Monosorb XL 60mg Prolonged-Release Tablets

Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to your doctor if you do not feel better or if you feel worse.

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

• If you are allergic to isosorbide mononitrate or any of the other ingredients of this medicine (listed in Section 6).
• If you have ever had a stroke.
• If you have very low blood pressure.
• If you have severe anaemia.
• If you have a heart problem called 'cardiomyopathy' or 'pericarditis' or you have narrow heart valves.
• If you are also taking riociguat. See the section "Other medicines and Monosorb XL 60mg".
• If you are taking sildenafil or similar medicines called Phosphodiesterase Type 5 Inhibitors, (used for male impotence). See the section "Other medicines and 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.

Talk to your doctor or pharmacist before taking Monosorb XL 60mg:

• If you suffer from an under-active thyroid gland.
• If you have hypoxaemia (low oxygen level in your blood, due to lung disease for example).
• If you suffer from hypothermia (symptoms include shivering, abnormal drowsiness, confusion).
• If you suffer from malnutrition.
• If you suffer from severe liver or renal disease.

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:

• Riociguat since this can cause hypotension (abnormally low blood pressure).
• Sildenafil or similar medicines called Phosphodiesterase Type 5 inhibitors, (used for male impotence).

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:

• noradrenaline (norepinephine) (used to treat sharp and severe drop in blood pressure)
• acetylcholine (used to shrink the pupil of the eye during cataract surgery and other types of eye surgery)
• histamine (used mostly as a diagnostic agent in some medical conditions)
• any drugs used to treat high blood pressure (e.g. beta-blockers, calcium channel blockers, vasodilators, angiotensin II receptor antagonists, ACE inhibitors).

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.

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.

You may experience headache or feel dizzy after taking Monosorb XL 60mg. If this happens, do not drive or use any tools or machines.

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.

• The tablets can be divided into equal doses.
• Take the tablets with half a glass of water.
• Do not crush or chew the tablets.

• The recommended dose is one or two Monosorb XL 60mg a day.
• Take the medicine in the morning.
• Your doctor may ask you to start a low dose so you are less likely to have a reaction to starting Monosorb XL 60mg. Your dose may be from half a tablet (30mg) up to 2 tablets (120mg) a day.

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).

Do not give these tablets to children.

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 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 a dose, take it as soon as you remember it. However, if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

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.

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.

• The active substance is isosorbide mononitrate. Each tablet contains 60 mg of the active substance.
• The other ingredients are hydroxypropyl methylcellulose 2208, lactose, compressible sugar (composed of sucrose and maltodextrin), magnesium stearate, silica colloidal anhydrous, ferric oxide yellow E-172.

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.