Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-122713 · Präparat HOS-095563

− Hypersensitivity to the active substances, to other sulphonamide derivatives, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1. − Second and third trimesters of pregnancy (see sections 4.4 and 4.6). − Hepatic impairment, biliary cirrhosis or cholestasis. − Severe renal impairment (GFR <30 ml/min/1.73 m2), anuria and patients undergoing dialysis. − Concomitant use of Dafiro HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1). − Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia. − Severe hypotension. − Shock (including cardiogenic shock). − Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis). − Haemodynamically unstable heart failure after acute myocardial infarction.

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

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-122714 · Präparat HOS-095563

No formal interaction studies with other medicinal products have been performed with Dafiro HCT. Thus, only information on interactions with other medicinal products that are known for the individual active substances is provided in this section.

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

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-122715 · Präparat HOS-095563

However, it is important to take into account that Dafiro HCT may increase the hypotensive effect of other antihypertensive agents.

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

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8–9

HOS-122716 · Präparat HOS-095563

8 Concomitant use not recommended

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

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-122717 · Präparat HOS-095563

Dafiro HCT Known interactions Effect of the interaction with other medicinal products individual with the following component agents Valsartan Lithium Reversible increases in serum lithium concentrations and and toxicity have been reported during concomitant HCT administration of lithium with ACE inhibitors, angiotensin II receptor antagonists including valsartan or thiazides. Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Dafiro HCT. Therefore careful monitoring of serum lithium concentrations is recommended during concomitant use. Valsartan Potassium-sparing If a medicinal product that affects potassium levels is diuretics, potassium considered necessary in combination with valsartan, supplements, salt frequent monitoring of potassium plasma levels is advised. substitutes containing potassium and other substances that may increase potassium levels Amlodipine Grapefruit or grapefruit Administration of amlodipine with grapefruit or grapefruit juice juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering 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): potassium (HOS-086929) lithium (HOS-085952)

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-122718 · Präparat HOS-095563

Caution required with concomitant use

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

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-122719 · Präparat HOS-095563

Dafiro HCT Known interactions Effect of the interaction with other medicinal products individual with the following component agents Amlodipine CYP3A4 inhibitors Concomitant use of amlodipine with strong or moderate (i.e. ketoconazole, CYP3A4 inhibitors (protease inhibitors, azole antifungals, itraconazole, ritonavir) macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure. The clinical translation of these pharmacokinetic variations may be more pronounced in the elderly. Clinical monitoring and dose adjustment may thus be required. CYP3A4 inducers Upon co-administration of known inducers of the (anticonvulsant agents CYP3A4, the plasma concentration of amlodipine may [e.g. carbamazepine, vary. Therefore, blood pressure should be monitored and phenobarbital, dose regulation considered both during and after phenytoin, concomitant medication particularly with strong CYP3A4 fosphenytoin, inducers (e.g. rifampicin, hypericum perforatum). primidone], rifampicin, Hypericum perforatum [St. John’s wort]) Simvastatin Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine.

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): fosphenytoin (HOS-110222) diltiazem (HOS-086288) protease (HOS-085623) phenobarbital (HOS-085617) ketoconazole (HOS-084513) carbamazepine (HOS-085618) simvastatin (HOS-086158) itraconazole (HOS-084516) clarithromycin (HOS-084517) erythromycin (HOS-084514) ritonavir (HOS-084521) phenytoin (HOS-084531) primidone (HOS-090551) verapamil (HOS-090602)

