Adverse reactions : תופעות לוואי

4.8.        Undesirable effects
If the patient does not tolerate the dosage given or overdosage occurs, the typical symptoms of hyperthyroidism may occur, especially if the dose is increased too rapidly at the start of treatment. In these cases, the daily dosage should be reduced, or the medication should be stopped for several days. Treatment may be restarted with cautious dose adjustment once the side effects have disappeared.
In case of hypersensitivity against levothyroxine or against other ingredients of L-THYROXINE SERB 200 micrograms/ml solution for injection/infusion, allergic reactions on the skin (e.g. angioedema, rash, urticaria) and on the respiratory tract may occur.
Adverse reactions are classified into the following categories in order of frequency: 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), not known (cannot be estimated from the available data).
Immune system disorders not known: hypersensitivity

Endocrine disorders
Common: hyperthyroidism

Psychiatric disorders very common: insomnia common: nervousness not known: agitation
Nervous system disorders very common: headache rare: pseudotumor cerebri particularly in children not known: tremors

Cardiac disorders very common: palpitations common :tachycardia not known: cardiac arrhythmias, anginal pain

Vascular disorders not known: flushing, circulatory collapse in low birth weight preterm neonates (see section 4.4) Gastrointestinal disorders not known: diarrhoea, vomiting and nausea

Skin and subcutaneous disorders
Not known: angioedema, rash, urticaria, sweating

Musculoskeletal and connective tissue disorders not known: muscle weakness and cramps, osteoporosis at suppressive doses of levothyroxine, especially in postmenopausal women, mainly when treated for a long period.

Reproductive system and breast disorders not known: menstrual irregularities

General disorder and administration site conditions not known: heat intolerance, fever.
Investigations not known: weight loss

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: https://sideeffects.health.gov.il