Sedacoron Adverse Reactions







Mega Lifesciences
Full Prescribing Info
Adverse Reactions
The evaluation of undesirable effects is based on the following information on frequency: 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), Not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Very rare: Thrombocytopenia, haemolytic or aplastic anaemia.
Not known: Neutropenia, agranulocytosis.
Immune system disorders: Not known: Angioedema (Quincke's oedema), anaphylactic reaction, anaphylactic shock.
Endocrine disorders: Common: Hyperthyroidism or hypothyroidism. Severe hyperthyroidism, in some cases with fatal outcome, has been described.
(For follow-up examinations, diagnostic and therapeutic measures see Precautions.)
Very rare: Syndrome of inappropriate secretion of antidiuretic hormone (SIADH).
Metabolic and nutrition disorders: Not known: Decreased appetite.
Psychiatric disorders: Uncommon: Decreased libido.
Not known: Delirium (including confusion), hallucinations.
Nervous system disorders: Common: Extrapyramidal tremors, nightmares, dyssomnia.
Uncommon: Peripheral sensory neuropathy and/or myopathy, usually reversible after discontinuation of treatment (see Warnings), dizziness.
Very rare: Benign increases of intracranial pressure (pseudotumour cerebri), cerebral ataxia, headaches.
Not known: Parkinsonism, parosmia.
Eye disorders: Very common: Microdeposits at the anterior surface of the cornea (can also be described as Cornea verticillata) usually limited to the area under the pupil and may cause impaired vision (blurred vision, coloured halos around light sources). The microdeposits consist of complex lipid deposits and are usually reversible within 6 - 12 months after discontinuation.
Very rare: Optic neuropathy and/or optic neuritis that may progress to blindness (see Warnings).
Cardiac disorders: Common: Bradycardia (usually moderate and dose-dependent).
Uncommon: Conduction disturbances (SA block, AV block); in individual cases asystole was observed (see Warnings and Precautions).
Proarrhythmic effects such as changes or enhancement of the cardiac arrhythmia, which may cause a severe impairment of cardiac activity with the possible consequence of cardiac arrest (see Warnings and Interactions).
Very rare: Marked bradycardia or sinus node arrest especially in elderly patients or with impaired sinus node function (see Warnings).
Not known: Torsades de pointes (see Warnings and Interactions).
Individual cases of ventricular fibrillation flutter have been described (see Precautions concerning follow-up examinations, diagnostic and therapeutic measures).
Vascular disorders: Very rare: Vasculitis.
Respiratory, thoracic and mediastinal disorders: Common: As a result of the pulmonary toxicity of amiodarone, atypical pneumonia as symptom of a hypersensitivity reaction (hypersensitivity pneumonitis), alveolar or interstitial pneumonitis or fibroses, pleuritis, bronchiolitis obliterans with pneumonia/BOOP may occur (see Warnings). Individual cases with fatal outcome have been reported.
Non-productive cough and dyspnoea are often first signs of the pulmonary alterations as previously mentioned. Furthermore, weight loss, fever, asthenia may occur.
Very rare: Bronchospasm in patients with severe respiratory failure and especially in patients with asthma.
Cases of shock lung (ARDS) occurred mostly after surgery, in individual cases with fatal outcome (possible interaction with high oxygen concentration, see Interactions).
Not known: Pulmonary haemorrhage.
(For follow-up examinations, diagnostic and therapeutic measures see Precautions.)
Gastrointestinal disorders: Very common: Nausea, vomiting, taste disturbances at the beginning of treatment (during ingestion of the loading dose), which disappear with dose reduction.
Common: Constipation.
Uncommon: Dry mouth.
Not known: Pancreatitis (acute).
Hepatobiliary disorders: Very common: Isolated elevation of serum transaminases at the beginning of therapy, which are generally moderate (1.5- to 3-fold the normal value). The values usually normalise spontaneously or with dose reduction.
Common: Acute hepatitis with high serum transaminases and/or cholestatic icterus, including hepatic failure, in some cases fatal.
Very rare: Chronic liver disease (in some cases with fatal outcome), liver cirrhosis.
(For follow-up examinations, diagnostic and therapeutic measures see Precautions).
Skin and subcutaneous tissue disorders: Very common: Photosensitisation with increased tendency to sunburns, which can lead to erythema and rash (see Precautions).
Common: Eczema. During longer-term treatment, especially body areas exposed to sunlight may become hyperpigmented with black-violet to slate-grey discolouration of the skin (pseudocyanosis). The discolouration slowly recedes within 1-4 years after discontinuing the preparation.
Very rare: Erythema during the course of radiation therapy, erythema nodosum and little specific exanthema, exfoliative dermatitis, alopecia.
Not known: Urticaria, severe skin reactions, sometimes fatal, as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, Drug reaction with eosinophilia and systematic symptoms (DRESS).
(For preventive measures, see Precautions).
Musculoskeletal and connective tissue disorders: Common: Muscle weakness.
Not known: Lupus-like syndrome.
Renal and urinary disorders: Rare: Impaired renal function (temporarily).
Reproductive system and breast disorders: Very rare: Epididymitis, impotence.
General disorders and administration site disorders: Uncommon: Fatigue.
Not known: Granuloma, including bone marrow granuloma.
Investigations: Very rare: Increased serum creatinine.
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