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.
Nyzamac SR Capsules
⚠ 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 The name of your medicine is Nyzamac SR Capsules. The active ingredient is isosorbide mononitrate. Nyzamac SR Capsules belong to a group of medicines called nitrates. They are called prolonged-release capsules because they are manufactured in a way that allows the isosorbide mononitrate to be released and slowly absorbed by your body over a period of several hours. Nyzamac SR Capsules are used in adults to prevent angina (chest pain) and work by opening up blood vessels and reducing the pain.
What you need to know before you take it
e Nyzamac SR Capsules Do not take Nyzamac SR Capsules if you:
- are under 18 years of age;
- are allergic to isosorbide mononitrate or any other medicines known as nitrates (glyceryl trinitrate, isosorbide dinitrate), or any of the other ingredients of Nyzamac SR Capsules listed in section 6 (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);
- have any inflammation of the heart such as pericarditis;
- have been diagnosed with any of the following heart conditions
- Low cardiac filling pressure,
- Cardiac tamponade,
- Hypertrophic obstructive cardiomyopathy;
- have had any serious damage to your heart, such as cardiomyopathy or have narrow heart valves;
- suffer from severe anaemia (low levels of red blood cells in the blood);
- have a low volume of blood in your body (hypovolaemia);
- have a head injury or bleeding of the brain;
- have closed-angle glaucoma (high pressure in the eyes);
- have low blood pressure (hypotension);
- have decreased blood supply to the brain (cerebrovascular insufficiency);
- are taking a medicine called Viagra (sildenafil) used for male erectile dysfunction. Warnings and precautions Talk to your doctor or pharmacist before taking Nyzamac SR Capsules if you:
- have recently had a heart attack;
- have an underactive thyroid gland (hypothyroidism);
- have angina due to other causes (such as a large heart muscle), or have an increased circulatory volume;
- have a head injury or bleeding of the brain;
- develop low blood pressure (hypotension), a slow heart rate (bradycardia), or worsening your angina;
- are at risk of having a stroke;
- have liver or kidney problems, especially if you are elderly;
- have cirrhosis of the liver;
- have a poor diet;
- have poor circulation;
- have consumed alcohol as this may lead to low blood pressure (hypotension);
- feel that you are developing a tolerance to Nyzamac SR Capsules;
- have a very low body temperature (hypothermia). If you have an attack of angina whilst taking Nyzamac SR Capsules, do not stop taking your Nyzamac SR Capsules. Your doctor will provide another medicine to treat your condition. Children Nyzamac SR Capsules are not suitable for use in children. Other medicines and Nyzamac SR Capsules Tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking:
- medicines used to treat high blood pressure (e.g. propranolol, furosemide);
- medicines used to treat heart failure (e.g. nifedipine, ramipril);
- medicines used in the treatment of erectile dysfunction (e.g. sildenafil);
- any medication which may cause a lowering of your blood pressure (e.g. causing dizziness or light-headedness, especially on standing);
- medicines such as noradrenaline, which are used to treat high blood pressure or a heart attack;
- acetylcholine, which is used during some operations;
- medicines such as histamine, which is used to treat allergic reactions;
- medicines used to treat migraines (e.g. ergotamine). Nyzamac SR Capsules with food, drink and alcohol Do not take Nyzamac SR Capsules at the same time as an alcoholic drink. Pregnancy and breast-feeding 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. The safety of Nyzamac SR Capsules during pregnancy or whilst breastfeeding has not been established. Driving and using machines You can drive while taking Nyzamac SR Capsules but do not drive until you know how the capsules affect you. They may give you low blood pressure or make you feel dizzy, if they affect you in this way, do not drive or operate any machinery. Nyzamac SR Capsules contain lactose, sucrose and sodium. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
How to take it
Nyzamac SR Capsules Always take Nyzamac SR Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended dose for adults is 40mg or 60mg a day, taken in the morning. Your doctor may increase this dose to 120mg, to be taken as a single dose. You can take your medicine with or without food.
