Actigrip Nasal Spray Bottle 10 ml

WARNINGS
Xylometazoline should be administered with caution in patients with marked reaction to sympathomimetic substances. The use of substances of this type can 'cause in these patients a series of disturbances, such as insomnia, dizziness, tremors, arrhythmia or blood pressure. Particular caution is required in the case of patients suffering from cardiovascular diseases, hypertension, hyperthyroidism or diabetes, as well as in the case of patients with prostatic hypertrophy and pheochromocytoma. In case of prolonged treatment with xylometazoline, the reappearance of symptoms of rhinitis and edema of the mucous membrane is sometimes observed with the suspension of therapy. In these cases, it may also be the so-called "rebound" phenomenon caused by the drug itself, which progresses to chronic edema and atrophy of the nasal mucosa (rhinitis medicamentosa and dry rhinitis). To avoid this, the duration of treatment should be as short as possible. Nasal and paranasal inflammations of bacterial origin must be treated appropriately. For the treatment of allergic rhinitis, this product can only be used temporarily as a supportive therapy.
PHARMACOTHERAPEUTIC CATEGORY
Preparations for nasal use, Sympathomimetics, unassociated.
STORAGE
Do not store above 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
The medicine must not be used: in patients with hypersensitivity to the active substance or to any of the excipients; in patients with elevated intraocular pressure, particularly in the presence of narrow-angle diglaucoma; in patients with "dry" inflammation of the nasal mucosa (dry rhinitis); in children under the age of 12; after transphenoidal hypophysectomy or other transnasal / transoral surgery with exposure of the dura mater; in patients treated with monoamine oxidase inhibitors (MAOIs) or who have used these drugs in the previous 2 weeks, or in patients taking other medicinal products with potential for hypertensive effect; in patients with atrophic or vasomotor rhinitis.
NAME
ACTIGRIP NASALE 1 MG / ML NASAL SPRAY, SOLUTION
EXCIPIENTS
Sodium hyaluronate, sorbitol (E420), glycerol (E422), sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium, chloride, water for injections.
SIDE EFFECTS
The most frequently reported side effects of this medicine are tingling or burning of the nose and throat and dryness of the nasal mucosa. Based on their frequency, undesirable effects were divided into the following categories: very common> = 1/10, common> = 1/100 to <1/10, uncommon> = 1/1000 to <1/100 , rare> = 1 / 10,000 to <1/1000, very rare <1 / 10,000 including isolated reports, not known. Disorders of the immune system. Rare: systemic allergic reactions. Psychiatric disorders. Rare: nervousness, insomnia. Nervous system disorders. Rare: headache, dizziness; eye pathologies. Rare: transient visual disturbances. Cardiac pathologies. Rare: palpitation. Vascular pathologies. Rare: rise in blood pressure. Respiratory, thoracic and mediastinal disorders. Common: itching and burning of the nose and throat and dryness of the nasal mucosa; not known: rebound effect). Gastrointestinal disorders. Rare: nausea.
PREGNANCY AND BREASTFEEDING
There are no data regarding the trans-placental passage of xylometazoline, nor its secretion in breast milk. Due to the potential systemic vascular constricting effect, this medicinal product should not be used in pregnancy. During lactation this drug should be used with caution as it is not known whether or not the active substance is transferred into breast milk.
INDICATIONS
Temporary symptomatic treatment of nasal congestion due to rhinitis or sinusitis.
INTERACTIONS
The use of the product is not recommended in conjunction with tricyclic or tetracyclic antidepressant drugs or monoamine oxidase inhibitors (MAOIs), or in the two weeks following the use of MAO inhibitors.
DOSAGE
For nasal use. Adults and children over 12 years: one delivery in each nostril no more than three times a day. This medicine must be used for a maximum of 7 days, unless otherwise prescribed. To minimize the risk of infections, the product must not be used by more than one person and the spout must be cleaned after each use. Children: contraindicated in children under 12 years. Elderly: Same dosage as adults.
ACTIVE PRINCIPLES
Xylometazoline hydrochloride 1 mg in 1 ml of solution: Each spray-dose (140mcl) contains 140mcg of xylometazoline hydrochloride.