Isosorbide Dinitrate Tablets Bp 20mg
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Essential Generics 107-8/L/e/4
12Jun-09b
Outline 120 x 385 Text 100 x 365
ESSENTIAL GENERICS
107-8/L/e/3
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine it available from a pharmacy or it may have 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What this medicine is and what it is used for
Isosorbide dinitrate tablets contain isosorbide dinitrate which is a nitrate vasodilator.
Nitrate vasodilators cause the blood vessels to widen which helps the heart to pump blood through the blood vessels. They may also improve blood supply to the heart itself.
They are used to:
• prevent angina (chest pain), which occurs when there is an inadequate supply of oxygen for the work the heart is performing
• treat the symptoms of congestive heart failure.
These tablets are not suitable for treating an attack that has already started as the tablets will not work quickly enough.
2. Before you take
Do NOT take Isosorbide dinitrate tablets if you:
• are allergic to isosorbide dinitrate, to any other nitrate medicines or to any of the other ingredients (see Section 6)
• take medicines for male erectile problems (e.g. sildenafil, tadalafil, or vardenafil). Taking these medicines with Isosorbide dinitrate may cause a dangerous fall in blood pressure and result in collapse, unconsciousness and could be fatal
• have suffered a heart attack or shock
• have heart problems such as those affecting the valves or walls of the heart
• have severely low blood pressure
• have low blood volume for any reason
• have severe anaemia
• have had a head injury, have increased pressure on the brain or bleeding in the brain.
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Isosorbide dinitrate tablets
Before taking the tablets, tell your doctor if you have:
• an underactive thyroid gland (fatigue, weight gain, constipation, feeling cold, dry skin, hair problems)
• hypothermia (feeling cold with pale looking skin and low body temperature)
• malnutrition (are undernourished)
• increased pressure in the eye(s) (glaucoma)
• severe liver or kidney problems
• a tendency to feel dizzy or faint on standing up quickly
• been taking nitrate or nitrite medicines similar to Isosorbide dinitrate.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Some medicines may be affected by Isosorbide dinitrate or they may affect how well Isosorbide dinitrate will work. Tell your doctor or pharmacist if you are taking:
• medicines used to treat male erectile problems (see 'Do NOT take' Section above)
• medicines containing alcohol (see 'Taking with alcohol' section below for symptoms of use with alcohol)
• medicines used to reduce blood pressure (e.g. ACE-inhibitors, beta-blockers, calcium antagonists, vasodilators, angiotensin II antagonists)
• a medicine for male erectile problems, called alprostadil
• medicines used to treat depression, called tricyclic antidepressants
• medicines used to treat some psychiatric illnesses and severe anxiety, called neuroleptics
• a medicine used for kidney cancer, called aldesleukin
• medicines mainly used in hospitals, containing noradrenaline, acetylcholine or histamine.
Taking with alcohol
Drinking alcohol or taking medicines which contain alcohol while taking these tablets may cause these tablets to lower your blood pressure too much, or you may find that alcohol has more effect than usual.
Pregnancy and breast-feeding
Do not take the tablets if you are pregnant or breast-feeding unless advised to by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Isosorbide dinitrate tablets may cause headache, tiredness and dizziness, especially when you first start taking them. If any of these occur do not drive, use machinery, or perform any tasks that may require you to be alert.
Important information about some of the ingredients of Isosorbide Dinitrate Tablets • lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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3. How to take
Always take Isosorbide dinitrate tablets exactly as your doctor or pharmacist has told you and always read the label. Your doctor or pharmacist will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.
• Swallow the tablets whole with water.
Doses
Adults: the usual dose is 1 or 2 tablets three or four times daily.
Children: this medicine is NOT suitable for children.
Take at the times directed by your doctor or pharmacist, to allow a "nitrate free" period (usually when you are sleeping) when no tablets are taken. This is to prevent your tablets from becoming less effective.
If you take more than you should
If you take more tablets than you should, you may feel very drowsy or faint. If this happens it could mean your blood pressure is low; lie down and raise your legs.
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take your tablets pack and any remaining tablets with you so that people can see what you have taken.
3. Do this even if feel you well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking
Do not stop taking these tablets, or lower the dose, without first checking with your doctor.
Keep taking your tablets until the doctor tells you to stop.
Do not let yourself run out of medicine especially over the weekend or on holidays.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Isosorbide dinitrate tablets can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin.
Seek immediate medical attention if you have any of the following symptoms:
• nausea, vomiting, feeling restless, sweating, looking pale, or feeling faint. This may be due to very low blood pressure
• angina pain which is worse than usual.
Tell your doctor if you get the following symptoms. These side effects may reduce or disappear with time:
Very common side effects (in more than 1 in 10 people)
• headache
Common side effects (in less than 1 in 10 people)
• light-headedness or dizziness (especially on standing up)
• tiredness, feeling weak
• rapid heart rate
Uncommon side effects (in less than 1 in 100 people)
• mild skin rashes
• flushing
• nausea or vomiting
Side effects of unknown frequency
• heartburn.
If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store
• Keep out of the reach and sight of children.
• Do not take after the expiry date which is stated on the label and on the carton. The expiry date refers to the last day of that month.
• Store below 25°C.
• Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
6. Further information
What Isosorbide Dinitrate Tablets contain
• The active ingredient is isosorbide dinitrate (10 mg or 20 mg).
• The other ingredients are:
lactose monohydrate, compressible sugar (which contains sucrose), colloidal silicon dioxide and magnesium stearate.
(See end of Section 2 for further information on lactose and sucrose).
What Isosorbide Dinitrate Tablets look like and contents of the pack
• Isosorbide Dinitrate Tablets 10 mg are white round tablets marked 'IDN 10' on one side.
• Isosorbide Dinitrate Tablets 20 mg are white round tablets marked 'IDN 20' on one side.
They are available in white or grey plastic containers of 30, 56, 60, 90, 100,
120, 180 and 240 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW.
This leaflet was last revised in
June 2009
107-8/L/e/3 ESSENTIAL GENERICS
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