Swissmedic Nr.: 38840010
Index: 07.07.22
Pharmacode: 1580494
GTIN/EAN: 7680388400109
Markteintritt: 11.11.1975
Kategorie: B Charges répétée sur une prescription médicale.
(0/5 , 1568)Pour obtenir du Spiricort® (5 mg), vous devez disposer d'une prescription médicale.
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Nous pouvons organiser l'envoi du Spiricort® (5 mg) par la poste
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Spiricort contient comme principe actif la prednisolone, une hormone synthétique, qui appartient aux corticostéroïdes. Les corticostéroïdes sont des hormones qui sont produites dans l?organisme par la glande surrénale. Ils ont un effet sur les processus vitaux de l?organisme, comme par exemple l?équilibre hydrique, le métabolisme des sels minéraux et l?adaptation de l?organisme aux situations stressantes. Indépendamment de l?affection de base, Spiricort inhibe en outre, comme tous les corticostéroïdes, les réactions inflammatoires et allergiques.
Spiricort est utilisé sur prescription du médecin et sous contrôle médical constant dans le traitement de toutes les affections qui exigent un traitement général par les corticostéroïdes. Parmi celles-ci:
les affections rhumatismales (par exemple polyarthrite chronique, arthroses, inflammation rhumatismale du coeur, inflammations des bourses séreuses ou des gaines synoviales tendineuses, tennis elbow) comme traitement adjuvant à court terme durant une poussée aiguë ou, dans des cas sélectionnés, comme traitement continu à faible dose;
maladies cutanées inflammatoires graves (par exemple eczéma généralisé, psoriasis);
formes sévères des affections allergiques (par exemple asthme bronchique, rhume des foins, réactions d?hypersensibilité aux médicaments, eczémas de contact) lorsque celles-ci ne répondent pas ou ne répondent pas suffisamment aux traitements conventionnels;
certaines maladies du sang (par exemple certaines formes d?anémie);
certaines maladies des reins (par exemple syndrome néphrotique);
comme traitement adjuvant dans certaines proliférations malignes (tumeurs) des globules blancs (certaines formes de leucémies) et de certains organes (par exemple tumeur des ganglions lymphatiques);
certaines maladies gastro-intestinales (par exemple durant les phases critiques de la destruction de la paroi intestinale semblable à des ulcères, appelée colite ulcéreuse ou entérite régionale);
accumulation accrue de liquide dans les tissus (oedèmes), par exemple en cas de tumeur au cerveau ou d?opérations du cerveau;
troubles hormonaux dans les affections de certains organes (par exemple en cas d?hypofonction des glandes surrénales). Dans un tel cas, le médecin prescrira un corticoïde minéral. Chez les enfants, la prise simultanée de cette seconde préparation est particulièrement importante.
En général, Spiricort n?est pas utilisé comme substitution, mais comme traitement adjuvant de la maladie de base.
L?observation des recommandations suivantes contribue à l?amélioration de la tolérance d?un traitement au long cours:
pas de prise de poids (se peser tous les jours, adaptation du poids par l?adaptation de l?apport calorifique);
ne consommer du sel et du sucre qu?en très petites quantités;
alimentation riche en potassium si possible (fruits et légumes, en particulier abricots et bananes);
apport suffisant en calcium (lait, produits laitiers);
quantité suffisante de protéines dans l?alimentation.
Il ne faut pas prendre Spiricort en cas d?hypersensibilité au principe actif, la prednisolone.
Il convient de renoncer à un traitement prolongé par Spiricort dans les maladies ou états suivants: infections générales par des amibes ou des champignons (mycoses), ulcères gastriques et intestinaux, infections bactériennes et affections virales (herpès [zona], rougeole, varicelle, poliomyélite), fragilité osseuse extrêmement élevée (ostéoporose), tension artérielle difficile à contrôler par les médicaments, pression intra-oculaire élevée (glaucome), insuffisance rénale, diabète sévère, tuberculose pulmonaire et osseuse active, affections musculaires graves, altérations des ganglions lymphatiques secondaires à une vaccination contre la tuberculose et environ 8 semaines avant et jusqu?à 2 semaines après l?administration d?un vaccin vivant (par exemple contre la varicelle ou la rougeole).
Votre médecin sait ce qu?il faut faire dans de tels cas. Dans les cas d?urgence, il peut décider de vous prescrire également les comprimés pelliculés dans ces maladies pour un traitement à court terme (d?une durée de quelques jours au maximum).
Chez les enfants de moins de 12 ans, le médecin se limitera en général à prescrire Spiricort uniquement dans les cas d?urgence.
