Monicor 60 mg Film-Coated Tablets

MONICOR 60 mg SR contains an active substance called isosorbide - 5 - mononitrate. This belongs to a group of medicines called ‘nitrates’. It works by improving the supply of blood and oxygen to the heart muscle. The tablets will release your medicine slowly and will treat your condition throughout the day.

MONICOR 60 mg SR is prescribed by doctors for the preventative treatment of angina pectoris, a condition characterised by frequent and intense pain in the chest.

Do not take MONICOR 60 mg SR:

• if you are hypersensitive (allergic) to isosorbide - 5 - mononitrate, organic nitrate type medications or any of the other ingredients of MONICOR 60 mg SR (see section 6)
• if you have very low blood pressure, a low amount of blood in the body, a clear reduction in the amount of red blood cells in the body (severe anaemia), a weak heart due to blockage of your heart arteries or increased pressure in the skull due to head injury or bleeding in the brain
• if you have a heart problem called cardiomyopathy (chronic disease of the heart muscle) or pericarditis (swelling and irritation of the thin, sac - like membrane surrounding the heart) or you have narrow heart valves
• if you have angle closure glaucoma (increased pressure in the eye/eyes), as MONICOR 60 mg SR may increase the pressure in the eye further

Warnings and precautions

Take special care with MONICOR 60 mg SR:

• if you have consumed alcohol as this may lead to low blood pressure (hypotension)
• if you have cirrhosis of the liver
• if you have recently had a heart attack
• if you have severe cerebral arteriosclerosis (hardening and/or thickening of the walls of the smaller arteries of the brain) or severe low blood pressure (see Do not take MONICOR 60 mg SR)
• if you are undernourished, have severely weakened kidney or liver function, decreased function of the thyroid gland, malnutrition, or have a low body temperature
• if you have angina due to other causes (such as a large heart muscle), or have an increased circulatory volume
• if you feel that you are developing a tolerance to MONICOR 60 mg SR
• if you have angle closure glaucoma (increased pressure in the eye/eyes), as MONICOR 60 mg SR may increase the pressure in the eye further (see Do not take MONICOR 60 mg SR).

MONICOR 60 mg SR is not indicated for the relief of sudden attacks of angina pectoris. Your doctor will prescribe sublingual (under the tongue) nitroglycerin tablets to be used in these situations (see How to take MONICOR 60 mg SR).

Other medicines and MONICOR 60 mg SR

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

• if you intend taking alcohol or other medicines that cause widening of the blood vessels (such as calcium channel blockers used to treat a variety of cardiovascular conditions by relaxing and widening blood vessels, and slow the heart rate, water tablets)
• sildenafil and other medicines used to treat a man who cannot get or keep a hard, erect penis suitable for sexual activity
• dihydroergotamine to treat acute migraine headaches with or without aura
• other antihypertensive medicines (medicines used for high blood pressure)
• drinking alcohol while taking MONICOR 60 mg SR may increase the feeling of dizziness, light-headedness, or even fainting
• medicines such as noradrenaline, which are used to treat high blood pressure or a heart attack
• acetylcholine, which is used during some operations
• histamine, which is used to treat allergic reactions.

Do not share medicines prescribed for you with any other person. Always take/use MONICOR 60 mg SR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults: The usual dose is one MONICOR 60 mg SR tablet daily, in the morning. This dosage may be increased to two MONICOR 60 mg SR tablets once daily, in the morning. Treatment may be started with a half MONICOR 60 mg SR tablet daily, in the morning for the first two to four days to decrease the possibility of headache. MONICOR 60 mg SR tablets may be broken in half, but should not be chewed or crushed and should be taken with half a glass of water.

Elderly patients: 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 which case you should follow your doctor's instructions. If you are already taking medication such as beta blockers (to reduce the speed and force of your heartbeat) or calcium channel blockers (to lower blood pressure), let your doctor know, as he/she may need to adjust your dose of MONICOR 60 mg SR or existing treatment.

Children: MONICOR 60 mg SR tablets are not for use in children. Your doctor will tell you how long your treatment with MONICOR 60 mg SR will last. Do not stop treatment early because your condition may worsen. If you have the impression that the effect of MONICOR 60 mg SR is too strong or too weak, tell your doctor or pharmacist.

MONICOR 60 mg SR may be used on its own or in combination with other medicines to control angina pectoris.

NOTE: MONICOR 60 mg SR tablets are not to be used for the relief of sudden attacks of angina pectoris.

If you take more MONICOR 60 mg SR than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include:

• pulsing headache, excitation, flushing, cold perspiration, nausea, vomiting, vertigo, fainting, rapid heartbeat, low blood pressure, confusion, shortness of breath, unconsciousness, a bluish or greyish discoloration of the skin, convulsions (fits), abnormal increase in pressure within the skull that can damage the brain.

If you forget to take MONICOR 60 mg SR, take as soon as you remember on the same day. If you do not take a tablet that same day, take your normal dose the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking MONICOR 60 mg SR, do not suddenly stop taking MONICOR 60 mg SR, 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.

MONICOR 60 mg SR can have side effects. Not all side effects reported for MONICOR 60 mg SR are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using MONICOR 60 mg SR, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using MONICOR 60 mg SR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MONICOR 60 mg SR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• rapid and irregular heartbeat, severe or prolonged headache, difficulty breathing
• methaemoglobinaemia (a blood disorder in which too little oxygen is delivered to your cells with symptoms including skin, nails or lips that are a distinctive shade of blue or purple)
• a bluish discolouration of the skin, lips or nails (cyanosis) which can be a sign of various underlying health conditions, particularly those affecting the lungs or heart.

circulatory collapse (a severe medical condition where the circulatory system (heart and blood vessels) fails to deliver enough blood and oxygen to the body's tissues and organs), symptoms include severe low blood pressure (with fainting), rapid heart rate, and signs of impaired organ function, such as confusion or decreased urine output. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• dizziness, restlessness
• low blood pressure (tiredness, dizziness), headache
• nausea
• flushing of the face.

Less frequent side effects:

• blurred vision
• vomiting, diarrhoea
• rash, itching
• muscle aches and pain.

The following side effects have been reported but the frequency for them to occur is not known:

• red or scaly skin (exfoliative dermatitis)
• drowsiness, bleeding in the brain, symptoms may include a sudden and severe headache, vision problems like double vision or vision loss, and potentially nausea, vomiting, and neurological symptoms such as weakness or altered mental state
• low blood pressure when standing up (postural hypotension), which may make you feel sick or dizzy, flushing, abnormal paleness of the skin or mucous membranes
• hypoxia (restlessness, headache, confusion, and rapid heart and breathing rates)
• asthenia (general feeling of weakness, fatigue, and lack of energy).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of MONICOR 60 mg SR. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children.

Store at or below 30 °C. Store in the original container. Protect from light. Keep the container tightly closed. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).