Concore AM Adverse Reactions

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).
Blood and lymphatic system disorders: Very rare: Leukopenia, thrombocytopenia.
Immune system disorders: Rare: Allergic reactions, mainly affecting the skin.
Metabolism and nutrition disorders: Very rare: Hyperglycemia.
Psychiatric disorders: Uncommon: Insomnia, mood changes (including anxiety), depression, sleep disorder. Rare: Nightmare, hallucination, confusion.
Nervous system disorders: Common: Dizziness*, headache*, somnolence*. Uncommon: Hypesthesia, paresthesia, dysgeusia, tremor. Very rare: Peripheral neuropathy.
Eye disorders: Uncommon: Visual disturbance (including diplopia). Rare: Decreased tear secretion (to be considered if the patient uses contact lenses). Very rare: Conjunctivitis.
Ear and labyrinth disorders: Uncommon: Tinnitus. Rare: Hearing disorders.
Cardiac disorders: Common: Palpitations, bradycardia*. Uncommon: Atrioventricular-conduction disturbances, worsening of pre-existing heart failure, bradycardia**. Very rare: Myocardial infarction, arrhythmia.
* applies only to second line indication.
** applies only to substitution therapy (third line indication).
Vascular disorders: Common: Flushing, feeling of coldness and numbness in the extremities. Uncommon: Hypotension, syncope. Very rare: Vasculitis.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnea, bronchospasm in patients with bronchial asthma or a history of obstructive pulmonary disease, rhinitis. Rare: Allergic rhinitis. Very rare: Cough.
Gastrointestinal disorders: Common: Gastrointestinal complaints such as nausea, vomiting, diarrhea, constipation, abdominal pain. Uncommon: Dyspepsia, dry mouth. Very rare: Gastritis, gingival hyperplasia, pancreatitis.
Hepatobiliary disorders: Rare: Hepatitis**. Very rare: Jaundice**.
Skin and subcutaneous tissue disorders: Uncommon: Alopecia, discolorations on the skin, hyperhydrosis, pruritus, exanthema. Very rare: Angio-edema, urticaria, exfoliative dermatitis, psoriasis (psoriasis-like skin disorders or aggravated psoriasis), erythema multiforme, Stevens-Johnson syndrome, photosensitivity. Not known: Toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: Uncommon: Arthralgia, myalgia, muscular weakness, muscle cramps, back pain. Very rare: Muscular hypertonia.
Renal and urinary disorders: Uncommon: pollakiuria, micturition disorder, nocturia.
Reproductive system and breast disorders: Uncommon: Erectile dysfunction, gynecomastia.
General disorders: Common: Edema (e.g. ankle edema), fatigue*. Uncommon: Asthenia*, chest pain, pain, malaise.
Investigations: Uncommon: Weight increase, weight decrease. Rare: Increased triglycerides, increased liver enzymes (ALAT, ASAT).
*These symptoms especially occur at the beginning of the therapy. They are generally mild and often disappear within 1-2 weeks.
** In most cases with cholestasis.
At the first sign of any adverse drug reaction, patient must seek medical attention immediately.