Patient leaflet - ISOSORBIDE MONONITRATE 20 MG TABLETS
Medreich PLC
PACKAGE LEAFLET: INFORMATION FOR THE USER
Isosorbide Mononitrate 20mg Tablets
Isosorbide Mononitrate 40mg Tablets
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 furtherquestions, 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.
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1. What Isosorbide mononitrate Tablets are and what are they used for
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2. Before you take Isosorbide mononitrate Tablets
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3. How to take Isosorbide mononitrate Tablets
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4. Possible side effects
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5. How to store Isosorbide mononitrate Tablets
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6. Further information
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1. What Isosorbide mononitrate Tablets are and what are they used for
Isosorbide mononitrate 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.
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2. Before you take Isosorbide mononitrate Tablets
Do not take Isosorbide mononitrate Tablets - Ifyou are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients in the product (see Section 6 and end of Section 2)
- ifyou 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)
- if you have been told that you have a problem with your heart. Ask your doctor ifyou are not sure if this applies to you
- Ifyou are being treated for severe anaemia (low iron content in your body)
- Ifyou have closed angle glaucoma (high pressure in eyes)
- Ifyou have a disease or have suffered a head injury, that causes pressure or bleeding in the brain (raised intra-cranial pressure).
- Ifyou are taking drugs used forerectile dysfunction e.g.
Phosphodiesterase type-5 inhibitors such as sildenafil (Viagra), tadalafil andvardenafil.
Take special care with Isosorbide mononitrate 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 haveproblemswithyourliverorkidneys
- Ifyou sufferfrom hypothyroidism (underactivity of the thyroid gland)
- Ifyou 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 Isosorbide mononitrate (see section ‚Do not take Isosorbide mononitrate 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 Isosorbide mononitrate Tablets if you are pregnant, planning to become pregnant or are breastfeeding.
Ask your doctorfor advice before taking any medicine.
Driving and using machines
You may experience dizziness, tiredness or blurred vision when you start taking Isosorbide mononitrate 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 Isosorbide mononitrate Tablets
This product contains lactose – if you know you have intolerance to some sugars, contact your doctor before use.
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3. Howtotake Isosorbide mononitrate Tablets
Always take Isosorbide mononitrate Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.
Dosage:
The usual oral adult 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 Isosorbide Mononitrate 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 Isosorbide Mononitrate 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 Isosorbide Mononitrate Tablets
Do not stop taking your tablets without first discussing this with your doctor as this may be harmful.
4. possible side effects
Like all medicines Isosorbide Mononitrate Tablets can cause side effects, although not everybody gets them.
If you develop an allergic (hypersensitivity) reaction e.g. skin rash or itching, swelling of the face, lips, tongue or throat or difficulty breathing or swallowing then stop taking Isosorbide Mononitrate tablets and tell your doctor immediately.
A severe hypotensive response may occur with nausea, vomiting, restless pallor and excessive perspiration. Uncommonly collapse may occur.
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 (affecting between 1 in 100 and 1 in 1000 patients)
- slow heart beat
- fainting
- worsening of chest pains
Infrequently 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.
Store your tablets 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 how to dispose of medicnes no longer required. These measures will help to protect the environment.
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6. Further information
What Isosorbide mononitrate Tablets containThe 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.
What Isosorbide mononitrate Tablets looks like and contents of the pack
The tablets are white to off-white, round flat, embossed with ‚I20‘ (20mg) or „I40“ (40mg) on one side.
They are available in blister packs of 56 and 60 tablets.
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail :
This leaflet was last approved in July 2013 [pl
5. Howto store Isosorbide mononitrate Tablets
Keep out of sight and reach of children.
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