Index
It is indicated for treating nasal congestion caused by allergic, vasomotor, and chronic rhinitis (acute and subacute).
Mainly with the presence of discharge (mucus) and scabs and for treating acute and chronic sinusitis.
Presentation of Rinofluimucil
- Laboratory: Zambon
- Nasal solution: a bottle containing 12 mL with a dropper.
- Active ingredients: acetylcysteine, tuaminoeptan sulfate.
Composition of Rinofluimucil
Every 1 ml of nasal solution contains:
- Acetylcysteine (10 mg).
- Sulfato de tuaminoeptano (5 mg).
- Excipients: dithiothreitol, disodium edetate, sodium hydroxide, dibasic sodium phosphate, monobasic sodium phosphate, hypromellose, benzalkonium chloride, ethanol, sorbitol, peppermint flavor, and reverse osmosis water (qsp1 mL).
Each 1 mL contains 27 drops.
How does this medication work?
Rinofluimucil is a nasal decongestant with two substances in its formula: acetylcysteine , which loosens secretions or mucus in the respiratory tract (nose), and tuaminoeptan sulfate, which promotes immediate relief of nasal congestion caused by inflammation of the nasal mucosa as occurs in rhinitis and sinusitis.
Contraindications and risks of Rinofluimucil
This drug is contraindicated for patients with:
- History of known hypersensitivity to acetylcysteine, tuaminoeptan sulfate, and other components of its formulation.
- Angle-closure glaucoma (elevated intraocular pressure).
- Cardiovascular disease (including hypertension).
- Pheochromocytoma (tumor of the supra-, hypophysectomy (surgical removal of the pituitary), or surgery with exposure of the dura.
- Concomitant use with other sympathomimetic agents (including nasal decongestants).
This medicine should not be used during treatment with the group of monoamine oxidase inhibitors (MAOIs), including monoamine oxidase inhibitors, and for two weeks after the end of treatment.
This drug is contraindicated for children under six years of age.
Pregnant women should not use this medicine without medical or dental surgeon guidance.
What should you know before using this medicine?
Rinofluimucil Precautions and Warnings
Sympathomimetic agents should be used with caution in patients with occlusive vascular disease, beta-blockers, diabetes mellitus, hyperthyroidism, and prostatic hyperplasia (enlarged prostate) can increase the difficulty of urination.
Prolonged vasoconstrictors can cause a rebound effect with nasal congestion and induce drug rhinitis. Keep out of the eyes.
Rinofluimucil contains benzalkonium chloride as a preservative that is an irritant; it can cause skin reaction or bronchospasm.
Use in the elderly
The general and medical instructions described in the package insert should be followed.
Pediatric use
It should be administered with caution in asthmatic children. It can be used safely in children over six years of age.
Only sports practitioners
The use of Rinofluimucil may cause positive drug test results.
This medicine can cause doping.
Rinofluimucil does not interfere with the patient’s wakefulness and care, allowing him to drive and use machines generally while using the drug.
Rinofluimucil drug interactions
Sympathomimetic agents should be used with caution in patients with occlusive vascular disease, beta-blockers, diabetes mellitus, hyperthyroidism, and prostatic hyperplasia (enlarged prostate) (which may increase the difficulty of urination).
Prolonged vasoconstrictors can cause a rebound effect with nasal congestion and induce drug rhinitis. Keep out of the eyes.
Rinofluimucil contains benzalkonium chloride as a preservative that is an irritant; it can cause skin reaction or bronchospasm.
The absorption of nasally administered peptide drugs, such as calcitonin, was increased with the concomitant use of nasal acetylcysteine in animal models.
Patients using MAO inhibitors (including reversible monoamine oxidase inhibitors) and moclobemide and, tranylcypromine, selegiline should interrupt treatment 14 days before starting treatment with Rinofluimucil due to the increased risk of hypertensive crisis.
Treatment with MAO inhibitors increases the amount of norepinephrine available in nerve endings for up to 2 weeks after discontinuation of use, and the administration of sympathomimetics, such as tuaminoeptan, during this period can result in a hypertensive episode.
