Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-27 · 1381 Präparate · 72104 Quellenpassagen · 204 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · Tandemact
Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-115646 · Präparat HOS-094329
Adverse reactions reported in double-blind studies and post marketing experience 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.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-09-13T13:32:00Z · SHA-256 2f687843aaa08f3b2b5add2ddc427b0f290d7d4b353b767838c175de06dc93d0 · Passage 456467dbea557a9d80f9139e01ee4f57116f1b325b2c594127cf8272fd45dc25 · Zeichen 788–1312 im Abschnitt
Nebenwirkungen · Tandemact
Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-115647 · Präparat HOS-094329
Adverse reaction Frequency of adverse reactions
Pioglitazone Glimepiride Tandemact
Infections and infestations
upper respiratory tract infection common common
sinusitis uncommon uncommon
Neoplasms benign, malignant and unspecified
(including cysts and polyps)
bladder cancer uncommon uncommon
Blood and lymphatic system disorders
changes in haematology1 rare rare
Immune system disorders
allergic shock2 very rare very rare
allergic vasculitis2 very rare very rare
hypersensitivity and allergic reactions3 not known not known
Metabolism and nutrition disorders
hypoglycaemia uncommon
appetite increased uncommon
Nervous system disorders
dizziness common
hypo-aesthesia common common
headache uncommon
insomnia uncommon uncommon
Eye disorders
visual disturbance4 common uncommon
macular oedema not known not known
Ear and labyrinth disorders
vertigo uncommon
Gastrointestinal disorders5
flatulence common
vomiting very rare very rare
diarrhoea very rare very rare
nausea very rare very rare
abdominal pain very rare very rare
abdominal pressure very rare very rare
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-09-13T13:32:00Z · SHA-256 2f687843aaa08f3b2b5add2ddc427b0f290d7d4b353b767838c175de06dc93d0 · Passage e20e1ca722a10906123a7d0af26f55d7fba35ccafdccfec6676130e6cecf069d · Zeichen 1320–4049 im Abschnitt
Nebenwirkungen · Tandemact
Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets · Abschnitt 4.8 · PDF-Seite 9–10
HOS-115648 · Präparat HOS-094329
9
Adverse reaction Frequency of adverse reactions
Pioglitazone Glimepiride Tandemact
feeling of fullness in the stomach very rare very rare
Hepatobiliary disorders6
hepatitis very rare very rare
impairment of liver function (with cholestasis and very rare very rare
jaundice)
Skin and subcutaneous tissue disorders
sweating uncommon
hypersensitivity to light very rare very rare
urticaria2 not known not known
itching2 not known not known
rash2 not known not known
Musculoskeletal and connective tissue disorders
bone fracture7 common common
Renal and urinary disorders
glycosuria uncommon
proteinuria uncommon
General disorders and administration site
conditions
oedema8 common
fatigue uncommon
Investigations
weight increased9 common common common
increased lactic dehydrogenase uncommon
decrease in sodium serum concentrations very rare very rare
alanine aminotransferase increase10 not known not known
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-09-13T13:32:00Z · SHA-256 2f687843aaa08f3b2b5add2ddc427b0f290d7d4b353b767838c175de06dc93d0 · Passage 8154b4ba7a398c597345ef81c877d8554c38b3fb66116cc9e33731937afe4958 · Zeichen 4102–6342 im Abschnitt
Nebenwirkungen · Tandemact
Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-115649 · Präparat HOS-094329
Description of selected adverse reactions
1
Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia,
agranulocytosis, haemolytic anaemia and pancyto-penia may occur. These are in general reversible
upon discontinuation of treatment.
2
In very rare cases mild hypersensitivity reactions may develop into serious reactions with dyspnoea,
fall in blood pressure and sometimes shock. Hypersensitivity reactions of the skin may occur as
itching, rash, and urticaria. Cross allergenicity with sulphonylureas, sulphonamides or related
substances is possible.
3
Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been
reported. These reactions include anaphylaxis, angioedema, and urticaria.
4
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 medicinal products.
5
Gastro-intestinal complaints are very rare and seldom lead to discontinuation of therapy.
6
Elevation of liver enzymes may occur. In very rare cases, impairment of liver function (e.g. with
cholestasis and jaundice) may develop, as well as hepatitis which may progress to liver failure.
7
A pooled analysis was conducted of adverse event reports of bone fractures from randomised,
comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated
groups and 7,400 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%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-09-13T13:32:00Z · SHA-256 2f687843aaa08f3b2b5add2ddc427b0f290d7d4b353b767838c175de06dc93d0 · Passage 20d83eff0897e79f1bdda8db6c324a39eae87c72cf29a01ff1c15643f578ddcf · Zeichen 6344–8126 im Abschnitt
Nebenwirkungen · Tandemact
Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets · Abschnitt 4.8 · PDF-Seite 10–11
HOS-115650 · Präparat HOS-094329
10
In the 3.5 year PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of
pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per
100 patient years) of female patients treated with comparator. The observed excess risk of fractures for
women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use. 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).
8
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
reports of oedema were generally mild to moderate and usually did not require discontinuation of
treatment.
9
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 a sulphonylurea resulted in a mean weight increase over one
year of 2.8 kg.
10
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.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-09-13T13:32:00Z · SHA-256 2f687843aaa08f3b2b5add2ddc427b0f290d7d4b353b767838c175de06dc93d0 · Passage bc77af9d998341b8ffe9670b01a2e7c12c8d1576e885043b5a3e68b2f995eca9 · Zeichen 8181–9705 im Abschnitt
Nebenwirkungen · Tandemact
Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-115651 · Präparat HOS-094329
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 in 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 (see section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-09-13T13:32:00Z · SHA-256 2f687843aaa08f3b2b5add2ddc427b0f290d7d4b353b767838c175de06dc93d0 · Passage 2da495bba675dfbec4968762f4f67637eed964f892ed19691ce19d89d5ecb09a · Zeichen 9707–10816 im Abschnitt
Nebenwirkungen · Tandemact
Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-115652 · Präparat HOS-094329
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.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-09-13T13:32:00Z · SHA-256 2f687843aaa08f3b2b5add2ddc427b0f290d7d4b353b767838c175de06dc93d0 · Passage 42f7144177697b690f59b1bda795c3fd216297691cf296a2e1269a137feab3cd · Zeichen 10818–11173 im Abschnitt
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.