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SPC, UK: CARVEDILOL 12.5 mg Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Carvedilol 12.5 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 12.5 mg of carvedilol. Excipient(s) with known effect: Each tablet contains 114.5 mg of lactose monohydrate and 2.5 mg of sucrose. For a full list of excipients, see section 6.1. ...

Pharmaceutical form

Film-coated tablet. Film-coated tablets white to off-white, oval, engraved with F58 on one side and scored on the other side. The tablet can be divided into equal doses.

Therapeutic indications

Essential hypertension. Chronic stable angina pectoris. Adjunctive treatment of moderate to severe stable chronic heart failure.

Posology and method of administration

Oral use. Essential Hypertension Carvedilol may be used for the treatment of hypertension alone or in combination with other antihypertensives, especially thiazide diuretics. Once daily dosing is recommended, ...

Contraindications

Hypersensitivity to the carvedilol or to any of the excipients of Carvedilol listed in section 6.1. Heart failure belonging to NYHA Class IV of the heart failure classification with marked fluid retention ...

Special warnings and precautions for use

Warnings to be considered particularly in heart failure patients In chronic heart failure patients carvedilol should be administered principally in addition to diuretics, ACE inhibitors, digitalis and/or ...

Interaction with other medicinal products and other forms of interaction

Antiarrhythmics Isolated cases of conduction disturbance (rarely compromised haemodynamics) have been reported, if oral carvedilol and oral diltiazem verapamil and/or amiodarone are given concomitantly. ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of carvedilol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Beta-blockers ...

Effects on ability to drive and use machines

This medicinal product has minor influence on the ability to drive and use machines. Some individuals may have reduced alertness especially on initiation and adjustment of medication.

Undesirable effects

Summary of the safety profile The frequency of adverse reactions is not dose-dependent, with the exception of dizziness, abnormal vision and bradycardia. Tabulated list of adverse reactions The risk of ...

Overdose

Symptoms and signs In the event of overdose, there may be severe hypotension, bradycardia, heart failure, cardiogenic shock and cardiac arrest. There may also be respiratory problems, bronchospasm, vomiting, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Alpha and beta blocking agents ATC code: C07AG02 Carvedilol is a vasodilatory non-selective beta-blocker, which reduces the peripheral vascular resistance by selective alpha ...

Pharmacokinetic properties

Absorption Carvedilol is rapidly absorbed after oral administration. In healthy subjects, maximum serum concentration is achieved approximately 1 hour after administration. The absolute bioavailability ...

Preclinical safety data

Carvedilol demonstrated no mutagenic or carcinogenic potential. High doses of carvedilol impaired fertility and affected pregnancy in rats (increased resorptions). Decreased fetal weight and delayed skeletal ...

List of excipients

Tablet core: Lactose monohydrate Silica colloidal anhydrous Crospovidone (Type A) Crospovidone (Type B) Povidone 30 Sucrose Magnesium stearate Tablet coating: Macrogol 400 Polysorbate 80 Titanium dioxide ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

PVC/PE/PVDC Aluminum: Package sizes: 5, 7, 10, 14, 15, 20, 28, 30, 40, 50, 56, 60, 90, 98, 100, 120, 150, 200, 250, 300, 400, 500 and 1000 film-coated tablets. Bottle of high density polyethylene (HDPE) ...

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

Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Marketing authorization number(s)

PL 16363/0353

Date of first authorization / renewal of the authorization

Date of first authorisation: 04/10/2012 Date of last renewal: 03/02/2018

Date of revision of the text

03/02/2018

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