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SPC, UK: VASCACE Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Roche Products Limited
Διεύθυνση :
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
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Δωρεάν εγγραφή

Name of the medicinal product

Vascace 0.5 mg Film-coated Tablets. Vascace 1 mg Film-coated Tablets. Vascace 2.5 mg Film-coated Tablets. Vascace 5 mg Film-coated Tablets.

Qualitative and quantitative composition

Each film-coated tablet contains: 0.522 mg cilazapril equivalent to 0.5mg cilazapril anhydrous 1.044 mg cilazapril equivalent to 1mg cilazapril anhydrous 2.61 mg cilazapril equivalent to 2.5 mg cilazapril ...

Pharmaceutical form

Film-coated tablet: White, oval, biconvex film-coated tablets with a score on one side and imprinted CIL 0.5 on the other side. Light yellow, oval, biconvex film-coated tablets with a score on one side ...

Therapeutic indications

Vascace is indicated for the treatment of hypertension. Vascace is indicated for the treatment of chronic heart failure.

Posology and method of administration

Posology Hypertension: The initial dose is 1 mg/day. Blood pressure should be assessed, and dosage adjusted individually in accordance with the blood pressure response. The usual dose range of Vascace ...

Contraindications

Hypersensitivity to cilazapril or any components of the product, or to other ACE inhibitors. History of angioedema associated with previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. ...

Special warnings and precautions for use

Pregnancy ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive ...

Interaction with other medicinal products and other forms of interaction

Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Concomitant use of thiazide diuretics may ...

Pregnancy and lactation

Pregnancy The use of ACE inhibitors such as cilazapril is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors such as cilazapril is contraindicated during ...

Effects on ability to drive and use machines

When driving and operating machines, it should be taken into account that occasionally dizziness and fatigue may occur, especially when starting therapy (see sections 4.4 and 4.8).

Undesirable effects

Summary of the safety profile The most frequent drug-attributable adverse events observed in patients taking ACE inhibitors are cough, skin rash and renal dysfunction. Cough is more common in women and ...

Overdose

Limited data are available for overdosage in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, ...

Pharmacodynamic properties

Pharmacotherapeutic group: ACE inhibitor ATC code: C09AA08 Mechanism of action Vascace is a specific, long-acting angiotensin-converting enzyme (ACE) inhibitor which suppresses the renin-angiotensin-aldosterone ...

Pharmacokinetic properties

Absorption Cilazapril is efficiently absorbed and rapidly converted to the active form, cilazaprilat. Ingestion of food immediately prior to Vascace administration delays and reduces absorption to a minor ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Angiotensin converting enzyme ...

List of excipients

In the tablet core: Lactose monohydrate Maize starch Hypromellose 3cP Talc Sodium stearyl fumarate In the film coat: Hypromellose 6cP Talc Titanium dioxide E171 Vascace 1 mg: in addition Iron oxide yellow ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

0.5 mg: Do not store above 25°C. 1 mg: Do not store above 25°C. 2.5 mg: Do not store above 25°C. 5 mg: This medicinal product does not require any special storage conditions.

Nature and contents of container

ALU/ALU blisters containing 14, 20, 28, 30, 50, 56, 60, 98 film-coated tablets. Amber glass bottles containing 28, 100 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

Marketing authorization number(s)

0.5mg Tablets: PL 00031/0244 1.0mg Tablets: PL 00031/0245 2.5mg Tablets: PL 00031/0246 5.0mg Tablets: PL 00031/0247

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 October 1990 Date of last renewal: 7 December 2001

Date of revision of the text

08 August 2012