Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd, Aharnon Str, Limassol Industrial Estate, 3056 Limassol, Cyprus
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Monorem R should not be used in patients with constrictive cardiomyopathy and pericarditis, acute myocardial infraction with low filling pressure, head trauma, cerebral haemorrhage, severe hypotension or hypovolaemia and marked anaemia.
Patients treated with Monorem R must not be given Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil).
The use of Monorem R in patients with severe cerebrovascular insufficiency is contraindicated.
Nitrates may give rise to symptoms of collapse after the first dose in patients with labile circulation. These symptoms can largely be avoided if the treatment is started with a 30 mg dose.
The safety and efficacy of Monorem R has not been established in children.
Monorem R should be used with caution in patients suffering from hypothyroidism, hypothermia, malnutrition, severe liver or renal disease.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Some of the effects of alcohol and other vasodilators may be potentiated by this agent.
Concomitant administration of Monorem R and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of Monorem R with the potential result of serious side effects such as syncope or myocardial infraction. Therefore, Monorem R and Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil) must not be given concomitantly.
The safety and efficacy of Monorem R during pregnancy or lactation has not been established. Monorem R should not be used during pregnancy or lactation unless considered essential by the physician.
It is not known whether isosorbide mononitrate is secreted in human milk.
Patients may develop dizziness when first using Monorem R. Patients should be advised to determine how they react to Monorem R before they drive or operate machinery.
Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Headache may occur when treatment is initiated, but usually disappears during continued treatment. Hypotension, with symptoms such as dizziness and nausea with syncope in isolated cases, has occasionally been reported. These symptoms generally disappear during continued treatment.
The following definitions of frequencies are used: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Adverse drug reactions by frequency and system organ class (SOC):
| System Organ Class | Frequency | Reaction |
|---|---|---|
| Nervous system disorders | Common | Headache, dizziness |
| Rare | Fainting | |
| Cardiac and vascular disorders | Common | Hypotension, tachycardia |
| Gastrointestinal disorders | Common | Nausea |
| Uncommon | Vomiting, diarrhoea | |
| Skin and subcutaneous tissue disorders | Rare | Rash, pruritus |
| Musculoskeletal and connective tissue disorders | Very rare | Myalgia |
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 the national reporting system.
Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.
Not applicable.
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