Isosorbide Mononitrate 40 Mg Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER
Monomil® 20mg Tablets Monomil® 40mg Tablets
(lsosorbide-5-mononitrate)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Monomil®Tablets are and what are they used for
2. What you need to know before you take Monomil® Tablets
3. How to take Monomil® Tablets
4. Possible side effects
5. How to store Monomil®Tablets
6. Content of the pack and other information
1. What Monomil® Tablets are and what are they used for
Monomil® belongs to a group of medicines called Nitrates. The tablets are used to relieve the symptoms of angina pectoris. Angina pectoris is a painful tightness in the chest, which occurs when the muscles of the heart are not receiving enough oxygen. Pain may also be felt in the neck and arms.
The tablets are used to prevent chest pain (angina) or to treat heart failure. It works by relaxing the blood vessels to the heart, so the blood and oxygen supply to the heart is increased.
2. What you need to know before you take Monomi I® Tablets
Do not take Monomil®Tablets
• If you are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients in the product (see Section 6 and end of Section 2)
• if you have suffered a stroke or have any other condition which may affect the blood supply to your brain
• Ifyou have very low blood pressure (hypotension)
• Ifyou have been told that you have a problem with your heart. Ask your doctor ifyou are not sure if this applies to you
• If you are being treated for severe anaemia (low iron content in your body)
• Ifyou have closed angle glaucoma (high pressure in eyes)
• If you have a disease or have suffered a head injury, that causes pressure or bleeding in the brain (raised intra-craniafpressure).
• If you are taking drugs used for erectile dysfunction e.a. Phosphodiesterase type-5 inhibitors such as sildenafil (Viagra), tadalafil and vardenafil.
Take special care with Monomil®Tablets
You should letyourdoctor know:
• Ifyou have had a recent heart attack
• Ifyou sufferfrom low blood pressure (hypotension)
• Ifyou have a poor diet or do not have enough to eat (malnutrition)
• Ifyou are suffering from low body temperature (hypothermia)
• Ifyou have problems with your liver or kidneys
• If you suffer from hypothyroidism (underactivity of the thyroid gland)
• If you have alcohol problem as you should not drink with these tablets
Interaction with other medicines
Do not take medicines for erectile dysfunction e. g. sildenafil known as Viagra with Monomil® (see section 'Do not take Monomil® Tablets'). You should tell your doctor before taking these tablets if you are currently taking any of the following medicines:
• Beta-blockers, vasodilators (e.g. alprostadil), aldesleukin and Angiotensin II receptor antagonists e.g. captopril, enalapril used to reduce blood pressure.
• Tricyclic antidepressants e.g. Imipramine, amitriptyline
• Medicines used to treat a mental condition, e.g. chlorpromazine, risperidone, clozapine
• Medicines used to treat migraine, e.g. Dihydroergotamine, as these tablets may increase the hypertensive effects of this medicine.
Pregnancy and breast-feeding
Do not take Monomil® Tablets ifyou are pregnant, planning to become pregnant or are breastfeeding. Ask your doctor for advice before taking any medicine.
Driving and using machines
You may experience dizziness, tiredness or blurred vision when you start taking Monomil® Tablets. You should therefore know how you react to these tablets before you drive or use machines.
Important information about some of the ingredients of Monomil® Tablets
This product contains lactose - if you know you have intolerance to some sugars, contact your doctor before use.
3. How to take Monomil® Tablets
Always take Monomil® Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.
Dosage:
The usual dose to be taken orally is:-
Adults: One tablet to be taken two to three times a day. The dose may be Increased to 120mg per day. Always follow your doctor's advice. Elderly: The usual dose Is the same as the adult dose.
Children: Not recommended for use In children.
If you take more Monomil6 Tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child has swallowed any of these tablets, contact your nearest hospital casualty department or your doctor Immediately. Take this leaflet and your tablets with you. The symptoms of an overdose are pulsing headache, reddening of the skin, cold perspiration, nausea, vomiting and a fast heart beat.
If you forget to take Monomil6 Tablets
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose though, do not double up on the dose just carry on as before.
If you stop taking Monomil6Tablets
Do not stop taking your tablets without first discussing with your doctor. If your treatment is stopped your dose should be reduced gradually. It is harmful to stop taking these tablets suddenly or before yourdoctortellsyou.
4. Possible side effects
Like all medicines Monomil6 Tablets can cause side effects, although
not everybody gets them.
Stop taking Monomil6Tablets and tell your doctor immediately if:
• you develop an allergic (hypersensitivity reaction) e.g. skin rash or itching, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing.
• you develop widespread scaling of the skin called an Exfoliative dermatitis, the symptoms include itching, skin redness and hair loss.
• you develop a severe hypotensive response occurs with nausea, vomiting, restless pallor and excessive perspiration. Uncommonly collapse may occur.
Otherside effects are as follows:
Very common side effects (affecting more than 1 in 10 patients):
• Headache (at the start of the treatment, you may have a headache. Usually this disappears after a few days)
Common side effects (affecting between 1 in 10 and 1 in 100 patients)
• Light headedness in the upright position
• Hypotension (low blood pressure)
• Dizziness, drowsiness, feeling weak
• Fast heart beat
Uncommon side effects
• slow heart beat
• fainting
• worsening of chest pains
Infrequent side effects (< 1 % patients)
• Nausea and vomiting
• Flushing (reddening of the skin)
• Allergic skin reaction e.g. rash
• Change in heartbeat
• Heartburn
If you experience these or any other undesirable side effects tell your doctor or pharmacist. You can also report side effects directly via the yellow card scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of the medicine.
5. Howtostore Monomil6 Tablets
Keep out of the reach and sight of children.
Store yourtablets in the original package. Do not store above 25°C Do not use your medicine after the expiry date shown on the label. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist now to dispose of medicines no longer required. These measures will help to protect the environment.
6. Content of the packand other information
What Monomil6Tablets contain
The active substance is isosorbide-5- mononitrate.
• each 20mg tablet contains 20 mg of isosorbide-5- mononitrate.
• each 40mg tablet contains 40 mg of isosorbide-5- mononitrate.
The other substances are: Microcrystalline cellulose, Lactose Monohydrate, Colloidal Anhydrous Silica, Maize starch, Talc and Magnesium stearate.
What Monomil6Tablets looks like and contents of the pack
The tablets are white to off-white, round flat, embossed with '115' (20mg) or "116" (40mg) on one side.
They are available in blister packs of 56 and 60 tablets.
Marketing Authorization Holder and Manufacturer
Milpharm Limited,
Ares, Odyssey Business Park, West End Road,
South Ruislip, HA4 6QD, United Kingdom
This leaflet was last revised in January 2015.