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SPC, UK: CARDURA Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CARDURA 2mg Tablets.

Qualitative and quantitative composition

Doxazosin mesilate: 2.43mg equivalent to 2mg doxazosin. Excipients of known effect: Each tablet contains 40 mg of lactose monohydrate Each tablet contains 0.06 mg sodium. For the full list of excipients, ...

Pharmaceutical form

Tablets. 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

Posology 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 ...

Contraindications

Doxazosin is contraindicated in: Hypersensitivity to the active substance or other types of quinazolines (e.g. prazosin, terazosin,), or to any of the excipients listed in section 6.1 Patients with a history ...

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 (e.g. sildenafil, tadalafil, vardenafil) Concomitant administration of doxazosin with a PDE-5 inhibitor may lead to symptomatic hypotension in some patients (see section ...

Fertility, pregnancy and lactation

For the hypertension indication 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, during ...

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. ...

Overdose

Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures may be appropriate in individual cases. If this measure is inadequate, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Alpha-adrenoreceptor antagonists ATC code: C02CA04 Mechanism of action Doxazosin is a potent and selective post-junctional alpha-1-adrenoceptor antagonist. This action results ...

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. Although no teratogenic effects ...

List of excipients

Lactose Magnesium stearate Microcrystalline cellulose Sodium lauryl sulfate Sodium starch glycollate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

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)

PL 00057/0277

Date of first authorization / renewal of the authorization

11 October 2006

Date of revision of the text

05/2019

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