ISOSORBIDE MONONITRATE 30 MG TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take isosorbide mononitrate tablets

Do not take Isosorbide Mononitrate Tablets:

• if you are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from severe anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
• if you have had a heart attack (myocardial infarction)
• if you have had a brain haemorrhage (bleeding)
• if you have had a head injury (trauma)
• if you have severely low blood volume
• if you have severe low blood pressure
• if you are suffering from ‘shock’ as the blood has stopped circulating properly around your body (circulatory failure)
• if you take sildenafil, tadalafil or vardenafil (medicines to treat impotence and/or pulmonary hypertension) or any other phosphodiesterase inhibitor.
• if you have an eye disease called glaucoma
• if you have been diagnosed with any of the following heart conditions: hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with raised intra-cranial (head) pressure.
• if you take products that contain riociguat a medicine used in treating pulmonary hypertension.

If any of the above applies to you talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking isosorbide mononitrate tablets:

• if you have an underactive thyroid gland
• if you are malnourished (severely underfed)
• if you have liver or kidney disease
• if you suffer from hypothermia (a very low body temperature)
• if you suffer from very poor circulation
• if you have abnormally low level of oxygen in the blood and impaired gas exchange due to lung disease or ischaemic heart failure.

Other medicines and Isosorbide Mononitrate tablets

• Do not take isosorbide mononitrate tablets with phosphodiesterase inhibitors such as Sildenafil , Alprostadil, Tadalafil and Vardenafil used for impotence. Using isosorbide mononitrate tablets with these medicines could cause your blood pressure to fall to a dangerously low level. You must not stop taking isosorbide mononitrate tablets to take these medicines as this will increase your chances of having an angina attack.
• Do not take isosorbide mononitrate tablets with products that contain riociguat.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:

• Medicines to lower your blood pressure such as beta blockers (atenolol, propranolol), calcium channel blockers (nifedipine,dil­tiazem), vasodilators (glycerol trinitrate,met­hyldopa), ACE- inhibitors, angiotensin receptor blockers (olmesartan medoxomil, candesartan cilexetil)
• Tricyclic antidepressants such as amitriptyline, clomipramine (used to treat depression)
• Neuroleptics to treat psychosis (delusions, hallucinations and/or disordered thought) such as henothiazines (fluphenazine) or butyrophenones (haloperidol)
• Ergotamine used for migraine.
• Aldesleukin (for kidney cancer)
• Sapropterine containing medicines for the treatment of high levels of phenylalanine (hyperphenyla­laninaemia)
• Any other medicine, including medicines obtained without a prescription.

If any of the above applies to you talk to your doctor.

Isosorbide Mononitrate Tablets with alcohol

Do not drink alcohol. It could increase the effect of isosorbide mononitrate Tablets and lower your blood pressure too much. If this happens, you may feel dizzy or faint.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking isosorbide mononitrate Tablets. Your doctor will decide whether you should take this medicine.

Driving and using machines

Isosorbide mononitrate Tablets may give you a headache, blurred vision or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery.

Isosorbide Mononitrate Tablets contains lactose

This medicine contains lactose. If you have an intolerance to some sugars, tell your doctor before taking this medicine.

Isosorbide Mononitrate Tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take isosorbide mononitrate tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

Adults:

• The usual adult dose is one tablet two or three times a day.
• Your doctor will tell you when you should take your tablets. You will need to have a period of time (usually when you are sleeping) when no tablets are taken. This is called a “nitrate low” period and is needed to make sure your medicine remains effective.
• Swallow the tablets whole with a drink of water after meals.
• Your doctor may increase your dose, up to a maximum of 120 mg per day.
• If you do not take the dose as prescribed by your doctor, you may develop a tolerance to isosorbide mononitrate.

Do not use isosorbide mononitrate to treat an actual angina attack. Your doctor will give you a different medicine such as a GTN (glyceryl trinitrate) spray or tablet for this.

Use in children

This medicine is not suitable for children.

If you take more isosorbide mononitrate than you should

Do not take more isosorbide mononitrate than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor.

Too much isosorbide mononitrate may cause your blood pressure to fall too low, making you feel sick, faint and dizzy. A very large overdose could cause a coma or collapse and require immediate resuscitation.

If you forget to take Isosorbide Mononitrate

Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time.

If you stop taking Isosorbide Mononitrate

Do not stop taking isosorbide mononitrate without first talking to your doctor. You should keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the tablets your condition may get worse. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines isosorbide mononitrate can cause side effects, although not everybody gets them.

Seek immediate help if you are having an allergic reaction. This includes any of the following symptoms:

• Difficulty in breathing
• Swelling of your eyelids, face or lips
• Rash or itching especially those covering your whole body
• Collapse
• Fainting
• Serious redness and scaling of the skin
• Worsening of angina (tight pain in the chest, neck or arm area)

Very common side effects (affects more than 1 in 10 people):

• Headache

Common side effects (affects less than 1 in 10 people):

• Light headed on standing upright
• Dizziness
• Sleepiness
• Feeling weak
• Fast heartbeat
• Drowsiness

They may occur for the first few days of treatment or after your dosage has been increased.

Uncommon side effects (affects less than 1 in 100 people):

• Fainting or collapse
• Feeling sick or being sick
• Skin rashes
• Looking pale
• Excessive sweating
• Restlessness
• Worsening angina (tight pain in the chest, neck or arm area)
• Flushing
• Worsening angina (tight pain in the chest, neck or arm area)
• Flushing

Very rare side effects (affects less than 1 in 10,000 people):

• Heartburn
• Red or scaly skin (exfoliate dermatitis)
• Low blood pressure
• Swelling of the skin

You may also suffer with increased chest pain due to a lack of oxygen to the heart muscle and areas around the chest.

Very slow heart rate has been reported with use of nitrates. If you experience any symptoms of shock or collapse after first dose, please contact your doctor immediately.

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 Yellow Card Scheme at: 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 isosorbide mononitrate

• 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 and blister pack after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• 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 informationwhat isosorbide mononitrate containsthe active substance is isosorbide mononitrate. each tablet contains t10mg, 20mg, 30mg or 40mg isosorbide mononitrate.

The other ingredients are cellulose microcrystalline, lactose monohydrate, maize starch, silica, colloidal anhydrous, sodium starch glycolate, purified talc and magnesium stearate.

What Isosorbide Mononitrate looks like and contents of the pack

10 mg :

White to off white, round tablet, flat with bevelled edge, score & engraving (I/10) on one side and plain on other side. Dimension: 6.35mm

20 mg :

White to off white, round tablet, flat with bevelled edge, score & engraving (I/20) on one side and plain on other side. Dimension: 8.00mm

30 mg :

White to off white, round tablet, flat with bevelled edge, score & engraving (I/30) on one side and plain on other side. Dimension: 9.50mm

40 mg :

White to off white, round tablet, flat with bevelled edge, score & engraving (I/40) on one side and plain on other side. Dimension: 10.50mm

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Isosorbide mononitrate 10 mg, 20 mg, 30 mg and 40 mg Tablets are available in Alu-PVC/PVdC and Alu/PVC blister packs of 28, 30, 56, 60, 84 tablets.

Not all pack sizes may be marketed.

This leaflet was last revised in May 2021

Marketing Authorisation Holder and Manufacturer:

Rudipharm Limited

Unit 6, Salbrook Road Industrial Estate Salbrook Road, Redhill, Surrey, RH1 5GJ, United Kingdom

Isosorbide mononitrate Tablets - S/L - English - PIL Dimensions: 170 x 350 mm (Open Size)

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