Ce médicament peut affecter les réactions, l?aptitude à la conduite et l?aptitude à utiliser des outils ou des machines!
Dans les affections suivantes, l?utilisation ne doit se faire que sur prescription médicale expresse: diabète sucré, tuberculose, hypertension, insuffisance cardiaque et rénale, infarctus du myocarde récent, maladie hépatique grave, hypofonction de la glande thyroïde, maladies accompagnées de troubles hormonaux (par exemple maladie de Cushing), faiblesse musculaire, troubles psychiques (par exemple dépressions, psychoses).
Veuillez absolument informer votre médecin si vous souffrez de diabète car le traitement par Spiricort peut détériorer le métabolisme du sucre. Chez les patient(e)s diabétiques et chez les patient(e)s présentant des antécédents familiaux, le médecin procédera par conséquent à des contrôles plus fréquents de la glycémie, et il est possible qu?il doive réajuster la posologie des médicaments contre une glycémie trop élevée.
Veuillez absolument informer votre médecin si vous avez eu l?une des maladies suivantes: maladies contagieuses (par exemple tuberculose), troubles cardiocirculatoires (tension artérielle élevée, faiblesse cardiaque, infarctus du myocarde), maladies gastro-intestinales comme ulcères (Ulcus), destruction de la paroi intestinale semblable à un ulcère (colite ulcéreuse), inflammations des diverticules (diverticulite), diarrhée chronique, affections hépatiques ou rénales graves, maladies accompagnées de troubles hormonaux, affections osseuses (ostéoporose), faiblesse musculaire (Myasthenia gravis), glaucome, caillots de sang dans les jambes ou dans le poumon (thrombose, embolie), troubles psychiques (par exemple dépressions, psychoses).
Chez les femmes durant la ménopause ou après celle-ci, mais également chez les hommes âgés, le médecin surveillera le traitement par Spiricort de façon particulièrement rigoureuse en raison de la tendance accrue à l?ostéoporose.
Etant donné que la prise prolongée de corticostéroïdes peut provoquer une opacité du cristallin (cataracte) ou une pression intra-oculaire accrue (glaucome), le médecin vous fera éventuellement examiner périodiquement par l?ophtalmologue. Si vous souffrez d?un ulcère gastrique ou intestinal ou que vous avez eu un infarctus du myocarde il y a peu, une prudence accrue est de rigueur lors d?un traitement par Spiricort. Votre médecin discutera de la procédure avec vous.
Informez en outre votre médecin si vous devez suivre un régime particulier (avec peu de sel et/ou beaucoup de potassium), si vous êtes atteint(e) d?une blessure grave ou si vous avez été vacciné(e) avec des vaccins vivants, comme par exemple le vaccin contre la poliomyélite ou BCG (contre la tuberculose).
Vous ne devriez pas vous faire vacciner durant le traitement par Spiricort. Votre médecin sait ce qu?il faut faire dans ce cas précis. Veuillez également l?informer si vous vous êtes rendu(e) récemment dans des pays tropicaux.
Informez immédiatement votre médecin si une maladie infectieuse survient durant le traitement par Spiricort. Ceci est particulièrement important lorsque les enfants contractent la varicelle (ceci est rare chez les adultes), étant donné que la varicelle pourrait prendre une forme évolutive grave dans ces circonstances. Votre médecin sait ce qu?il faut faire dans ce cas précis. Si vous vous soumettez à un test médical, il est important d?informer le médecin concerné que vous prenez Spiricort, car comme tout corticostéroïde, cette préparation peut également fausser les résultats de certains tests cutanés.
Etant donné que les corticostéroïdes inhibent la croissance et le développement chez les enfants, Spiricort ne sera administré aux enfants qu?avec la plus grande prudence. Les instructions du médecin doivent être respectées rigoureusement.
De nombreux autres médicaments et Spiricort peuvent diminuer ou augmenter leur effet en cas d?administration concomitante. En font partie certains antibiotiques, certains médicaments qui doivent être pris afin d?empêcher des crampes déclenchées par le cerveau (en particulier les crampes semblables aux crampes épileptiques), pour l?apaisement psychique des états anxieux et des états d?excitation, pour la contraception («pilule») ainsi que pour le traitement de la faiblesse du myocarde, le diabète, les ulcères, une certaine forme de faiblesse musculaire (myasthénie) ou des troubles de la coagulation. La prudence est également de rigueur lorsque vous prenez simultanément certains médicaments contre les affections inflammatoires ou rhumatismales ou des médicaments diurétiques.
