Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-112381 · Präparat HOS-093659

Other forms of interaction Cholestagel did not induce any clinically significant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year. However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption. In these patients, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.

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): vitamin K (HOS-091176) vitamin A (HOS-087475)

Nebenwirkungen · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-112383 · Präparat HOS-093659

Summary of the safety profile The most frequently occurring adverse reactions are flatulence and constipation, found within the gastrointestinal disorders system organ class.

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

Nebenwirkungen · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-112384 · Präparat HOS-093659

Tabulated list of adverse reactions In controlled clinical studies involving approximately 1400 patients and during post-approval use, the following adverse reactions were reported in patients given Cholestagel.

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

Nebenwirkungen · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-112385 · Präparat HOS-093659

The reporting rate is classified 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) and 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 · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-112386 · Präparat HOS-093659

Nervous system disorders Common: Headache Gastrointestinal disorders Very common: Flatulence*, constipation* Common: Vomiting, diarrhoea*, dyspepsia*, abdominal pain, abnormal stools, nausea, abdominal distension Uncommon: Dysphagia Very rare: Pancreatitis Not known: Intestinal obstruction*,** Musculoskeletal and connective tissue disorders Uncommon: Myalgia Investigations Common: Serum triglycerides increased Uncommon :Serum transaminases increased * see section below for further information ** adverse reactions from post-marketing experience

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

Nebenwirkungen · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-112387 · Präparat HOS-093659

Description of selected adverse events The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies. Only constipation and dyspepsia were reported by a higher percentage among those receiving Cholestagel, compared with placebo.

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

Nebenwirkungen · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-112388 · Präparat HOS-093659

The incidence of intestinal obstruction is likely to be increased among patients with a history of bowel obstruction or removal.

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

Nebenwirkungen · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6–7

HOS-112389 · Präparat HOS-093659

6 Cholestagel in combination with statins and in combination with ezetimibe was well tolerated and the adverse reactions observed were consistent with the known safety profile of statins or ezetimibe alone.

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

Nebenwirkungen · Cholestagel

Cholestagel 625 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-112390 · Präparat HOS-093659

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.

Wechselwirkungen · Orphacol

Orphacol 50 mg hard capsules Orphacol 250 mg hard capsules · Abschnitt 4.5 · PDF-Seite 5

HOS-213190 · Präparat HOS-155060

Bile acid sequestrants (cholestyramine, colestipol, colesevelam) and certain antacids (e.g. aluminium hydroxide) bind bile acids and lead to their elimination. Administration of these medicinal products is expected to reduce the effect of cholic acid. The dose of bile acid sequestrants or antacids must be separated from the dose of cholic acid by an interval of 5 hours, regardless of which medicinal product is administered first.

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): colestipol (HOS-089168) lead (HOS-085592) colesevelam (HOS-112356)

Wechselwirkungen · Lojuxta

Lojuxta 2 mg hard capsules Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11–12

HOS-127372 · Präparat HOS-096397

11  Medicinal Effects on lomitapide levels Recommendation concerning products co-administration with lomitapide Bile acid Lomitapide has not been tested for Because bile acid sequestrants can interfere sequestrants interaction with bile acid with the absorption of oral medicines, bile sequestrants (resins such as acid sequestrants should be taken at least colesevelam and cholestyramine). 4 hours before or at least 4 hours after Lojuxta.

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): colesevelam (HOS-112356)

Wechselwirkungen · Amglidia

AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension · Abschnitt 4.5 · PDF-Seite 7

HOS-226721 · Präparat HOS-217644

Colesevelam binds to glibenclamide and reduces glibenclamide absorption from the gastrointestinal tract. No interaction was observed when glibenclamide was taken at least 4 hours before colesevelam. Therefore, glibenclamide should be administered at least 4 hours prior to colesevelam.

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): colesevelam (HOS-112356)

Wechselwirkungen · Amglidia

AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension · Abschnitt 4.5 · PDF-Seite 8–10

