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 Tardisc XL 60 Prolonged Release Tablets (referred to as Tardisc XL 60 throughout this leaflet) contains an active substance called Isosorbide Mononitrate. This belongs to a group of medicines called 'nitrates'.
E TARDISC XL 60 Do not take Tardisc XL 60: DO NOT use these tablets to treat sudden chest pain (acute angina). Instead seek immediate medical attention. These tablets work too slowly to treat this and are only used to prevent symptoms of angina from happening. • • •
If you are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients of Tardisc XL 60 (listed in Section 6). If you have ever had a stroke. If you have very low blood pressure.
If you have severe anaemia. If you have a heart problem called 'cardiomyopathy' or 'pericarditis' or you have narrow heart valves.
• •
Warnings and precautions Talk to your doctor or pharmacist before taking Tardisc XL 60:
•
any drugs used to treat high blood pressure (e.g. beta-blockers, calcium channel blockers, vasodilators, angiotensin II receptor antagonists, ACE inhibitors)
Taking Tardisc 60 XL with alcohol Avoid drinking alcohol while taking Tardisc 60 XL, as the side-effect of low blood pressure may be worse than normal and you may feel dizzy or faint. 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. Driving and using machines You may get headache or feel dizzy after taking Tardisc 60 XL. If this happens, do not drive or use any tools or machines. Tardisc XL 60 contains lactose and sucrose If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
TARDISC XL 60 Always take this medicine 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. Taking this medicine • The tablets can be divided into equal doses. • Take the tablets with half a glass of water. • Do not crush or chew the tablets. How much to take • The recommended dose is one or two tablets a day. • Take the medicine in the morning. • Your doctor may ask you to start with a low dose so that you are less likely to have a reaction to starting Tardisc XL 60. You must not take Tardisc XL 60 for a sudden attack of angina. If you have a sudden attack, take a glyceryl trinitrate tablet (follow the instructions given on the label). Use in Children Do not give these tablets to children. Elderly If you are an elderly person, your dosage should be the same as above, unless you suffer from low blood pressure or have a severe liver or kidney disorder – in any case you should follow your doctor's instructions. If you are already taking medication such as beta-blockers or calcium channel blockers, let your doctor or pharmacist know, as he/she may need to adjust your dose of Tardisc 60 XL or existing treatment (see Section 2 "Other medicines and Tardisc 60 XL"). If you take more Tardisc XL 60 than you should If you take more Tardisc XL 60 than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you so the tablets can be identified.
Symptoms of an overdose can include: pounding headache, excitation, cold sweat, nausea (feeling sick), vomiting (being sick), vertigo (a feeling of dizziness or "spinning"), fainting, racing pulse. If you forget to take Tardisc XL 60 • If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. • Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you stop taking Tardisc XL 60 Do not suddenly stop taking Tardisc XL 60 tablets, as this could make your angina worse. If your treatment is to be stopped this should be done gradually. Be sure to follow your doctor's instructions. Ask your doctor or pharmacist any further questions you may have.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Scheme at: 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.
TARDISC XL 60 • Keep this medicine out of the sight and reach of children. • Do not store above 25°C. • Do not transfer them to another container. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
What Tardisc XL 60 contains • The active substance is isosorbide mononitrate. Each tablet contains 60mg of the active substance. • The other ingredients are Hydroxypropyl methylcellulose 2208, lactose, compressible sugar (composed of sucrose and maltodextrin), magnesium stearate, silica colloidal anhydrous, ferric oxide yellow E-172. What Tardisc XL 60 looks like and contents of the pack Tardisc XL 60 tablets are light yellow, biconvex, oval-shaped, scored on both sides and marked "DX 31" on one side. Tardisc XL 60 is available in packs of 28 tablets in foil blister strips (2 blister packs of 14 tablets); 30 tablets in foil blister strips (3 blister packs of 10 tablets). Not all pack sizes may be marketed. Marketing Authorization Holder and Manufacturer: Dexcel®-Pharma Ltd., 2nd Floor, Bourn, 1 Manor House Drive, Coventry, CV1 2FX, UK. This leaflet was last revised in June 2026.
