Patient leaflet - Zemon 40XL tablets
1. WHAT ISMN 40 XL IS AND WHAT IT IS USED FOR
The active ingredient in your tablets is isosorbide-5-mononitrate which belongs to a group of medicines known as nitrates. These are used to prevent heart attacks (angina pectoris) by opening the blood vessels and reducing pain. ISMN 40 XL is used for the long term prevention of heart attacks. It should not be used to treat a sudden (acute) attack of angina (sudden heart attack).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISMN 40 XL
Do not take ISMN 40 XL if you:
- are allergic (hypersensitive) to isosorbide-5-mononitrate, other nitrates or any of the other ingredients in the tablets (listed in section 6)
- have had a heart attack associated with certain complications such as very low filling pressure. Your doctor will be able to advise you.
- suffer from acute circulatory failure, have very low blood pressure or low blood volume (hypovolaemia)
- have recently had a heart attack (myocardial infarction)
- have a heart valve disorder or suffer from low cardiac filling pressures
- suffer from a condition called hypertrophic obstructive cardiomyopathy (HCOM) which affects the muscle of the heart (causing it to enlarge). This can cause chest pain, dizziness, fainting, heart failure, light-headedness, feeling the heartbeat (palpitations), and shortness of breath.
- suffer from inflammation of the heart lining (constrictive pericarditis) or a condition where an increase in the fluid that surrounds the heart and puts pressure on it (cardiac tamponade)
- You have narrowing of the main artery which may cause breathlessness, dizziness, fainting or chest pain (aortic stenosis)
- You have narrowing of the mitral valve, which may cause shortness of breath, fainting, dizziness, tiredness, irregular heartbeat and chest pain (mitral stenosis)
- have ever had a serious head injury, bleeding in the brain (cerebral haemorrhage), a disease which is associated with increased pressure on the brain, stroke or reduced blood flow to the brain
- are severely anaemic (suffer from low haemoglobin in your blood)
- have a rapid increase in pressure in the eye, which can cause pain, red eye, blurred vision and headache (closed-angle glaucoma)
are taking Riociguat e.g. Adempas for pulmonary hypertension as it can cause hypotension
- are taking medicines used to treat male erection problems (erectile dysfunction) such as sildenafil, tadalafil or vardenafil.
Warnings and Precautions
Before you take ISMN 40 XL you should tell your doctor if you:
- have recently had a heart attack (myocardial infarction)
- suffer from postural hypotension
- suffer from an under-active thyroid (hypothyroidism)
- suffer from low body temperature (hypothermia)
- have a poor diet and your body lacks nutrients (malnutrition)
- suffer from severe liver or kidney disease
- you suffer from postural hypotension - a fall in blood pressure on standing making you dizzy and feeling faint
This medicine may make you feel dizzy, light-headed or faint after the first dose or when you stand up, particularly after drinking alcohol, so special care should be taken. On rare occasions this medicine may cause low blood pressure which can result in a slow heart rate and increased chest pain.
ISMN 40 XL should not be used to treat a heart attack. If this happens, you should use a glyceryl trinitrate (GTN) spray or tablets. You should follow your doctors instructions on how to take this medicine, otherwise tolerance might develop. The doctor will prescribe the lowest effective dose for you.
You should not suddenly stop taking your medicine, your doctor will advise you on how to stop gradually over a period of time (see also Section 3: How to take ISMN 40 XL).
Other medicines and ISMN 40 XL
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as they may increase the effect of ISMN 40 XL or change the effect of the medicines
- sildenafil (Viagra), tadalafil or vardenafil for treating male erection problems (erectile dysfunction). Taking ISMN 40 XL alongside these medicines can result in a severe and possibly dangerous fall in blood pressure. This can result in collapse and unconsciousness and could be fatal. You should not take these medicines whilst taking ISMN 40 XL.
- Hydralazine for high blood pressure (antihypertensive)
- Vasodilators, such as diazoxide
- Calcium channel blockers, such as diltiazem
- Diuretics (water tablets)
- ACE inhibitors, such as captopril
- Beta-blockers, such as atenolol
- Angiotensin II receptor antagonists such as losartan
- Alprostadil for erectile dysfunction
- Aldesleukin for kidney cancer and melanoma
- Tricyclic antidepressants (used to treat depression)
- Neuroleptics (used to treat anxiety)
- Dihydroergotamine (used to treat migraine)
- Riociguat (used to treat pulmonary hypertension)
It may still be alright for you to take ISMN 40 XL and your doctor will be able to decide what is suitable for you.
