Sevredol 10 инструкция по применению

Страна: Швейцария

Язык: немецкий

Источник: Swissmedic (Swiss Agency for Therapeutic Products)

Активный ингредиент:

morphinum

Доступна с:

Mundipharma Medical Company, Hamilton, Bermuda, Basel Branch

код АТС:

N02AA01

ИНН (Международная Имя):

morphinum

Фармацевтическая форма:

Filmtabletten

состав:

morphini sulfas pentahydricus 10 mg corresp. morphinum 7.52 mg, lactosum 207.5 mg, amylum pregelificatum, povidonum K 25, talcum, magnesii stearas, Überzug: hypromellosum, E 171, macrogolum 400, E 133, pro compresso obducto.

класс:

A+

Терапевтическая группа:

Synthetika

Терапевтические области:

Narkotisches Analgetikum

Статус Авторизация:

zugelassen

Дата Авторизация:

1970-01-01

тонкая брошюра

                                •
Suche
•
Suche SAI
•
Neue Texte
•
Geänderte Texte
•
Herunterladen
•
Hilfe
•
Anmelden
DE
FR
IT
EN
AIPS - EINZELABFRAGE
Elektronisches Vigilance-Meldeportal ElViS
PATIENTENINFORMATION
Inhaltsverzeichnis
Strukturierte Informationen
Inhaltsverzeichnis
Information für Patientinnen und Patienten
SEVREDOL®
Was ist Sevredol und wann wird es angewendet?
Wann darf Sevredol nicht angewendet werden?
Wann ist bei der Anwendung von Sevredol Vorsicht geboten?
Darf Sevredol während einer Schwangerschaft oder in der Stillzeit
angewendet werden?
Wie verwenden Sie Sevredol?
Welche Nebenwirkungen kann Sevredol haben?
Was ist ferner zu beachten?
Was ist in Sevredol enthalten?
Zulassungsnummer
Wo erhalten Sie Sevredol? Welche Packungen sind erhältlich?
Zulassungsinhaberin
Diese Packungsbeilage wurde im Juni 2023 letztmals durch die
Arzneimittelbehörde (Swissmedic) geprüft.
Information für Patientinnen und Patienten
Lesen Sie diese Packungsbeilage sorgfältig, bevor Sie das
Arzneimittel einnehmen bzw. anwenden. Dieses
Arzneimittel ist Ihnen persönlich verschrieben worden und Sie dürfen
es nicht an andere Personen
weitergeben. Auch wenn diese die gleichen Krankheitssymptome haben wie
Sie, könnte ihnen das
Arzneimittel schaden.
Bewahren Sie die Packungsbeilage auf, Sie wollen sie vielleicht
später nochmals lesen.
SEVREDOL®
Mundipharma Medical Company
Untersteht dem Bundesgesetz über die Betäubungsmittel und die
psychotropen Stoffe
Was ist Sevredol und wann wird es angewendet?
Sevredol ist ein Schmerzmittel zur Behandlung mittelstarker bis
starker akuter und andauernder Schmerzen.
Es enthält den Wirkstoff Morphin.
Sevredol darf nur auf Verschreibung und unter Kontrolle des Arztes
bzw. der Ärztin verwendet werden.
Wann darf Sevredol nicht angewendet werden?
·Wenn Sie überempfindlich (allergisch) gegenüber dem Wirkstoff
Morphin oder einem der Hilfsstoffe sind,
·bei ausgeprägter Beeinträchtigung der Atemfunktion, wie z.B.
schwerem Bronchialasthma oder schwerer
chronischer Einengung der Atemwege,
·bei ak
                                
                                Прочитать полный документ
                                
                            

Характеристики продукта

                                FACHINFORMATION
Sevredol®
Mundipharma Medical Company
Untersteht dem Bundesgesetz über die Betäubungsmittel und die
psychotropen Stoffe
Zusammensetzung
Wirkstoff: Morphini sulfas pentahydricus.
Hilfsstoffe
Filmtabletten
Sevredol 10 mg: lactosum monohydricum, color.: E 133 (Brillantblau
FCF), excip. pro compresso
obducto.
Sevredol 20 mg: lactosum monohydricum, color.: E 110 (Gelborange S), E
127 (Erythrosin), excip.
pro compresso obducto.
Suppositorien
Excipiens ad suppositorio.
Galenische Form und Wirkstoffmenge pro Einheit
Sevredol 10 mg (teilbar): blaue, kapselförmige, bikonvexe
Filmtablette mit einer Bruchrille und der
Prägung «IR» sowie «10» auf einer Seite, enthält 10 mg
Morphinsulfat-Pentahydrat entsprechend
7,5 mg Morphin.
Sevredol 20 mg (teilbar): rosafarbene, kapselförmige, bikonvexe
Filmtablette mit einer Bruchrille
und der Prägung «IR» sowie «20» auf einer Seite, enthält 20 mg
Morphinsulfat-Pentahydrat
entsprechend 15 mg Morphin.
Sevredol Suppositorien enthalten 10 mg, 20 mg bzw. 30 mg
Morphinsulfat-Pentahydrat entsprechend
7,5 mg, 15 mg bzw. 22,5 mg Morphin.
Indikationen/Anwendungsmöglichkeiten
Mittelstarke bis starke akute und prolongierte Schmerzen bzw. bei
ungenügender Wirksamkeit nicht-
opioider Analgetika und/oder schwacher Opioide.
Dosierung/Anwendung
Art der Anwendung
Die Filmtabletten können sowohl während als auch zwischen den
Mahlzeiten mit ausreichend
Flüssigkeit eingenommen werden.
Die Filmtabletten verfügen über eine Bruchrille und können zur
Einstellung der Dosierung geteilt
werden.
Die Suppositorien werden rektal eingeführt.
Dosierung
Die Dosierung ist an die Schmerzintensität und an die individuelle
Empfindlichkeit, das Alter und
das Gewicht des Patienten anzupassen.
Es gelten folgende allgemeine Dosierungsempfehlungen:
Erwachsene und Jugendliche über 12 Jahre
Nicht-Opioid-gewöhnte (opioidnaive) Patienten
Die Anfangsdosis beträgt für opioidnaive Patienten im Allgemeinen 10
mg alle 4 Stunden.
Ergänzende Schmerzmedikation und Dosistitration
Die Tagesdosis 
                                