Tardisc XL 60 Prolonged Release Tablets comes as tablet. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Tardisc XL 60 Prolonged Release Tablets is isosorbide mononitrate.
Medicines with the same active substance, strength and form include: Chemydur 60XL Tablets, Eumon 40 XL Modified Release Tablets (Isosorbide Mononitrate), Xismox 60 XL Prolonged Release Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Tardisc XL 60 Prolonged Release Tablets, 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.
Prophylactic treatment of angina pectoris.
Posology
Adults
The recommeded dose is one 60 mg tablet, once daily, given in the morning. The dose may be increased to 120 mg (two tablets) daily, both to be taken once daily in the morning. This will produce effective nitrate blood levels during the day with low blood levels at night to prevent the development of tolerance.
The dose can be titrated, to minimize the possibility of headache, by initiating treatment with 30mg (half a tablet) for the first 2-4 days.
Note that isosorbide mononitrate is not indicated for the relief of acute attacks, in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.
Paediatric population
The safety and efficacy of this medicine in children has not been established.
Elderly
No evidence of a need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.
There is a risk of tolerance developing when nitrate therapy is given. For this reason it is important that the tablets are taken once a day to achieve an interval with low nitrate concentration, thereby reducing the risk of tolerance development.
When necessary the product may be used in combination with beta-adrenoreceptor blockers and calcium antagonists. Dose adjustments of either class of agent may be necessary.
Method of administration
The tablets must not be chewed or crushed. They should be swallowed with half a glass of water.
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Acute myocardial infarction with low filling pressure, head trauma, cerebral haemorrhage, severe hypotension or hypovolaemia, constrictive cardiomyophaty and pericarditis, aortic stenosis, cardiac temponade, mitral stenosis and severe anaemia.
Patients treated with the medicine must not be given Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil).
Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of the medicine.
Co-administration with riociguat (see section 4.5).
The medicine is not indicated for relief of accute angina attacks; in the event of accute attack, sublingual or buccal glyceryl trinitrate tablets should be used. Nitrates may give rise to symptoms of collapse after the first dose in patients with labile circulation. These symptoms can largely be avoided if the treatment is started with a 30 mg dose.
Use with extreme caution in hypotension with or without other signs of shock and in cases of cerebrovascular insufficiency.
Other special warnings and precautions with Isosorbide mononitrate:
Significant aortic or mitral valve stenosis.
Hypertrophic obstructive cardiomyopathy.
Anaemia, Hypoxaemia, Hypothyroidism,hypothermia, malnutrition, severe liver or renal disease
The tablets are not indicated for relief of acute angina attacks.
Patients with rare hereditary problems of fructose intolerance or galactose intolerance, total lactase deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medicine.
Isosorbide mononitrate may act as a physiological antagonist to noradrenaline, acetylcholine, histamine and many other agents. The effect of anti-hypertensive drugs may be enhanced. Alcohol may enhance the hypotensive effects of isosorbide mononitrate.
Concomitant administration of the tablets and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of the tablets with the potential result of serious side effects such as syncope or myocardial infarction. Therefore, this medicine 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.
The safety and efficacy of Isosorbide Mononitrate Tablets during pregnancy or lactation has not been established. The tablets should not be used during pregnancy and lactation.
Patients may develop headache or dizziness when first using the tablets. Patients should be advised to determine how they react to the tablets before they drive or use machinery.
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. The dose can be titrated to minimize the possibility of headache, by initiating treatment with 30mg. 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 suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medical 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.
Symptoms:
Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure. Very large doses may give rise to methaemoglobinaemia.
In case of cyanosis as a result of methaemoglobinaemia, methyl thionine (methylene blue) 1-2mg/Kg, slow intravenous delivery). Expert advice should be sought.
Managment
Induction of emesis, activated charcoal. In case of pronounced hypothension the patient should first be placed in the supine position with legs raised. If necessary fluids should be administrated intravenously.
Ask anything about Tardisc XL 60 Prolonged Release 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.
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