Please read the back of this leaflet
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A lower dose may be prescribed for the first 2-4 days. The capsules should be swallowed whole with a glass of water. Do not crush or chew the capsules. If Nyzamac SR Capsules are taken frequently and for long periods the effectiveness of the drug may decrease. If you notice that your capsules are no longer working as well at relieving the pain as they have done before, consult your doctor.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
If you are elderly and suffer from low blood pressure, liver or kidney disease, your doctor may prescribe a lower dose for you to take.
If Nyzamac SR Capsules are taken frequently and for long periods the effectiveness of the drug may decrease. If you notice that your capsules are no longer working as well at relieving the pain as they have done before, consult your doctor.
Use in children Nyzamac SR Capsules are NOT recommended for children under 18 years of age. If you take more Nyzamac SR Capsules than you should If you take more Nyzamac SR Capsules than you should, contact your doctor or nearest hospital emergency department immediately. Take this leaflet and any remaining capsules with you. Symptoms of overdose include headache, feeling over-excited, flushing, cold perspiration, feeling sick, being sick, feeling dizzy, fainting, a fast heart beat, low blood pressure, confusion, shortness of breath and unconciousness. If you forget to take Nyzamac SR Capsules If you remember within 8 hours take the forgotten dose immediately. If you remember after 8 hours take the dose at the usual time. If you stop taking Nyzamac SR Capsules Ask your doctor before stopping treatment with Nyzamac SR Capsules, as treatment should be reduced gradually over several days and you must be monitored carefully by your doctor.
Possible side effects
Like all medicines, Nyzamac SR Capsules can cause side effects, although not everyone gets them. If you experience the following side effects, you should STOP taking your medicine and tell your doctor IMMEDIATELY or go to your nearest casualty department.
- skin troubles such as rash or itching;
- wheezing or shortness of breath. These may be signs of an allergic reaction. Very Common (may affect more than 1 in 10 people):
- headache, which may be throbbing this usually becomes less after a few days of treatment. Common (may affect up to 1 in 10 people):
- dizziness;
- lowered blood pressure (feeling light-headed, dizzy and a speeding up of the heart rate when standing up. Also feeling of weakness, drowsiness or increased heart rate). Uncommon (may affect up to 1 in 100 people):
- nausea, vomiting;
- flushing;
- skin rashes;
- heartburn;
- paleness, sweating and restlessness – if your blood pressure drops severely, leading to passing out (collapse). Worsening of angina symptoms can occur if blood pressure drops severely. Rare (may affect up to 1 in 1,000 people):
- increase in your heart rate (tachycardia).
- decrease in your heart rate (paroxysmal bradycardia). These symptoms generally disappear during long-term treatment. Not known (frequency cannot be estimated from the available data):
- muscle pain;
- weakness;
- inadequate supply of oxygen in the body (hypoxia);
- restlessness;
- sleepiness;
- pituitary haemorrhage;
- itching and allergic dermatitis;
- skin peeling;
- diarrhoea.
How to store it
Nyzamac SR Capsules Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package. KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Nyzamac SR Capsules contain The active ingredient is isosorbide mononitrate. Each 40mg prolonged-release capsule contains 40 mg of isosorbide mononitrate. Each 60mg prolonged-release capsule contains 60 mg of isosorbide mononitrate. The other ingredients are: lactose monohydrate, sugar spheres (containing sucrose and maize starch), bleached dewaxed shellac, dewaxed shellac, talc, copolymer of methacrylic acid and methyl methacrylate (1:1) and copolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate chloride (1:2:0:1) and the capsule shells are made of gelatin and also contain the colouring titanium dioxide (E171). The black printing ink contains shellac, propylene glycol, ammonium hydroxide, potassium hydroxide and black iron oxide (E172). What Nyzamac SR Capsules look like and contents of the pack The 40mg capsule is a size 2 capsules and has an opaque white cap printed with "ISMN SR" in black ink and an opaque white body printed with "40" in black ink, containing off-white to yellowish microgranules. The 60mg capsule is a size 1 capsule and has an opaque white cap printed with "ISMN SR" in black ink and an opaque white body printed with "60" in black ink, containing off-white to yellowish microgranules. They are packaged in blister packs of 28, 30, 56 or 60 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder: Ethypharm 194, Bureaux de la Colline – Bâtiment D, 92213 Saint-Cloud cedex, France Manufacturer: Macarthys Laboratories Limited TA Martindale Pharma Bampton road, Harold hill, Romford, RM3 8UG United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom: Ethypharm UK Ltd email: [email protected] PL 06934/0200 PL 06934/0201 This leaflet was last revised in September 2020.
