Roflumilast (topical use)

Roflumilast (topical use)

Roflumilast (topical use)

Possible uses for roflumilast

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

Before using roflumilast

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 topical roflumilast cream in children younger than 6 years. Safety and effectiveness have not been established.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of topical roflumilast cream in the elderly. However, older patients are more sensitive to the effects of this drug than younger adults.

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. Tell your doctor if you are taking other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Leberprobleme, mittelschwer bis schwer – sollte bei Patienten mit dieser Erkrankung nicht angewendet werden.

Correct use of roflumilast

It is very important that you only use this medicine as directed by your doctor. Do not use more of it, do not use it more often or for longer than prescribed by your doctor.

This medicine should only be used on the skin, including areas with skin folds. Do not get it in your eyes, nose, mouth or vagina. Do not apply this medicine to your nipple or areola if you are breast-feeding. If it does get on these areas, rinse it off immediately.

This medicine comes with a package leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Use:

• Waschen Sie Ihre Hände vor und nach der Anwendung dieses Arzneimittels mit Wasser und Seife, es sei denn, Sie verwenden es zur Handbehandlung.
• Tragen Sie eine dünne Schicht auf die betroffene Hautstelle auf. Reiben Sie es sanft ein.

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 die topische Darreichungsform (Creme):
  • Bei Plaque-Psoriasis:
    • Erwachsene und Kinder ab 6 Jahren: Einmal täglich auf die betroffene Hautstelle auftragen.
    • Kinder unter 6 Jahren: Anwendung und Dosierung 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.

storage

Keep away from children.

Do not keep medications that are outdated or no longer needed.

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

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

Precautions when using roflumilast

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for any unwanted effects.

If your condition does not improve or worsens, contact your doctor.

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.

Roflumilast side effects

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:

Less common

• Blasenschmerzen
• blutiger oder trüber Urin
• schwieriges, brennendes oder schmerzhaftes Wasserlassen
• häufiger Harndrang
• Schmerzen im unteren Rücken oder an der Seite

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

• Körperschmerzen oder Schmerzen
• Schüttelfrost
• Husten
• Durchfall
• Schwierigkeiten beim Atmen
• verstopfte Ohren
• Fieber
• Kopfschmerzen
• Verlust der Stimme
• Brechreiz
• Schmerzen im Bereich der Anwendung des Arzneimittels
• niesen
• Halsentzündung
• verstopfte oder laufende Nase
• Schlafstörungen
• ungewöhnliche Müdigkeit oder Schwäche

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

• Zoryve

Available dosage forms:

• Creme

Therapeutic class: Antipsoriatics

Pharmacological class: Phosphodiesterase inhibitor

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