                                Прочитать полный документ
                                
                            

Сердол (Serdol) инструкция по применению

📜 Инструкция по применению Сердол

💊 Состав препарата Сердол

✅ Применение препарата Сердол

📅 Условия хранения Сердол

⏳ Срок годности Сердол

Беталок^®
(ASTRAZENECA, Швеция)

Беталок^® ЗОК
(ASTRAZENECA, Швеция)

Метокард^®
(Pharmaceutical Works «POLPHARMA», Польша)

Метокор Адифарм
(ADIPHARM, Болгария)

Метопролол
(БРАЙТ ВЭЙ, Россия)

Метопролол
(ОЗОН, Россия)

Метопролол
(МОСКОВСКИЙ ЭНДОКРИННЫЙ ЗАВОД, Россия)

Метопролол
(АВЕКСИМА, Россия)

Метопролол
(БИОХИМИК, Россия)

Метопролол
(МАРБИОФАРМ, Россия)

Анальгин-хинин
(СОФАРМА, Болгария)

Беллатаминал^®
(ФАРМЦЕНТР ВИЛАР, Россия)

Номигрен^®
(БОСНАЛЕК, Босния и Герцеговина)

Норматенс
(VIATRIS HEALTHCARE, Германия)

Олиговит
(GALENIKA, Сербия)

Офломелид^®
(МС-ВИТА, Россия)

ПАГЛЮФЕРАЛ^®
(МОСКОВСКАЯ ФАРМАЦЕВТИЧЕСКАЯ ФАБРИКА, Россия)

Прегнакеа
(VITABIOTICS, Великобритания)

Пропицил^®
(ADMEDA ARZNEIMITTEL, Германия)

Теофедрин-Н^®
(ЭНДОКРИННЫЕ ТЕХНОЛОГИИ, Россия)

Состав:

Применение:

Sevredol

Morphine Sulfate

Таблетки, покрытые оболочкой

Потенцирует эффекты транквилизаторов, анестетиков, снотворных и седативных препаратов.

Источники:

• https://www.drugs.com/search.php?searchterm=sevredol
• https://pubmed.ncbi.nlm.nih.gov/?term=sevredol

Доступно в странах

Найти в стране:

Top 20 medicines with the same components:

Top 20 medicines with the same treatments:

Each tablet contains Morphine Sulfate 10 mg, 20 mg, 50 mg

Excipient with known effect:

Lactose, anhydrous

Film-coated tablet.

10 mg

Blue, film-coated, capsule-shaped, biconvex tablet with a score line on one side. «IR» is marked on the left side and «10» on the right.

20 mg

Pink, film-coated, capsule-shaped, biconvex tablet with a score line on one side. «IR» is marked on the left side and «20» on the right.

50 mg

Pale, green film-coated, capsule-shaped, biconvex tablet with a score line on one side. «IR» is marked on the left side and «50» on the right.

Posology

Adults and children over 12 years.

The dosage of Sevredol tablets is dependent on the severity of pain and the patient’s previous history of analgesic requirements. One tablet to be taken every four hours or as directed by a physician. Increasing severity of pain or tolerance to morphine will require increased dosage of Sevredol tablets using 10 mg, 20 mg or 50 mg alone or in combination to achieve the desired relief.

Patients receiving Sevredol tablets in place of parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction in analgesic effects associated with oral administration. Usually such increased requirement is of the order of 100%. In such patients individual dose adjustments are required.

Elderly:

A reduction in adult dosage may be advisable.

Paediatric population:

Sevredol
tablets 50 mg are not recommended for children below 12 years of age.

Route of administration

Oral.

<

Respiratory depression, head injury, obstructive airways disease, paralytic ileus, acute abdomen, delayed gastric emptying, known morphine sensitivity, acute hepatic disease, concurrent administration of mono-amine oxidase inhibitors or within two weeks of discontinuation of their use.

