Adverse reactions : תופעות לוואי

4.8.   Undesirable effects
The following table presents the undesirable effects observed in seven clinical studies comprising a total of 1,051 patients, 649 of whom were taking Tardyferon, for which a causal relationship with the product cannot be excluded, as well as those observed during the post-marketing experience or in the literature.

The undesirable effects are presented according to their MedDRA System Organ Class and listed below as very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).


System organ class            Common                  Uncommon                  Not known (≥ 1/100               (≥ 1/1,000         (cannot be estimated
< 1/10)                < 1/100)          from the available data)
Immune system                                                             Hypersensitivity disorders
Respiratory,                                     Laryngeal oedema         *Pulmonary necrosis, thoracic and                                                              *Pulmonary mediastinal                                                               granuloma, disorders                                                                 *Bronchostenosis *Pharyngeal ulceration
Gastrointestinal        Constipation,            Abnormal faeces,         *Oesophageal lesions disorders               Diarrhoea,               Dyspepsia,
*Oesophageal
Abdominal                Vomiting,
ulceration distension,              Gastritis
**Tooth discolouration,
Abdominal pain,
mouth ulceration,
alteration in faeces
Gastrointestinal colour, Nausea melanosis (see section 4.4),
*** Gastric haemorrhage
Gastric ulcer

***Haemorrhagic gastric ulcer
*** Erosive gastritis
Skin and                                         Pruritus,                Urticaria subcutaneous                                     Erythematous rash tissue disorders
* Patients, particularly elderly patients and patients with swallowing difficulties, may also be at risk of oesophageal lesions (oesophageal ulceration), throat ulcers, bronchial granulomas and/or bronchial necrosis, which can cause bronchostenosis in the event of inhalation of tablets containing ferrous sulphate (see section 4.4).

** Tooth discolouration and mouth ulceration: due to incorrect administration, when the tablets are chewed, sucked or kept in the mouth.

***According to the literature, serious cases of gastric ulcer and gastric haemorrhage have been reported even at therapeutic doses in patients treated with iron sulphate tablets.

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 at http://sideeffects.health.gov.il In addition, you can report to Padagis via the following address: Padagis.co.il