Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Isosorbide mononitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR
blood and impaired gas exchange due to lung disease or ischaemic heart failure.
E blockers (nifedipine, diltiazem), vasodilators (glycerol ISOSORBIDE MONONITRATE TABLETS trinitrate, methyldopa) ACE-inhibitors, angiotensin receptor blockers (olmesartan medoxomil, Do not take Isosorbide mononitrate Tablets: candesartan cilexetil) monoamine oxidase inhibitors,
350 mm
ISOSORBIDE MONONITRATE TABLETS Always take Isosorbide mononitrate Tablets exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Very rare side effects (may affects less than 1 in 10,000 people):
Like all medicines, Isosorbide mononitrate Tablets can cause side effects, although not everybody gets them.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.
ISOSORBIDE MONONITRATE Do not use Isosorbide mononitrate to treat an actual TABLETS angina attack. Your doctor will give you a different medicine such as a GTN (glyceryl trinitrate) spray or Keep this medicine out of the sight and reach of children. tablet for this. Do not use Isosorbide mononitrate Tablets after the expiry Children date which is stated on the carton after EXP. The expiry This medicine is not suitable for children. date refers to the last day of that month. If you take more Isosorbide Mononitrate Tablets than This medicinal product does not require any special you should Do not take more Isosorbide mononitrate than you should. storage conditions. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor. Too much Isosorbide mononitrate may cause your blood pressure to fall too low, making you feel sick, faint and dizzy. A very large overdose could cause a coma or collapse and require immediate resuscitation. If you forget to take Isosorbide Mononitrate Tablets If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. If you stop taking Isosorbide Mononitrate Tablets Do not stop taking your tablets without first discussing this with your doctor as this may be harmful. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What Isosorbide Mononitrate Tablets contain: The active substance is diluted isosorbide mononitrate.
Isosorbide mononitrate 20 mg Tablets Seek immediate medical help if you are having an allergic Microcrystalline cellulose, lactose monohydrate, colloidal reaction. silicon dioxide (E551), talc and stearic acid. This includes any of the following symptoms: Isosorbide mononitrate 40 mg Tablets
Marketing Authorization Holder: Flamingo Pharma (UK) Ltd. 1st Floor, Kirkland House, 11-15 Peterborough Road, Harrow, Middlesex, HA1 2AX, United Kingdom.
Uncommon: may affect up to 1 in 100 people
This leaflet was last revised in 02/2026.
Manufacturer: Flamingo Pharma (UK) Limited, The Bloc, 38 Springfield Way, Anlaby, Hull, HU10 6RJ, United Kingdom.
PL43461/0014 PL43461/0013 PL43461/0012
P MPLLISOXXXXTBCOM FPLXXX025V04
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Important: Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
Isosorbide mononitrate
Isosorbide Mononitrate 10 mg Tablets Isosorbide Mononitrate 20 mg Tablets Isosorbide Mononitrate 40 mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
160 mm
Isosorbide Mononitrate 40 mg Tablet comes as tablet containing 40mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Isosorbide Mononitrate 40 mg Tablet is isosorbide mononitrate.
Medicines with the same active substance, strength and form include: ISMO Retard, 40 mg, prolonged-release tablets, Isotard 40 mg XL Tablets, Isosorbide Mononitrate Tablets 40 mg. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Isosorbide Mononitrate 40 mg Tablet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the prophylaxis and long term management of angina pectoris.
As adjunctive therapy after acute myocardial infarction and chronic congestive heart failure.
For oral administration
Tablet should be swallowed whole with water.
Isosorbide mononitrate 40 mg Tablets: one tablet daily, twice daily, or three times daily
Adults:
One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. The dosage may be increased up to 120mg per day.
Dosage regime should be designed according to the clinical response of the patient. Tablets should be taken after meals, unchewed with water.
The lowest effective dose should be used.
In patients taking one tablet twice daily the second dose should be taken 8 hours after the first dosage. If the dose is one tablet three times daily, take one every 6 hours and ensure 12 hours treatment-free interval every 24 hours
Paediatric population: The safety and efficacy of Isosorbide Mononitrate 40mg Tablets in children has not been established.
