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SPC, UK: BUDENOFALK Gastro-resistant capsules (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Budenofalk 3 mg gastro-resistant capsules.

Qualitative and quantitative composition

Each capsule contains 3 mg budesonide. Excipients with known effect: each capsule contains 240 mg sucrose and 12 mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Gastro-resistant capsules, hard (gastro-resistant capsules). Capsule, hard, pink containing white gastro-resistant granules.

Therapeutic indications

Crohns disease.Induction of remission in patients with mild to moderate active Crohns disease affecting the ileum and/or the ascending colon. Collagenous colitis.Induction of remission in patients with ...

Posology and method of administration

Posology Crohns disease Adults aged >18 years The recommended daily dose is three capsules once daily in the morning or one capsule (containing 3 mg budesonide) three times daily (morning, midday and evening; ...

Contraindications

Budenofalk 3mg must not be used in patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic cirrhosis.

Special warnings and precautions for use

Treatment with Budenofalk 3mg results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy. Transfer from other glucocorticosteroid therapy may result in symptoms relating ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Cardiac glycosides The action of the glycoside can be potentiated by potassium deficiency. Saluretics Potassium excretion can be enhanced. Pharmacokinetic interactions Cytochrome ...

Fertility, pregnancy and lactation

Pregnancy Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Budenofalk 3mg. There are few data of pregnancy outcomes after oral administration of budesonide ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

The following frequency conventions are used in the evaluation of 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: ...

Overdose

To date, no cases of overdose with budesonide are known.

Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticosteroid ATC code: A07EA06 The exact mechanism of budesonide in the treatment of Crohns disease is not fully understood. Data from clinical pharmacology studies and ...

Pharmacokinetic properties

Absorption Budenofalk 3mg capsules, which contain gastric juice resistant granules, have – due to the specific coating of the granules a lag phase of 2-3 hours. In healthy volunteers, as well as in patients ...

Preclinical safety data

Preclinical data in acute, subchronic and chronic toxicological studies with budesonide showed atrophies of the thymus gland and adrenal cortex and a reduction especially of lymphocytes. These effects ...

List of excipients

Capsule contents: Ammonio methacrylate copolymer (type A) (Eudragit RL) Ammonio methacrylate copolymer (type B) (Eudragit RS) Lactose monohydrate Maize starch Methacrylic acid-methyl methacrylate copolymer ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Al/PVC/PVDC blister strips. Pack sizes: 10, 50, 90, 100 or 120 capsules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108, Freiburg, Germany

Marketing authorization number(s)

PL 08637/0002

Date of first authorization / renewal of the authorization

04/01/2009

Date of revision of the text

08/11/2018

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