IKOREL Tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Ikorel 10 mg Tablets or Nicorandil 10 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 10 mg nicorandil. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablets. Off-white, round tablets with facetted edge, scored on one side and with inscription IK10 on the other side. The tablet can be divided into equal doses.
Therapeutic indications
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 ...
Posology and method of administration
Posology 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 ...
Contraindications
Hypersensitivity to nicorandil or to any of the excipients listed in section 6.1. Patients with shock (including cardiogenic shock), severe hypotension, or left ventricular dysfunction with low filling ...
Special warnings and precautions for use
Ulcerations Gastrointestinal ulcerations, skin and mucosal ulceration have been reported with nicorandil (see section 4.8). Gastrointestinal ulcerations Nicorandil induced ulceration may occur at different ...
Interaction with other medicinal products and other forms of interaction
Concurrent use of nicorandil and phosphodiesterase 5 inhibitors, e.g. sildenafil, tadalfil, vardenafil, is contraindicated, since it can lead to a serious drop in blood pressure (synergic effect). Concomitant ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of nicorandil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ...
Effects on ability to drive and use machines
Ikorel has an influence on the ability to drive and use machines. Indeed, as with other vasodilators, blood pressure lowering effects as well as dizziness and feeling weakness induced by nicorandil can ...
Undesirable effects
Summary of safety profile The most common adverse reaction reported in clinical trials is headache occurring in more than 30% of patients, particularly in the first days of treatment and responsible for ...
Overdose
Symptoms In case of acute overdose, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia. Management Monitoring cardiac function and general supportive ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other vasodilators used in cardiac disease ATC code: C01DX16 Mechanism of action Nicorandil, a nicotinamide ester, is a vasodilator agent with a dual mechanism of action, which ...
Pharmacokinetic properties
Nicorandil pharmacokinetics are linear from 5 mg to 40 mg. Absorption After oral administration, nicorandil is absorbed rapidly and completely from the gastrointestinal tract, independent from food intake. ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Impairment of fertility Fertility ...
List of excipients
Maize starch Croscarmellose sodium Stearic acid (E570) Mannitol (E421)
Incompatibilities
Not applicable.
Shelf life
2 years. <u>After opening:</u> Each blister strip should be used within 30 days of opening at below mentioned storage conditions.
Special precautions for storage
Do not store above 25°C. Store in the original packaging in order to protect from moisture.
Nature and contents of container
For each blister strip, there are: 10 cavities containing Ikorel tablets, and 1 bigger cavity containing a silica gel desiccant capsule positioned at one end of the strip. Each cavity containing an Ikorel ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
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
Marketing authorization number(s)
PL 04425/0327
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 August 1992 Date of latest renewal: 06 May 2005
Date of revision of the text
12/04/2021
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