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 The name of your medicine is Zevona XL 30 mg prolonged-release tablets, referred to as Zevona XL tablets throughout this leaflet. Zevona XL tablets contain the active ingredient isosorbide mononitrate, which belongs to a group of medicines called nitrates.
e Zevona XL tablets Do not take Zevona XL tablets
and some medicines can have an effect on Zevona XL tablets. Do not take Zevona XL tablets if you are taking the following medicines:
Zevona XL tablets Always take this medicine exactly as your doctor, or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine
Other possible side effects Common (may affect up to 1 in 10 people)
not listed in this leaflet. You can also report side effects directly via the Yellow Card 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.
Zevona XL tablets Keep this medicine out of the sight and reach of children. 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. This medicine does not require any special storage conditions. 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.
What Zevona XL tablets contain
For information on large print, Braille or audio CD call emc accessibility on 0800 198 5000
1065049597
Zevona XL 30mg prolonged release tablets comes as tablet containing 30mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Zevona XL 30mg prolonged release tablets is isosorbide mononitrate.
This leaflet reproduces the patient information leaflet approved for Zevona XL 30mg 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
Usual dose is 60mg (two tablets) taken once daily in the morning. The dose may be increased to 120 mg (four tablets) daily, to be taken once daily in the morning. The dose can be titrated to minimise the possibility of headache, by initiating treatment with 30 mg (one tablet) for the first 2-4 days.
Paediatric population
The safety and efficacy of Zevona XL 30 mg prolonged-release tablets in children have not yet been established.
Elderly
No evidence of a need for routine dosage adjustment for elderly patients has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.
The core of the tablet is insoluble in the digestive juices but disintegrates into small particles when all active substance has been released. Very occasionally the matrix may pass through the gastrointestinal tract without disintegrating and be found visible in the stool, but all active substance has been released.
Method of administration
Zevona XL 30 mg prolonged-release tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Constrictive cardiomyopathy and pericarditis, aortic stenosis, cardiac tamponade, mitral stenosis and severe anaemia.
- Patients treated with Zevona XL 30 mg prolonged-release tablets must not be given Phosphodiesterase Type-5 Inhibitors (e.g. sildenafil)
- Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of Zevona XL 30 mg prolonged-release tablets.
- Co-administration with riociguat (see section 4.5).
Zevona XL 30 mg prolonged-release tablets is not indicated for relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.
Excipients
This medicinal product contains lactose. Patients with any of the following rare hereditary conditions: galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; should not take this medicine.
Concomitant administration of Zevona XL 30 mg prolonged-release tablets and Phosphodiesterase Type-5 Inhibitors can potentiate the vasodilatory effect of Zevona XL mg prolonged-release tablets with the potential result of serious side effects such as syncope or myocardial infarction. Therefore, Zevona XL 30 mg prolonged-release tablets 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 Zevona XL 30 mg prolonged-release tablets during pregnancy have not been established.
Patients may develop dizziness when first using Zevona XL 30 mg prolonged-release tablets. Patients should be advised to determine how they react to Zevona XL 30 mg prolonged-release tablets before they drive or operate machinery.
Most of the undesirable effects are pharmacodynamically mediated and dose-dependent.
Headache may occur when the treatment is initiated, but usually disappears after 1-2 weeks of treatment. The dose can be titrated to minimise the possibility of headache, by initiating treatment with 30 mg. 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), Rate not known (cannot be estimated from available data).
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 tract 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
Pulsing headache. More serious symptoms include excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.
Management
Induction of emesis, activated charcoal. In the case of pronounced hypotension the patient should first be placed in the supine position with the legs raised. If necessary fluids should be administered intravenously.
Ask anything about Zevona XL 30mg 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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