Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Montelukast sodium
Krka UK Ltd
R03DC03
Montelukast sodium
5mg
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03030200; GTIN: 5391512452032
What is in this leaflet 1. What Montelukast is and what it is used for 2. What you need to know before you give Montelukast to your child 3. How to take Montelukast 4. Possible side effects 5. How to store Montelukast 6. Contents of the pack and other information 1. WHAT MonTelukAsT Is AnD WHAT IT Is useD FoR Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma. Your doctor has prescribed Montelukast to treat your child’s asthma, preventing asthma symptoms during the day and night. • Montelukast 5 mg chewable tablets are used for the treatment of 6 to 14 year old patients who are not adequately controlled on their medication and need additional therapy. • Montelukast 5 mg chewable tablets may also be used as an alternative treatment to inhaled corticosteroids for 6 to 14 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids. • Montelukast 5 mg chewable tablets also help prevent the narrowing of airways triggered by exercise for 6 year old patients and older. Your doctor will determine how Montelukast should be used depending on the symptoms and severity of your child’s asthma. What is asthma? Asthma is a long-term disease. Asthma includes: • difficulty breathing because of narrowed airways. This narrowing of airways worsens and improves in response to various conditions. • sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise. • swelling (inflammation) in the lining of airways. Symptoms of asthma include: Coughing, wheezing, and chest tightness. 2. WHAT you neeD To knoW beFoRe you gIve MonTelukAsT To youR cHIlD Tell your doctor about any medical problems or allergies your child has now or has had. Do not give Montelukast to your child: • if your child is allerg Lees het volledige document
OBJECT 1 MONTELUKAST 5 MG CHEWABLE TABLETS Summary of Product Characteristics Updated 23-May-2016 | Consilient Health Ltd 1. Name of the medicinal product Montelukast 5 mg chewable tablets 2. Qualitative and quantitative composition Each chewable tablet contains 5 mg montelukast (as montelukast sodium). Excipient(s) with known effect: Each chewable tablet contains 1.5 mg aspartame. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Chewable tablet. Pink, marbled, round, slightly biconvex tablets with bevelled edges and inscription 5 on one side. 4. Clinical particulars 4.1 Therapeutic indications Montelukast is indicated in the treatment of asthma as add-on therapy in those 6 to 14 year old children with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom 'as-needed' short-acting beta-agonists provide inadequate clinical control of asthma. Montelukast may also be an alternative treatment option to low-dose inhaled corticosteroids for 6 to 14 year old children with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2) Montelukast is also indicated in the prophylaxis of asthma from 6 years of age and older children in which the predominant component is exercise-induced bronchoconstriction. 4.2 Posology and method of administration Posology _General recommendations_ The therapeutic effect of Montelukast on parameters of asthma control occurs within one day. Patients should be advised to continue taking Montelukast even if their asthma is under control, as well as during periods of worsening asthma. No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients. _Montelukast as an alternative treatment option Lees het volledige document