EZETIMIBE MEVON TABLET 10 MG

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Nusipirk tai dabar

Parsisiųsti Prekės savybės (SPC)
07-05-2024

Veiklioji medžiaga:

Ezetimibe

Prieinama:

NOVEM PHARMA PRIVATE LIMITED

ATC kodas:

C10AX09

Vaisto forma:

TABLET

Sudėtis:

Ezetimibe 10 mg

Vartojimo būdas:

ORAL

Recepto tipas:

Prescription Only

Pagaminta:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Autorizacija statusas:

ACTIVE

Leidimo data:

2022-03-08

Prekės savybės

                                EZETIMIBE MONOTHERAPY
SYSTEM ORGAN CLASS
ADVERSE REACTIONS
FREQUENCY
Metabolism and Nutrition
Disorders
decreased appetite
Uncommon
Vascular Disorders
hot flush; hypertension
Uncommon
Respiratory, Thoracic and
Mediastinal Disorders
cough
Uncommon
Gastrointestinal Disorders
abdominal pain; diarrhoea; flatulence
Common
dyspepsia; gastrooesophageal reflux disease; nausea
Uncommon
Musculoskeletal And
Connective Tissue Disorders
arthralgia; muscle spasms; neck pain
Uncommon
General Disorders And
Administration Site Condition
fatigue
Common
chest pain, pain
Uncommon
Investigations
ALT and/or AST increased; blood CPK increased; gamma -
glutamyltransferase increased; liver function test abnormal
Uncommon
ADDITIONAL ADVERSE REACTIONS WITH EZETIMIBE CO-ADMINISTERED WITH A
STATIN
SYSTEM ORGAN CLASS
Nervous System Disorders
Gastrointestinal Disorders
Skin And Subcutaneous
Tissue Disorders
Musculoskeletal And
Connective Tissue Disorders
General Disorders And
Administration Site Condition
Uncommon
Investigations
POST-MARKETING EXPERIENCE (WITH OR WITHOUT A STATIN)
SYSTEM ORGAN CLASS
Blood and lymphatic system
disorders
Immune system disorders
Psychiatric disorders
Nervous system disorders
Respiratory, Thoracic and
Mediastinal Disorders
Gastrointestinal Disorders
Hepatobiliary disorders
Skin And Subcutaneous
Tissue Disorders
Musculoskeletal And
Connective Tissue Disorders
General Disorders And
Administration Site Condition
ADVERSE REACTIONS
headache
paraesthesia
dry mouth; gastritis
pruritus; rash; urticaria
myalgia
back pain; muscular weakness; pain in extremity
asthenia; oedema peripheral
ALT and/or AST increased
ADVERSE REACTIONS
thrombocytopaenia
hypersensitivity, including rash,
urticaria, anaphylaxis and angiooedema
depression
dizziness; paraesthesia
dyspnoea
pancreatitis; constipation
hepatitis; cholelit
hiasis; cholecystitis
erythema multiforme
myalgia; myopathy/rhabdomyolysis
(see section 4.4)
asthenia
FREQUENCY
Common
Uncommon
Uncommon
Uncommon
Common
Uncommon
Common
FREQUENCY
Not known
Not known
Not known
Not known
N
                                
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