Rinofluimucil

Package leaflet: Information for the patient

Rinofluimucil 1% + 0,5% nasal spray solution

N-acetylcysteine + tuaminoheptane sulfate
Please read carefully this leaflet before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any of the listed side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after one week of treatment.

Contents of this leaflet:

1. What Rinofluimucil is and what it is used for
2. What you need to know before using Rinofluimucil
3. How to use Rinofluimucil
4. Possible side effects
5. How to store Rinofluimucil
6. Contents of the pack and other information

1. What Rinofluimucil is and what it is used for

Rinofluimucil contains the active substances N-acetylcysteine, which belongs to a group of medicines called mucolytics used to liquefy nasal mucus, and tuaminoheptane sulfate, which belongs to a group of medicines called vasoconstrictors used as nasal decongestants.
This medicine is used to treat inflammations of the nasal mucosa (acute and subacute rhinitis with mucopurulent secretions and slow resolution, chronic and muco-crusted rhinitis, vasomotor rhinitis) and of the paranasal sinuses (sinusitis).
If you do not feel better or feel worse after one week of treatment, consult your doctor.

2. What you need to know before using Rinofluimucil

Do not use Rinofluimucil

• if you are allergic to acetylcysteine or tuaminoheptane sulfate or to any of the other ingredients of this medicine (listed in section 6);
• if you have a heart and/or blood vessel disease, including high blood pressure (hypertension);
• if you have previously suffered from a cerebrovascular disease;
• if you have previously had seizures;
• if you have a eye disease with increased pressure inside the eye (narrow-angle glaucoma);
• if you have excessive production of thyroid hormones (hyperthyroidism);
• if you are being treated with medicines for depression (monoamine oxidase inhibitors) or within two weeks after stopping such treatment (see "Other medicines and Rinofluimucil");
• if you are using other sympathomimetic medicines, including other nasal decongestants (see "Other medicines and Rinofluimucil");
• if you have a rare tumour of the adrenal gland called phaeochromocytoma;
• if you have had surgical removal of the pituitary gland (hypophysectomy) or have undergone surgical procedures involving exposure of the outer membrane covering the brain (dura mater);
• if you are under 12 years of age (see "Children and adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before using Rinofluimucil.
Discontinue treatment if you experience high blood pressure (arterial hypertension), rapid heartbeat (tachycardia), palpitations, heart rhythm disturbances, nausea, or any neurological signs or symptoms (such as headache or worsening of pre-existing headache).
In children over 12 years of age, this product should be used only when strictly necessary and under medical supervision.
Use this medicine only after consulting your doctor

• if you are elderly or suffer from prostate enlargement (prostatic hypertrophy), due to the risk of inability or reduced ability to empty the bladder (urinary retention);
• if you have heart and/or blood vessel problems, especially high blood pressure;
• if you suffer from asthma, diabetes, blood vessel obstruction (occlusive vascular disease), or are being treated with beta-blockers used in the treatment of certain cardiovascular conditions. Consult your doctor even if you have previously experienced any of these conditions.
  Prolonged use of medicines containing substances that act on blood vessels (vasoconstrictors) may alter the normal function of the nasal and paranasal sinuses mucosa, potentially leading to tolerance (drug dependence). Repeated use over long periods may be harmful. Prolonged use may cause swelling of the nasal mucosa. The action of this medicine may be complemented, at the physician's discretion, with appropriate antibacterial coverage.

Rinofluimucil is not an eye medicine.
Caution for those engaged in sports activities:

• the product contains substances banned for doping. Any use differing from the dosage regimen and route of administration indicated is prohibited.
• the use of medicines containing ethyl alcohol may result in positive anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.

Children and adolescents
This medicine is contraindicated in children under 12 years of age (see "Do not use Rinofluimucil").
In children and adolescents over 12 years of age, this medicine should be used only when strictly necessary and under medical supervision.
Other medicines and Rinofluimucil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Rinofluimucil together with:

• medicines for depression (monoamine oxidase inhibitors (MAOIs), including reversible inhibitors of monoamine oxidase (RIMAs)), due to the risk of sudden increase in blood pressure (hypertensive crisis). Use is also contraindicated within two weeks after stopping such treatment (see "Do not use Rinofluimucil").
• sympathomimetic medicines, including other nasal decongestants (see "Do not use Rinofluimucil").

