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CELEBREX Capsules (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Celebrex 100 mg capsules, hard.

Qualitative and quantitative composition

Each capsule contains 100 mg celecoxib. Excipient with known effect: Lactose (each capsule contains 149.7 mg lactose monohydrate; see section 4.4). For the full list of excipients, see section 6.1.

Pharmaceutical form

Capsule, hard. Opaque, white with two blue bands marked 7767 and 100.

Therapeutic indications

Celebrex is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective cyclooxygenase-2 (COX-2) ...

Posology and method of administration

Posology As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patients need ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known hypersensitivity to sulfonamides. Active peptic ulceration or gastrointestinal (GI) bleeding. Patients ...

Special warnings and precautions for use

Gastrointestinal (GI) effects Upper and lower gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Anticoagulants Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in patients receiving warfarin ...

Fertility, pregnancy and lactation

Pregnancy Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see sections 4.3 and 5.3). Inhibition of prostaglandin synthesis might adversely affect pregnancy. ...

Effects on ability to drive and use machines

Patients who experience dizziness, vertigo or somnolence while taking Celebrex should refrain from driving or operating machinery.

Undesirable effects

Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources: Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis ...

Overdose

There is no clinical experience of overdose. Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects for nine days without clinically significant ...

Pharmacodynamic properties

Pharmacotherapeutic group: Non-steroidal anti-inflammatory and antirheumatic drugs, NSAIDs, Coxibs ATC code: M01AH01 Mechanism of action Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor ...

Pharmacokinetic properties

Absorption Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours. Dosing with food (high fat meal) delays absorption of celecoxib by about 1 hour resulting in a T ...

Preclinical safety data

Non-clinical safety data revealed no special hazard for humans based on conventional studies of repeated dose toxicity, mutagenicity or carcinogenicity beyond those addressed in section 4.4, 4.6, and 5.1 ...

List of excipients

Capsules content: Lactose monohydrate Sodium laurilsulfate Povidone Croscarmellose sodium Magnesium stearate Capsule shells: Gelatin Titanium dioxide E171 Sodium laurilsulfate Sorbitan monolaurate Printing ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Clear or opaque PVC/aluminium blisters. Pack of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose, 5x(10x10). Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization number(s)

PL 00057/1275

Date of first authorization / renewal of the authorization

03/05/2011

Date of revision of the text

10 October 2018

Πηγαίο έγγραφο

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