GERMAN

4. Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei jedem auftreten müssen. Viele der bekannten unerwünschten Wirkungen sind auf die anticholinergen Eigenschaften von XXXXXXXX zurückzuführen. Diese anticholinergen Effekte sind im Allgemeinen mild und selbstlimitierend. Bei den Häufigkeitsangaben zu Nebenwirkungen werden folgende Kategorien zugrunde gelegt:

Sehr häufig: mehr als 1 Behandelter von 10
Häufig: 1 bis 10 Behandelte von 100
Gelegentlich: 1 bis 10 Behandelte von 1.000
Selten: 1 bis 10 Behandelte von 10.000
Sehr selten: weniger als 1 Behandelter von 10.000
Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar

Erkrankungen des Immunsystems
Gelegentlich: Hautreaktionen, z. B. Nesselsucht (Urtikaria), Juckreiz
Nicht bekannt: Atemnot (Dyspnoe), Überempfindlichkeitsreaktionen, schwere Überempfindlichkeitsreaktionen bis zum anaphylaktischen Schock mit Blutdruckabfall und Hitzegefühl (Flush)

Herzerkrankungen
Gelegentlich: Steigerung der Herzfrequenz

Gefäßerkrankungen
Gelegentlich: Blutdruckabfall, Schwindel

Augenerkrankungen
Sehr selten: Störungen des „Nah-Sehens“ (Akkommodationsstörungen), starke Augenschmerzen bei „Grünem Star“ (Glaukomanfall)

Erkrankungen des Magen-Darm-Systems
Gelegentlich: Mundtrockenheit (Hemmung der Speichelsekretion), Durchfall, Übelkeit, Erbrechen, Magenbeschwerden

Erkrankungen der Haut und des Unterhautzellgewebes
Gelegentlich: Trockene Haut (Hemmung der Schweißsekretion)

Erkrankungen der Nieren und Harnwege
Selten: Störungen beim Wasserlassen wie z. B. Harnverhaltung, Nachtröpfeln, verminderter Harnstrahl

Allgemeine Erkrankungen
Gelegentlich: Müdigkeit

ENGLISH

4. What are the possible side effects?

Like all medications, this medication can also have side effects, but they need not occur for everyone. Many of the known unwanted effects can be attributed to the anticholinergic properties of XXXXXXXX. These anticholinergic effects are generally mild and self-limiting. The frequency data for side effects is based on the following categories:

Very common: more than 1 treated patient out of 10
Common: 1 to 10 treated patients out of 100
Occasional: 1 to 10 treated patients out of 1,000
Rare: 1 to 10 treated patients out of 10,000
Very rare: less than 1 treated patient out of 10,000
Not known: Frequency cannot be estimated based on the available data

Immunological diseases
Occasional: Skin reactions, e.g. urticaria, itching
Not known: Shortness of breath (dyspnea), hypersensitivity reactions, severe hypersensitivity reactions up to anaphylactic shock with blood pressure drop and heat sensation (flushing).

Cardiac diseases
Occasional: Increased heart rate

Vascular diseases
Occasional: Blood pressure drop, dizziness

Eye diseases
Very rare: “Near vision” problems (accommodation problems), severe eye pain with acute glaucoma

Gastrointestinal diseases
Occasional: Dry mouth (inhibition of saliva secretion), diarrhea, nausea, vomiting, stomach troubles

Skin and hypodermal diseases
Occasional: Dry skin (inhibition of sweat secretion)

Kidney and urinary tract diseases
Rare: Problems with urination such as urinary retention, leakage, reduced urine stream

General diseases
Occasional: Fatigue

ITALIAN

Uso negli anziani: Negli studi clinici non è stata dimostrata nessuna differenza legata all'età nei profili di efficacia o di sicurezza dell'alendronato. Non è pertanto necessario alcun aggiustamento del dosaggio nei pazienti anziani.

Uso in caso di alterazione della funzione renale: Non è necessario aggiustare il dosaggio nei pazienti con GFR (velocità di filtrazione glomerulare) maggiore di 35 ml/min. L'alendronato non è raccomandato in pazienti con funzione renale compromessa quando la GFR è minore di 35 ml/min, in quanto non sono disponibili informazioni in proposito.

Pazienti pediatrici: l'uso dell'alendronato sodico non è raccomandato in bambini di età inferiore a 18 anni a causa dei dati insufficienti sulla sicurezza e sull'efficacia nelle condizioni associate con l'osteoporosi pediatrica (vedere anche paragrafo 5.1).

ENGLISH

Use in elderly patients: No difference in the efficacy or safety profiles of alendronate linked to age has been demonstrated in clinical studies.  Therefore, it is not necessary to adjust the dosage in elderly patients.

Use in case of changes in kidney function: It is not necessary to adjust the dosage in patients with a GFR (glomerular filtration rate) greater than 35 ml/min. Alendronate is not recommended in patients with compromised kidney function if the GFR is less than 35 ml/min, since information in this regard is not available.

