Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Clonnirit 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 Clonnirit 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 (See Section 4.2).

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 Clonnirit, the physician should reduce the dose gradually over 2-4 days.

Patients who wear contact lenses should be warned that treatment with Clonnirit 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 can not 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.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that they may experience undesirable effects such as dizziness, sedation and accommodation disorder during treatment with Clonnirit. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.