The side effects identified in clinical trials and in the post-marketing use of Isoptyp® CP 240 are presented below in organ systems and in the frequency of their occurrence according to the WHO classification: very often (≥1/10); often (from ≥ 1/100 to <1/10); infrequently (from ≥1 / 1000 to <1/100); rarely (from ≥ 1/10000 to <1/1000); very rarely (<1/10000); frequency is unknown (can not be determined from available data). The most common side effects were: headache,dizziness, nausea, constipation, abdominal pain, bradycardia, tachycardia, palpitations, marked decrease in blood pressure, "flushes" of blood to the skin of the face, peripheral edema and increased fatigue.
Immune system disorders: frequency is unknown: hypersensitivity.
Disorders from the metabolism and nutrition:frequency is unknown: hyperkalemia.
Disorders of the psyche:rarely: drowsiness.
Impaired nervous system:often: dizziness, headache; rarely: paresthesia, tremor; frequency is unknown: extrapyramidal disorders, paralysis (tetraparesis)1, convulsive seizures.
Hearing disorders and labyrinthine disorders:rarely: noise in ears; frequency is unknown: Vertigo.
Heart Disease:often: bradycardia; infrequently: palpitation, tachycardia; frequency is unknown: AV-blockade I, II, III degree; heart failure, stopping the sinus node ("sinus arrest"), sinus bradycardia, asystole.
Vascular disorders:often: "tides" of blood to the skin of the face. marked decrease in blood pressure.
Disturbances from the respiratory system, chest and mediastinal organs: frequency is unknown: bronchospasm, shortness of breath.
Disturbances from the gastrointestinal tract:often: constipation, nausea; infrequently: abdominal pain; rarely: vomiting; frequency is unknown: discomfort in the abdomen, gingival hyperplasia, intestinal obstruction.
Disturbances from the skin and subcutaneous tissues: rarely: hyperhidrosis; frequency is unknown: angioedema, Stevens-Johnson syndrome, erythema multiforme, alopecia, itching, itchy skin, purpura, maculopapular rash, urticaria.
Disturbances from the musculoskeletal and connective tissue: frequency is unknown: arthralgia, muscle weakness, myalgia.
Disorders from the nights and urinary tract:frequency is unknown: renal insufficiency.
Violations of the genitals and breast: frequency is unknown: erectile dysfunction, galactorrhea, gynecomastia.
General disorders: often: peripheral edema; infrequently: increased fatigue.
Laboratory and instrumental data:frequency is unknown: an increase in the concentration of prolactin, an increase in the activity of liver enzymes.
1 - in the period of post-marketing application of Isoptin® reported a single case of development of paralysis (tetraparesis) associated with the combined use of verapamil and colchicine. This could be due to the penetration of colchicine through the blood-brain barrier due to the suppression of isoenzyme activity CYP3A4 and R- glycoprotein under the influence of verapamil (see the section "Interaction with other medicinal products").