Patient leaflet - MODISAL XL 40 MG PROLONGED-RELEASE TABLETS
1. what modisal xl is and what it is used for
Modisal XL 40mg Prolonged Release Tablets contain the active substance isosorbide mononitrate. This belongs to a group of medicines called nitrates that act on your cardiovascular system (the heart and blood vessels). They work by reducing the frequency of your angina attacks. They are called prolonged release tablets because they have been made in a way that allows the isosorbide mononitrate to be released and slowly absorbed by your body over a period of several hours.
These tablets work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it.
Modisal XL is used to prevent chest pain (angina pectoris).
Angina usually feels like a tight pain in the chest, arm or neck area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing.
2. what you need to know before you take modisal xl
Do not take Modisal XL if you:
! Are allergic to isosorbide mononitrate, other nitrates (e.g. glyceryl trinitrate) or any other ingredients of this medicine (listed in section 6)
! Suffer from severely impaired blood supply to the brain (cerebrovascular insufficiency)
! Are taking Viagra (sildenafil) for erectile dysfunction or other phosphodiesterase-5-inhibitors e.g. tadalafil or vardenafil. (See section „Other medicines and Modisal XL“)
! Have had an acute (short-lived) heart attack (myocardial infarction)
! Are suffering from shock or vascular collapse which causes the blood to stop circulating around your body (acute circulatory failure)
! Are suffering from very low blood pressure (hypotension)
! Have a heart condition which causes the heart muscle to become thick (hypertrophic obstructive cardiomyopathy).
! Have inflammation of the lining surrounding the heart (constrictive pericarditis)
! Suffer from excessive fluid around the heart (cardiac tamponade)
! Have narrowing of the main artery (aortic stenosis) or mitral valve (mitral stenosis)
! Have a low blood volume (hypovolaemia)
! Suffer from an eye condition caused by too much pressure inside the eye (closed-angle glaucoma)
! Have a severe reduction in red blood cells (anaemia) which can make the skin pale and cause weakness or breathlessness
nogen Pharma
! Suffer from conditions associated with an increased pressure within the skull (intracranial). For example, following a blow to the head or bleeding inside the brain (cerebral haemorrhage)
! Are taking riociguat e.g. Adempas for pulmonary hypertension (See section „Other medicines and Modisal XL“).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Modisal XL if you:
! Suffer from an underactive thyroid gland (hypothyroidism) ! Have a poor diet and your body lacks nutrients (malnutrition)
! Have severe kidney or liver problems
! Suffer from a very low body temperature (hypothermia)
! Have recently had a heart attack (myocardial infarction)
! Have scarring of the liver caused by long-term liver
damage (cirrhosis)
! Suffer from a fall in blood pressure when standing up causing dizziness and lightheadedness (postural hypotension).
This medicine should not be used to treat an angina attack. Your doctor should prescribe buccal glyceryl trinitrate or sublingual tablets for you to take if you have an angina attack.
You should not just stop treatment with these tablets. If you wish to stop taking them you should talk to your doctor (see section 3).
Other medicines and Modisal XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Modisal XL if you are taking Viagra (sildenafil) for erectile dysfunction or other phosphodiesterase-5-inhibitors e.g. tadalafil or vardenafil. If taken together it could cause a severe fall in blood pressure resulting in collapse, unconsciousness and may be fatal.
Do not take Modisal XL if you are taking riociguat, e.g. Adempas for pulmonary hypertension. When taken together, a fall in blood pressure can occur.
Medicines which may interact with or be affected by Modisal
XL, include:
! Hydralazine for high blood pressure (antihypertensive)
! Vasodilators, such as hydralazine or diazoxide
! Calcium channel blockers, such as nifedipine or diltiazem ! Diuretics (water tablets), such as furosemide
! ACE inhibitors, such as ramipril or captopril
! Beta-blockers, such as atenolol
! Angiotensin II receptor antagonists, such as losartan
! Alprostadil for erectile dysfunction
! Aldesleukin for kidney cancer and melanoma
! Dihydroergotamine for migraines.
Modisal XL with alcohol
If you drink alcohol while taking Modisal XL it may cause a severe drop in blood pressure when standing up causing dizziness and lightheadedness (postural hypotension). You should not drink alcohol while taking this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
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
Do not drive or operate machinery when taking Modisal XL if you develop low blood pressure (you may experience this as dizziness, tiredness or feeling sick) or if you have blurred vision.
Modisal XL 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 medicine.
3. how to take modisal xl
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
These tablets should be taken whole, with a glass of water. Do not crush or chew the tablets.
Adults and the elderly
The recommended dose is one tablet (40mg) once daily in the morning. This may be increased to two tablets (80mg) daily, taken at the same time, if necessary.
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.
Use in children
These tablets are not recommended for children.
If you take more Modisal XL than you should
If you take too many tablets by mistake, contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.
If you have taken more tablets than you should, symptoms may include low blood pressure, headache and confusion, feeling excited, cold sweats, sensation that you, or the environment around you, is moving or spinning, feeling sick, being sick, restlessness, warm flushed skin, blurred vision, fainting, fast heart rate, palpitations and a blood disorder in which an abnormal amount of methaemoglobin is produced.
If you forget to take Modisal XL
Do not take a double dose to make up for a forgotten dose. Take your next dose at the normal time. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.
If you stop taking Modisal XL
These tablets should not be discontinued suddenly but should be tapered gradually. Consult your doctor on how to stop taking these tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
! allergic reactions (including rashes). Signs of an allergic reaction may include a rash, itching, swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing.
Other side effects
Most side effects are dose-dependent. The most common side effect is headache. This side effect occurs in more than 10% of patients at the beginning of treatment. The headache usually disappears after 1 – 2 weeks of treatment.
Very common (may affect more than 1 in 10 people)
-
! headache.
5. how to store modisal xl
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.
Do not store above 25°C. Store in the original package.
In case of any visible signs of deterioration, you should discard the package.
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.
6. contents of the pack and other information
What Modisal XL contains
The active substance is isosorbide mononitrate. Each tablet contains 40mg of isosorbide mononitrate.
The other ingredients are:
Stearic acid, carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, talc, purified siliceous earth, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172).
What Modisal XL looks like and contents of the pack
Modisal XL Tablets are round, cream coloured tablets marked IM40 on one side and plain on the other side. The dimensions of the tablets are 8 mm x 4.58 mm.Modisal XL is available in packs of 28, 30, 56, 60 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in October 2020.
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