Relistor (oral)

Relistor (oral)

Uses for Relistor

This medicine is only available with a doctor's prescription.

Before using Relistor

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the relationship between age and the effects of methylnaltrexone in children and adolescents. Safety and effectiveness have not been established.

geriatrics

Studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of methylnaltrexone in the elderly. However, elderly patients are at higher risk of diarrhea and caution in dosing may be necessary in patients receiving this drug.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Morphium
• Morphinsulfat-Liposom
• Naldemedine
• Naloxegol
• Oxycodon
• Oxymorphon

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Morbus Crohn oder
• Divertikulitis bzw
• Ogilvie-Syndrom (verminderte Bewegung der Nahrung im Darm) oder
• Magengeschwür oder
• Magen- oder Darmkrebs – Kann das Risiko schwerwiegenderer Nebenwirkungen erhöhen.

• Lebererkrankung bzw
• Schwere Nierenerkrankung – mit Vorsicht anwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

• Magen- oder Darmverschluss, bekannt, vermutet oder erhöhtes Risiko: Sollte bei Patienten mit diesen Erkrankungen nicht angewendet werden.

Proper use of Relistor

Take this medicine exactly as your doctor has told you. Do not take more of it, do not take it more often, or take it for longer than your doctor prescribed. This may increase the risk of side effects.

This medicine comes with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with water on an empty stomach at least 30 minutes before the first meal of the day.

Stop taking other laxatives before starting treatment with methylnaltrexone. You should stop using this medicine even if you have stopped taking narcotic painkillers.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für orale Darreichungsform (Tabletten):
  • Bei durch Opioide verursachter Verstopfung bei Patienten mit chronischen, nicht krebsbedingten Schmerzen:
    • Erwachsene – 450 Milligramm (mg) einmal täglich morgens für mindestens 4 Wochen (mit narkotischen Schmerzmitteln).
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not double the dose.

storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Protect from freezing.

Keep away from children.

Keep away from children.

Ask your doctor how to throw away medicines you don't use.

Precautions when using Relistor

It is very important that your doctor check your progress at regular visits. This will help your doctor determine whether the medicine is working properly and decide whether you should continue using it.

This medicine may cause a tear (perforation) in your stomach or intestines. Consult your doctor immediately if you have severe stomach pain that doesn't go away.

If severe or persistent (uninterrupted) diarrhea occurs while using this medication, contact your doctor immediately.

Do not stop using this medicine suddenly without consulting your doctor first. This can cause withdrawal symptoms such as anxiety, chills, increased tearing, redness of the face, neck, arms, and upper chest, feeling cold, diarrhea, irritability, stomach pain, increased sweating, and yawning.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Side effects of Relistor

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

Incident not known

• Schüttelfrost
• Durchfall
• Angst oder Nervosität
• vermehrtes Schwitzen
• starke Bauch- oder Magenschmerzen
• schwerer oder anhaltender Durchfall
• Gähnen

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Less common

• Völlegefühl oder Völlegefühl
• Kopfschmerzen
• Muskelkrämpfe
• Druck im Magen
• laufende Nase
• Schwellung des Bauch- oder Magenbereichs
• Erbrechen

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Relistor

Available dosage forms:

• Tablette

Therapeutic class: Gastrointestinal agent

Pharmacological class: Methylnaltrexone

• Welche Medikamente verursachen opioidbedingte Verstopfung?

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