HOS-226728 · Präparat HOS-217644

Anabolic steroids and male Potentiation of the Hypoglycaemia sex hormones blood-glucose lowering effect Barbiturates Weakening of the Increased blood-glucose blood-glucose lowering levels effect Beta-receptor blockers Potentiation of the Hypoglycaemia blood-glucose lowering effect Signs of adrenergic Incorrect control of plasma counter-regulation to glucose hypoglycaemia may be reduced or absent Biguanides Potentiation of the Hypoglycaemia blood-glucose lowering effect Bosentan Increase liver enzymes Incorrect control of plasma glucose Calcium channel blockers Weakening of the blood- Increased blood-glucose glucose-lowering effect levels Chloramphenicol Potentiation of the Hypoglycaemia blood-glucose lowering effect Cimetidine Weakening of the blood- Increased blood-glucose glucose lowering effect levels Clarithromycin Potentiation of the blood- Hypoglycaemia glucose lowering effect Clonidine Potentiation of the blood- Hypoglycaemia glucose lowering effect Potentiation or weakening of Incorrect control of plasma the blood-glucose lowering glucose effect Signs of adrenergic counter- Incorrect control of plasma regulation to hypoglycaemia glucose may be reduced or absent Weakening of the blood- Increased blood-glucose glucose lowering effect levels Colesevelam Reduction of glibenclamide Incorrect control of plasma absorption from the glucose gastrointestinal tract Corticosteroids Weakening of the blood- Increased blood-glucose glucose lowering effect levels Coumarin derivatives Potentiation of the blood- Hypoglycaemia glucose lowering effect Potentiate or weaken the Incorrect dose of coumarin effect of coumarin derivatives administered derivatives Cyclophosphamides Potentiation of the blood- Hypoglycaemia glucose lowering effect Diazoxide Weakening of the blood- Increased blood-glucose glucose lowering effect levels Disopyramide Potentiation of the blood- Hypoglycaemia glucose lowering effect Diuretics Weakening of the blood- Increased blood-glucose glucose lowering effect levels Fenfluramine Potentiation of the blood- Hypoglycaemia glucose lowering effect Fenyramidol Potentiation of the blood- Hypoglycaemia glucose lowering effect Fibrates Potentiation of the blood- Hypoglycaemia glucose lowering effect Fluoxetine Potentiation of the blood- Hypoglycaemia glucose lowering effect Glucagon Weakening of the blood- Increased blood-glucose glucose lowering effect levels Guanethidine Potentiation of the blood- Hypoglycaemia glucose lowering effect Signs of adrenergic counter- Incorrect control of plasma regulation to hypoglycaemia glucose may be reduced or absent H2-receptor antagonists Potentiation or weakening of Incorrect control of plasma the blood-glucose lowering glucose effect Heparin Potentiation of the blood- Hypoglycaemia glucose lowering effect Ifosfamide Potentiation of the blood- Hypoglycaemia glucose lowering effect Insulin Potentiation of the blood- Hypoglycaemia glucose lowering effect Isoniazid Weakening of the blood- Increased blood-glucose glucoselowering effect levels Large doses of laxatives Weakening of the blood- Increased blood-glucose glucose lowering effect levels Long-acting Potentiation of the blood- Hypoglycaemia sulphonamides glucose lowering effect MAO inhibitors Potentiation of the blood- Hypoglycaemia glucose lowering effect Miconazole Potentiation of the blood- Hypoglycaemia glucose lowering effect Nicotinic acid (in high Weakening of the blood- Increased blood-glucose doses) glucose lowering effect levels Oestrogens Weakening of the blood- Increased blood-glucose glucose lowering effect levels Other oral antidiabetics Potentiation of the blood- Hypoglycaemia glucose lowering effect Oxypentifylline Potentiation of the blood- Hypoglycaemia glucose lowering effect Oxyphenbutazone Potentiation of the blood- Hypoglycaemia glucose lowering effect Phenothiazine derivatives Weakening of the blood- Increased blood-glucose glucose lowering effect levels Phenytoin Weakening of the blood- Increased blood-glucose glucose lowering effect levels Phosphamides Potentiation of the blood- Hypoglycaemia glucose lowering effect Probenecid Potentiation of the blood- Hypoglycaemia glucose lowering effect Progestogens Weakening of the blood- Increased blood-glucose glucose lowering effect levels Quinolone antibiotics Potentiation of the blood- Hypoglycaemia glucose lowering effect Reserpine Potentiation of the blood- Hypoglycaemia glucose lowering effect Potentiation or weakening of Incorrect control of plasma  the blood-glucose lowering glucose effect Signs of adrenergic counter- Incorrect control of plasma regulation to hypoglycaemia glucose may be reduced or absent Rifampicin Weakening of the blood- Increased blood-glucose glucose lowering effect levels Thyroid hormones Weakening of the blood- Increased blood-glucose glucose lowering effect levels Salicylates Potentiation of the blood- Hypoglycaemia glucose lowering effect Sulfamethoxazole with Potentiation of the blood- Hypoglycaemia trimethoprim (Co- glucose lowering effect trimoxazole) Tetracycline compounds Potentiation of the blood- Hypoglycaemia glucose lowering effect Tritoqualine Potentiation of the blood- Hypoglycaemia glucose lowering effect

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): sulfamethoxazole (HOS-084533) trimethoprim (HOS-085184) fenfluramine (HOS-115627) tetracycline (HOS-115153) cimetidine (HOS-085835) clonidine (HOS-088594) diazoxide (HOS-088588) glucose (HOS-088412) coumarin (HOS-088372) heparin (HOS-086930) ifosfamide (HOS-091529) calcium (HOS-085615) disopyramide (HOS-085595) clarithromycin (HOS-084517) probenecid (HOS-085208) tritoqualine (HOS-115631) fluoxetine (HOS-085946) chloramphenicol (HOS-115623) guanethidine (HOS-088596) bosentan (HOS-086291) colesevelam (HOS-112356) isoniazid (HOS-088590) reserpine (HOS-088597) phenytoin (HOS-084531) glucagon (HOS-088589) miconazole (HOS-115630) oxyphenbutazone (HOS-226734)

Wechselwirkungen · Lyvdelzi (previously Seladelpar Gilead)

Lyvdelzi 10 mg hard capsules · Abschnitt 4.5 · PDF-Seite 4

HOS-289923 · Präparat HOS-287268

Bile acid binding resins such as cholestyramine, colestipol, or colesevelam, may reduce the absorption of other medicinal products administered concurrently. Patients should take seladelpar at least 4 hours before or 4 hours after taking a bile acid binding resin.

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): colestipol (HOS-089168) seladelpar (HOS-289907) colesevelam (HOS-112356)