Package leaflet: Information for the patient

NASOMIXIN C.M. 2.5 mg/ml nasal drops, solution

Phenylephrine hydrochloride
Please read this leaflet carefully 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.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any 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 any improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

What NASOMIXIN C.M. is and what it is used for
What you need to know before using NASOMIXIN C.M.
How to use NASOMIXIN C.M.
Possible side effects
How to store NASOMIXIN C.M.
Contents of the pack and other information

1. What NASOMIXIN C.M. is and what it is used for

This medicine contains the active substance phenylephrine hydrochloride, which belongs to a group of
medicines called nasal decongestants.
NASOMIXIN C.M. is used to relieve nasal congestion through local application.
Consult your doctor if you do not feel better or feel worse after 5 days.

2. What you need to know before using NASOMIXIN C.M.

Do not use NASOMIXIN C.M.

if you are allergic to phenylephrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
if you have a heart disease or suffer from high blood pressure (severe arterial hypertension);
if you have a serious thyroid disorder (hyperthyroidism);
if you have an eye disorder characterized by increased eye pressure (closed-angle glaucoma);
if you are taking or have taken within the previous two weeks medicines used for depression or Parkinson’s disease (monoamine oxidase inhibitors) (see section “Other medicines and NASOMIXIN C.M.”);
if the person using this medicine is a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using NASOMIXIN C.M.
Use this medicine with caution and under medical supervision if:

you suffer from high blood pressure (hypertension);
you suffer from heart diseases, including heart rhythm disorders (arrhythmias);
you suffer from thyroid disorders;
you have diabetes mellitus;
you have an eye disorder due to high intraocular pressure (glaucoma);
you have an enlarged prostate (prostatic hypertrophy).

Use NASOMIXIN C.M. at the recommended doses, as prolonged use may cause rebound congestion, which
may lead to excessive use of this medicine.
Prolonged use of this medicine may cause:

alteration of the function of the nasal mucosa and of the cavities connected to the nose (paranasal sinuses), and in severe cases, inflammation of the internal parts of the nose with reduced mucus production (medicamentosa atrophic rhinitis);
reduced effectiveness of the medicine (tachyphylaxis).

Other medicines and NASOMIXIN C.M.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Use this medicine with caution and consult your doctor if you are taking:

medicines used to treat depression (tricyclic antidepressants), as they may increase the effects of NASOMIXIN C.M. on blood pressure.

Do not use this medicine if you are taking or have taken within the previous two weeks medicines used for
depression or Parkinson’s disease (monoamine oxidase inhibitors), as serious adverse effects may occur.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine with caution and under direct medical supervision.
Driving and using machines
NASOMIXIN C.M., when used at the recommended doses, does not affect the ability to drive or operate
machinery. However, this medicine, when used at high doses, may cause dizziness, difficulty concentrating, and
drowsiness (sedation). Therefore, if this occurs, avoid driving or operating machinery.
NASOMIXIN C.M. contains benzalkonium chloride
This medicine contains benzalkonium chloride, which may cause bronchospasm.

3. How to use NASOMIXIN C.M.

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.
Instructions for opening the bottle: press and simultaneously unscrew, keeping the bottle placed on a flat surface. Screw back on to close the bottle.
Instructions for use: instill the drops into each nostril with the head turned sideways and lowered.
The recommended dose is 1-2 drops in each nostril, up to 3-4 times a day, repeated if necessary.
Do not use doses higher than those recommended and do not use NASOMIXIN C.M. for longer than 5 days.
Use in elderly patients
The doctor will determine the appropriate dose and may consider reducing it.
If you use more NASOMIXIN C.M. than you should
Following accidental ingestion or excessive use of this medicine, toxic effects may occur.
If you take an excessive dose of this medicine, you may experience increased blood pressure (arterial hypertension), increased heart rate (tachycardia), light sensitivity (photophobia), severe headache, chest tightness, and particularly in children, decreased body temperature (hypothermia), and severe depression of the central nervous system with profound sedation.
In case of accidental ingestion/overuse of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use NASOMIXIN C.M.
Do not use a double dose to make up for the missed 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 everybody will experience them.
The following side effects may occur after using this medicine, especially for periods longer than 5 days:

temporary local irritation;
dilation of blood vessels (vasodilation) or rebound congestion.

Contact your doctor if you experience any of the following side effects:

effects on the heart and blood vessels: increased blood pressure (hypertension) followed by reduced blood pressure (rebound hypotension), sweating, reduced heart rate (bradycardia), paleness of the skin;
stimulation of the nervous system: headache (cephalalgia), sleep disturbance (insomnia), tremors, dizziness, restlessness.

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 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 NASOMIXIN C.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp”. The expiry date refers to the last day of that month.
Store the bottle tightly closed and protected from light.
Do not use this medicine if you notice any change in the colour of the solution.
Store at a temperature not exceeding 25 °C.
Use this medicine within 30 days of first opening the bottle. Any remaining medicine should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What NASOMIXIN C.M. contains

The active substance is phenylephrine hydrochloride: 1 ml of solution contains 2.5 mg of phenylephrine hydrochloride.
The other components are: sodium citrate, sodium chloride, phenoxyethanol, benzalkonium chloride, anhydrous citric acid, purified water.

Description of the appearance of NASOMIXIN C.M. and contents of the pack
Pack containing one 15 ml bottle with dropper.
The bottle has a child-resistant closure to make opening difficult for children.
Marketing Authorization Holder
TEOFARMA S.r.l. - via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l. - Viale Certosa 8/A - Pavia.