- isosorbide mononitrate
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 14017/0020.
Monosorb XL 60 Prolonged-release tablets
Package leaflet: Information for the user
MONOSORB® XL 60 PROLONGED RELEASE TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist has told you.
What is in this leaflet:
1. What MONOSORB XL 60mg is and what it is used for
2. What you need to know before you take MONOSORB XL 60mg
3. How to take MONOSORB XL 60mg
4. Possible side effects
5. How to store MONOSORB XL 60mg
6. Contents of the pack and other information
1. WHAT MONOSORB XL 60mg IS AND WHAT IT IS USED FOR
MONOSORB XL 60mg Prolonged release Tablets (referred to as MONOSORB XL 60mg throughout this leaflet) contains the active substance called isosorbide mononitrate. This belongs to a group of medicines called ‘nitrates’.
The tablets are made so that they release the medicine slowly over a number of hours.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MONOSORB XL 60mg
DO NOT use these tablets to treat sudden chest pain (acute angina). Instead seek immediate medical attention. These tablets work too slowly to treat this and are only used to prevent symptoms of angina from happening.
Do not take MONOSORB XL 60mg:
Isosorbide mononitrate should not be used in patients with acute myocardial infarction with low filling pressure, head trauma, cerebral haemorrhage and severe hypotension or hypovolaemia.
Do not take Monosorb XL 60mg if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Monosorb XL 60mg.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Monosorb XL 60mg:
Other medicines and Monosorb XL 60mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Monosorb XL 60mg can affect the way some medicines work and some medicines can have an effect on Monosorb XL 60mg.
Do not take Monosorb XL 60mg if you are taking the following medicines:
If you take one of these drugs for erectile dysfunction, taking nitrate preparations such as MONOSORB XL 60 mg as well can cause a severe and possibly dangerous fall in blood pressure. This could result in fainting, or even worse, in a heart attack.
The following medicines may interfere with the way MONOSORB XL 60 mg works:
Taking MONOSORB XL 60 mg with alcohol
Avoid drinking alcohol while taking MONOSORB XL 60 mg, as the side-effect of low blood pressure may be worse than normal and you may feel dizzy or faint.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you may be pregnant or are planing to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may experience headache or feel dizzy after taking Monosorb XL 60mg. If this happens, do not drive or use any tools or machines.
MONOSORB XL 60mg contains lactose and sucrose
If you have been told by your doctor that you have intolerance to one of more sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE MONOSORB XL 60 mg
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
How much to take
You must not take Monosorb XL 60mg for a sudden attack of angina. If you have a sudden attack, take a glyceryl trinitrate tablet (follow the instructions given on the label).
Use in Children
Do not give these tablets to children.
Use in Elderly
If you are an elderly person, your dosage should be the same as above, unless you suffer from low blood pressure or have a severe liver or kidney disorder – in any case you should follow your doctor's instructions.
If you are already taking medication such as beta-blockers or calcium channel blockers, let your doctor or pharmacist know, as he/she may need to adjust your dose of MONOSORB XL 60 mg or existing treatment (see Section 2 "What you need to know before you take MONOSORB XL 60 mg").
If you take more MONOSORB XL 60mg than you should
If you take more Monosorb XL 60mg Tablets than you should, talk to a doctor or go to a hospital straight away.
Take the medicine pack with you so the tablets can be identified.
Symptoms of an overdose can include:
Pounding headache, excitation, cold sweat, nausea (feeling sick), vomiting (being sick), vertigo (a feeling of dizziness or "spinning"), fainting, racing pulse.
If you forget to take MONOSORB XL 60mg
If you stop taking MONOSROB XL 60 mg
Do not suddenly stop taking MONOSORB XL 60 mg tablets, as this could make your angina worse. If your treatment is to be stopped this should be done gradually. Be sure to follow your doctor's instructions. Ask your doctor or pharmacist any further questions you may have.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Headache may occur when treatment is initiated but usually disappears after 1-2 weeks of treatment.
Hypotension with symptoms such as dizziness and nausea with syncope in isolated cases, has occasionally been reported. These symptoms generally disappear during continued treatment.
Other possible side effects:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: 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.
5. HOW TO STORE MONOSORB XL 60 mg
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What MONOSORB XL 60 mg contains
What MONOSORB XL 60mg looks like and contents of the pack
MONOSORB XL 60 mg tablets are light yellow, biconvex, oval-shaped, scored on both sides and marked "DX 31" on one side.
MONOSORB XL 60 mg tablets are available in packs of 28, 30 or 98 tablets in blister strips. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
This leaflet was last revised in January 2018.
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+44 (0) 1748 828 784