Elderly: There is no evidence to suggest that an adjustment of the dosage is necessary.
Treatment with Isosorbide mononitrate tablets, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.4)
Method of administration
For oral administration
Isosorbide mononitrate tablets should not be given to patients with a known sensitivity to isosorbide mononitrate, the listed ingredients or other nitrates.
Isosorbide mononitrate tablets should not be used in cases of acute myocardial infarction with low filling pressures, acute circulatory failure (shock, vascular collapse), or very low blood pressure (systolic blood pressure below 90 mmHg), hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage.
Isosorbide mononitrate Tablets should not be used in patients with severe anaemia, severe hypotension, closed angle glaucoma or severe hypovolaemia.
Phosphodiesterase type-5 inhibitors (e.g. sildenafil, tadalafil and vardenafil) have been shown to potentiate the hypotensive effects of nitrates, and their co- administration with nitrates or nitric oxide donors is therefore contraindicated (see section 4.4 and 4.5)
During nitrate therapy, the soluble guanylate cyclase stimulator riociguat must not be used (see section 4.5).
Isosorbide mononitrate Tablets should be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition and severe liver or renal disease.
Isosorbide should be used with caution in patients who have a recent history of myocardial infarction low filling pressures e.g. in acute myocardial infarction, impaired left ventricular function (left ventricular failure), or orthostatic dysfunction. Reducing systolic blood-pressure below 90 mmHg must be avoided.
Symptoms of circulatory collapse may arise after first dose, particularly in patients with labile circulation.
This product may give rise to symptoms of postural hypotension and syncope in some patients. Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol.
Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.
Isosorbide mononitrate 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.
In the event of an acute angina attack, a sublingual treatment such as a GTN spray or tablet should be used instead of Isosorbide mononitrate Tablets. The onset of action of Isosorbide mononitrate Tablets is not sufficiently rapid to be useful to treat an acute anginal attack.
If the tablets are not taken as indicated (see section 4.2), tolerance to the medication could develop. The lowest effective dose should be used.
Treatment with Isosorbide mononitrate, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.2)
In patients with decreased gastrointestinal transit time, a decrease in release of the active ingredient may occur.
Patients who undergo a maintenance treatment with Isosorbide mononitrate should be informed that they must not use phosphodiesterase inhibitor- containing products (e.g. sildenafil, tadalafil, vardenafil).
Isosorbide mononitrate therapy should not be interrupted to take phosphodiesterase inhibitor-containing products (e.g. sildenafil, tadalafil, vardenafil), because the risk of inducing an attack of angina pectoris could increase by doing so (see section 4.3 & 4.5).
Hypoxaemia
Caution should be exercised in patients with hypoxaemia and ventilation/perfusion imbalance due to lung disease or ischaemic heart failure.
As a potent vasodilator, isosorbide mononitrate could result in increased perfusion of poorly ventilated areas, worsening of the ventilation/perfusion imbalance, and a further decrease in the arterial partial pressure of oxygen. During treatment with isosorbide mononitrate alcohol should be avoided as it may potentiate the hypotensive effect of isosorbide mononitrate (see section 4.5).
Concurrent administration of drugs with blood pressure lowering properties, e.g. beta-blockers, calcium channel blockers, vasodilators, alprostadil, aldesleukin, ACE-inhibitor, monoamine oxidase inhibitor, angiotensin II receptor antagonists etc. and/or alcohol may potentiate the hypotensive effects of Isosorbide mononitrate Tablets. This may occur with neuroleptics and tricyclic antidepressants.
The concurrent intake of ISMN with ACE-inhibitors or arterial vasodilators could be a desirable interaction, unless the antihypertensive effects are excessive in which case consider reducing the dose of one or both drugs.