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9–11

HOS-122720 · Präparat HOS-095563

9  Dantrolene (infusion) In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene. Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia. Tacrolimus There is a risk of increased tacrolimus blood levels when co-administered with amlodipine. In order to avoid toxicity of tacrolimus, administration of amlodipine in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate. Valsartan Non-steroidal anti- NSAIDS can attenuate the antihypertensive effect of both and HCT inflammatory drugs angiotensin II antagonists and hydrochlorothiazide when (NSAIDs), including administered simultaneously. Furthermore, concomitant selective use of Dafiro HCT and NSAIDs may lead to worsening of cyclooxygenase-2 renal function and an increase in serum potassium. inhibitors (COX-2 Therefore, monitoring of renal function at the beginning of inhibitors), the treatment is recommended, as well as adequate acetylsalicylic acid hydration of the patient. (>3 g/day), and non- selective NSAIDs Valsartan Inhibitors of the uptake The results of an in vitro study with human liver tissue transporter (rifampicin, indicate that valsartan is a substrate of the hepatic uptake ciclosporin) or efflux transporter OATP1B1 and of the hepatic efflux transporter transporter (ritonavir) MRP2. Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan. HCT Alcohol, barbiturates Concomitant administration of thiazide diuretics with or narcotics substances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension. Amantadine Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine. Anticholinergic agents The bioavailability of thiazide-type diuretics may be and other medicinal increased by anticholinergic agents (e.g. atropine, products affecting biperiden), apparently due to a decrease in gastrointestinal gastric motility motility and the stomach emptying rate. Conversely, it is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics. Antidiabetic agents Thiazides may alter glucose tolerance. Dose adjustment of (e.g. insulin and oral the antidiabetic medicinal product may be necessary. antidiabetic agents) − Metformin Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide. Beta blockers and Concomitant use of thiazide diuretics, including diazoxide hydrochlorothiazide, with beta blockers may increase the risk of hyperglycaemia. Thiazide diuretics, including hydrochlorothiazide, may enhance the hyperglycaemic effect of diazoxide. Ciclosporin Concomitant treatment with ciclosporin may increase the risk of hyperuricaemia and gout-type complications. 10 Cytotoxic agents Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects. Digitalis glycosides Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects, favouring the onset of digitalis-induced cardiac arrhythmias. Iodine contrasting In case of diuretic-induced dehydration, there is an agents increased risk of acute renal failure, especially with high doses of iodine products. Patients should be re-hydrated before the administration. Ion exchange resins Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine or colestipol. This could result in sub-therapeutic effects of thiazide diuretics. However, staggering the dosage of hydrochlorothiazide and resin such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins would potentially minimise the interaction. Medicinal products The hypokalaemic effect of hydrochlorothiazide may be affecting serum increased by concomitant administration of kaliuretic potassium level diuretics, corticosteroids, laxatives, adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G and salicylic acid derivatives or antiarrhythmics. If these medicinal products are to be prescribed with the amlodipine /valsartan /hydrochlorothiazide combination, monitoring of potassium plasma levels is advised. Medicinal products The hyponatraemic effect of diuretics may be intensified affecting serum sodium by concomitant administration of medicinal products such level as antidepressants, antipsychotics, antiepileptics, etc. Caution is indicated in long-term administration of these medicinal products. Medicinal products that Due to the risk of hypokalaemia, hydrochlorothiazide could induce torsades should be administered with caution when associated with de pointes medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics. Medicinal products Dose adjustment of uricosuric medicinal products may be used in the treatment of necessary as hydrochlorothiazide may raise the level of gout (probenecid, serum uric acid. Increase of dose of probenecid or sulfinpyrazone and sulfinpyrazone may be necessary. allopurinol) Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol. Methyldopa There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa. Non-depolarising Thiazides, including hydrochlorothiazide, potentiate the skeletal muscle action of curare derivatives. relaxants (e.g. tubocurarine) Other anti-hypertensive Thiazides potentiate the antihypertensive action of other medicinal products antihypertensive drugs (e.g. guanethidine, methyldopa, beta-blockers, vasodilators, calcium channel blockers, ACE inhibitors, ARBs and Direct Renin Inhibitors [DRIs]).

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) sulfinpyrazone (HOS-089177) sodium (HOS-109681) cisapride (HOS-085610) allopurinol (HOS-089178) diazoxide (HOS-088588) colestipol (HOS-089168) dantrolene (HOS-109261) atropine (HOS-089182) glucose (HOS-088412) amphotericin (HOS-088524) salicylic acid (HOS-088803) calcium (HOS-085615) lead (HOS-085592) amantadine (HOS-086615) biperiden (HOS-085953) probenecid (HOS-085208) uric acid (HOS-089176) tacrolimus (HOS-085202) cyclophosphamide (HOS-084539) guanethidine (HOS-088596) ritonavir (HOS-084521) potassium (HOS-086929) methyldopa (HOS-086564) penicillin G (HOS-121627) tubocurarine (HOS-089174) carbenoxolone (HOS-089156) iodine (HOS-087479) metformin (HOS-091032) methotrexate (HOS-087522) verapamil (HOS-090602)

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-122721 · Präparat HOS-095563

11  Pressor amines (e.g. Hydrochlorothiazide may reduce the response to pressor noradrenaline, amines such as noradrenaline. The clinical significance of adrenaline) this effect is uncertain and not sufficient to preclude their use. Vitamin D and calcium Administration of thiazide diuretics, including salts hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium. Concomitant use of thiazide type diuretics may lead to hypercalcaemia in patients pre-disposed for hypercalcaemia (e.g. hyperparathyroidism, malignancy or vitamin-D-mediated conditions) by increasing tubular calcium reabsorption.

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): calcium (HOS-085615) lead (HOS-085592) vitamin D (HOS-086114)

Wechselwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-122722 · Präparat HOS-095563

Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Clinical trial data have shown that dual blockade of the RAAS through the combined use of ACE inhibitors, ARBs 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): aliskiren (HOS-086927)

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-122723 · Präparat HOS-095563

The safety profile of Dafiro HCT presented below is based on clinical studies performed with Dafiro HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.

