Dilikorell Tablets – Nicorandil 10 mg, 20 mg

• Each Dilikorell 10mg tablet contains: Nicorandil 10mg.
• Each Dilikorell 20mg tablet contains: Nicorandil 20mg

Therapeutic indications

Dilikorell tablets are indicated for the following:

1. The prevention and long term treatment of chronic stable angina pectoris.
2. A reduction in the risk of acute coronary syndromes in patients with chronic stable angina and at least one of the following risk factors:
   • Previous MI
   • Previous CABG
   • CHD on angiography or a positive exercise test together with one of the following:
     1. LVH on ECG,
     2. left ventricular dysfunction,
     3. Age > 65,
     4. diabetes mellitus (type I or II excluding those on sulphonylureas),
     5. hypertension or documented vascular disease

Posology and method of administration

Route of administration: oral.

Adults: The recommended starting dose is 10mg nico Dilikorell twice daily, although 5mg twice daily may be employed in patients particularly susceptible to headache. Subsequently the dosage should be titrated upward depending on the clinical response. The usual therapeutic dosage is in the range 10 to 20mg nico Dilikorell twice daily, although up to 30mg twice daily may be employed if necessary.

Elderly: For elderly patients use of the lowest effective dose is recommended.

Children: A paediatric dosage has not been established and use of nico Dilikorell is not recommended.

Contraindications

• Dilikorell is contraindicated in patients with hypersensitivity to nico Dilikorell or any of the excipients.
• Nicorandil must not be used in the case of cardiogenic shock, hypotension or left ventricular failure with low filling pressure.
• Concurrent use of nico Dilikorell and phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is contraindicated since it can lead to a serious drop in blood pressure.

Special warnings and precautions for use

Gastrointestinal ulcerations, skin and mucosal ulceration have been reported with nico Dilikorell. These are refractory to treatment and most only respond to withdrawal of nico Dilikorell treatment. If ulcerations develop, nico Dilikorell should be discontinued.

Gastrointestinal perforations in context of concomitant use of nico Dilikorell and corticosteroids have been reported. Caution is advised when concomitant use is considered.

Nicorandil must be used with caution in patients who may have blood volume depletion or in those who present,

• low systolic blood pressure (e.g below 100 mm Hg),
• acute pulmonary oedema or acute myocardial infarction with acute left ventricular failure and low filling pressures.

Caution is advised if nico Dilikorell is used in combination with other medicinal products with blood pressure lowering effect.

The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake.

Besides the nico Dilikorell tablets, each blister contains active substance-free silica gel as desiccant in a separate sachet which is marked accordingly. The patients should be advised not to take this sachet. Although any accidental intake of this desiccant is usually harmless.

Paediatric patients: Dilikorell is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.

Interaction with other medicinal products and other forms of interaction

Gastrointestinal perforations in the context of concomitant use of nico Dilikorell and corticosteroids have been reported. Caution is advised when concomitant use is considered.

Concurrent use of nico Dilikorell and phosphodiester-ase 5 inhibitors, e.g. sildenafil, tadalfil, vardenafil, is contraindicated, since it can lead to a serious drop in blood pressure. Therapeutic doses of nico Dilikorell may lower the blood pressure of hypotensive patients.

If nico Dilikorell is used concomitantly with antihypertensive agents or other medicinal products with blood-pressure-lowering effect (e.g vasodilators, tricyclic antidepressants, alcohol) the blood-pressure-lowering effect may be increased.

Pregnancy & lactation

Pregnancy: Although animal studies have not shown any teratogenic effect of nico Dilikorell, the medicinal product has not been studied in human pregnancy; therefore, Dilikorell must only be used in pregnant women if the anticipated benefit outweighs any potential risks.

Lactation: Animal studies have shown that nico Dilikorell is excreted in small amounts into the breast milk. It is not known whether nico Dilikorell is excreted in human milk, therefore Dilikorell is not recommended during breast feeding.

Effects on ability to drive and use machines

Blood pressure-lowering effects of nico Dilikorell can reduce the ability to drive or to use machines. This effect can be increased in conjunction with alcohol or other products with blood-pressure-lowering effect (e.g. vasodilators, tricyclic antidepressants).

Patients should be warned not to drive or operate machinery until it is established that their performance is unimpaired by nico Dilikorell.

Undesirable effects

The following definitions apply to the frequency terminology used hereafter:

• Very common (>1/10);
• common (>1/100, <1/10);
• uncommon (>1/1,000, <1/100);
• rare (>1/10,000, <1/1,000);
• very rare (<1/10,000).

Freq	ADR
very common	headache, particularly during the first few days of treatment
common	dizziness
common	increase heart rate, following the adminstration of high doses
common	cutaneous vasodilation with flushing
uncommon	drecrease in blood pressure
common	nausea and vomiting
rare	GI ulceration, such as stomatitis, mouth ulcers, tongue ulcers, interstinal and anal ulcers.
very rare	liver disorders, such as hepatitis, cholestasis, or jaundice
rare	different types of rash, pruritus
common	feeling of weakness

Dilikorell = Randil

Both Dilikorell & Randil contains the same active ingredient (Nicorandil).- For more information: you can read Randil information leaflet from the link below

Refernaces ATC code: C01DX16