MONTELUKAST Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
