Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Adverse reactions from all sources (clinical trials, literature and post-marketing) are listed in the following table based on the classification of Systems and Organs Class by MedDRA. Within class grouping, adverse reactions are ranked by frequency. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. In addition, the frequency category corresponding to any adverse reactions is based on the following convention (CIOMS III): Very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10, 000 to <1/1, 000) very rare (<1/10, 000), frequency not known (can not be estimated from the available data).


Nervous System Disorders
Uncommon:                                           Headache

Not known:                                          Convulsions *, dizziness 
Cardiac disorders
Not known:                                          Palpitations
Vascular disorders
Uncommon:                                           Hypertension, hypotension Respiratory, thoracic and mediastinal disorders
Not known:                                           Dyspnea
Gastrointestinal Disorders
Common:                                             Vomiting, nausea, diarrhoea, abdominal pain
Uncommon:                                           Dysgeusia, dyspepsia, dry mouth 
Skin and subcutaneous tissue disorders
Uncommon:                                           Skin odour abnormal ** Not known:                                           Pruritus, rash
Musculoskeletal and connective tissue disorders
Uncommon:                                           Muscle spasms
Not known:                                          Myasthenia***, muscle tightness Systemic disorders and administration site conditions
Uncommon:                                           Chest pain, feeling abnormal, pyrexia 
Diagnostic tests
Uncommon:                                             Blood pressure increased Very rare:                                            Increased INR**** 
* Seizures have been reported in patients, with or without a history of seizure activity, who receive L-carnitine orally. L-carnitine administration may increase the incidence and/or severity of seizure attacks. In patients with underling predisposing conditions, treatment with L-carnitine could trigger convulsive crisis.
** Mild myasthenic symptoms have been reported in uremic patients.
*** In subjects with renal impairment or on dialysis, chronic oral administration of L-carnitine may cause accumulation of TMA and TMAO in the blood with consequent trimethylaminuria, pathological condition characterized by a strong "fishy odor" present in urine, in the breath and sweat of the patient (see section 5.2 "Pharmacokinetic properties")
**** Very rare cases of increased INR (International Normalized Ratio) have been reported in patients treated concomitantly with coumarin drugs (see sections 4.4 and 4.5).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form http://sideeffects.health.gov.il