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Frequently asked questions about Nyzamac SR Capsules
How do I take Nyzamac SR Capsules?
Nyzamac SR Capsules comes as capsule. 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 Nyzamac SR Capsules?
The active substance in Nyzamac SR Capsules is isosorbide mononitrate.
Are there equivalent medicines to Nyzamac SR Capsules?
Medicines with the same active substance, strength and form include: Isodur 25XL Capsules, Isodur 50XL Capsules. 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 Nyzamac SR Capsules, 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 Nyzamac SR Capsules 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
Nyzamac SR capsules are indicated in adults for the prophylactic treatment of angina pectoris.
4.2. Posology and method of administration
Posology
Adults:
One capsule once daily given in the morning. The dose may be increased up to 120 mg.
The product must not be given in divided doses as a daily nitrate free period is required in order to prevent the development of tolerance. Thus, if more than one capsule is needed they must be taken simultaneously.
The dose can be titrated to minimise the possibility of headache by initiating treatment by a lower dose for the first two to four days.
Paediatric population
The safety and efficacy of Nyzamac SR Capsules in children have not been established.
Elderly:
There is no need for routine dose adjustment in the elderly, but care may be needed in those patients with increased susceptibility to hypotension, and in those with marked hepatic or renal insufficiency.
The lowest effective dose should be used.
There is a risk of tolerance developing to prolonged-release preparations. In such patients, intermittent therapy may be more appropriate (see section 4.4).
As with other drugs for the treatment of angina pectoris, abrupt discontinuation of therapy may lead to exacerbation of symptoms. When discontinuing long-term treatment, the dosage should be reduced gradually over several days, and the patient carefully monitored (see section 4.4).
Method of administration
For oral administration
The capsules may be taken with or without food.
The capsules should be swallowed whole with half a glass of fluid and they should not be chewed or crushed to avoid damage to the prolonged-release characteristics of the microgranules.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
This product should not be given to patients with a known sensitivity to nitrates.
Acute myocardial infarction with low filling pressures, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, aortic/mitral stenosis and severe anaemia, hypovolaemia, conditions causing raised intracranial pressure (e.g. cerebral haemorrhage, head trauma) and closed-angle glaucoma. Severe cerebrovascular insufficiency or hypotension are contraindications to use.
Phosphodiesterase type-5 inhibitors (e.g. sildenafil) have been shown to potentiate the hypotensive effects of nitrates, their co-administration with nitrates or nitric oxide donors is therefore contraindicated.
4.4. Special warnings and precautions for use
The lowest effective dose should be used.
There is a risk of tolerance developing to modified release preparations. In such patients intermittent therapy may be more appropriate.
Therapy should not be discontinued suddenly. Both dosage and frequency should be tapered gradually (see section 4.2).
Symptoms of circulatory collapse may arise after the first dose, particularly in patients with labile circulation.
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.
Nyzamac SR Capsules are not indicated for relief of acute anginal attacks: in the event of an acute attack, glyceryl trinitrate should be used.
The administration of isosorbide mononitrate causes a decrease of effective renal plasma flow (eRPF) in cirrhotic patients and should be used with caution.
Caution should be used in patients who have a recent history of myocardial infarction and in patients suffering from hypothyroidism, hypothermia, malnutrition, and severe liver or renal disease. Oral nitrates should also be used with caution in patients with angina due to other causes, or pre-existing hyperdynamic conditions.
Since oral nitrates can cause venous dilatation, they should not be used in patients with increased intracranial pressure.
Nyzamac SR Capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Nyzamac SR Capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
The hypotensive effect of nitrates will be increased if used together with phosphodiesterase type-5 inhibitors (e.g. sildenafil). This might lead to life threatening cardiovascular complications.