Exercise particular caution if you are taking:

• medicines to lower blood pressure (antihypertensives), including adrenergic neuron blockers and beta-blockers, due to the risk of blocking blood pressure-lowering effects;
• medicines acting on the heart (cardiac glycosides), as they may increase the risk of irregular heartbeat (arrhythmia);
• medicines for migraine (ergot alkaloids), as they may increase the risk of ergot alkaloid poisoning (ergotism);
• medicines for Parkinson's disease, as they may increase the risk of cardiovascular toxicity;
• oxytocin (a hormone), as it may increase the risk of increased blood pressure (hypertension).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Rinofluimucil is not recommended during pregnancy.
Breastfeeding
Do not use Rinofluimucil during breastfeeding.
Driving and using machines
Rinofluimucil does not affect attention or reaction times. However, hallucinations have been reported.
Rinofluimucil contains benzalkonium chloride
Rinofluimucil contains 0.005 mg of benzalkonium chloride per spray.
It may cause bronchospasm (narrowing of the bronchial tubes, resulting in breathing difficulty).
It may cause irritation and swelling inside the nose, especially if used for prolonged periods.
Rinofluimucil contains d-limonene
d-Limonene may cause allergic reactions.

3. How to use Rinofluimucil

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended doses are:
Adults: 2 sprays into each nostril, 3–4 times daily.
Use in children and adolescents over 12 years of age: 1 spray into each nostril, 3–4 times daily.
Caution: Do not exceed the recommended doses without medical advice.
Use only for short-term treatment, and in any case not longer than one week.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.
Rinofluimucil should be sprayed into the nasal cavities using the provided spray device.

Instructions for use:

Open the bottle by squeezing the sides of the capsule and unscrewing it at the same time.

1. Screw the spray pump onto the bottle after removing the protector from the dip tube.
2. Remove the cap from the spray nozzle.
3. Prime the pump by pressing it several times.

If you use more Rinofluimucil than you should
In case of accidental ingestion/over-administration of an excessive dose of Rinofluimucil, immediately inform your doctor or go to the nearest hospital.
In case of overdose, increased blood pressure (arterial hypertension), excessive sensitivity to light (photophobia), severe headache, chest tightness, and in children a drop in body temperature (hypothermia) with marked sedation may occur, requiring immediate emergency measures.

If you forget to use Rinofluimucil
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
This medicine may cause local allergic reactions (sensitization) and mucosal congestion as a consequence of a phenomenon known as "rebound effect" (recurrence of symptoms after discontinuation of pharmacological treatment).
Frequent administration at higher doses may cause sympathomimetic side effects (such as increased excitability, palpitations, tremor, etc.). Occasionally, dryness of the nose and throat and acneiform eruptions may occur. These effects disappear upon discontinuation of treatment.
Side effects with unknown frequency (frequency cannot be estimated from the available data):

• hypersensitivity,
• high blood pressure (hypertension),
• nausea,
• urticaria,
• appearance on more or less extensive areas of skin of red spots or patches (rash),
• inability or reduced ability to empty the bladder (urinary retention). Particularly with prolonged and/or excessive use:
• anxiety,
• hallucinations,
• delirium,
• headache,
• restlessness,
• agitation,
• insomnia,
• tremor,
• palpitations,
• increased heart rate (tachycardia),
• irregular heartbeat (arrhythmia),
• dryness of the nose and throat,
• nasal discomfort and congestion,
• irritability,
• tolerance to the medicine (tachyphylaxis).

Following the information contained in this leaflet reduces the risk of side effects. These side effects are generally transient.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rinofluimucil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month. The expiry date indicated applies to the product in its original, unopened packaging, correctly stored.
The opened bottle must be used within 20 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rinofluimucil contains
The active substances are: N-acetylcysteine and tuaminheptane sulfate. 1 ml of solution contains 10 mg of
N-acetylcysteine and 5 mg of tuaminheptane sulfate.

• Other components are: benzalkonium chloride, dithiothreitol, edetate sodium, disodium phosphate, monosodium phosphate, sodium hydroxide, alcohol, hypromellose, sorbitol, natural peppermint flavour (containing d- limonene), purified water.

Description of the appearance of Rinofluimucil and contents of the pack
Rinofluimucil is a solution for nebulizer (spray).
Pack sizes are 10 ml or 25 ml.
Marketing Authorization Holder
Zambon Italia s.r.l. - via Lillo del Duca 10 - 20091 Bresso (MI)
Manufacturer
Zambon S.p.A. - via della Chimica, 9 - 36100 Vicenza