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SPC, UK: Celebrex 100mg & 200mg Capsules (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Pfizer Limited
Διεύθυνση :
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Name of the medicinal product

Celebrex 100 mg capsule, hard. Celebrex 200 mg capsule, hard.

Qualitative and quantitative composition

Each capsule contains 100 mg or 200 mg celecoxib. Excipients: Each 100 mg capsule contains 149.7 mg lactose monohydrate (see section 4.4). Each 200 mg capsule contains 49.8 mg lactose monohydrate (see ...

Pharmaceutical form

Capsule, hard. Opaque, white with two blue bands marked 7767 and 100 (Celebrex 100 mg). Opaque, white with two gold bands marked 7767 and 200 (Celebrex 200 mg).

Therapeutic indications

Symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual ...

Posology and method of administration

As the cardiovascular 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 for symptomatic ...

Contraindications

History of hypersensitivity to the active substance or to any of the excipients (see 6.1). Known hypersensitivity to sulphonamides. Active peptic ulceration or gastrointestinal (GI) bleeding. Patients ...

Special warnings and precautions for use

Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib. Caution is advised with treatment ...

Interaction with other medicinal products and other forms of interaction

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

Pregnancy and lactation

No clinical data on exposed pregnancies are available for celecoxib. Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see 4.3 and 5.3). The potential for ...

Effects on ability to drive and use machines

Patients who experience dizziness, vertigo or somnolence while taking celecoxib 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 Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical ...

Pharmacokinetic properties

Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours. Dosing with food (high fat meal) delays absorption by about 1 hour. Celecoxib is mainly eliminated by metabolism. ...

Preclinical safety data

Conventional embryo-fetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat fetuses and of cardiovascular malformations in rabbit fetuses at systemic exposures to free ...

List of excipients

Capsules 100 mg contain Lactose monohydrate Sodium lauryl sulphate Povidone K30 Croscarmellose sodium Magnesium stearate Capsule shells contain: Gelatin Titanium dioxide E171 Ink contains: Indigotine E132 ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Clear or opaque PVC blisters or aluminium cold-formed 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 ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom

Marketing authorization number(s)

Celebrex 100 mg: PL 00057/1275 Celebrex 200 mg: PL 00057/1276

Date of first authorization / renewal of the authorization

03/05/2011

Date of revision of the text

03/05/2011