Concor AM Adverse Reactions

The undesirable effects observed in the course of using active ingredients separately are to be given according to the following frequency grouping: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Frequency not known (cannot be estimated from the available data).
In connection with amlodipine: The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.
Blood and lymphatic system disorders: Very rare: Leukopenia, thrombocytopenia.
Immune system disorders: Very rare: Allergic reactions.
Metabolism and nutrition disorders: Very rare: Hyperglycaemia.
Psychiatric disorders: Uncommon: Depression, mood changes (including anxiety), insomnia.
Rare: Confusion.
Nervous system disorders: Common: Somnolence, dizziness, headache (especially at the beginning of the treatment).
Uncommon: Tremor, dysgeusia, syncope, hypoaesthesia, paraesthesia.
Very rare: Hypertonia, peripheral neuropathy.
Eye disorders: Common: Visual disturbances (including diplopia).
Ear and labyrinth disorders: Uncommon: Tinnitus.
Cardiac disorders: Common: Palpitation.
Uncommon: Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation).
Very rare: Myocardial infarction.
Vascular disorders: Common: Flushing.
Uncommon: Hypotension.
Very rare: Vasculitis.
Respiratory, thoracic and mediastinal disorders: Common: Dyspnoea.
Uncommon: Cough, rhinitis.
Gastrointestinal disorders: Common: Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation).
Uncommon: Vomiting, dry mouth.
Very rare: Pancreatitis, gastritis, gingival hyperplasia.
Hepatobiliary disorders: Very rare: Hepatitis, jaundice, hepatic enzyme increased*.
Skin and subcutaneous tissue disorders: Uncommon: Alopecia, purpura, skin discolouration, hyperhydrosis, pruritus, rash, exanthema, urticaria.
Very rare: Angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity.
Not known: Toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: Common: Ankle swelling, muscle cramps.
Uncommon: Arthralgia, myalgia, back pain.
Renal and urinary disorders: Uncommon: Micturition disorder, nycturia, increased urinary frequency.
Reproductive system and breast disorders: Uncommon: Erectile dysfunction, gynecomastia.
General disorders and administration site conditions: Very common: Oedema.
Common: Fatigue, asthenia.
Uncommon: Chest pain, pain, malaise.
Investigations: Uncommon: Weight increase, weight decrease.
*In most cases with cholestasis.
Exceptional cases of extrapyramidal syndrome have been reported.
In connection with bisoprolol: Metabolism and nutrition disorders: Rare: Elevated triglyceride level.
Psychiatric disorders: Uncommon: Depression, sleep disorders.
Rare: Nightmares, hallucinations.
Nervous system disorders: Common: Dizziness**, headache**.
Rare: Syncope.
Eye disorders: Rare: Decreased tear secretion (it must be taken into consideration if the patient wears contact lenses).
Very rare: Conjunctivitis.
Ear and labyrinth disorders: Rare: Hearing impairments.
Cardiac disorders: Uncommon: AV-conduction disorders, deterioration of preexisting heart failure, Bradycardia.
Vascular disorders: Common: Feeling of coldness and numbness in the extremities.
Uncommon: Hypotension.
Respiratory, thoracic and mediastinal disorders: Uncommon: Bronchospasm in patients with bronchial asthma or a history of obstructive pulmonary disease.
Rare: Allergic rhinitis.
Gastrointestinal disorders: Common: Gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.
Hepatobiliary disorders: Rare: Hepatitis.
Skin and subcutaneous tissue disorders: Rare: Hypersensitivity reactions such as pruritus, flush, rash.
Very rare: Alopecia. Beta-blockers can provoke or aggravate psoriasis or may cause psoriasis like skin disorder.
Musculoskeletal and connective tissue disorders: Uncommon: Muscle weakness and cramps.
Reproductive system and breast disorders: Rare: Erectile dysfunction.
General disorders and administration site conditions: Common: Fatigue**.
Uncommon: Asthenia**.
Investigations: Rare: 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.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.