Any blood pressure lowering effect of Isosorbide mononitrate tablets will be increased if used together with phosphodiesterase type-5- inhibitors, which are used for erectile dysfunction (see special warning and contraindications). This may lead to life threatening cardiovascular complications. Patients who are on Isosorbide mononitrate therapy therefore must not use phosphodiesterase type-5 inhibitors. (e.g. sildenafil, tadalafil, vardenafil).
The use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see section 4.3) since concomitant use can cause hypotension.
Reports suggest that concomitant administration of Isosorbide mononitrate tablets may increase the blood levels of dihydroergotamine and its hypertensive effects.
Sapropterine (Tetrahydrobiopterine, BH4) is a cofactor for nitric oxide synthetase. Caution is recommended during concomitant use of sapropterine-containing medicine with all agents that cause vasodilation by affecting nitric oxide (NO) metabolism or action, including classical NO donors (e.g. glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), isosorbide 5-mononitrate (5-ISMN) and others).
Pregnancy
Safety in pregnancy has not been established for isosorbide mononitrate. There is data that nitrates are excreted in breast milk and may cause methemoglobinemia in infants.
Therefore Isosorbide mononitrate tablets should only be used in pregnancy and during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.
Breast-feeding
The extent of excretion of isosorbide mononitrate in human breast milk has not been determined. Therefore caution should be exercised when administered to nursing women.
Fertility
There is no data available on the effect of isosorbide mononitrate on fertility in humans.
Dizziness, tiredness or blurred vision might occur at the start of the treatment.
The patient should therefore be advised that if affected, they should not drive or operate machinery. This effect may be increased by alcohol.
Frequency categories are defined according to the following convention:
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)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
During administration of Isosorbide Mononitrate Tablets the following undesirable effects may be observed:
Nervous system disorders:
• very common: headache
• common: dizziness (including dizziness postural),somnolence
Cardiac disorders:
• common: tachycardia
• uncommon: angina pectoris aggravated
Vascular disorders:
• common: orthostatic hypotension
• uncommon: circulatory collapse (sometimes accompanied by bradyarrhythmia and syncope)
• not known: hypotension
Gastrointestinal disorders:
• uncommon: nausea, vomiting
• very rare: heartburn
Skin and subcutaneous tissue disorders:
• uncommon: allergic skin reactions (e.g. rash), flushing
• not known: dermatitis exfoliative
Immune system disorders:
• not known: angioedema
General disorders and administration site conditions:
• common: asthenia.
Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration.
During treatment with Isosorbide Mononitrate Tablets, a temporary hypoxemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardialhypoxia.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store.
Animal experience:
In rats and mice, significant lethality at oral doses of 1965 mg/kg and 2581 mg/kg, respectively, was observed.
Human experience:
Symptoms:
- Fall of blood pressure ≤90 mmHg
- Paleness
- Sweating
- Weak pulse
- Tachycardia
- Light-headedness on standing
- Headache
- Weakness
- Dizziness
- Nausea
- Vomiting
- Diarrhoea
Methaemoglobinaemia has been reported in patients receiving other organic nitrates. During isosorbide mononitrate biotransformation nitrite ions are released, which may induce methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cardiac arrest. It cannot be excluded that an overdose of isosorbide mononitrate may cause this adverse reaction.
In very high doses the intracranial pressure may be increased. This might lead to cerebral symptoms.
General procedure:
• Stop intake of the drug
• General procedures in the event of nitrate-related hypotension
- Patients should be kept horizontal with the head lowered and legs raised
- Supply oxygen
- Expand plasma volume (i.v. fluids)
- Specific treatment for shock (admit patient to intensive care unit)
Special procedure:
• Raising the blood pressure if the blood pressure is very low.
• Treatment of methaemoglobinaemia
- Reduction therapy of choice with vitamin C, methylene-blue or toluidine- blue
- Administer oxygen (if necessary)
- Initiate artificial ventilation
- Hemodialysis (if necessary)
• Resuscitation measures
In case of signs of respiratory and circulatory arrest, initiate resuscitation measures immediately.
Ask anything about Isosorbide Mononitrate 40 mg Tablet. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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