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SPC, UK: CARDURA Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Pfizer Limited
Διεύθυνση :
Ramsgate Road, Sandwich, Kent, CT13 9NJ
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Δωρεάν εγγραφή

Name of the medicinal product

CARDURA™ 1mg and 2mg.

Qualitative and quantitative composition

Doxazosin mesilate: 1.213mg equivalent to 1mg doxazosin 2.43mg equivalent to 2mg doxazosin For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablets for oral administration. 1mg round tablets marked CN1 on one side and PFIZER on the other. 2mg oblong tablets marked CN2 on one side and PFIZER on the other.

Therapeutic indications

Hypertension: Cardura is indicated for the treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. In patients inadequately controlled on single ...

Posology and method of administration

Cardura may be administered in the morning or the evening. Hypertension: Cardura is used in a once daily regimen: the initial dose is 1mg, to minimise the potential for postural hypotension and/or syncope ...

Contraindications

Doxazosin is contraindicated in: Patients with a known hypersensitivity to quinazolines (e.g. prazosin, terazosin, doxazosin), or any of the excipients Patients with a history of orthostatic hypotension ...

Special warnings and precautions for use

Postural Hypotension/Syncope Initiation of Therapy: In relation with the alpha-blocking properties of doxazosin, patients may experience postural hypotension evidenced by dizziness and weakness, or rarely ...

Interaction with other medicinal products and other forms of interaction

Phosphodiesterase-5-inhibitors (eg. sildenafil, tadalafil, vardenafil) Concomitant administration of doxazosin with a PDE-5 inhibitor may lead to symptomatic hypotension in some patients (see section 4.4: ...

Pregnancy and lactation

For the hypertension indication Use during pregnancy: As there are no adequate and well-controlled studies in pregnant women, the safety of Cardura during pregnancy has not yet been established. Accordingly, ...

Effects on ability to drive and use machines

The ability to drive or use machinery may be impaired, especially when initiating therapy.

Undesirable effects

Hypertension: In clinical trials involving patients with hypertension, the most common reactions associated with Cardura therapy were of a postural type (rarely associated with fainting) or non-specific. ...

Pharmacodynamic properties

Doxazosin is a potent and selective post-junctional alpha-1-adrenoceptor antagonist. This action results in a decrease in systemic blood pressure. Cardura is appropriate for oral administration in a once ...

Pharmacokinetic properties

Absorption: Following oral administration in humans (young male adults or the elderly of either sex), doxazosin is well absorbed and approximately two thirds of the dose is bioavailable. Biotransformation/Elimination: ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional animal studies in safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity. For further information see section ...

List of excipients

Lactose Magnesium stearate Microcrystalline cellulose Sodium lauril sulfate Sodium starch glycollate

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Cardura 1mg and 2mg Tablets are available as calendar packs of 28 tablets. Aluminium/PVC/PVdC blister strips, 14 tablets/strip, 2 strips in a carton box.

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)

Cardura 1mg: PL 00057/0276 Cardura 2mg: PL 00057/0277

Date of first authorization / renewal of the authorization

11 October 2006

Date of revision of the text

06/2012