Patient leaflet - ZEMON 40XL TABLETS
PATIENT INFORMATION LEAFLET ZEMON 40 XL PROLONGED RELEASE TABLETS
The name of this medicine is Zemon 40 XL Prolonged Release Tablets, which will be referred to as Zemon 40 XL throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others; it may harm them, even if their symptoms are the same as yours.
- If you get side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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1. What Zemon 40 XL is and what it is used for
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2. What you need to know before you take Zemon 40 XL
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3. How to take Zemon 40 XL
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4. Possible side effects
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5. How to store Zemon 40 XL
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6. Contents of the pack and other information
1. what zemon 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. Zemon 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 zemon 40 xl
Do not take Zemon 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 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)
- suffer from inflammation of the heart lining (constrictive pericarditis) or a condition where an increase in the fluid that surrounds the heart puts pressure on it (cardiac tamponade)
- 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 an eye disease called closed angle glaucoma
- are taking Riociguat 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 Zemon 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)
- are undernourished
- suffer from severe liver or kidney disease
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.
Zemon 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 Zemon 40 XL).
Other medicines and Zemon 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 Zemon 40 XL or change the effect of the medicines
- sildenafil (Viagra), tadalafil or vardenafil for treating male erection problems (erectile dysfunction). Taking Zemon 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 Zemon 40 XL.
- medicines which reduce blood pressure such as beta-blockers, ACE-inhibitors, calcium channel blockers, vasodilators, alprostadil, aldesleukin, diuretics or angiotensin II receptor agonists
- 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 Zemon 40 XL and your doctor will be able to decide what is suitable for you.
Zemon 40 XL with food and drink
Zemon 40 XL should be taken with half a glass of water and can be taken with or with food. The feelings of dizziness and light-headedness may be increased by drinking alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to have a baby, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine, as the safety of this drug is not known during pregnancy or breast-feeding.
Driving and using machines
Zemon 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.
Zemon 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 zemon 40 xl
Always take Zemon 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 Zemon 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.
Zemon 40 XL is for use in Adults only.
Method of Administration
Zemon 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 Zemon 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 Zemon 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 Zemon 40 XL
Do not suddenly stop taking your medicine. Your doctor will tell you how to reduce and then stop taking Zemon 40 XL.
If you have any further questions about this product ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Zemon 40 XL can cause side effects, although not everybody gets them. The following side effects have been reported:
- headaches occasionally occur when treatment is first started although these usually
disappear after 1 – 2 weeks of treatment
- a drop in blood pressure or light-headedness with symptoms such as dizziness, feeling sick (nausea) or drowsiness
- flushing and allergic skin reactions may occur rarely
- uncommonly, you may experience feeling sick (nausea), vomiting, pallor and excessive perspiration
- worsened angina due to very low blood pressure
- heartburn
- change in the rhythm of your heart leading to an increase (tachycardia) or decrease (bradycardia) in heart rate
- muscle pain.
- diarrhoea
5. how to store zemon 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 Zemon 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 Zemon 40 XL looks like and the contents of the pack
Zemon 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, The Bower, 4 Roundwood Avenue, Stockley Park, Heathrow, United Kingdom, UB11 1AF.
Manufacturer responsible for batch release
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last revised in February 2020
CHXP091FUG
Customer: Kent Pharma UK Ltd
Designer: DOB (AWG)
Code: CHXP091FUG Proof: 1
Size: 297mm x 210mm
CCRF: 19112–7 (COO)
Date: 18/02/2020
Supercedes: CHXP091FUF (P2)