PACKAGE LEAFLET
Read this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed to you personally and you should not pass it to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What ISOSOR -tablets are and what they are used for
2. Before you use ISOSOR -tablets
3. How to use ISOSOR -tablets
4. Possible side effects
5. Storing ISOSOR-tablets
ISOSOR 10 mg and 20 mg -tablets
The active substance is isosorbide-5-mononitrate 10 mg or 20 mg in one tablet.
The other ingredients are pregelatinised maize starch, magnesium stearate, microcrystalline cellulose, calcium hydrogen phosphate duhydrate and anhydrous colloidal silica.
ISOSOR tablets are lactosefree and sugarfree.
1. WHAT ISOSOR-TABLETS ARE AND WHAT THEY ARE USED FOR
ISOSOR-tablets are used for prophylaxis of angina pectoris and for adjunctive therapy in chronc congestive heart failure. The doctor may prescribe ISOSOR-tablets also for other illness.
2. BEFORE YOU USE ISOSOR-TABLETS
ISOSOR-tablets should not be used, if you
- are hypersensitive to organic nitrates
- have tendency to dizziness or fainting caused by low blood pressure
- have valvular or other cardiovascular disease, except coronary disease and heart insufficiency.
Consult your doctor before using ISOSOR, if you
- have had celebral circulatory disorders or head trauma
- have anemia or pulmonary disorder
- have deficient methemoglobin reductase activity (which may lead to worsened ability of oxygen transfer in blood) or abnormal structure of hemoglobin.
Pregnancy and breast-feeding
There are not sufficient data when using ISOSOR during pregnancy and lactation. Therefore, consult a doctor before using ISOSOR if you are planning to get pregnant, during pregnancy or during breast-feeding.
Driving and using machines
Especially in the beginning of the treatment with ISOSOR may occur dizziness, which is caused by lowering of blood pressure. Because of the occurence of dizziness as side effect, be careful when driving, using machinery or in other tasks which demand accuracy. If no adverse side effects exists, ISOSOR does not affect the ability to drive or use machinery.
Taking other medicines
Please consult your doctor before using ISOSOR concomitantly with other mediciness. This concerns both prescription and OTC medicines, especially the following medicines:
- antihypertensive agents
- medicines which distend veins, other nitrates
- antidepressants and antipsychotics
- dihydroergotamine medicines for migraine
- medicine for potency like sildenafil, tadalafil or vardenafil, because these may intensify the blood pressure-lowering effect of ISOSOR, and may cause fatal hypotension.
If you are unsure of using concomitantly all medicines prescribed to you, you can also consult your pharmacist.
Overdose
If you accidentally take larger dose of ISOSOR than prescribed to you, symptoms of overdosage like tachycardia, flushing, headache, confusion, vomiting and dizziness may occur. In case above mentioned symptoms occur, please contact your doctor. Part of symptoms may be caused by too large dose. Your doctor may adjust dose again if necessary.
Take special care with ISOSOR- tablets
ISOSOR-tablets are not suitable for treatment of acute attacks of angina pectoris. In that case immediate release medicines should be used.
Acute attacks of angina pectoris and arrhythmia of the heart may occur if ISOSOR treatment is suddenly withdrawn after several weeks of treatment. If the treatment of ISOSOR should be withdraw, please contact your doctor to get more information.
Be careful of using alcohol eith ISOSOR because concomitant ise may intensify the effect of ISOSOR and may cause hypotension.
If you use other medicines, it is important to follow the doctor's instructions with all your medicines.
3. HOW TO USE ISOSOR TABLET
Dosage should be adjusted by a doctor.
4. POSSIBLE SIDE EFFECTS
Some adverse effects may occur especially whrn starting the treatment, because of the veins distending effect of ISOSOR. Adverse effect normally disappear or subside after some days of continued treatment, and they can be avoided by starting the treatment with a lower dosage, which is then increased after a few days. The most common adverse effect is headache. If headache doesn't disappear during couple of days or it is intense, contact your doctor. Rare adverse effects, such as dizziness, weakness or giddiness (especially when quickly getting up from bed or rising from a chair), facial flush, palpitation and slight abdominal pain may occur.
If other symptoms than above mentioned occur, contact your doctor.
5. STORING ISOSOR-TABLETS
KEEP THE TABLETS OUT OF THE REACH AND SIGHT OF CHILDREN.
No special storage conditions.
Use before date stated on the package.
Marketing authorisation holder and manufacturer
Vitabalans Oy, Varastokatu 8 13500 Hämeenlinna
Date of the package leaflet 20.8.2004
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