Any medication which may cause hypotension may have its hypotensive effects potentiated by concurrent administration of Nyzamac SR Capsules (e.g. alcohol, antihypertensives, vasodilators, calcium channel blockers, and diuretics).
Reports suggest that concomitant administration of isosorbide mononitrate may increase the blood level of dihydroergotamine and its hypertensive effect.
Alcohol can attenuate cerebral ischaemia associated with postural hypotension.
Isosorbide mononitrate can act as a physiological antagonist to noradrenaline, acetylcholine and histamine.
Nyzamac SR Capsules should not be taken at the same time as alcohol. In vitro data suggests that in combination with Nyzamac SR Capsules, alcohol may increase the rate of in vivo release of the product from the prolonged release preparation. Alcohol may increase dose-dependent effects and lead to potential adverse pharmacodynamic interactions.
Alcohol use could therefore increase the rate and seriousness of isosorbide mononitrate adverse drug reactions such as vasodilatory related events.
There is no evidence of interaction with food.
4.6. Fertility, pregnancy and lactation
Pregnancy
The safety and efficacy of Nyzamac SR Capsules during pregnancy in humans has not been established. Animal studies have shown reproductive toxicity (see section 5.3). Isosorbide mononitrate should only be used in pregnancy if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.
Breast-feeding
The safety and efficacy of Nyzamac SR Capsules during lactation in humans has not been established. It is not known whether nitrates are excreted in human milk and therefore caution should be exercised when administered to nursing women. Isosorbide mononitrate should only be used during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.
4.7. Effects on ability to drive and use machines
The patient should be warned not to drive or operate machinery if hypotension or dizziness occurs. These effects may be increased by alcohol.
4.8. Undesirable effects
Most of the adverse reactions are pharmacodynamically mediated and dose dependent.
The frequency of possible side effects listed below is defined using 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 <1/1000), Not known (cannot be estimated from available data).
System Organ Class
Very common
Common
Uncommon
Rare
Not Known
Nervous system disorders
Headache1
Restlessness,
Somnolence,
Pituitary haemorrhage
Cardiac disorders
Tachycardia2
Paroxysmal bradycardia2
Vascular disorders
Hypotension3,
Light-headedness in the upright position (orthostatic hypotension)
(may be associated with flushing, dizziness, drowsiness, tachycardia, feeling of weakness).
Collapse4
Respiratory, thoracic and mediastinal disorders
Hypoxia
Gastrointestinal disorders
Nausea
Vomiting
Heartburn5
Diarrhoea
Skin and subcutaneous tissue disorders
Hyperhidrosis
Pruritus
Exfoliative dermatitis
Allergic skin reaction (e.g. rash)
Musculoskeletal and connective tissue disorders
Myalgia
General disorders and administration site conditions
Asthenia
1 The incidence of headache usually disappears after 1-2 weeks of treatment. (see section 4.2)
2 These symptoms generally disappear during long-term treatment.
3 Severe hypotensive responses have been reported with organic nitrates with nausea, vomiting, restlessness, pallor, and excessive perspiration. Uncommonly, severe hypotension may lead to enhanced angina pectoris symptom (see section 4.4)
4 Sometimes accompanied by bradyarrhythmia, bradycardia and syncope
5 Most likely due to a nitrate-induced sphincter relaxation.
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 (Website: www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms and signs
Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur.
Methaemoglobinaemia (cyanosis, hypoxaemia, change in mental status, respiratory depression, convulsions, cardiac arrhythmias, circulatory failure and raised intracranial pressure) occurs rarely.
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 administrated intravenously.
Consider oral activated charcoal if ingestion of a potentially toxic amount has occurred within 1 hour. Observe for at least 12 hours after the overdose. Monitor blood pressure and pulse.
If methaemoglobinaemia occurs seek expert advice. Treat with supplemental oxygen and methylene blue. In cases not responding to methylene blue or where methylene blue is contraindicated consider exchange transfusion or red blood cell concentrates. In case of cerebral convulsions, consider diazepam or clonazepam IV or, if therapy fails, phenobarbital, phenytoin or propofol anaesthesia.
💬 Ask about this leaflet
Ask anything about Nyzamac SR Capsules. 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 20, 20 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