Seul votre médecin peut décider sous quelle forme le traitement par Spiricort et par l?un de ces médicaments doit être adapté.
Pendant le traitement par Spiricort, vous devriez renoncer à la consommation de boissons alcoolisées.
Veuillez informer votre médecin ou votre pharmacien si vous souffrez d?une autre maladie, si vous êtes allergique ou si vous prenez déjà d?autres médicaments en usage interne ou externe (même en automédication)!
Si vous êtes enceinte ou si vous désirez le devenir ou si vous allaitez votre enfant, vous devriez par mesure de précaution renoncer aux médicaments dans la mesure du possible.
Les principes actifs tels que Spiricort contient, traversent le placenta et passent également dans le lait maternel et peuvent entraver le développement de votre enfant. Par conséquent, le médicament ne doit être pris durant la grossesse, en particulier pendant les 3 premiers mois, que sur prescription médicale expresse et uniquement dans les cas d?urgence.
En cas de grossesse soupçonnée ou avérée, vous devriez en avertir le médecin avant de poursuivre la prise de Spiricort. Si un traitement par Spiricort devait s?avérer absolument nécessaire pendant la grossesse, le médecin examinera le nourrisson particulièrement rigoureusement après la naissance afin de déceler tout symptôme qui pourrait être attribué à Spiricort, et il instaurera, le cas échéant, le traitement qui s?impose.
Etant donné que les corticostéroïdes passent dans le lait maternel, il existe un risque d?effets indésirables chez le nourrisson. Par conséquent, vous ne devez pas prendre Spiricort si vous allaitez votre enfant ou vous devez arrêter l?allaitement.
Le médecin fixe la dose en fonction de chaque individu et en fonction de la nature et de la sévérité de l?affection. Le médecin décidera également si le traitement par Spiricort doit être précédé d?une injection intraveineuse («piqûre») d?un autre médicament du même type, si la posologie doit être augmentée au cours du traitement ou diminuée progressivement ou si le passage à un autre médicament du même type que Spiricort est nécessaire.
Comme prescrit par le médecin, Spiricort se prend une ou plusieurs fois par jour. En général, les adultes prennent au début du traitement 5 à 60 mg de Spiricort par jour. Afin d?éviter des troubles gastriques, prendre Spiricort au moment des repas. Dans les traitements au long cours, il peut être avantageux de prendre la dose journalière totale le matin avant 8 heures (en harmonie avec le rythme de la production autologue (par le propre corps) de corticostéroïdes; le plus important s?appelle cortisol).
Dès que votre état le permettra, le médecin diminuera autant que possible et progressivement la posologie afin d?atténuer ces effets secondaires.
Chez les enfants, le médecin prescrira une posologie qui s?oriente davantage au degré de sévérité de la maladie qu?à l?âge et qu?au poids corporel.
Si vous avez oublié de prendre ou d?administrer une dose, prenez ou administrez le médicament dès que vous y pensez. Si vous vous apercevez cependant de l?oubli au moment de la prise ou de l?administration de la dose suivante, ne prenez pas la dose oubliée et prenez ou administrez le comprimé pelliculé tout simplement au moment habituel et à la quantité qui vous a été prescrite par le médecin. Vous ne devez en aucun cas prendre ou administrer une double dose. Si vous avez pris considérablement plus de comprimés pelliculés que la quantité prescrite par votre médecin, vous devez en informer votre médecin immédiatement.
Etant donné que sous un traitement au long cours par les corticostéroïdes, la réaction du corps aux forts efforts soudains («stress», infections graves, blessures ou interventions chirurgicales) est perturbée, votre médecin augmentera éventuellement la posologie de Spiricort à titre provisoire avant, pendant et après de telles situations ou il vous prescrira en outre un autre médicament. Après un traitement au long cours, la réaction au stress peut dans certaines circonstances encore être perturbée jusqu?à un an après l?arrêt du traitement et rend une prise de corticostéroïdes à titre préventif nécessaire dans les situations stressantes! Votre médecin fixera la procédure à suivre.
Afin d?agir contre une perte accrue éventuelle de potassium et une accumulation accrue de sel ou d?eau durant un traitement prolongé par de hautes doses de Spiricort, votre médecin vous recommandera peut-être l?utilisation de sel diététique. Vous pouvez prévenir vous-même une perte de potassium en prenant Spiricort avec un verre de jus d?orange.
