Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-290306 · Präparat HOS-287314

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • History of recurrent episodes of neutropenia. • History of agranulocytosis. • Pregnancy (see section 4.6). • Breast-feeding (see section 4.6). • Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.5).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-290307 · Präparat HOS-287314

Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.3).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5–6

HOS-290308 · Präparat HOS-287314

5 Since deferiprone binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation-dependent medicinal products such as aluminium-based antacids. Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-290309 · Präparat HOS-287314

The safety of concurrent use of deferiprone and vitamin C has not been formally studied. Based on the reported adverse interaction that can occur between deferoxamine and vitamin C, caution should be used when administering deferiprone and vitamin C concurrently.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): deferoxamine (HOS-089829)

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-290311 · Präparat HOS-287314

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-290312 · Präparat HOS-287314

The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients. The most serious adverse reaction reported in clinical trials with deferiprone was agranulocytosis, defined as an absolute neutrophil count less than 0.5 x 109/l, which occurred in approximately 1% of patients. Less severe episodes of neutropenia were reported in approximately 5% of patients.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6–7

HOS-290313 · Präparat HOS-287314

6 Tabulated list of adverse reactions

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Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-290314 · Präparat HOS-287314

The adverse reactions are listed below by system organ class (SOC) and by frequency, with the following frequency grouping: 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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

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HOS-290315 · Präparat HOS-287314

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-290316 · Präparat HOS-287314

System organ class Very common Common Frequency not known Blood and lymphatic system Agranulocytosis disorders Neutropenia Immune system disorders Hypersensitivity reactions Metabolism and nutrition Increased appetite disorders Nervous system disorders Headache Gastrointestinal disorders Vomiting Diarrhoea Nausea Abdominal pain Skin and subcutaneous tissue Rash disorders Urticaria Musculoskeletal and Arthralgia connective tissue disorders Renal and urinary disorders Chromaturia General disorders and Fatigue administration site conditions Investigations Increased liver enzymes

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

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HOS-290317 · Präparat HOS-287314

Description of selected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-290318 · Präparat HOS-287314

The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5 x 109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4). Data from pooled clinical trials in patients with systemic iron overload show that 63% of the episodes of agranulocytosis occurred within the first six months of treatment, 74% within the first year and 26% after one year of therapy. The median time to onset of the first episode of agranulocytosis was 190 days (ranged 22 days- 17.6 years) and median duration was 10 days in clinical trials. A fatal outcome was observed in 8.3% of the reported episodes of agranulocytosis from clinical trials and post-marketing experience.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-290319 · Präparat HOS-287314

The observed incidence of the less severe form of neutropenia (neutrophils <1.5 x 109/l) is 4.9% (2.5 cases per 100 patient-years). This rate should be considered in the context of the underlying elevated incidence of neutropenia in thalassaemia patients, particularly in those with hypersplenism.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-290320 · Präparat HOS-287314

Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone. Gastrointestinal effects are more frequent at the beginning of therapy and resolve in most patients within a few weeks without the discontinuation of treatment. In some patients it may be beneficial to reduce the dose of deferiprone and then scale it back up to the former dose. Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone. Mild arthropathies are generally transient.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7–8

HOS-290321 · Präparat HOS-287314

7 Increased levels of serum liver enzymes have been reported in some patients taking deferiprone. In the majority of these patients, the increase was asymptomatic and transient, and returned to baseline without discontinuation or decreasing the dose of deferiprone (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-290322 · Präparat HOS-287314

Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-290323 · Präparat HOS-287314

Low plasma zinc levels have been associated with deferiprone in a minority of patients. The levels normalised with oral zinc supplementation.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-290324 · Präparat HOS-287314

Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years. Episodes of hypotonia, instability, inability to walk, and hypertonia with inability of limb movement have been reported in children in the post-marketing setting with standard doses of deferiprone. The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.4 and 4.9).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-290325 · Präparat HOS-287314

The safety profile of combination therapy (deferiprone and deferoxamine) observed in clinical trials, post-marketing experience or published literature was consistent with that characterised for monotherapy.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Deferiprone Lipomed

Deferiprone Lipomed 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-290326 · Präparat HOS-287314

Data from the pooled safety database from clinical trials (1 343 patient-years exposure to deferiprone monotherapy and 244 patient-years exposure to deferiprone and deferoxamine) showed statistically significant (p<0.05) differences in the incidence of adverse reactions based on System Organ Class for “Cardiac disorders”, “Musculoskeletal and connective tissue disorders” and “Renal and urinary disorders”. The incidences of “Musculoskeletal and connective tissue disorders” and “Renal and urinary disorders” were lower during combination therapy than monotherapy, whereas the incidence of “Cardiac disorders” was higher during combination therapy than monotherapy. The higher rate of “Cardiac disorders” reported during combination therapy than monotherapy was possibly due to the higher incidence of pre-existing cardiac disorders in patients who received combination therapy. Careful monitoring of cardiac events in patients on combination therapy is warranted (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.