Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-211970 · Präparat HOS-154792

Other interactions The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides. Anticholinergic agents (e.g. atropine, beperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate. Thiazides may increase the risk of adverse effects caused by amantadine. Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.

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): diazoxide (HOS-088588) atropine (HOS-089182) amantadine (HOS-086615) cyclophosphamide (HOS-084539) methotrexate (HOS-087522)

Wechselwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-211974 · Präparat HOS-154792

Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).

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): angiotensin II (HOS-085480) aliskiren (HOS-086927)

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-211975 · Präparat HOS-154792

Irbesartan/hydrochlorothiazide combination

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-211976 · Präparat HOS-154792

Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions. The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%). In addition increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-211977 · Präparat HOS-154792

Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials.

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-211978 · Präparat HOS-154792

The frequency of adverse reactions listed below is defined using the following convention: 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-211979 · Präparat HOS-154792

Table 1. Adverse Reactions In Placebo-Controlled Trials and Spontaneous Reports Increases in blood urea nitrogen Common: (BUN), creatinine and creatine Investigations: kinase Uncommon: Decreases in serum potassium and sodium Cardiac disorders: Uncommon: Syncope, hypotension, tachycardia, oedema Common: Dizziness Nervous system disorders: Uncommon: Orthostatic dizziness Not known: Headache Ear and labyrinth disorders Not known: Tinnitus Respiratory, thoracic and Not known: Cough mediastinal disorders: Common: Nausea/vomiting Gastrointestinal disorders: Uncommon: Diarrhoea Not known: Dyspepsia, dysgeusia Common: Abnormal urination Impaired renal function Renal and urinary disorders: Not known: including isolated cases of renal failure in patients at risk (see section 4.4) Musculoskeletal and connective Uncommon: Swelling extremity tissue disorders: Not known: Arthralgia, myalgia Metabolism and nutrition Not known: Hyperkalaemia disorders: Vascular disorders: Uncommon: Flushing General disorders and Common: Fatigue administration site conditions:

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10–11

HOS-211980 · Präparat HOS-154792

10  Cases of hypersensitivity Immune system disorders: Not known: reactions such as angioedema, rash, urticaria Hepatobiliary disorders: Uncommon: Jaundice Not known: Hepatitis, abnormal liver function Reproductive system and breast Uncommon: Sexual dysfunction, libido disorders: changes

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11

HOS-211981 · Präparat HOS-154792

Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Irbesartan/Hydrochlorothiazide Teva. Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan/Hydrochlorothiazide Teva.

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11

HOS-211982 · Präparat HOS-154792

Table 2. Adverse reactions reported with the use of irbesartan alone General disorders and Uncommon: Chest pain administration site conditions: Blood and lymphatic system Not known: Anaemia, thrombocytopenia disorders: Gastrointestinal disorders: Rare: Intestinal angioedema Immune system disorders: Not known: Anaphylactic reaction including anaphylactic shock Metabolism and nutrition Not known: Hypoglycaemia disorders:

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11

HOS-211983 · Präparat HOS-154792

Table 3. Adverse reactions reported with the use of hydrochorothiazide alone Neoplasms benign, malignant Not known Non-melanoma skin cancer and unspecified (incl cysts and (Basal cell carcinoma and polyps) Squamous cell carcinoma) Electrolyte imbalance (including hypokalaemia and Investigations: Not known: hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides Cardiac disorders: Not known: Cardiac arrhythmias Aplastic anaemia, bone marrow depression, Blood and lymphatic system Not known: neutopenia/agranulocytosis, disorders: haemolytic anaemia, leucopenia, thrombocytopenia Nervous system disorders: Not known: Vertigo, paraesthesia, light- headedness, restlessness Eye disorders: Not known: Transient blurred vision, xanthopsia, choroidal effusion, acute myopia and secondary acute angle-closure glaucoma Respiratory, thoracic and Very rare: Acute respiratory distress mediastinal disorders: syndrome (ARDS) (see section 4.4) Not known: Respiratory distress (including pneumonitis and pulmonary oedema)

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11–12

HOS-211984 · Präparat HOS-154792

11  Pancreatitis, anorexia, Gastrointestinal disorders: Not known: diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite Renal and urinary disorders: Not known: Interstitial nephritis, renal dysfunction Anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous Skin and subcutaneous tissue Not known lupus erythematosus-like disorders: reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria Musculoskeletal and connective Not known: Weakness, muscle spasm tissue disorders: Vascular disorders: Not known: Postural hypotension General disorders and Not known: Fever administration site conditions: Hepatobiliary disorders: Not known: Jaundice (intrahepatic cholestatic jaundice) Psychiatric disorders: Not known: Depression, sleep disturbances

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12

HOS-211985 · Präparat HOS-154792

The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12

HOS-211986 · Präparat HOS-154792

Description of selected adverse reactions Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose- dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).

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

Nebenwirkungen · Irbesartan/Hydrochlorothiazide Teva

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12

HOS-211987 · Präparat HOS-154792

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.