Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-214039 · Präparat HOS-155248

Pioglitazone is contraindicated in patients with:

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Gegenanzeigen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-214040 · Präparat HOS-155248

- hypersensitivity to the active substance or to any of the excipients listed in 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria

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Wechselwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-214041 · Präparat HOS-155248

Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea. Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4. In vitro studies have shown no inhibition of any subtype of cytochrome P450. Interactions with

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): digoxin (HOS-086172) phenprocoumon (HOS-091031) warfarin (HOS-085950) metformin (HOS-091032)

Wechselwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.5 · PDF-Seite 6–7

HOS-214042 · Präparat HOS-155248

6 substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): calcium (HOS-085615)

Wechselwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-214043 · Präparat HOS-155248

Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone. Since there is a potential for an increase in dose- related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered. Close monitoring of glycaemic control should be considered (see section 4.4). Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone. The pioglitazone dose may need to be increased when rifampicin is concomitantly administered. Close monitoring of glycaemic control should be considered (see section 4.4).

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): gemfibrozil (HOS-088403)

Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-214044 · Präparat HOS-155248

Tabulated list of adverse reactions

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-214045 · Präparat HOS-155248

Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency. Frequencies are defined as: 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). Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-214046 · Präparat HOS-155248

Adverse reaction Frequency of adverse reactions of pioglitazone by treatment regimen

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-214047 · Präparat HOS-155248

Combination

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-214048 · Präparat HOS-155248

Mono- with with sulpho- with with insulin therapy metformin nylurea metformin

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 7–8

HOS-214049 · Präparat HOS-155248

7  and sulpho- nylurea Infections and infestations upper respiratory tract common common common common common infection bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon Blood and lymphatic system disorders anaemia common Immune System Disorders hypersensitivity and allergic not known not known not known not known not known reactions1 Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon Nervous system disorders

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-214050 · Präparat HOS-155248

hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon Eye disorders visual disturbance2 common common uncommon macular oedema not known not known not known not known not known Ear and labyrinth disorders vertigo uncommon Cardiac disorders heart failure3 common Respiratory, thoracic and mediastinal disorders dyspnoea common Gastrointestinal disorders flatulence uncommon common Skin and subcutaneous tissue disorders sweating uncommon Musculoskeletal and connective tissue disorders fracture bone4 common common common common common arthralgia common common common back pain common

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 8–9

HOS-214051 · Präparat HOS-155248

8  Renal and urinary disorders haematuria common glycosuria uncommon proteinuria uncommon Reproductive system and breast disorders erectile dysfunction common General disorders and administration site conditions Oedema5 very common fatigue uncommon Investigations weight increased6 common common common common common blood creatine phospho- common kinase increased increased lactic dehydro- uncommon genase alanine aminotransferase not known not known not known not known not known increased 7

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 9

HOS-214052 · Präparat HOS-155248

Description of selected adverse reactions 1 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported. These reactions include anaphylaxis, angioedema, and urticaria. 2 Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.

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

Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 9

HOS-214053 · Präparat HOS-155248

3 In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin. In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin. However, this did not lead to an increase in mortality in this study. In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥65 years compared with those less than 65 years (9.7% compared to 4.0%). In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65 years. Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure. 4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration. A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%). In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%). Post- marketing, bone fractures have been reported in both male and female patients (see section 4.4). 5 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials. The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%. The

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 9–10

HOS-214054 · Präparat HOS-155248

9 reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment. 6 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2–3 kg over one year. This is similar to that seen in a sulphonylurea active comparator group. In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg. In comparator groups addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg. 7 In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups. Mean levels of liver enzymes decreased with treatment with pioglitazone. Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience. Although in very rare cases fatal outcome has been reported, causal relationship has not been established.

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Nebenwirkungen · Pioglitazone Accord

Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-214055 · Präparat HOS-155248

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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