Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
ISMO 20, 20 mg, tablets
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
FOR ISMO® 20 belongs to a group of medicines called nitrates. The nitrates make the arteries of the heart dilate, increasing the blood supply to the heart muscle. ISMO® 20 is used to treat:
- angina pectoris. Angina pectoris is a type of chest pain caused when your heart muscle does not get enough blood supply. ISMO® 20 will help to:
- lower the number of your episodes of angina
- lower the severity of your attacks of angina
- heart failure (when your heart cannot pump enough blood around the body)
What you need to know before you take it
E ISMO® 20 Do NOT take ISMO® 20
- if you are allergic to isosorbide-5-mononitrate or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to isosorbide dinitrate (the same type of medicine as ISMO® 20)
- if you have marked low blood pressure (systolic blood pressure ≤ 90 mmHg)
- if you suffer from circulatory collapse or shock
- if you suffer from cardiogenic shock
- if you suffer from acute myocardial infarction with low left ventricular filling pressure
- if you have been diagnosed with any of the following:
- hypertrophic obstructive cardiomyopathy (a thickened heart muscle),
- constrictive pericarditis (an inflammation of the heart sac),
- cardiac tamponade (accumulation of fluid around the heart),
- aortic/mitral valve stenosis (narrowing of heart valves).
- if you suffer from severe anaemia (low level of red blood cells)
- if you suffer from closed angle glaucoma (high pressure in the eye)
- if you suffer from conditions associated with raised pressure on the brain (e.g. following head trauma and cerebral haemorrhage)
- if you suffer from severe hypovolaemia (decreased blood volume)
- if you are taking sildenafil (as in Viagra®), vardenafil or tadalafil used in the treatment of male erectile dysfunction (when you cannot get an erection) Warnings and precautions Talk to your doctor or pharmacist before taking ISMO® 20. ISMO® 20 is used to stop angina attacks from happening. It is not intended to treat a sudden attack of angina. The lowest effective dose should be used. Do not stop taking ISMO® 20 suddenly. It should be withdrawn gradually. Take special care with ISMO® 20, if
- you suffer from hypothyroidism (your thyroid gland does not produce sufficient amounts of thyroid hormone)
- you suffer from malnutrition
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Description: Country/Lang.: Date/Time: Material No.: MAH No.: Manufact. No.: Dimensions/TD: Color: Cutting die: LAETUS Code: Font Type/Size: SKU/DU:
Ismo 20 mg Mock up Grossbritannien 28.01.2022 07:17 Artensis XXXXXXXXX XXXXXXX-XX 155 x 203 mm P061 P 281 Cyan 174 CentSchbook 9 Pkt. 4000172
- you have severe problems with your liver or kidneys
- you have low body temperature (hypothermia)
- you have recent history of myocardial infarction (heart attack)
- you are already taking medicine to lower blood pressure
- you are taking any other medication
- you are pregnant or breast-feeding If any of the above apply to you, you should not take this medicine until you have talked to your doctor about it. A low blood pressure caused by nitrates may occur with paradoxical bradycardia (slowing of the heart rate) and worsening of the symptoms of angina. A severe drop in blood pressure,when standing up or move suddenly, with light-headedness and dizziness is frequently observed after drinking alcohol. You can develop a tolerance to this medicine or if you are taking another medicine containing nitrates. In order to avoid any lessening or loss of the effect of the medicine, you should not take high doses on a continual basis. Taking ISMO® 20 may cause transient hypo xaemia (an abnormally low level of oxygen in the blood). This happens because blood flow in your body is redistributed with an increase in perfusion of poorly ventilated areas of the lung. This may cause ischaemia (not enough blood g oing to your heart muscle) if you have coronary heart disease. Increasing doses and/or changes in intervals between doses can lead to this medicine not working with the effect that it should or not work at all. Children The safety and effectiveness of ISMO® 20 in children has not been established. Other medicines and ISMO® 20 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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Taking the following medicines at the same time as ISMO® 20 can increase the blood pressure lowering (hypotensive) effect of ISMO® 20:
- other vasodilatators,
- antihypertensives (medicines to treat high blood pressure) such as ACE-inhibitors, angiotensin-II-receptor antagonists, beta- blockers, calcium antagonists and diuretics,
- neuroleptics (used to treat psychiatric d isorders),
- sapropterin (used to lower phenylalanine levels in the blood of patients with phenylketonuria),
- alprostadil (for male erection problems),
- aldesleukin (for cancer treatment), and
- alcohol You must not take any treatments for erectile dysfunction whilst taking ISMO® 20. Do not take sildenafil (as in Viagra®), vardenafil or tadalafil whilst taking ISMO® 20. Treatments for erectile dysfunction can cause a severe and dangerous fall in blood pressure when taken together with ISMO® 20. This can be fatal. ISMO® 20 with food, drink and alcohol Do not drink alcohol whilst taking ISMO® 20 as it may increase the blood pressure lowering (hypotensive) effect of ISMO® 20. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy There is insufficient experience with the use of isosorbide-5-mononitrate in pregnant women. Animal studies having shown no adverse effects on the foetus. Use of ISMO® 20 in pregnancy is not recommended unless considered essential by your doctor. Lactation It is unknown if isosorbide-5-mononitrate is excreted in breast milk. Use during breast- feeding is not recommended unless considered essential by your doctor. Fertility There are no fertility data.
