MOMENXSIN 12 CPR

Descriere

Active ingredients Each film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride. For a full list of excipients, see section 6.1. Excipients Tablet core Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Croscarmellose sodium Maize starch Colloidal anhydrous silica Magnesium stearate Tablet coating Hypromellose Macrogol 400 Talc Titanium dioxide (E171) Yellow iron oxide (E172) Therapeutic indications Symptomatic treatment of nasal congestion associated with acute rhinosinusitis of suspected viral origin with headache and/or fever. Momenxsin is indicated in adults and adolescents aged 15 years and older. Contraindications/Side effects • Hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or to any of the excipients listed in section 6.1; • Patients under 15 years of age; • Women in the third trimester of pregnancy (see section 4.6); • Breastfeeding women (see section 4.6); • Patients with a history of hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); • History of gastrointestinal bleeding or perforation associated with previous NSAID therapy; • Current or previous recurrent peptic ulcer/haemorrhage (at least two distinct episodes of proven ulceration or bleeding); • Cerebrovascular or other bleeding; • Haematopoietic abnormalities of unknown origin; • Severe hepatic insufficiency; • Severe renal insufficiency; • Severe cardiac insufficiency; • Severe cardiovascular disorders, coronary heart disease (heart disease, hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes, pheochromocytoma; • History of stroke or presence of risk factors for stroke (due to the α-sympathomimetic activity of pseudoephedrine hydrochloride); • Risk of narrow-angle glaucoma; • Risk of urinary retention related to urethroprostatic disorders; • History of myocardial infarction; • History of seizures; • Systemic lupus erythematosus; • Concomitant use of other vasoconstrictors such as nasal decongestants, administered orally or nasally (e.g. phenylpropanolamine, phenylephrine and ephedrine), and methylphenidate (see section 4.5); • Concomitant use of non-selective monoamine oxidase inhibitors (MAOIs) (iproniazid) (see section 4.5) or use of MAOIs within the last two weeks. Dosage Dosage: Adults and adolescents aged 15 years and over: 1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 6 hours as needed. For more severe symptoms, 2 tablets (equivalent to 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride) every 6 hours as needed, up to a maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride). Do not exceed the maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride). For short-term use. If symptoms worsen, consult a doctor. The maximum duration of treatment is 4 days for adults and 3 days for adolescents aged 15 years and over. In cases where symptoms consist predominantly of pain/fever or nasal congestion, administration of a product containing a single active ingredient is preferable. Undesirable effects can be minimized by using the lowest dose necessary to achieve symptom control for the shortest possible duration (see section 4.4). Paediatric population Momenxsin is contraindicated in paediatric patients under 15 years of age (see section 4.3). Method of administration For oral use. The tablets should be swallowed whole and not chewed, with a glass of water, preferably during meals.