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.
Monomax XL 60 mg Prolonged Release 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 Monomax XL Prolonged-release Tablets contain isosorbide mononitrate which belongs to a group of medicines called nitrates that act on the cardiovascular system (the heart and blood vessels). Monomax has been given to you by your doctor or pharmacist to reduce the frequency of your anginal attacks (chest pains). They are called prolonged-release tablets 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. In angina, isosorbide mononitrate works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occurring when extra strain is placed upon the heart.
What you need to know before you take it
e Monomax Do not take Monomax:
- if you are taking the drug, sildenafil or similar medicines called Phosphodiesterase Type 5 Inhibitors, for the treatment of male erectile dysfunction (see also: Section 2 – Taking other medicines)
- if you are allergic to isosorbide mononitrate, other nitrates (e.g glyceryl trinitrate or isosorbide dinitrate) or any of the other ingredients in Monomax (listed in section 6)
- if you have suffered a stroke or have any other condition which may affect the blood supply to your brain
- if you suffer from low blood pressure
- if you have been told that you have a problem with your heart such as 'cardiomyopathy' or 'pericarditis' or you
have narrow heart valves. Ask your doctor if you are not sure if this applies to you
- if you suffer from a reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
- to treat an angina attack as it occurs. Your doctor will probably have given you another tablet to take for sudden attacks. Take special care with Monomax and always tell your doctor or pharmacist if:
- you suffer from increased pressure in your eyes
- you suffer from an underactive thyroid gland
- you suffer from an abnormally low body temperature
- you suffer from poor health caused by a poor diet
- you suffer from severe liver or kidney disease
- you have suffered from a head injury or bleeding in the brain
- you have ever had any serious damage to your heart, such as a heart attack or operation. Taking other medicines Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Monomax. In particular, tell your doctor or pharmacist if you are taking:
- medicines for the treatment of high blood pressure, such as hydralazine or minoxidil
- water tablets, such as frusemide Taking these types of medicines with Monomax can increase the risk of low blood pressure occurring, especially if you are elderly. Do not take sildenafil, or similar medicines called Phosphodiesterase Type 5 Inhibitors used for the treatment of erectile dysfunction at the same time as Monomax. If taken at the same time it could cause a severe fall in blood pressure resulting in collapse, unconsciousness and may be fatal. Taking Monomax with food, drink and alcohol: If you drink alcohol while you are taking Monomax it can increase the risk of low blood pressure occurring, especially if you are elderly. Pregnancy, breast-feeding and fertility: Do not take Monomax if you are pregnant, trying to become pregnant or are breast- feeding. Driving and using machines: If you feel faint, dizzy or light headed when you stand up or move suddenly after taking Monomax, then do not drive or operate machinery. Important information about some of the ingredients of Monomax: Monomax contains lactose monohydrate. 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
Monomax Always take Monomax exactly as your doctor or pharmacist has told you to. You should check with your doctor or pharmacist if you are not sure. Please read the back of this leaflet
Cod. 01126/5 Tipo di materiale
Descrizione
Destinazione
Paese
PROSPETTO MONOMAX XL 60 mg Tablets
VENDITA
Formato mm
Colore 3
N°. colori
190 x 254
1
PELLICOLA DI PROPRIETÀ
Colore 1
Colore 2
UK
NERO
Mipharm S.p.A.
Off. di Produzione
RETRO
CODICE
LAETUS/2D CODE
934151 UK
934151
TEXT 9 pt / line spacing 10,5 MAIN HEADINGS 10 pt / line spacing 12
VIETATA LA MANOMISSIONE – RENDERE DOPO LA STAMPA
22-05-24
The label on the carton will tell you how many tablets you should take and when. It is very important that you take your tablets regularly. Do not stop treatment even if you feel better unless told to do so by your doctor. Monomax is formulated so that you only have to take your tablets once a day. It is important that you take your tablets at the same time each day, preferably in the morning. Your tablet may be swallowed whole or broken in half if this is easier and swallowed with a glass of water. Do not crush or chew your tablets. Adults and the elderly: the usual dose is 60 mg once a day. Your doctor may decide to increase your dose to a maximum of 120 mg of Monomax once a day. To reduce the possibility of headaches you may initially be given half a tablet (30 mg) once a day for the first 2-4 days. 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. Do not stop taking your medicine until your doctor tells you. Children must not take this medicine. You must not take Monomax for a sudden attack of angina. If you have a sudden attack, take a glyceryl trinitrate tablet (follow the instructions given on the label). Very occasionally, some people see the remains of the tablet in their bowel motions. This is quite normal and does not mean that the medicine has not been released. If you take more Monomax than you should If you accidentally take more Monomax than you should, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. If you forget to take Monomax If you forget a dose, take it as soon as you remember it. 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 missed dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Monomax can cause side effects, although not everyone gets them. If you experience a headache when you first start taking your tablets, contact your doctor or pharmacist immediately. Your doctor or pharmacist may need to adjust your dose. The following side effects do not usually last long and are most likely to occur when you first start to take your medicine or if your dose has been increased. If they continue or if you are worried, contact your doctor or pharmacist immediately:
- light headedness when you stand up or move suddenly
- faintness
- feeling sick (nausea)
- flushing Common (may affect up to 1 in 10 people)
- Low blood pressure. This may make you feel faint or dizzy.