Driving and using machines When you take ISMO® 20 you may feel dizzy or light-headed if you stand up or move suddenly. You may experience blurred vision. If you experience such symptoms you should not drive or operate machinery. ISMO® 20 contains milk sugar (lactose) ISMO® 20 contains 148 mg milk sugar (lactose) per tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take it
ISMO® 20 Always take ISMO® 20 exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is 2 to 3 tablets per day (40 mg – 60 mg), but can range from 20 mg to 120 mg daily. Your doctor will tell you how many to take. You should always take ISMO® 20 at the times your doctor has told you to take it. You should swallow the tablets whole, with a drink of water. If you have not taken ISMO® 20 before, your doctor may prescribe you an ISMO® Starter Pack with 10 mg tablets for a few days. In this case you will take one ISMO® 10 mg tablet daily for 2 days, followed by two ISMO® 10 mg tablets (one tablet in the morning and one in the evening) for a further 3 days. Duration of treatment Angina needs long-term treatment. Keep taking your ISMO® 20 unless your doctor tells you to stop. If you take more ISMO® 20 than you should If you have taken too many tablets (overdose), tell your doctor at once, or contact the nearest hospital casualty department. If you feel faint or dizzy, lie flat with your legs raised higher than your head. Symptoms of an overdose may be the following: nausea, vomiting, restlessness, warm flushed skin, blurred vision, headache, fainting, tachy cardia (a fast heart beat), hypotension and palpitations.
At high doses (more than 20 mg/kg body weight), methaemoglobin formation (an oxidation form of haemoglobin in the blood), bluish discoloration of the skin and mucous membranes due to reduced oxygen content of the blood (cyanosis), shortness of breath (dyspnoea) and rapid shallow breathing (tachypnoea) can be expected. At very high doses, increased pressure within the scull (intracranial pressure) with related symptoms may occur. If you forget to take ISMO® 20 If you forget to take a tablet, take one as soon as you remember on that day. Continue your treatment as usual the following morning. Do not take a double dose to make up for a forgot ten tablet. If you stop taking ISMO® 20 You may feel unwell if you suddenly stop taking ISMO® 20. Tell your doctor if you stop taking this medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you develop chest pains or experience worsening of chest pains, contact your doctor. If you experience any of the following side effects, please tell your doctor or pharmacist. Very Common (in more than 1 in 10 patients treated)
- Particularly at the start of treatment, a temporary "nitrate headache" may occur which normally subsides after some days of continued treatment. Common (in 1 to 10 out of 100 patients treated)
- low blood pressure (hypotension) and/or drop in blood pressure when standing up or move suddenly (postural hypotension) , especially at the beginning of treatment, which may be accom panied by a fast heart beat (tachycardia), slight states of dizziness or feeling weak
- gastro-intestinal symptoms, e.g. nausea and/or vomiting, especially when first used
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Frequently asked questions about ISMO 20, 20 mg, tablets
How do I take ISMO 20, 20 mg, tablets?
ISMO 20, 20 mg, tablets comes as tablet containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in ISMO 20, 20 mg, tablets?
The active substance in ISMO 20, 20 mg, tablets is isosorbide mononitrate.
