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אלטרוקסין טבליות 50 מק"ג ELTROXIN TABLETS 50 MCG (LEVOTHYROXINE SODIUM)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

טבליה : TABLETS

Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The undesirable effects disappear when reducing the daily dose or upon discontinuation.

Classification of side effects into exact estimates of frequency is not possible due to insufficient clinical data.

Endocrine disorders
Frequency not known (cannot be             Hyperthyroidism (if the initial dose is estimated from the available data)         increased too rapidly).
Psychiatric disorders
Frequency not known (cannot be             Irritability, anxiety, emotional lability, estimated from the available data)         nervousness, restlessness, agitation, insomnia.
Nervous system disorders
Rare (>1/10,000 to <1/1,000)               Benign intracranial hypertension (especially in children).
Frequency not known (cannot be             Tremor, seizures (muscular spasms, estimated from the available data)         shaking), cephalalgia.
Cardiac disorders
Frequency not known (cannot be             Angina pectoris, arrhythmias, estimated from the available data)         palpitations, tachycardia, hypertension, heart insufficiency,
myocardial infarction.
Vascular disorders                         Redness, hot flashes.

Skin and subcutaneous tissue disorders

Frequency not known (cannot be             Hyperhidrosis, hair loss, angioedema, estimated from the available data)         rash, urticaria.
Metabolism and nutrition disorders
Frequency not known (cannot be             Increased appetite, excessive weight estimated from the available data)         loss.
Gastrointestinal disorders                 Abdominal pain, nausea, diarrhoea, vomiting
Respiratory, thoracic and mediastinal disorders
Dyspnoea.
Frequency not known (cannot be estimated from the available data)
Immune system disorders
Frequency not known (cannot be             Hypersensitivity reactions: rash, estimated from the available data)         pruritus and anaphylactic reactions.


Musculoskeletal and connective tissue disorders
Muscular weakness, muscle cramps.
Frequency not known (cannot be estimated from the available data)        An overdose may cause premature epiphyseal closure in children, leading to compromised height.
Reproductive system and breast disorders
Frequency not known (cannot be            Irregular menstrual periods, infertility.
estimated from the available data)
Congenital, familial and genetic          An overdosage may cause disorders                                 craniosynostosis in infants.

General disorders and administration site conditions
Frequency not known (cannot be            Tiredness, temperature intolerance, estimated from the available data)        pyrexia.
Investigations
Frequency not known (cannot be            Reduced bone mineral density estimated from the available data)

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.
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 Additionally, you can also report to Padagis via following address: Padagis.co.il 
שימוש לפי פנקס קופ''ח כללית 1994 Thyroid deficiency states
תאריך הכללה מקורי בסל 01/01/1995
הגבלות תרופה שאושרה לשימוש כללי בקופ'ח

רישום

055 82 20571 00

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אלטרוקסין טבליות 50 מק"ג

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