RINOFLUIMUCIL 1% + 0.5% Nasal spray, solution

Зміст інструкції

1. Rinofluimucil 1% + 0,5% nasal spray solution
   1. What is Rinofluimucil and what is it 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

Rinofluimucil 1% + 0,5% nasal spray solution

N-acetylcysteine + tuaminoheptane sulfate

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse after a week of treatment.

Contents of this leaflet:

• 1. What Rinofluimucil is and what it is used for
• 2. What you need to know before you use 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 is Rinofluimucil and what is it used for

Rinofluimucil contains the active ingredients 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 for the treatment of inflammation of the nasal mucosa (acute and subacute rhinitis, with
mucopurulent and slow-resolving exudates, chronic and muco-crusty rhinitis, vasomotor rhinitis) and of the paranasal sinuses
(sinusitis).
See your doctor if you do not feel better or if you feel worse after a week of treatment.

2. What you need to know before using Rinofluimucil

Do not use Rinofluimucil

• if you are allergic to N-acetylcysteine or tuaminoheptane sulfate or to any of the other ingredients of this medicine (listed in section 6);
• if you have heart and/or blood vessel disease, including high blood pressure (hypertension);
• if you have previously suffered from a cerebrovascular disease;
• if you have previously suffered from convulsions;
• if you have an eye disease with high pressure inside the eye (narrow-angle glaucoma);
• if you have excessive production of thyroid hormones (hyperthyroidism);
• if you are being treated with medicines against depression (monoamine oxidase inhibitors) or within two weeks of 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 tumor of the adrenal gland called pheochromocytoma;
• if your pituitary gland has been surgically removed (hypophysectomy) or if you have undergone surgery exposing the outer membrane surrounding the brain (dura mater);
• if you are under 12 years of age (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before using Rinofluimucil.
Stop treatment in case of high blood pressure (arterial hypertension), accelerated heartbeat
(tachycardia), palpitations, irregular heartbeat, nausea or any neurological signs and symptoms (such as a
headache or worsening of an existing headache).
In children over 12 years of age, the product should only be used if absolutely necessary and under medical supervision.

Use this medicine only after consulting your doctor

• If you are elderly or if you suffer from an enlarged prostate (prostatic hypertrophy), due to the risk of inability or reduced ability to empty the bladder (urinary retention),
• if you have problems with the heart and/or blood vessels, especially high blood pressure,
• if you suffer from asthma, diabetes, occlusive vascular disease or if you are being treated with beta-blockers, used in the treatment of certain cardiovascular diseases. Also consult your doctor if these conditions have occurred in the past. Prolonged use of medicines containing substances that act on blood vessels (vasoconstrictors) can alter the normal function of the nasal and paranasal sinus mucosa, also inducing tolerance to the medicine (habituation). Repeating applications for long periods can be harmful. Prolonged use can cause swelling of the nasal mucosa. The action of the medicine can be supplemented, at the doctor's discretion, with appropriate antibacterial coverage.

Rinofluimucil is not a medicine for the eyes.
Caution for those who engage in sports:

• the product contains substances prohibited for doping. Taking it differently than the dosage regimen and route of administration specified is prohibited.
• the use of medicines containing ethyl alcohol can result in a positive doping test in relation to the blood alcohol concentration limits indicated by some 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, the medicine should only be used if absolutely necessary and under
medical supervision.

Other medicines and Rinofluimucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Do not use Rinofluimucil together with:

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

Be particularly careful if you are taking:

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask
your doctor or pharmacist for advice 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 and reaction times. However, effects such as
hallucinations have been reported.

Rinofluimucil contains benzalkonium chloride
Rinofluimucil contains 0.005 mg of benzalkonium chloride per dose.
It can cause bronchospasm (narrowing of the bronchi that manifests with difficulty breathing).
It can cause irritation and swelling inside the nose, especially if used for long periods.

Rinofluimucil contains d-limonene
d-limonene can cause allergic reactions.

3. How to use Rinofluimucil

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended doses are:
Adults: 2 sprays in each nostril, 3-4 times a day.

Use in children and adolescents over 12 years: 1 spray in each nostril, 3-4 times a day.
Caution: do not exceed the indicated doses without consulting your doctor.
Use only for short periods of treatment, and in any case not for more than one week.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.
Rinofluimucil must be nebulized into the nasal cavities using the appropriate applicator.

Instructions for use:

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

• 1. Screw on the spray pump after removing the dip tube from the protection.
• 2. Remove the cap from the applicator.
• 3. Activate the pump several times.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The medicine may locally determine allergic phenomena (sensitization) and congestion of the mucous membranes as a
consequence of a phenomenon known as “rebound effect” (recurrence of symptoms after a pharmacological treatment
has been discontinued).
Frequent administrations of the medicine at the highest doses can cause sympathomimetic-type side effects
(such as increased excitability, palpitations, tremor, etc.). Sometimes dryness may occur
of the nose and throat and acneiform eruptions. These effects disappear with discontinuation of treatment.

Side effects with unknown frequency(frequency cannot be estimated based on available data):

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

Side effects are generally transient.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or your
pharmacist. You can also report side effects directly through the national reporting system
at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
help to 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 which is stated on the packaging after “Scad”. The expiry date
refers to the last day of that month. The expiry date indicated refers to the product in intact packaging,
correctly stored.
The opened bottle can be used for a period not exceeding 20 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• The other components are: benzalkonium chloride, dithiotreitol, sodium edetate, disodium phosphate, monosodium phosphate, sodium hydroxide, alcohol, hypromellose, sorbitol, natural mint flavour (containing d-limonene), purified water.

Description of the appearance of Rinofluimucil and contents of the pack
Rinofluimucil is presented as a solution with a nebulizer (spray).
The pack contains 10 or 25 ml.

Marketing Authorisation 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