Are there equivalent medicines to ISMO 20, 20 mg, tablets?
Medicines with the same active substance, strength and form include: Isosorbide Mononitrate 20 mg Tablet, Isosorbide Mononitrate Tablets 20 mg, Isosorbide Mononitrate/Carmil/Monomil 20mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for ISMO 20, 20 mg, tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get ISMO 20, 20 mg, tablets without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: isosorbide mononitrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
ISMO products are indicated for use in the treatment and prophylaxis of angina pectoris and as adjunctive therapy in congestive heart failure which does not respond adequately to cardiac glycosides and/or diuretics.
4.2. Posology and method of administration
Posology
Paediatric Population
The safety and efficacy of ISMO in children has not been established.
Adults
The recommended dosage is from 20 to 120 mg isosorbide-5-mononitrate daily in divided doses. The majority of patients will require a dosage in the range of 40 to 60 mg daily in divided doses. The tablets should be taken with fluid and swallowed whole without chewing.
The lowest effective dose should be used.
For patients who have not previously received prophylactic nitrate therapy it is recommended that the ISMO Starter Pack be employed. This provides an initial dosage of 10 mg isosorbide-5-mononitrate (1 tablet) daily for 2 days followed by a dosage of 20 mg daily (1 tablet morning and evening) for a further 3 days. Subsequently the daily dosage may be increased to the normal prophylactic level using the ISMO 20 tablets also included in the Starter Pack. Patients already accustomed to chronic nitrate therapy normally may be transferred directly to a therapeutic dose of ISMO.
For those previously treated with isosorbide dinitrate in conventional form the dosage of ISMO should be the same initially. ISMO is effectively twice as potent as sustained release forms of isosorbide dinitrate and patients transferred from such treatment should receive ISMO at half the previous dosage.
Therapy should not be discontinued suddenly. Both dosage and frequency should be tapered gradually (see section 4.4).
Elderly
There is no evidence to suggest an adjustment of dose is necessary. However, caution may be required in elderly patients who are known to be susceptible to the effects of hypotensive medication.
Renal and hepatic impairment
No dosage reduction is necessary.
Method of administration
Oral.
4.3. Contraindications
• hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
• hypersensitivity to isosorbide dinitrate,
• in cases of marked low blood pressure (BP ≤ 90 mm Hg systolic)
• circulatory collapse
• shock
• cardiogenic shock
• acute myocardial infarction with low left ventricular filling pressure
• hypertrophic obstructive cardiomyopathy
• constrictive pericarditis
• cardiac tamponade
• aortic/mitral valve stenosis
• severe anaemia
• closed-angle glaucoma and conditions associated with raised intracerebral pressure e.g. following head trauma and cerebral haemorrhage
• severe hypovolaemia
• Phosphodiesterase-5 inhibitors, e.g. sildenafil, vardenafil and tadalafil have been shown to potentiate the hypotensive effects of nitrates (see section 4.8), and their co-administration with nitrates or nitric oxide donors is therefore contraindicated.
4.4. Special warnings and precautions for use
ISMO is not indicated for relief of an acute attack; sublingual or buccal glyceryl trinitrate tablets or spray should be used.
The lowest effective dose should be used (see section 4.2).
Since a rebound phenomenon cannot be excluded, therapy with isosorbide-5-mononitrate should be terminated gradually rather than stopping abruptly (see section 4.2).
Caution should be exercised in patients suffering from hypothyroidism, malnutrition, severe renal or hepatic impairment, hypothermia and recent history of myocardial infarction and in patients already taking medicine to lower blood pressure or taking any other medication (see section 4.5).
Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.
Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol.
Tolerance development and occurrence of cross-tolerance with other nitrate compounds have been described. In order to avoid any attenuation or loss of effect, high continuous dosing regimens should be avoided.
Administration of isosorbide-5-nitrate may produce transient hypoxaemia as a result of redistribution of blood flow with a relative increase in perfusion of poorly ventilated areas of the lung. This may cause ischaemia in patients with coronary heart disease.
Dose escalation and/or changes in the dosing interval can lead to an attenuation or loss of the effect.
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 other vasodilatators, antihypertensives (e.g. ACE-inhibitors, angiotensin-II-receptor antagonists, beta-blockers, calcium antagonists, diuretics), neuroleptics, sapropterin, alprostadil, aldesleukin and alcohol can potentiate the hypotensive effect of ISMO 20.