ISMN 40 XL with food and drink
ISMN 40 XL should be taken with half a glass of water and can be taken with or without food. If you drink alcohol whilst taking ISMN 40 XL it may cause a severe drop in blood pressure making you feel dizzy or light-headed, especially on standing up (postural hypotension).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Customer: Kent Pharma UK Ltd Designer: KBN (AWG)
Code: CHXP091FUJ Proof: 1 Size: 297mm x 240mm
Colours: Black
CCRF: 24010 (Brand Review) Date: 16/04/24
Supercedes: CHXP091FUI (P1) Pregnancy
This medicine should only be used during pregnancy if your doctor thinks the benefits outweigh the possible risks.
Breast-feeding
This medicine should only be used whilst breast-feeding if your doctor thinks the benefits outweigh the possible risks.
Driving and using machines
ISMN 40 XL may cause blurred vision or may make you feel dizzy or tired especially if you suffer from low blood pressure. The effect may be increased after drinking alcohol. Do not drive or operate machines until you are sure you are not affected.
ISMN 40 XL contains lactose
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.
3. HOW TO TAKE ISMN 40 XL
Always take ISMN 40 XL exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure. The label on the carton will tell you how many tablets you should take and when.
Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines. Do not change your dose unless your doctor tells you to do so.
Dosage
The usual dosage for ISMN 40 XL is:
Adults
One 40mg tablet, taken once a day in the morning. This may be increased by your doctor to two tablets (80mg) once a day if necessary.
Elderly
The dose is as for adults; however, your doctor will take special care, especially if you have low blood pressure, or liver or kidney disease.
ISMN 40 XL is for use in Adults only.
Method of Administration
ISMN 40 XL should be swallowed whole with half a glass of water. The tablets should be taken regularly in the morning with or without food. The tablets should not be chewed or crushed.
If you take more ISMN 40 XL than you should
If you have accidentally taken more than the prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. The common signs of overdose are dizziness, faintness, headache, nausea, vomiting, sweating, rapid heartbeat, restlessness, flushing of the skin and blurred vision.
If you forget to take ISMN 40 XL
It is important that you take your medicine every day. However, if you forget to take one or more doses, take your next dose when it is due and then go on as prescribed. Do not take a double dose to make up for a forgotten dose.
If you stop taking ISMN 40 XL
Do not suddenly stop taking your medicine. Your doctor will tell you how to reduce and then stop taking ISMN 40 XL.
If you have any further questions about this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ISMN 40 XL can cause side effects, although not everybody gets them. Seek medical advice immediately if you develop the following:
Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness
Very common side effect (may affect more than 1 in 10 people)
- Headache. A throbbing headache may occur when treatment is started. This usually disappears after 1 or 2 weeks of treatment.
Other side effects (frequency not known)
Low blood pressure (hypotension) including postural hypotension (a drop in blood pressure on standing from a lying or sitting position), which may cause dizziness, tiredness and nausea (feeling sick). Flushing and allergic reactions (including rashes) can also occur. These symptoms usually disappear during long-term treatment.
- Severely low blood pressure, which may cause vomiting (being sick), restlessness, pale skin colour and excessive sweating. Although uncommon, collapse (sometimes with a slow heartbeat and fainting) and increased symptoms of chest pain (angina) may occur
- Dizziness
- Feeling (nausea) or being sick (vomiting)
- Drowsiness
- Scaling of the skin (exfoliative dermatitis)
- Change in the rhythm of your heart leading to an increase (tachycardia) or decrease (bradycardia) in heart rate
- Muscle pain (myalgia)
- Diarrhoea
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 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 medicines.
5. HOW TO STORE ISMN 40 XL
Do not store your tablets above 25°C. Store in the original package.
Do not take this medicine after the expiry date stated. The expiry date refers to the last day of that month.
Keep all medicines out of the sight and reach of children.
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ISMN 40 XL contain
The active ingredient is isosorbide-5-mononitrate. Each tablet contains 40mg of isosorbide mononitrate. The other ingredients are stearic acid, carnauba wax, hydroxyproplymethylcellulose, lactose, magnesium stearate, talc, silica colloidal anhydrous, polyethylene glycol 4000, titanium dioxide (E171), yellow iron oxide (E172).
What ISMN 40 XL looks like and the contents of the pack
ISMN 40 XL are round, cream coloured tablets with ‘IM40’ marked on one side. Your medicine is available in blister packs of 28, 30, 56, 60 and 100 tablets. (Not all pack sizes may be marketed).
Marketing Authorisation Holder
Kent Pharma UK Limited, 2nd Floor, Connect 38, 1 Dover Place, Ashford, Kent, England, TN23 1FB.
Manufacturer responsible for batch release
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last revised in April 2024
CHXP091FUJ