CARMIL XL Prolonged release tablet Ref.[27626] Active ingredients: Isosorbide mononitrate

Monomil XL/Carmil XL tablets are not indicated for the relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.

Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol. Consumption of alcohol should be avoided during the treatment with Carmil/Monomil XL tablets as the vasodilator activity of isosorbide mononitrate may be enhanced.

Monomil XL/ Carmil XL tablets should be used with caution in patients who have a recent history of myocardial infarction, or who are suffering from hypothyroidism, hypothermia, malnutrition and severe liver or renal disease.

Monomil XL/Carmil XL tablets contain lactose and therefore should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Concomitant administration of Monomil XL/Carmil XL tablets and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of Monomil XL/Carmil XL tablets with the potential result of serious side effects such as syncope or myocardial infarction. Therefore, Monomil XL/Carmil XL tablets and Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil) must not be given concomitantly.

The safety and efficacy of Monomil XL/Carmil XL tablets during pregnancy or lactation has not been established.

Patients may develop dizziness when first using Monomil XL/Carmil XL tablets. Patients should be advised to determine how they react to Monomil XL/Carmil XL tablets before they drive or operate machinery.

The adverse reactions which follow have been reported in studies with isosorbide mononitrate. Most of the adverse reactions are pharmacodynamically mediated and dose dependent.

Headache may occur when treatment is initiated, but usually disappears after 1-2 weeks of 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).

Nervous system disorders

Common: Headache, Dizziness

Rare: Fainting

Cardiac and vascular disorders

Common: Tachycardia, Hypotension

Gastrointestinal disorders

Common: Nausea

Uncommon: Vomiting, Diarrhoea

Skin and subcutaneous tissue disorders

Rare: Rash and pruritus

Musculoskeletal and connective tissue disorders

Very rare: Myalgia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal products 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 or search for MHRA Yellow Card in thr Google Play or Apple App Store.

None known.