Pediatric patients: the use of sodium alendronate is not recommended in children under 18 years of age due to insufficient data on safety and efficacy for conditions associated with pediatric osteoporosis (see also paragraph 5.1).

DUTCH

Overschakelen van XXXX tabletten naar XXXX drank

Het wordt niet aanbevolen om van XXXX tabletten naar XXXX drank over te schakelen tenzij dit klinisch nodig is. Als omschakeling van XXXX tabletten naar XXXX drank om klinische redenen noodzakelijk is, moet de xxxxxxxx dosis worden aangepast zoals hieronder in de tabel wordt beschreven en moet de bloeddruk nauwkeurig worden gevolgd. De dosis moet getitreerd worden afhankelijk van de bloeddruk en tolerantie.

Als omschakeling van XXXX drank naar XXXX tabletten om klinische redenen noodzakelijk is, moet dezelfde aanvangsdosis in milligram worden toegediend. Vervolgens moet regelmatig de bloeddruk worden gevolgd terwijl men rekening houdt met de mogelijkheid van onderdosering en moet verder worden getitreerd gebaseerd op de respons van de bloeddruk en tolerantie. XXXX tabletten zijn niet geschikt voor kinderen in de leeftijd van 1 tot 5 jaar oud en voor degenen die moeilijkheden hebben met het inslikken van tabletten.

ENGLISH

Switching from XXXX tablets to XXXX oral solution

It is not recommended to switch from XXXX tablets to XXXX oral solution unless clinically necessary. If it is necessary to switch from XXXX tablets to XXXX oral solution for clinical reasons, the xxxxxxxx dosage must be adjusted as described below in the table, and the blood pressure must be monitored closely. The dosage must be titrated depending on blood pressure and tolerance.

If it is necessary to switch from XXXX oral solution to XXXX tablets for clinical reasons, the same starting dosage in milligrams must be administered. Subsequently, blood pressure must be monitored regularly while bearing in mind the possibility of underdosing, and titration must continue to be based on the blood pressure response and tolerance. XXXX tablets are not suitable for children from 1 to 5 years of age or for those who have trouble swallowing tablets.

SPANISH

En particular, la Nanomedicina es un ámbito de investigación científico y tecnológico interdisciplinario que pretende mediante el desarrollo y la aplicación de la nanotecnologia, mejorar el diagnóstico, tratamiento y prevención de enfermedades y lesiones traumáticas, así como preservar y mejorar la salud y calidad de vida. Para ello, la Nanomedicina pretende mejorar el conocimiento y comprensión del cuerpo humano a nivel molecular con el fin de poder analizar, supervisar, controlar, reparar, reconstruir y mejorar cualquier sistema biológico humano. La Nanomedicina estudia las interacciones a la nanoescala (1 a 100 nanómetros) y para ello desarrolla y utiliza dispositivos, sistemas y tecnologías que incluyen nanoestructuras capaces de interactuar a escala molecular y que se interconectan en su caso con microsistemas para interaccionar a nivel celular o subcelular.

ENGLISH

In particular, nanomedicine is an interdisciplinary field of scientific and technological research that, by developing and applying nanotechnology, aims to improve the diagnosis, treatment and prevention of diseases and traumatic injuries, as well as to preserve and enhance health and quality of life. For this reason, nanomedicine aims to improve knowledge and comprehension of the human body at the molecular level, with the goal of analyzing, monitoring, examining, repairing, rebuilding and improving any human biological system whatsoever. Nanomedicine studies interactions at the nanoscale (1 to 100 nanometers), and, for this, it develops and uses devices, systems, and technologies that include nanostructures capable of interacting at the molecular scale, that interconnect in some cases with microsystems to interact at the cellular or subcellular level.

FRENCH

XXXXX S’ENGAGE À :

communiquer aux professionnels de santé et aux patients toutes les informations connues sur les bénéfices et les risques potentiels du produit étudié, avant de lancer un nouvel essai clinique. Nous surveillons étroitement la sécurité des produits au cours des essais cliniques selon les réglementations applicables et les bonnes pratiques cliniques, et nous fournissons aux professionnels de santé toutes les informations pertinentes au cours de l’étude;

assurer la bonne utilisation d’un produit depuis son lancement jusqu’à la fin de son cycle de vie en déployant tous les efforts pour fournir une brochure d’information du patient aussi claire et compréhensible que possible pour le patient; …

ENGLISH

XXXXX HEREBY UNDERTAKES TO:

communicate to health care professionals and patients all information known about the potential benefits and risks of the studied product before launching a new clinical trial. We shall strictly monitor the safety of the products in the course of the clinical trials according to the applicable regulations and good clinical practices, and we shall furnish to health care professionals all the pertinent information during the study;

ensure proper use of a product from its launch until the end of its life cycle, exerting all efforts to provide a patient information pamphlet that is as clear and understandable to the patient as possible; …