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PROPANOLOL Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

PROPRANOLOL TABLETS BP 160mg.

Qualitative and quantitative composition

Each tablet contains 160mg Propranolol hydrochloride PhEur. Excipients with known effect: Each 160mg tablet contains 230.00mg Lactose. Each tablet contains Carmoisine (E122). For the full list of excipients, ...

Pharmaceutical form

Pink film-coated tablets. Pink, circular, biconvex film-coated tablets impressed C on one face and the identifying letters P and D on either side of a central division line on the reverse.

Therapeutic indications

Management of angina pectoris. Control of hypertension. Long-term prophylaxis against reinfarction after recovery from acute myocardial infarction. Management of hypertrophic obstructive cardiomyopathy. ...

Posology and method of administration

Posology Adults and children over 12 years Hypertension Initially 80mg twice daily, which may be increased at weekly intervals according to response. The usual dose range is 160-320mg/daily. With concurrent ...

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Propranolol must not be used if there is a history of bronchial asthma, bronchospasm chronic obstructive airways ...

Special warnings and precautions for use

Special care should be taken with patients whose cardiac reserve is poor. Beta-adrenoceptor blocking drugs should be avoided in overt heart failure; however, they may be used in patients whose signs of ...

Interaction with other medicinal products and other forms of interaction

Adrenaline (epinephrine) Care should be taken in the parenteral administration of preparations containing adrenaline (epinephrine) to patients taking beta-adrenoceptor blocking drugs as, in rare cases, ...

Pregnancy and lactation

Pregnancy As with all other drugs, propranolol should not be given in pregnancy or lactation unless its use is essential. There is no evidence of teratogenicity with propranolol. However beta-adrenoceptor ...

Effects on ability to drive and use machines

The use of propranolol is unlikely to result in any significant impairment of the ability of patients to drive or operate machinery. However, patients should be warned that visual disturbances, hallucinations, ...

Undesirable effects

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); Frequency not known (cannot be estimated from the available data). The ...

Overdose

Clinical features Cardiac: Bradycardia, hypotension, pulmonary oedema, syncope and cardiogenic shock may develop. Conduction abnormalities such as first or second degree AV block may occur. Rarely arrhythmias ...

Pharmacodynamic properties

Pharmacotherapeutic group: beta blocking agents, non-selective ATC code: C07AA05 Propranolol hydrochloride is a beta-adrenoceptor blocking agent. Mechanism of action Propranolol is a competitive antagonist ...

Pharmacokinetic properties

Absorption Propranolol is almost completely absorbed from the gastrointestinal tract, but it is subject to considerable first-pass metabolism. Distribution Peak plasma concentrations occur about 1 to 2 ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

List of excipients

The tablets contain: Lactose Magnesium stearate Maize starch Stearic acid Hypromellose (E464) The coating contains: Carmoisine (E122) Hypromellose (E464) Polysorbate Titanium dioxide (E171) Iron oxide ...

Incompatibilities

None known.

Shelf life

Shelf life: Three years from the date of manufacture.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization number(s)

PL 0142/0142

Date of first authorization / renewal of the authorization

Date of first authorisation: 05 February 1980 Date of latest renewal: 16 September 2005

Date of revision of the text

14<sup>th</sup> May 2019

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