Not recommended during pregnancy.

Sevredol
10 mg/20 mg: Not recommended for children below 3 years of age.

Sevredol
tablets 50 mg: Not recommended for children below 12 years of age.

The major risk of opioid excess is respiratory depression.

As with all narcotics a reduction in dosage may be advisable in the elderly, in hypothyroidism, in renal and chronic hepatic disease. Use with caution in patients with impaired respiratory function, severe bronchial asthma, convulsive disorders, acute alcoholism, delirium tremens, raised intracranial pressure, hypotension with hypovolaemia, severe cor pulmonale, opioid dependent patients, patients with a history of substance abuse, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency.

Sevredol
tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, Sevredol tablets should be discontinued immediately.

Morphine may lower the seizure threshold in patients with a history of epilepsy.

Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs with opioids should be reserved for patients for whom alternative treatment options are not possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their environment to be aware of these symptoms.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive Sevredol tablets for 4 hours prior to the intervention. If further treatment with Sevredol tablets is indicated then the dosage should be adjusted to new post-operative requirements. Sevredol tablets should be used with caution pre-operatively and within the first 24 hours post-operatively. Sevredol tablets should also be used with caution following abdominal surgery as morphine impairs intestinal motility and should not be used until the physician is assured of normal bowel function.

The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with morphine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal

Hyperalgesia that will not respond to a further dose increase of morphine sulphate may occur in particular in high doses. A morphine sulphate dose reduction or change in opioid may be required.

Morphine has an abuse profile similar to other strong agonist opioids. Morphine may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence (addiction) to opioid analgesics, including morphine. The product should be used with particular care in patients with a history of alcohol and drug abuse.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.

Opioids, such as morphine sulfate, may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone in association with inappropriately low or normal ACTH, LH or FSH levels. Clinical symptoms may be manifest from these hormonal changes.

Treatment with Sevredol tablets may cause sedation and it is not recommended that patients drive or use machines if they experience drowsiness.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

— The medicine is likely to affect your ability to drive.

— Do not drive until you know how the medicine affects you.

— It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).

— This defence applies when:

— Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).”

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness. With chronic therapy, nausea and vomiting are unusual with Sevredol tablets but should they occur the tablets can be readily combined with an anti-emetic if required. Constipation may be treated with appropriate laxatives.

The following frequencies are the basis for assessing undesirable effects:

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).

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Signs of morphine toxicity and overdose are pin-point pupils, skeletal muscle flaccidity, bradycardia, hypotension, respiratory depression, pneumonia aspiration, somnolence and central nervous system depression which can progress to stupor or coma. Circulatory failure and deepening coma may occur in more severe cases. Overdose can result in death. Rhabdomyolysis progressing to renal failure has been reported in opioid overdose.

Treatment of morphine overdose

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

Oral activated charcoal (50g) for adults, 1g/kg for children) may be considered if a substantial amount has been ingested within one hour, provided the airway can be protected.

The pure opioid antagonists are specific antidotes against the effects of opioid overdose. Other supportive measures should be employed as needed.

In the case of massive overdose, administer naloxone 0.8 mg intravenously. Repeat at 2-3 minute intervals as necessary, or by an infusion of 2 mg in 500 ml of normal saline or 5% dextrose (0.004 mg/ml).

The infusion should be run at a rate related to the previous bolus doses administered and should be in accordance with the patient’s response. However, because the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established.

For less severe overdose, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on morphine. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.

Pharmacotherapeutic group: natural opium alkaloid

ATC code: N02A A01

Morphine acts as an agonist at opiate receptors in the CNS particularly mu and to a lesser extent kappa receptors. Mu receptors are thought to mediate supraspinal analgesia, respiratory depression and euphoria and kappa receptors, spinal analgesia, miosis and sedation.

Central Nervous System

The principal actions of therapeutic value of morphine are analgesia and sedation (i.e., sleepiness and anxiolysis). Morphine produces respiratory depression by direct action on brain stem respiratory centers.

Morphine depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia.

Morphine causes miosis, even in total darkness. Pinpoint pupils are a sign of narcotic overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of morphine overdose.

Gastrointestinal Tract and Other Smooth Muscle

Morphine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm resulting in constipation.

Morphine generally increases smooth muscle tone, especially the sphincters of the gastrointestinal and biliary tracts. Morphine may produce spasm of the sphincter of Oddi, thus raising intrabiliary pressure.

Cardiovascular System

Morphine may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Endocrine System

Opioids may affect the hypothalamic pituitary adrenal and hypothalamic pituitary gonadal system resulting in adrenal insufficiency or hypogonadism respectively.

Other Pharmacologic Effects

In vitro and animal studies indicate various effects of natural opioids, such as morphine, on components of the immune system; the clinical significance of these findings is unknown.

Tablet core

Lactose (anhydrous)

Pregelatinised maize starch

Povidone

Purified water

Magnesium stearate

Talc

Film coat

PVdC coated PVC blister packs and polypropylene containers with polyethylene lids containing 56 and 112 tablets.

Medical sample packs containing up to 24 tablets are also available.

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0GW