CLONIDINE HYDROCHLORIDE

Posology Adults Initially 2 tablets twice daily. If after two weeks there has been no remission, increase to 3 tablets 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 25 mcg Tablets are fully effective.

Paediatric population There is insufficient information 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. 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. Patient with Renal impairment Clonidine Hydrochloride should be used with caution in patients with renal insufficiency.

Careful monitoring of blood pressure is required. Method of administration For oral administration.

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 (≥ 1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (< 1/10,000) and unknown (cannot be calculated from the available data).

Cardiac disorders:

Bradyarrhythmia: not known Sinus bradycardia: uncommon AV-block: rare Nervous system disorders: Dizziness, Sedation: very common Headache: common Paraesthesia: uncommon Eye disorders: Lacrimation decreased: rare.

Accommodation disorder: not known Respiratory, thoracic and mediastinal disorders:

Nasal dryness: rare Gastrointestinal disorders: Dry mouth: very common Constipation, Nausea, Salivary gland pain, Vomiting: common Colonic pseudo-obstruction: rare Skin and subcutaneous tissue disorders: Pruritus, Rash, Urticaria: uncommon Alopecia: rare Vascular disorders: Orthostatic hypotension: very common Raynaud's phenomenon: uncommon General disorders and administration site conditions: Fatigue common Malaise: uncommon Reproductive system and breast disorders: Erectile dysfunction: common.

Endocrine disorders:

Gynaecomastia: rare Psychiatric disorders: Sleep disorder, depression: common Hallucination, delusional perception, nightmare: uncommon Confusional state, libido decreased: not known Investigations: Blood glucose increased: rare 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 this product is contraindicated. 4 Special warnings and precautions for use Clonidine Hydrochloride 25 mcg Tablets 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 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. Patients with renal failure require extreme care.

2). Patients should be instructed not to discontinue therapy without consulting their physician. Following sudden discontinuation of Clonidine 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, the physician should reduce the dose gradually over 2-4 days. Patients who wear contact lenses should be warned that treatment with clonidine may cause decreased lacrimation. The use and the safety of clonidine in children and adolescents under 18 years have insufficient 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 This medicine contains lactose.

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