A la fin d?un traitement prolongé par les corticostéroïdes, des symptômes de manque tels que de la fièvre, un malaise, des douleurs musculaires ou articulaires, mais également des troubles sévères, voire même menaçants, peuvent se manifester qui sont causés par une défaillance fonctionnelle des glandes surrénales. Par conséquent, un traitement prolongé ne doit en aucun cas être arrêté brutalement; Spiricort doit être arrêté très lentement et progressivement (sur une période de plusieurs semaines à plusieurs mois) sous contrôle médical.
Après un traitement au long cours, il est nécessaire que vous continuiez également à être examiné par un médecin après l?arrêt de Spiricort afin que des troubles récidivants soient décelés précocement et puissent être traités.
Ne changez pas de votre propre chef le dosage prescrit. Adressez-vous à votre médecin ou à votre pharmacien si vous estimez que l?efficacité du médicament est trop faible ou au contraire trop forte.
La prise de Spiricort peut provoquer les effets secondaires suivants:
Sous un traitement par des corticostéroïdes, des effets indésirables surviennent en fonction de la puissance de la dose et de la durée du traitement. Spiricort est généralement bien toléré lors de l?utilisation à court terme. Lors de l?administration de hautes doses ou durant une période prolongée, des effets indésirables typiques des corticostéroïdes peuvent cependant se manifester:
Des accumulations de liquide dans les tissus (oedèmes, par exemple gonflement des mains et des pieds), une augmentation de l?appétit, une soif accrue, une prise de poids, un trouble de la répartition des graisses (comme le visage lunaire et l?obésité du tronc), une élévation de la tension artérielle, de la transpiration excessive, une fatigue ou une faiblesse inhabituelles, de la faiblesse musculaire, une fragilité osseuse élevée (ostéoporose), des troubles gastro-intestinaux (nausées, vomissements) avec le risque d?une récidive des ulcères gastro-intestinaux, des douleurs musculaires, des douleurs dans le dos ou des douleurs osseuses générales, un ralentissement de la cicatrisation, des altérations cutanées (lignes rouges, hémorragies cutanées sous forme de points, épanchements sanguins), des altérations des yeux (opacité du cristallin [cataracte], une pression intra-oculaire élevée [glaucome]), une augmentation de la disposition aux infections et à la formation de caillots de sang dans les vaisseaux sanguins (thromboses), des altérations psychiques (accompagnées d?altérations de l?humeur et de la personnalité qui peuvent aller de l?euphorie [impression intense de bien-être général] à la dépression et aux états psychotiques), des troubles de la libération des hormones sexuelles (ce qui chez l?homme peut entraîner de l?impuissance et chez la femme l?absence de règles et une augmentation de la pilosité corporelle [hirsutisme]).
Chez les enfants, des troubles de la croissance peuvent se manifester.
Sous un traitement par les corticostéroïdes, une détérioration du métabolisme des hydrates de carbone peut survenir (cf. ci-dessus: «Quelles sont les précautions à observer lors de la prise de Spiricort?»).
Si vous remarquez des effets secondaires, veuillez en avertir votre médecin.
Un traitement par les corticostéroïdes 8 semaines avant et jusqu?à 2 semaines après une vaccination peut diminuer l?immunisation ou la rendre nulle.
À l?exception d?une fragilité osseuse (ostéoporose), le glaucome, la cataracte et les troubles de la croissance durant l?enfance, les effets secondaires s?estompent en général de plus en plus après l?arrêt de la préparation. Veuillez avertir votre médecin si vous constatez des signes de cet effet secondaire.
À l?exception des effets secondaires mentionnés ci-dessus, d?autres effets secondaires peuvent également se manifester dans des cas isolés.
Si vous remarquez d?autres effets secondaires, veuillez en informer votre médecin ou votre pharmacien.
A conserver hors de la portée des enfants.
Le médicament ne doit pas être utilisé au-delà de la date figurant après la mention «EXP.» sur le récipient. Conserver à température ambiante (15?25 °C).
Pour de plus amples renseignements, consultez votre médecin ou votre pharmacien, qui disposent d?une information détaillée destinée aux professionnels.
1 comprimé pelliculé sécable de Spiricort 5, respectivement 20 ou 50 contient 5, respectivement 20 ou 50 mg de prednisolone, acide sorbique (E 200) comme agent de conservation ainsi que d?autres excipients. Spiricort 20 contient en outre le colorant E 132.
38840 (Swissmedic).
En pharmacie, sur ordonnance médicale.
Emballages de 20 et 100 comprimés pelliculés sécables (Spiricort 5, 20, 50).
Spirig HealthCare SA, 4622 Egerkingen.
Cette notice d?emballage a été vérifiée pour la dernière fois en août 2012 par l?autorité de contrôle des médicaments (Swissmedic).
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