Special Warning : אזהרת שימוש

4.4 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 Normopresan should be used with caution in patients with cerebrovascular or coronary insufficiency.

Normopresan 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 Normopresan as there have been occasional reports of further depressive episodes during oral treatment in such patients.

As with other antihypertensive drugs, treatment with Normopresan should be monitored particularly carefully in patients with heart failure.

In hypertension caused by phaeochromocytoma no therapeutic effect of Normopresan can be expected.

Clonidine, the active ingredient of Normopresan, and its metabolites are extensively excreted in the urine. Dosage must be adjusted to the individual antihypertensive response, which can show high variability in patients with renal insufficiency (See Section 4.2); 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 Normopresan, 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.

If Normopresan is being given concurrently with a beta-blocker, Normopresan should not be discontinued until several days after the withdrawal of the beta- blocker.

Patients who wear contact lenses should be warned that treatment with Normopresan may cause decreased lacrimation.

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

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.

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 Normopresan. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.