Medicinal Products

ADANCOR 10 mg

Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Nicorandil
laboratory: Merck Serono

Tablet breackable
box of 30
All forms

Indication

Prophylactic treatment of stress angina attack as monotherapy or in combination with other antianginal agents.

ANSM alert of 11/12/2015:

Nicorandil is now indicated for the treatment of stable angina only in patients who are inadequately controlled or who have a contraindication or intolerance to first-line anti-anginal therapy such as beta-blockers and / or calcium antagonists.

Dosage ADANCOR 10 mg scored tablet box of 30

Prophylactic treatment of stress angina attack as monotherapy or in combination with other antianginal agents.

ANSM alert of 11/12/2015:

Nicorandil is now indicated for the treatment of stable angina only in patients who are inadequately controlled or who have a contraindication or intolerance to first-line anti-anginal therapy such as beta-blockers and / or calcium antagonists.

Against indications

Nicorandil MUST NEVER BE USED in the following cases:

· Known hypersensitivity to nicorandil or any of the excipients.

· Cardiogenic shock.

· Hypotension and left ventricular failure with low filling pressures.

· In combination with phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil), because of the risk of significant hypotension (see sections Interactions with other medicinal products and other forms of interaction and Warnings and precautions for use employment ):

o Any patient treated with nicorandil should not be prescribed phosphodiesterase type 5 inhibitors until the patient is under the action of nicorandil.

o In case of treatment with phosphodiesterase type 5 inhibitors, nicorandil is contraindicated.

In the patient without coronary history presenting a first anginal episode after the sexual activity, it is advisable to search by the questioning the possible taking of phosphodiesterase type 5 inhibitors (most often, in the hour preceding the sexual activity) and if this is the case to abstain from any treatment with nicorandil.

In general, based on the available data, the time to be given before administering nicorandil to a patient exposed to phosphodiesterase type 5 inhibitors is not precisely known, but can be estimated at a minimum of 24 hours.

ANSM alert of 11/12/2015:

Nicorandil is now contraindicated in patients with hypovolemia, acute pulmonary edema and the use of soluble guanylate cyclase stimulators such as riociguat.

Adancor Adverse Effects

The frequency terms used hereinafter have the following meanings:

Very common ≥ 1/10.

Frequent ≥ 1/100, <1/10.

Uncommon ≥ 1/1000, <1/100.

Rare ≥ 1/10 000, <1/1000.

Very rare <1/10 000.

Nervous system disorders:

Very common: headache, especially during the first days of treatment. A gradual increase in doses may reduce the frequency of these headaches.

Frequent: vertigo.

Heart conditions:

Frequent: increased heart rate after administration of high doses

Vascular disorders:

Frequent: cutaneous vasodilatation with flush.

Uncommon: drop in blood pressure, especially after high doses.

Gastrointestinal disorders:

Common: nausea, vomiting.

Rare: Cases of ulceration of the digestive tract such as mouth ulcers, mouth ulcers, ulcerations of the tongue, intestinal and anal ulcers have been reported. These digestive ulcers, if they progress, can progress to abscesses, perforations or fistulas (see section Warnings and precautions for use ).

Hepatobiliary disorders:

Very rare: Liver problems such as hepatitis, cholestasis, or jaundice.

Skin and subcutaneous tissue disorders:

Rare: rashes, pruritus.

Very rare: angioedema, ulcerations of the skin and mucous membranes (mainly perianal, genital and peristomal ulcerations) (see Warnings and precautions for use ).

Eye disorders:

Exceptional cases of corneal ulceration have been reported (see Warnings and Precautions for Use section ).

Musculoskeletal and systemic disorders:

Rare: myalgia.

General disorders:

Frequent: feeling of weakness

Additional information :

In addition, the following adverse events were reported at a different frequency in the IONA study (Impact of Nicorandil in angina), conducted only in patients with high cardiovascular risk.

Skin and subcutaneous tissue disorders:

Uncommon: angioedema.

Gastrointestinal disorders:

Frequent: rectorragie.

Uncommon: oral ulcerations.

Very rare: abdominal pain.

Musculoskeletal and systemic disorders:

Uncommon: myalgia.

ANSM alert of 11/12/2015:

Nicorandil can cause severe ulceration of the skin, mucous membranes and eye that may persist if treatment is not interrupted.

Gastrointestinal ulceration can lead to perforations, haemorrhages, fistulas or abscesses.

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