It can inhibit the hypotensive effect of antihypertensives, including beta-blockers and adrenergic neuron blockers, increase the risk of dysrhythmias with cardiac glycosides, and increase the risk of cardiovascular toxicity with antiparkinsonian drugs.
Interactions with laboratory tests
No abnormalities were observed in laboratory tests in patients using Rinofluimucil nasal.
Interactions with food
Because it is for nasal use, there is no interference between nasal Rinofluimucil and food.
Rinofluimucil use in pregnancy and lactation
Sympathomimetic agents should be used with caution in patients with occlusive vascular disease, beta-blockers, diabetes mellitus , hyperthyroidism, prostatic hyperplasia (enlarged prostate) (which may increase the difficulty of urination).
Prolonged vasoconstrictors can cause a rebound effect with nasal congestion and induce drug rhinitis. Keep out of the eyes.
Rinofluimucil contains benzalkonium chloride as a preservative that is an irritant, it can cause skin reaction or bronchospasm.
The number of pregnant women exposed to acetylcysteine did not show any adverse events related to pregnancy or the health of the fetus or newborn. Animal studies have not shown direct or indirect harmful effects related to reproducibility.
Current data did not show exposure to tuaminoeptan in pregnant women or animal studies.
There are no studies demonstrating the presence of acetylcysteine, tuaminoeptan sulfate, and derivatives in breast milk, and their use during lactation is not recommended.
Rinofluimucil should only be used by pregnant and lactating women in dire need and under careful medical supervision.
Where, how, and for how long can I store this medicine?
- Store at room temperature (between 15C and 30C).
- Lot number and dates of manufacture and validity: see packaging.
- Do not use expired medications. Could you keep it in the original packaging?
- After opening, valid for 15 days.
It is recommended to keep the bottle open for the shortest time possible during application.
Rinofluimucil is a nasal solution that is colorless and clear, with a slight minty odor with a sulfurous underside (sulfur), which is characteristic of this drug.
Before use, observe the appearance of the medicine. If it is within the validity period and you notice any change in appearance, ask your pharmacist to see if you can use it.
How should I use this medicine?
Dosage, dosage, and instructions for the use of Rinofluimucil:
Dosage
Adults: 3 to 4 drops in each nostril 3 to 4 times a day.
Children (age six years): 1 to 3 drops in each nostril 3 to 4 times a day.
Being a topical nasal decongestant, it is recommended not to use Rinofluimucil continuously for more than seven days.
How to use
- Open the jar.
- Approach the dropper of the solution.
- Aspirate the solution into the dropper.
- Apply the drops in the nostrils. The dropper should not be put inside the nose, as it can contaminate the medicine.
- Do not clean the dropper with water, but with absorbent paper, as water accelerates the breakdown of the medicine.
- Screw on the bottle with the dropper.
The drug is now ready for use; it is not necessary to dilute it with water.
Please do not take the solution; its use is nasal.
What should you do if you forget to use this medicine?
If you have missed a dose, you should apply it as soon as possible and administer the next dose, that is, at the regular time and without doubling the dose.
When in doubt, seek guidance from your pharmacist, doctor, or dental surgeon.
What are the ills that this medicine can cause me?
Rinofluimucil adverse reactions
The following adverse reactions may be associated with Rinofluimucil:
- Hypersensitivity
- Hypertension (increased hypertension).
- Sickness.
- Urticaria.
- Skin rash (reddish skin).
- Urinary retention.
And other reactions due to prolonged or excessive use such as:
- Anxiety.
- Hallucination.
- Imaginative visions (mirage).
- Headache.
- Restlessness and agitation.
- Insomnia.
- Palpitations
- Tachycardia.
- Arrhythmia.
- Nasal dryness.
- Nasal discomfort.
- Nasal congestion.
- Irritability.
- Drug tolerance.
Inform your doctor if you notice any other reaction not described in this leaflet.
Inform your doctor, dental surgeon, or pharmacist about the appearance of undesirable reactions from using the medicine. Also, inform the company through their helpdesk.
What to do if someone uses more than the amount indicated for this medicine?
Rinofluimucil overdose
In overdose situations, arterial hypertension (increased pressure), photophobia (sensitivity to light), severe headache, chest tightness, and, in children, hypothermia (reduced body temperature) with sedation may occur.
