Nevalin Adverse Reactions



Kimia Farma


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Full Prescribing Info
Adverse Reactions
The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. The other adverse reactions listed as follows: Infection and Infestation: Nasopharyngitis.
Blood and lymphatic system disorder: Neutropenia.
Metabolism and nutrition disorder: Appetite Increased, Anorexia, hypoglycaemia.
Psychiatric disorder: Euphoric mood, confusion, irritability, depression, disorientation, insomnia, libido decreased, Hallucination, restlessness, agitation, depressed mood, elevated mood, mood swings, depersonalization, abnormal dreams, word finding difficulty, libido increased, anorgasmia.
Nervous system disorder: Panic attack, disinhibition, apathy, Dizziness somnolence, Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoesthesia, sedation, balance disorder, lethargy, Syncope, myoclonus, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, Stupor, parsmia, hypokinesia, ageusia, dysgraphia, mental impairment.
Eye disorder: Vision blurred, diplopia, Peripheral vision loss, visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye lacrimation increased, eye irritation, Oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness, keratitis.
Ear and labyrinth disorder: Vertigo, Hyperacusis.
Cardiac disorder: Tachycardia, atrioventricular block first degree, sinus bradycardia, Sinus tachycardia, sinus arrhythmia, congestive heart failure.
Vascular disorder: Hypotension, hypertension, hot flushes, flushing, peripheral coldness.
Respiratory, thoracic and mediastinal disorder: Dyspnea, epistaxis, cough, nasal congestion, rhinitis, snoring, Throat tightness, nasal dryness, pulmonary oedema.
Gastrointestinal disorder: Vomiting, constipation, flatulence, abdominal distension, dry mouth, Gastroesophageal reflux disease, salivary hypersecretion, hypoesthesia oral, Ascites, pancreatitis, dysphagia, nausea, diarrhoea, swollen tongue.
Skin and subcutaneous tissue disorder: Rash popular, urticarial, sweating, Cold sweat, Steven Johnson syndrome, pruritus, face swelling.
Musculoskeletal and connective tissue disorder: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm, Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness, Rhabdomyolysis.
Renal and urinary disorder: Urinary incontinence, dysuria, Renal failure, oliguria, urinary retention.
Reproductive system and breast disorder: Erectile dysfunction, sexual dysfunction, ejaculation delayed, dysmenorrhoea, Breast pain, amenorrhea, breast discharge, breast enlargement, gynecomastia.
General disorder and administration site conditions: Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue, Generalized oedema, chest tightness, pain pyrexial, thirst, chill, asthenia, malaise.
Investigation: Weight increased, Blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood glucose increased, platelet count decreased, blood potassium decreased, weight decreased, White blood cell count decreased, blood creatinine increased.
Immune System Disorders: Hypersensitivity, angioedema, allergic reaction.
After discontinuation of short-term and long term treatment with Pregabalin, withdrawal symptoms have been observed in some patients. The following events have been mentioned: allergic reaction, hypersensitivity, pruritus, insomnia, headache, nausea, anxiety, diarrhea, flu syndrome, nervousness, depression, pain, sweating, and dizziness. The patients should be informed about this at the start of treatments.
Concerning discontinuation of long-term treatment of pregabalin there are no data of incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.
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