Company Details

  • NINGBO VOICE BIOCHEMIC CO. LTD

  •  [Zhejiang,China]
  • Business Type:Manufacturer , Trade Company
  • Main Mark: Worldwide
  • Exporter:61% - 70%
  • Description:Amlodipine Besylate Tablet,Amlodipine Besylate 5mg Tablets,Amlodipine Besylate 10mg
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NINGBO VOICE BIOCHEMIC CO. LTD

Amlodipine Besylate Tablet,Amlodipine Besylate 5mg Tablets,Amlodipine Besylate 10mg

Home > Products > Finished Drugs > Cardiovascular & Urine Drugs > Amlodipine Besylate Tablet 10mg

Amlodipine Besylate Tablet 10mg

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Product Description

Summary of the safety profile

The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.

Tabulated list of adverse reactions

The following adverse reactions have been observed and reported during treatment with amlodipine with the following frequencies: 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).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness:

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

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

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

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

*mostly consistent with cholestasis

Exceptional cases of extrapyramidal syndrome have been reported.

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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Product Categories : Finished Drugs > Cardiovascular & Urine Drugs

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