Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Ikorel is indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
The usual therapeutic range is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily (bid), in the morning and in the evening preferably. It is recommended that the dose be titrated upwards in accordance with the patient’s needs, response and tolerance up to 40 mg twice daily, if necessary. A lower starting dose of 5 mg twice daily may be used in patients particularly prone to headache.
There are no special dose requirements for elderly patients, but as with all medicines, use of the lowest effective dose is recommended.
There are no special dosage requirements for patients with liver and/or renal impairment.
Ikorel is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
Ikorel is administered by oral route.
The tablets are to be swallowed in the morning and in the evening as a whole with some liquid.
Administration is independent of food intake.
In case of acute overdose, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia.
Monitoring cardiac function and general supportive measures are recommended. If not successful, increase in circulating plasma volume by fluid substitution is recommended. In life-threatening situations, administration of vasopressors must be considered.
2 years.
After opening: Each blister strip should be used within 30 days of opening at below mentioned storage conditions.
Do not store above 25°C.
Store in the original packaging in order to protect from moisture.
For each blister strip, there are:
Each cavity containing an Ikorel tablet is connected with the desiccant capsule by a channel.
The desiccant capsule must not be swallowed.
The blister pack is sealed with the aluminium cover foil on the removal side.
Pack sizes available are: 30 or 60 tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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