Summary of Product Characteristics (SmPC) - Menisor XL 60 mg prolonged-release tablets
1 NAME OF THE MEDICINAL PRODUCT
Menisor XL 60 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg isosorbide mononitrate.
Excipient with known effect:
Each tablet also contains 215 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White capsule-shaped tablets with MP86 imprinted on one side and reverse scored.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prophylactic treatment of angina pectoris.
4.2 Posology and method of administration
Posology:
Adults
Isosorbide Mononitrate 60 mg (one tablet) once daily given in the morning. The dose may be increased to 120mg (two tablets) daily, both to be taken once daily in the morning. The dose can be titrated to minimise the possibility of headache by initiating treatment with 30 mg (half a tablet) for the first 2-4 days.
Paediatric Population
The safety and efficacy of isosorbide mononitrate in children has not yet been established.
Older people
No evidence of a need for routine dosage adjustment in the older people has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.
Method of administration: Oral
Menisor XL 60 mg Prolonged-release Tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Constrictive cardiomyopathy and pericarditis, aortic stenosis, cardiac tamponade, mitral stenosis and severe anaemia.
Patients treated with Menisor XL 60 mg Prolonged-release Tablets must not be given Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil). Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of Menisor XL 60 mg Prolonged-release Tablets. Co-administration with riociguat (see section 4.5).
4.4 Special warnings and precautions for use
Menisor XL 60 mg Prolonged-release Tablets is not indicated for relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant administration of Isosorbide Mononitrate and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of Isosorbide Mononitrate with the potential result of serious side effects such as syncope or myocardial infarction. Therefore, Isosorbide Mononitrate and Phosphodiesterase Type 5 Inhibitors (e.g.
sildenafil) must not be given concomitantly.
The use of Isosorbide Mononitrate with riociguat, a stimulator of soluble guanylate cyclase, is contra-indicated (see section 4.3), since concomitant use can cause hypotension.
4.6 Fertility, Pregnancy and lactation
The safety and efficacy of isosorbide mononitrate during pregnancy or lactation has not been established.
4.7 Effects on ability to drive and use machines
Patients may develop dizziness when first using Isosorbide Mononitrate. Patients should be advised to determine how they react to Isosorbide Mononitrate before they drive or operate machinery.
4.8 Undesirable effects
Most of the adverse reactions are pharmacodynamically mediated and dose dependant. Headache may occur when treatment is initiated, but usually disappears after 1-2 weeks of treatment. The dose can be titrated to minimise the possibility of headache, by initiating treatment with 30 mg. 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 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms:
Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.
Management:
Induction of emesis, activated charcoal. In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary, fluids should be administered intravenously.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Vasodilators used in cardiovascular disease (organic nitrates). ATC code: C01D A14
The principal pharmacological action of isosorbide mononitrate, an active metabolite of isosorbide dinitrate, is relaxation of vascular smooth muscle, producing vasodilation of both arteries and veins with the latter effect predominating. The effect of the treatment is dependent on the dose. Low plasma concentrations lead to venous dilatation, resulting in peripheral pooling of blood, decreased venous return and reduction in left ventricular end-diastolic pressure (preload). High plasma concentrations also dilate the arteries reducing systemic vascular resistance and arterial pressure leading to a reduction in cardiac after-load. Isosorbide mononitrate may also have a direct dilatory effect on the coronary arteries. By reducing the end diastolic pressure and volume, the preparation lowers the intramural pressure, thereby leading to an improvement in the sub-endocardial blood flow.
The net effect when administering isosorbide mononitrate is therefore a reduced workload of the heart and an improved oxygen supply/demand balance in the myocardium.
5.2 Pharmacokinetic properties
Isosorbide mononitrate is completely absorbed and is not subject to first pass metabolism by the liver. This reduces the intra- and inter-individual variations in plasma levels and leads to predictable and reproducible clinical effects.
The elimination half-life of isosorbide mononitrate is about 5 hours. The plasma protein binding is less than 5%. The volume of distribution for isosorbide mononitrate is about 0.6 l/kg and total clearance around 115 ml/minute. Elimination is primarily by denitration and conjugation in the liver. The metabolites are excreted mainly via the kidneys. Only about 2% of the dose given is excreted intact via the kidneys.
Impaired liver or kidney function have no major influences on the pharmacokinetic properties.
Menisor XL 60 mg Prolonged-release Tablets is an extended release formulation. The active substance is released independently of pH, over a 10- hour period. Compared to ordinary tablets the absorption phase is prolonged and the duration of effect is extended.
The extent of bioavailability of Menisor XL 60 mg prolonged-release tablets is about 90% compared to immediate release tablets. Absorption is not significantly affected by food intake and there is no accumulation during steady state. Menisor XL 60 mg Prolonged-release Tablets exhibits dose proportional kinetics up to 120 mg. After repeated peroral administration with 60 mg once daily, maximal plasma concentration (around 3000 nmol/l) is achieved after around 4 hours. The plasma concentration then gradually falls to under 500 nmol/l at the end of the dosage interval (24 hours after dosage intake). The tablets are divisible.
In placebo-controlled studies, Menisor XL 60 mg prolonged-release tablets once daily has been shown to effectively control angina pectoris both in terms of exercise capacity and symptoms, and also in reducing signs of myocardial ischaemia. The duration of the effect is at least 12 hours; at this point the plasma concentration is at the same level as at around 1 hour after dose intake (around 1300 nmol/l).
Menisor XL 60 mg prolonged-release tablets is effective as monotherapy as well as in combination with beta-blocker therapy.
The clinical effects of nitrates may be attenuated during repeated administration owing to high and/or even plasma levels. This can be avoided by allowing low plasma levels for a certain period of the dosage interval. Menisor XL 60 mg prolonged-release tablets, when administered once daily in the morning, produces a plasma profile of high levels during the day and low levels during the night. With isosorbide mononitrate 60 mg or 120 mg once daily no development of tolerance with respect to antianginal effect has been observed. Rebound phenomenon between doses as described with intermittent nitrate patch therapy has not been seen with Menisor XL 60 mg prolonged-release tablets.
5.3 Preclinical safety data
The accessible data indicate that isosorbide mononitrate has expected pharmacodynamic properties of an organic nitrate ester, has simple pharmacokinetic properties, and is devoid of toxic, mutagenic or oncogenic effects.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate
Hydroxypropylmethylcellulose (Methocel K4M)
Glyceryl palmitostearate
Maize starch
Magnesium stearate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Blister packs (PVC film 250 μm / aluminium foil 25 μm) of 28 tablets
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Genethics Europe Limited
41 - 43 Klimentos
Klimentos Tower
Nicosia 1061
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 42976/0064
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/02/2025
10 DATE OF REVISION OF THE TEXT
19/06/2026