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BRILIQUE Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Brilique 90 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 90 mg ticagrelor. Brilique contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially sodium-free. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet (tablet). Round, biconvex, yellow tablets marked with 90 above T on one side and plain on the other.

Therapeutic indications

Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with: acute coronary syndromes (ACS) or a history of myocardial infarction ...

Posology and method of administration

Posology Patients taking Brilique should also take a daily low maintenance dose of ASA 75-150 mg, unless specifically contraindicated. Acute coronary syndromes Brilique treatment should be initiated with ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.8). Active pathological bleeding. History of intracranial haemorrhage (see section 4.8). Severe ...

Special warnings and precautions for use

Bleeding risk The use of ticagrelor in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events (see sections 4.8 and 5.1). ...

Interaction with other medicinal products and other forms of interaction

Ticagrelor is primarily a CYP3A4 substrate and a mild inhibitor of CYP3A4. Ticagrelor is also a P-glycoprotein (P-gp) substrate and a weak P-gp inhibitor and may increase the exposure of P-gp substrates. ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during ticagrelor therapy. Pregnancy There are no or limited amount of data ...

Effects on ability to drive and use machines

Ticagrelor has no or negligible influence on the ability to drive and use machines. During treatment with ticagrelor, dizziness and confusion have been reported. Therefore, patients who experience these ...

Undesirable effects

Summary of the safety profile The safety profile of ticagrelor has been evaluated in two large phase 3 outcome trials (PLATO and PEGASUS) including more than 39,000 patients (see section 5.1). In PLATO, ...

Overdose

Ticagrelor is well tolerated in single doses up to 900 mg. Gastrointestinal toxicity was dose-limiting in a single ascending dose study. Other clinically meaningful adverse reactions which may occur with ...

Pharmacodynamic properties

Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin ATC code: B01AC24 Mechanism of action Brilique contains ticagrelor, a member of the chemical class cyclopentyltriazolopyrimidines ...

Pharmacokinetic properties

Ticagrelor demonstrates linear pharmacokinetics and exposure to ticagrelor and the active metabolite (AR-C124910XX) are approximately dose proportional up to 1260 mg. Absorption Absorption of ticagrelor ...

Preclinical safety data

Preclinical data for ticagrelor and its major metabolite have not demonstrated unacceptable risk for adverse effects for humans based on conventional studies of safety pharmacology, single and repeated ...

List of excipients

<u>Tablet core:</u> Mannitol (E421) Calcium hydrogen phosphate dihydrate Magnesium stearate (E470b) Sodium starch glycolate type A Hydroxypropylcellulose (E463) <u>Tablet coating:</u> Titanium dioxide ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC-PVDC/Al transparent blister (with sun/moon symbols) of 10 tablets; cartons of 60 tablets (6 blisters) and 180 tablets (18 blisters). PVC-PVDC/Al transparent calendar blister (with sun/moon symbols) ...

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

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization number(s)

EU/1/10/655/007-011

Date of first authorization / renewal of the authorization

Date of first authorisation: 03 December 2010 Date of latest renewal: 17 July 2015

Πηγαίο έγγραφο

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