- Faster heartbeat
- Headache
- Feeling dizzy
- Feeling sick (nausea) Uncommon (may affect up to 1 in 100 people)
- Being sick (vomiting)
- Diarrhoea Rare (may affect up to 1 in 1,000 people)
- Fainting
- Rash
- Itchy skin Very rare (may affect up to 1 in 10,000 people)
- Pain in muscles If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the YellowCard Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Monomax
- Keep this medicine out of the sight and reach of children.
- Do not store above 25°C. Store in the original packaging.
- Do not use Monomax after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Contents of the pack and other information
What Monomax contains:
- The active substance in your tablets is isosorbide mononitrate. Each tablet contains 60 mg of isosorbide mononitrate.
- The other ingredients are lactose monohydrate, hypromellose (E464), glyceryl palmitostearate, maize starch and magnesium stearate. What Monomax looks like and the contents of the pack: Monomax XL 60 mg Prolonged Release Tablets are white, oval and convex in shape with a break line between "SL" and "60", which are embossed on one side. They are available in blister packs of 28 tablets. Marketing Authorisation Holder and Manufacturer: The Marketing Authorisation holder and manufacturer is Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK. Is this leaflet hard to see or read? Phone 0161 488 5555 for help. This leaflet was last approved in 05/2024
CP0027/8
934151 UK
Frequently asked questions about Monomax XL 60 mg Prolonged Release Tablets
How do I take Monomax XL 60 mg Prolonged Release Tablets?
Monomax XL 60 mg Prolonged Release Tablets comes as tablet containing 60mg. 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 Monomax XL 60 mg Prolonged Release Tablets?
The active substance in Monomax XL 60 mg Prolonged Release Tablets is isosorbide mononitrate.
Are there equivalent medicines to Monomax XL 60 mg Prolonged Release Tablets?
Medicines with the same active substance, strength and form include: Carmil XL 60 mg Tablets, Imdur Tablets 60mg, Isotard 60 mg XL Tablets. In total there are 5 equivalent products. 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 Monomax XL 60 mg 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.
Can I get Monomax XL 60 mg Prolonged Release 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
For the prophylactic treatment of angina pectoris
4.2. Posology and method of administration
Method of administration
Oral use
Tablets may be taken with or without food, and should be swallowed whole and not chewed.
Posology
Adults: Usual adult dose is one isosorbide mononitrate XL 60 mg tablet per day (taken in the morning). If necessary, the dosage may be increased to 120 mg once daily (i.e. 2 x 60mg tablets taken in the morning). The dosage can be titrated to minimise the possibility of headache by initiating treatment with 30mg (half a tablet), for the first two to four days.
Paediatric Population: Safety and efficacy in children have not been established.
Older People: There is no evidence of a need for routine dosage adjustment in older people, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.
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 and a known hypersensitivity to the constituents of the tablets.
Relative contraindications to the use of isosorbide mononitrate are severe cerebral vascular insufficiency and hypotension
Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.
Isosorbide mononitrate is contraindicated in patients with constrictive cardiomyopathy and pericarditis, aortic stenosis, cardiac tamponade, mitral stenosis and severe anaemia.
Patients treated with Monomax XL must not be given Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil).
4.4. Special warnings and precautions for use
Isosorbide mononitrate XL 60 mg tablets are not indicated for relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets / sprays should be used.
Isosorbide mononitrate should be used with caution in patients who are predisposed to closed angle glaucoma.
Isosorbide mononitrate should be used with caution in patients suffering from head trauma, cerebral haemorrhage, recent history of myocardial infarction, hypothyroidism, hypothermia, malnutrition, severe liver or renal disease.
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
Only limited information is available on the possible interaction between isosorbide mononitrate and other drugs.
Some of the effects of alcohol may be potentiated by this agent.
Vasodilators, antihypertensives and diuretics may potentiate the hypotension caused by nitrates particularly in the elderly.
The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil.
Concomitant administration of Monomax XL and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of Monomax XL with the potential result of serious side effects such as syncope or myocardial infarction. Therefore, Monomax XL and Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil) must not be given concomitantly.
There is no evidence of interaction with food.
4.6. Fertility, pregnancy and lactation
Since its safety and efficacy have not been established, this product should not be used during pregnancy or lactation unless considered essential by the physician.
4.7. Effects on ability to drive and use machines
Since postural hypotension with symptoms such as dizziness has been reported, patients should be advised to be careful when driving or operating machinery if they suffer from these symptoms.
4.8. Undesirable effects
Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Side effects including flushing and dry skin rashes may occur occasionally. Headache may occur at the onset of treatment which usually disappears after 1-2 weeks of treatment but may be minimised by commencing with low doses of 30mg and gradually increasing the dose. Hypotension, with symptoms such as dizziness and nausea with syncope in isolated cases, has occasionally been reported. These symptoms generally disappear during continued treatment. Pruritis has been reported rarely and myalgia, reported very rarely.
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 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 at www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms
A pulsating headache is the commonest.
More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.
Management
Induce emesis. Use activated charcoal.
If pronounced hypotension, place the patient in the supine position with legs raised. If necessary, intravenous fluids should be administered.
💬 Ask about this leaflet
Ask anything about Monomax XL 60 mg 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.
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