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CELIPROLOL HYDROCHLORIDE Film-coated tablets (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Celiprolol hydrochloride 400 mg film-coated Tablets.

Qualitative and quantitative composition

Each tablet contains 400 mg celiprolol hydrochloride. Each tablet contains 3.6mg lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White coloured, capsule shaped, biconvex film coated tablets, debossed with 400 on one side of the breakline and a deep breakline on the other side. The tablet can be divided into equal ...

Therapeutic indications

Celiprolol is indicated for the treatment of hypertension.

Posology and method of administration

Adults The initial dose is 200 mg orally, taken once daily with a glass of water. Celiprolol should be taken on rising, one hour before meals, or 2 hours after meals. If response is inadequate, the dose ...

Contraindications

Hypersensitivity to celiprolol hydrochloride or to any of the excipients listed in section 6.1. Celiprolol is also contraindicated in patients with: Second or third degree heart block; Severe bradycardia ...

Special warnings and precautions for use

Although cardiac selective beta blockers may have less effect on lung function than non-selective beta blockers, as with all beta blockers, these should be avoided in patients with chronic obstructive ...

Interaction with other medicinal products and other forms of interaction

Combinations not recommended Celiprolol should not be prescribed for patients being treated with theophylline (see Section 4.3 Contraindications). It has been shown that the bioavailability of celiprolol ...

Pregnancy and lactation

Pregnancy The safety of celiprolol product for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect ...

Effects on ability to drive and use machines

It has been shown that driving ability is unlikely to be impaired in patients taking Celiprolol. However, it should be taken into account that occasional dizziness or fatigue may occur as well as the potential ...

Undesirable effects

Beta-adrenoceptor blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia (in particular, tachycardia). Occasional side effects, which are usually mild and transient have occurred. These include ...

Overdose

No data are available regarding overdose in humans. The most common symptoms to be expected following overdosage with a beta-adrenoceptor blocking drug are bradycardia, hypotension, bronchospasm and acute ...

Pharmacodynamic properties

Pharmacotherapeutic group: Betablocking agents, selective ATC Code: C07AB08 Mode of Action Celiprolol is a vasoactive, beta-1 selective adrenoceptor antagonist with partial beta-2 agonist activity indicated ...

Pharmacokinetic properties

Celiprolol is a hydrophilic compound that is incompletely absorbed from the gastrointestinal tract. Bioavailability of orally administered celiprolol ranges from 30 to 70% depending upon the dose administered. ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity.

List of excipients

Microcrystalline cellulose Mannitol Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Film coating material: Hypromellose Titanium dioxide (E171) Macrogol 400 Lactose monohydrate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in the original container.

Nature and contents of container

Blister strips comprising of white opaque PVC film with a backing of aluminium foil coated with heat seal lacquer. Pack of 10, 20, 28, 30, 50, 56 and 100 tablets.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Ranbaxy (UK) Limited, 5th floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom

Marketing authorization number(s)

PL 14894/0046

Date of first authorization / renewal of the authorization

27/06/2007

Date of revision of the text

20/07/2017

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