Source: Medicines Authority (MT) Revision Year: 2021 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Therapy should not be discontinued, but the dosage should be reduced gradually.
Like all antihypertensive agents, in patients with a recent history of vascular disorders (stroke, myocardial infarction), Hyperium should be administered under constant medical supervision.
Due to the risk of rilmenidine to decrease heart rate and trigger bradycardia, initiation of treatment should be carefully considered in patients with existing bradycardia or risk factors for bradycardia (e.g. in the elderly, patients with sick sinus syndrome, AV-block, pre-existing heart failure, or any condition when heart rate is maintained by an excessive sympathetic tone). Monitoring of heart rate, particularly in the first 4 weeks of therapy is warranted in such patients.
The consumption of alcohol is not recommended during treatment (see section 4.5).
The use of Hyperium in combination with beta-blockers administered in heart failure (bisoprolol, carvedilol, metoprolol) is not recommended (see section 4.5). The use of Hyperium in combination with MAO-Inhibitors is not recommended (see section 4.5).
Because of the possibility of orthostatic hypotension, older patients should be advised of the increased risk of falling.
Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, deficiency should not take this medicine.
Hyperium 1 mg, tablets contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.
Increased risk of ventricular arrhythmias, particularly torsades de pointes.
Alcohol increases the sedative effect of these substances. Impaired vigilance may render driving of vehicles and use of machinery dangerous. Alcoholic beverages and medicines containing alcohol should be avoided.
Central reduction of sympathetic tone and vasodilator effect of centrally acting antihypertensive agents that may be harmful in patients with heart failure undergoing treatment with beta-blockers and vasodilators.
The antihypertensive activity of rilmenidine may be partially antagonised.
Increased antihypertensive effect; blood pressure must be monitored and the dosage of the antihypertensive agent adjusted if necessary.
Marked increase in blood pressure in the event of abrupt discontinuation of treatment with the central antihypertensive agent. Avoid abrupt discontinuation of the central antihypertensive agent. Clinical monitoring is required.
Increased risk of ventricular arrhythmias, particularly torsades de pointes. Clinical and electrocardiographic monitoring.
The antihypertensive activity of rilmenidine may be partially antagonised.
Potentation of hypotensive effect. Increased risk of orthostatic hypotension.
Potentiation of hypotensive effect. Increased risk of orthostatic hypotension.
Increased antihypertensive effect.
Reduced antihypertensive effect (water/sodiurn retention through corticosteroids)
Increased antihypertensive effect and risk of orthostatic hypotension (cumulative effect).
Morphine derivatives (analgesics, antitussive agents and replacement treatments), benzodiazepines, anxiolytics other than benzodiazepines, hypnotics, neuroleptics, sedative H1 histamine antagonists, sedative antidepressants (amitriptyline, doxepine, mianserine, mirtazapine, trimipramine), other centrally acting antihypertensive agents, baclofen, thalidomide, pizotifen, indoramin.
Increased central depression. Impaired vigilance may render driving vehicles and operation of machinery dangerous.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of rilmenidine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Hyperium during pregnancy.
It is unknown whether rilmenidine/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of Rilmenidine/metabolites in milk.
A risk to the newborns/infants cannot be excluded.
Hyperium should not be used during breast-feeding.
Reproduction studies in the rat showed no effect of rilmenidine on fertility (see section 5.3).
No specific studies on the effects on the ability to drive and use machines have been performed. However, considering that somnolence is a common adverse reaction, patients should be cautioned about their ability to drive a car or operate machinery.
At the dose of 1 mg in a single daily administration, during controlled studies, the incidence of undesirable effects was comparable to that observed with placebo.
At a dose of 2 mg of Hyperium daily, the controlled comparative studies versus clonidine at a dose of 0.15 to 0.30 mg/day or alpha-methyldopa at a dose of 500 to 1000 mg/day showed that the incidence of undesirable effects was significantly lower than that observed with clonidine or alpha-methyldopa.
The following undesirable effects or events have been reported and ranked using the following frequency: 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 0000), not known (cannot be estimated from the available data).
| System Organ Class | Frequency | Preferred term |
|---|---|---|
| Psychiatric disorders | Common | Anxiety Depression Insomnia |
| Nervous system disorders | Common | Somnolence Headache Dizziness |
| Cardiac disorders | Common | Palpitations |
| Not known | Bradycardia | |
| Vascular disorders | Common | Peripheral coldness |
| Uncommon | Hot flushes Orthostatic hypotension | |
| Gastrointestinal disorders | Common | Abdominal pain upper Dry mouth Diarrhoea Constipation |
| Uncommon | Nausea | |
| Skin and subcutaneous tissue disorders | Common | Pruritus Rash |
| Musculoskeletal and connective tissue disorders | Common | Muscle spasms |
| Reproductive system and breast disorders | Common | Sexual dysfunction |
| General disorders and administration site conditions | Common | Asthenia Fatigue Oedema |
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via ADR Reporting, The Medicines Authority, Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann SĠN 3000, Website: www.medicinesauthority.gov.mt, e-mail: postlicensing.medicinesauthority@gov.mt.
Not applicable.
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