Amlodipino Besilato Tableta 10mg

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Descripción

Overview

Embalaje y entrega

Unidades de venta:: Box

Resumen del perfil de seguridad.

Las reacciones adversas notificadas con mayor frecuencia durante el tratamiento son somnolencia, mareos, dolor de cabeza, palpitaciones, rubor, dolor abdominal, náuseas, hinchazón de tobillos, edema y fatiga.

Lista tabulada de reacciones adversas

Se han observado e informado las siguientes reacciones adversas durante el tratamiento con amlodipino con las siguientes frecuencias: Muy frecuentes (≥1 / 10); común (≥1 / 100 a <1/10); poco frecuentes (≥1 / 1,000 a <1/100); raro (≥1 / 10,000 a <1 / 1,000); Muy raro (<1 / 10,000).

Dentro de cada grupo de frecuencia, las reacciones adversas se presentan en orden decreciente de gravedad:

System organ class	Frequency	Adverse reactions
Blood and lymphatic system disorders	Very rare	Leukocytopenia, thrombocytopenia
Immune system disorders	Very rare	Allergic reactions
Metabolism and nutrition disorders	Very rare	Hyperglycaemia
Psychiatric disorders	Uncommon	Depression, mood changes (including anxiety), insomnia
Psychiatric disorders	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 disturbance (including diplopia)
Ear and labyrinth disorders	Uncommon	Tinnitus
Cardiac disorders	Common	Palpitations
	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
Respiratory, thoracic and mediastinal disorders	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, hyperhidrosis, pruritus, rash, exanthema, urticaria
	Very rare	Angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity
	Unknown	Toxic Epidermal Necrolysis
Musculoskeletal and connective tissue disorders	Common	Ankle swelling, muscle cramps
Musculoskeletal and connective tissue disorders	Uncommon	Arthralgia, myalgia, back pain
Renal and urinary disorders	Uncommon	Micturition disorder, nocturia, increased urinary frequency
Reproductive system and breast disorders	Uncommon	Impotence, gynaecomastia
General disorders and administration site conditions	Very common	Oedema
	Common	Fatigue, asthenia
	Uncommon	Chest pain, pain, malaise
Investigations	Uncommon	Weight increased, weight decreased

* mayormente consistente con colestasis

Se han informado casos excepcionales de síndrome extrapiramidal.

Notificación de sospechas de reacciones adversas.

Es importante informar sospechas de reacciones adversas después de la autorización del medicamento. Permite la monitorización continua del equilibrio beneficio / riesgo del medicamento. Los profesionales de la salud deben informar cualquier sospecha de reacciones adversas a través del Esquema de la Tarjeta Amarilla en www.mhra.gov.uk/yellowcard o buscar la Tarjeta Amarilla MHRA en Google Play o Apple App Store.

PRODUCTOS POR GRUPO : Drogas terminadas > Medicamentos cardiovasculares y urinarios

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