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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

MONTELUKAST Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Montelukast 10 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains montelukast sodium 10.4 mg equivalent to 10 mg montelukast. Excipient(s) with known effect: Contain 130.95 mg of Lactose monohydrate per tablet. For a full list of excipients, ...

Pharmaceutical form

Film-coated tablet. 7.9 7.9 mm beige coloured, rounded square, biconvex, film coated tablet debossed M10 on one side and plain on other side.

Therapeutic indications

Montelukast 10 mg film-coated tablets is indicated in the treatment of asthma as add-on therapy in those patientswith mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids ...

Posology and method of administration

Posology The recommended dose for adults and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10 mg tablet daily to be taken in the evening. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, ...

Interaction with other medicinal products and other forms of interaction

Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interactions studies, the recommended clinical dose of montelukast did not ...

Pregnancy and lactation

Pregnancy Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/foetal development. Limited data from available pregnancy databases do not suggest a causal relationship ...

Effects on ability to drive and use machines

Montelukast has no or negligible influence on the ability to drive and use machines. However, individuals have reported drowsiness or dizziness.

Undesirable effects

Montelukast has been evaluated in clinical studies as follows: 10 mg film-coated tablets in approximately 4000 adult and adolescent asthmatic patients 15 years of age and older. 10 mg film-coated tablets ...

Overdose

In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short term studies, up to 900 mg/day to patients for approximately one week ...

Pharmacodynamic properties

Pharmacotherapeutic group: Leukotriene receptor antagonist ATC code: R03DC03 Mechanism of action The cysteinyl leukotrienes (LTC<sub>4</sub>, LTD<sub>4</sub>, LTE<sub>4</sub>) are potent inflammatory eicosanoids ...

Pharmacokinetic properties

Absorption Montelukast is rapidly absorbed following oral administration. For the 10 mg film-coated tablet, the mean peak plasma concentration (C<sub>max</sub>) is achieved 3 hours (T<sub>max</sub>) after ...

Preclinical safety data

In animal toxicity studies, minor serum biochemical alterations in ALT, glucose, phosphorus and triglycerides were observed which were transient in nature. The signs of toxicity in animals were increased ...

List of excipients

Tablet core: Lactose monohydrate Cellulose microcrystalline Low substituted hydroxypropylcellulose (LH-11) (E463) Croscarmellose sodium Magnesium stearate Film coat: Hydroxypropylcellulose (LF) (E463) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.

Nature and contents of container

Montelukast 10 mg tablets are packed in OPA-Al-PVC/Al blister. Pack size: Packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets in blister. 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

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization number(s)

PL 20075/0182

Date of first authorization / renewal of the authorization

03/11/2016

Date of revision of the text

28/05/2019

Πηγαίο έγγραφο

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