is required. Since only a minimal amount of clonidine is removed during routine haemodialysis there is no need to give supplemental clonidine following dialysis.

Sudden withdrawal of Clonidine 100 microgram Tablets, particularly in those patients receiving high doses, may result in rebound hypertension. Cases of agitation, restlessness, palpitations, nervousness, tremor, headache and abdominal symptoms have also been reported.

Patients should be instructed not to discontinue therapy without consulting their physician. When discontinuing therapy, the physician should reduce the dose gradually. However, if withdrawal symptoms should nevertheless occur, these can usually be treated with reintroduction of clonidine or with alpha and beta adrenoceptor blocking agents.

Clonidine 100 microgram Tablets should not be used in patients with known hypersensitivity to the active ingredient or other components of the product, and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree.

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to section