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

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-122724 · Präparat HOS-095563

Summary of the safety profile

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

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-122725 · Präparat HOS-095563

The safety of Dafiro HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide. Adverse reactions were generally mild and transient in nature and only infrequently required discontinuation of therapy. In this active controlled

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

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14

HOS-122726 · Präparat HOS-095563

13  clinical trial, the most common reasons for discontinuation of therapy with Dafiro HCT were dizziness and hypotension (0.7%).

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

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14

HOS-122727 · Präparat HOS-095563

In the 8-week controlled clinical study, no significant new or unexpected adverse reactions were observed with triple therapy treatment compared to the known effects of the monotherapy or dual therapy components.

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

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14

HOS-122728 · Präparat HOS-095563

In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Dafiro HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents. The presence of valsartan in the triple combination attenuated the hypokalaemic effect of hydrochlorothiazide.

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

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14

HOS-122729 · Präparat HOS-095563

Tabulated list of adverse reactions

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

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14

HOS-122730 · Präparat HOS-095563

The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Dafiro HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually. 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 · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14

HOS-122731 · Präparat HOS-095563

MedDRA Adverse reactions Frequency System Organ Dafiro Amlodipine Valsartan HCT Class HCT Neoplasms Non-melanoma skin cancer -- -- -- Not known benign, (Basal cell carcinoma and malignant and Squamous cell carcinoma) unspecified (incl cysts and polyps) Blood and Agranulocytosis, bone -- -- -- Very rare lymphatic system marrow failure disorders Haemoglobin and -- -- Not known -- haematocrit decreased Haemolytic anaemia -- -- -- Very rare Leukopenia -- Very rare -- Very rare Neutropenia -- -- Not known -- Thrombocytopenia, -- Very rare Not known Rare sometimes with purpura Aplastic anaemia -- -- -- Not known Immune system Hypersensitivity -- Very rare Not known Very rare disorders Metabolism and Anorexia Uncommon -- -- -- nutrition Hypercalcaemia Uncommon -- -- Rare disorders Hyperglycaemia -- Very rare -- Rare Hyperlipidaemia Uncommon -- -- -- Hyperuricaemia Uncommon -- -- Common Hypochloraemic alkalosis -- -- -- Very rare Hypokalaemia Common -- -- Very common Hypomagnesaemia -- -- -- Common Hyponatraemia Uncommon -- -- Common Worsening of diabetic -- -- -- Rare metabolic state Psychiatric Depression -- Uncommon -- Rare disorders Insomnia/sleep disorders Uncommon Uncommon -- Rare Mood swings -- Uncommon -- Confusion -- Rare -- --

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

Nebenwirkungen · Dafiro HCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14–15

HOS-122732 · Präparat HOS-095563

14 Nervous system Coordination abnormal Uncommon -- -- -- disorders Dizziness Common Common -- Rare Dizziness postural, dizziness Uncommon -- -- -- exertional Dysgeusia Uncommon Uncommon -- -- Extrapyramidal syndrome -- Not known -- -- Headache Common Common -- Rare Hypertonia -- Very rare -- -- Lethargy Uncommon -- -- -- Paraesthesia Uncommon Uncommon -- Rare Peripheral neuropathy, Uncommon Very rare -- -- neuropathy Somnolence Uncommon Common -- -- Syncope Uncommon Uncommon -- -- Tremor -- Uncommon -- -- Hypoesthesia -- Uncommon -- -- Eye disorders Acute angle-closure -- -- -- Not known glaucoma Visual disturbance -- Uncommon -- -- Visual impairment Uncommon Uncommon -- Rare Choroidal effusion -- -- -- Not Known Ear and labyrinth Tinnitus -- Uncommon -- -- disorders Vertigo Uncommon -- Uncommon -- Cardiac disorders Palpitations -- Common -- -- Tachycardia Uncommon -- -- -- Arrhythmias (including -- Very rare -- Rare bradycardia, ventricular tachycardia, and atrial fibrillation) Myocardial infarction -- Very rare -- -- Vascular Flushing -- Common -- -- disorders Hypotension Common Uncommon -- -- Orthostatic hypotension Uncommon -- -- Common Phlebitis, thrombophlebitis Uncommon -- -- -- Vasculitis -- Very rare Not known -- Respiratory, Cough Uncommon Very rare Uncommon -- thoracic and Dyspnoea Uncommon Uncommon -- -- mediastinal Acute respiratory distress -- -- -- Very rare disorders syndrome (ARDS) (see section 4.4) Respiratory distress, -- -- -- Very rare pulmonary oedema, pneumonitis Rhinitis -- Uncommon -- -- Throat irritation Uncommon -- -- --

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