Monomax XL 60 mg Prolonged Release Tablets

Monomax^® XL 60 mg Tablets

Isosorbide Mononitrate

Monomax XL Prolonged-release Tablets contain isosorbide mononitrate which belongs to a group of medicines called nitrates that act on the cardiovascular system (the heart and blood vessels). Monomax has been given to you by your doctor or pharmacist to reduce the frequency of your anginal attacks (chest pains). They are called prolonged-release tablets because they are manufactured in a way that allows the isosorbide mononitrate to be released and slowly absorbed by your body over a period of several hours.

In angina, isosorbide mononitrate works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occurring when extra strain is placed upon the heart.

Do not take Monomax:

• if you are taking the drug, sildenafil or similar medicines called Phosphodiesterase Type 5 Inhibitors, for the treatment of male erectile dysfunction (see also: Section 2 - Taking other medicines)
• if you are allergic to isosorbide mononitrate, other nitrates (e.g glyceryl trinitrate or isosorbide dinitrate) or any of the other ingredients in Monomax (listed in section 6)
• if you have suffered a stroke or have any other condition which may affect the blood supply to your brain
• if you suffer from low blood pressure
• if you have been told that you have a problem with your heart such as 'cardiomyopathy' or 'pericarditis' or you have narrow heart valves. Ask your doctor if you are not sure if this applies to you
• if you suffer from a reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• to treat an angina attack as it occurs. Your doctor will probably have given you another tablet to take for sudden attacks.

Always take Monomax exactly as your doctor or pharmacist has told you to. 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. It is very important that you take your tablets regularly. Do not stop treatment even if you feel better unless told to do so by your doctor.

Monomax is formulated so that you only have to take your tablets once a day.

It is important that you take your tablets at the same time each day, preferably in the morning. Your tablet may be swallowed whole or broken in half if this is easier and swallowed with a glass of water. Do not crush or chew your tablets.

Adults and the elderly: the usual dose is 60 mg once a day. Your doctor may decide to increase your dose to a maximum of 120 mg of Monomax once a day. To reduce the possibility of headaches you may initially be given half a tablet (30 mg) once a day for the first 2-4 days.

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.

Do not stop taking your medicine until your doctor tells you.

Children must not take this medicine.

You must not take Monomax for a sudden attack of angina. If you have a sudden attack, take a glyceryl trinitrate tablet (follow the instructions given on the label).

Very occasionally, some people see the remains of the tablet in their bowel motions. This is quite normal and does not mean that the medicine has not been released.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Monomax can cause side effects, although not everyone gets them.

If you experience a headache when you first start taking your tablets, contact your doctor or pharmacist immediately. Your doctor or pharmacist may need to adjust your dose.

The following side effects do not usually last long and are most likely to occur when you first start to take your medicine or if your dose has been increased. If they continue or if you are worried, contact your doctor or pharmacist immediately:

• light headedness when you stand up or move suddenly
• faintness
• feeling sick (nausea)
• flushing

Common (may affect up to 1 in 10 people)

• Low blood pressure. This may make you feel faint or dizzy.
• Faster heartbeat
• Headache
• Feeling dizzy
• Feeling sick (nausea)

Uncommon (may affect up to 1 in 100 people)

• Being sick (vomiting)
• Diarrhoea

Rare (may affect up to 1 in 1,000 people)

• Fainting
• Rash
• Itchy skin

Very rare (may affect up to 1 in 10,000 people)

• Pain in muscles

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 YellowCard Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store in the original packaging.
• Do not use Monomax after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
• 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 protect the environment.

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