In particular, the hypotensive effects of nitrates are potentiated by concurrent co-administration of phosphodiesterase type-5 inhibitors e.g. sildenafil, vardenafil and tadalafil (see section 4.3); these effects are potentially life threatening.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is inadequate evidence of safety of isosorbide-5-mononitrate in human pregnancy although nitrates have been in wide use for many years without ill consequence, animal studies having shown no adverse effects on the foetus. Use in pregnancy is not recommended unless considered essential by the patient's physician.
Lactation
There is no information on excretion of isosorbide-5-mononitrate in breast milk.
Use in lactation is not recommended unless considered essential by the patient`s physician.
Fertility
There are no fertility data.
4.7. Effects on ability to drive and use machines
In theory, the ability to drive or to operate machinery may be impaired in patients experiencing hypotensive side effects such as dizziness or blurred vision.
4.8. Undesirable effects
The following categories are used when stating the frequency of undesirable effects:
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 (frequency cannot be estimated from the available data)
Nervous system disorders
• Very common: Particularly at the start of treatment, a transient “nitrate headache” may occur which normally subsides after some days of continued treatment.
Vascular disorders
• Common: Especially at the beginning of treatment, hypotension (including postural hypotension) has been observed which may be accompanied by tachycardia and slight states of dizziness or feeling of weakness, which normally improves on continuation of therapy.
• Uncommon: A significant drop in blood pressure with exacerbation of angina pectoris symptoms has been observed as well as states of collapse, sometimes accompanied by bradyarrhythmias and syncope.
• Not known: Severe hypotensive responses including nausea, vomiting, restlessness, pallor, and hyperhidrosis have been reported for organic nitrates.
Skin and subcutaneous tissue disorders
• Uncommon: flushing
• Not known: exfoliative dermatitis
Immune system disorders
• Uncommon: allergic skin reactions
Blood and lymphatic system disorders
• Not known: formation of methaemoglobin, in particular in susceptible patients such as those with methaemoglobin reductase deficiency or in patients with diaphorase deficiency and abnormal haemoglobin structure
Gastrointestinal disorders
• Common: Especially when first used, gastro-intestinal symptoms, e.g. nausea and/or vomiting may occur.
• Not known: heartburn
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
Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
Symptoms of an overdose
nausea, vomiting, restlessness, warm flushed skin, blurred vision, headache, fainting, tachycardia, hypotension and palpitations
At high doses (more than 20 mg/kg body weight), methaemoglobin formation, cyanosis, dyspnoea and tachypnoea can be expected, as a result of the nitrite ion formed when isosorbide-5-mononitrate is degraded.
At very high doses, increased intracranial pressure with cerebral symptoms may occur.
In cases of chronic overdose, increased methaemoglobin levels have been measured, the clinical relevance of which is debated.
Management: Measures to treat overdose
In addition to general procedures, such as gastric lavage and keeping the patient horizontal with the legs raised, vital parameters must be monitored under intensive care conditions and corrected where necessary.
In the event of marked hypotension and/or shock, volume replacement should be given; in exceptional cases, norepinephrine and/or dopamine can be infused as circulatory therapy. Administration of epinephrine and related substances is contraindicated.
For methaemoglobinaemia, the following antidote is available:
Methylene blue: Up to 50 ml of a 1 % methylene blue solution IV
💬 Ask about this leaflet
Ask anything about ISMO 20, 20 mg, tablets. 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.
Medicines containing Isosorbide mononitrate
- Carmil XL 60 mg Tablets
- Chemydur 60XL Tablets
- Elantan LA 25 mg prolonged release capsules
- Elantan LA 50 mg prolonged release capsules
- Eumon 40 XL Modified Release Tablets (Isosorbide Mononitrate)
- Imdur Tablets 60mg
- ISMO 10, 10 mg, tablets
- ISMO Retard, 40 mg, prolonged-release tablets
- Isodur 25XL Capsules
- Isodur 50XL Capsules
- Isosorbide Mononitrate 10 mg Tablet
- Isosorbide Mononitrate 20 mg Tablet
- Isosorbide Mononitrate 40 mg Tablet
- Isosorbide Mononitrate Tablets 10 mg