Rinofluimucil Nasal Spray Solution 10ml

Rinofluimucil 1% + 0.5% Nasal Spray Solution

Rinofluimucil what it is for

Active ingredients contained in Rinofluimucil

Excipients of Rinofluimucil

Contraindications for the use of Rinofluimucil

How is Rinofluimucil used

Rinofluimucil warnings and precautions

Interactions

Undesirable effects from the use of Rinofluimucil

Rinofluimucil in Pregnancy and lactation

Rinofluimucil sales format

Rinofluimucil what it is for

Rinofluimucil is used for several purposes:

- Acute and subacute rhinitis, especially with slow-resolving mucopurulent exudates. - Chronic and mucus-crusted rhinitis. - Vasomotor rhinitis. - Sinusitis.

Active ingredients contained in Rinofluimucil

100 ml of solution contain: Active ingredients N-Acetylcysteine 1,000 g Tuaminoheptane sulfate 0,500 g For the full list of excipients, see section 6.1

Excipients of Rinofluimucil

Benzalkonium chloride, Dithiothreitol, Sodium edetate, Dibasic sodium phosphate, Monobasic sodium phosphate, Sodium hydroxide, Alcohol, Hypromellose, Sorbitol 70%, Natural mint flavor, Purified water.

Contraindications for the use of Rinofluimucil

Hypersensitivity to the active substance or to any of the excipients. Narrow angle glaucoma. Hyperthyroidism. During and in the two weeks following therapy with monoamine oxidase inhibitors (MAOIs). Children under the age of 12. Pheochromocytoma. During the use of other sympathomimetic agents, including other nasal decongestants. Hypophysectomy or surgery with exposure of the dura mater.

How is Rinofluimucil used

RINOFLUIMUCIL is used for applications in the nasal cavity, using the appropriate dosage dispenser (see section 6.6). ADULTS: 2 sprays in each nostril 3-4 times a day. CHILDREN over 12 years: 1 pump in each nostril 3-4 times a day. Do not exceed the indicated doses. The bottle, when opened, can be used for a period not exceeding 20 days.

Rinofluimucil warnings and precautions

In patients with cardiovascular diseases, and especially in hypertensive patients, the use of nasal decongestants must be subjected to the judgment of the physician from time to time. Administer with caution in subjects suffering from occlusive vascular disease, asthma, diabetes and in therapy with beta-blocking drugs. Rinofluimucil should be administered with caution in pediatric age and is however contraindicated in children under the age of 12 years. Prolonged use of preparations containing vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating applications for long periods can therefore be harmful. Use the product with caution, due to the risk of urinary retention, in the elderly and in patients with prostatic hypertrophy. The use, especially if prolonged, of topical products can give rise to sensitization phenomena: in this case it is necessary to interrupt the treatment and, if necessary, institute a suitable therapy. However, in the absence of a complete therapeutic response within a few days, consult your doctor; in any case, the treatment must not be continued for more than a week. The action of the preparation can be integrated, in the opinion of the doctor, with an appropriate antibacterial cover. Tuaminoheptane sulfate can determine a positive doping test. The preparation is not for ophthalmic use. Important information about some of the ingredients The preservative benzalkonium chloride may cause skin reactions or bronchospasm.

Interactions

Despite the poor systemic absorption of tuaminoheptane administered intranasally, the following potential interactions should be considered: - monoamine oxidase inhibitors (MAOIs), including reversible monoamine oxidase inhibitors (RIMA): increased risk of hypertensive crisis ; - antihypertensive agents (including adrenergic neuron blockers and beta blockers): they can block the hypotensive effects; -cardiac glycosides: can increase the risk of dysrhythmia; -ergot alkaloids: may increase the risk of ergotism; - antiparkinsonian drugs: they can increase the risk of cardiovascular toxicity; oxytocin: may increase the risk of hypertension.

Undesirable effects from the use of Rinofluimucil

Frequent administration of the preparation at the highest doses can cause sympathomimetic side effects (such as increased excitability, heart palms, tremors, etc.). Dry nose and throat, acne eruptions can sometimes occur. These effects disappear completely when the treatment is stopped. The following side effects may be associated with the use of Rinofluimucil; the frequency of these side effects is not known (cannot be estimated from the available data):

Rinofluimucil in Pregnancy and lactation

Pregnancy Data from a limited number of pregnant women exposed to N-acetylcysteine did not indicate any adverse effects on the pregnancy itself or on the health of the fetus / newborn. At present, no further relevant epidemiological data are available. Animal studies have not shown direct or indirect harmful effects with respect to reproductive toxicity. There are no data on pregnant women exposed to youraminoheptane or animal studies with youramonoheptane. Rinofluimucil is not recommended in pregnancy. Breastfeeding There is no information available on the excretion of N-acetylcysteine and tuaminoheptane in breast milk therefore the product should not be used by breastfeeding mothers.

Rinofluimucil sales format

Rinofluimucil is sold in Spray in 10 ml format

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