NASOMIXIN 2.5 mg/ml Nasal drops, solution

Зміст інструкції

1. NASOMIXIN C.M. 2.5 mg/ml nasal drops, solution
   1. What is NASOMIXIN C.M. and what is it used for
   2. What you need to know before using NASOMIXIN C.M.
   3. How to use NASOMIXIN C.M.
   4. Possible side effects
   5. How to store NASOMIXIN C.M.
   6. Contents of the pack and other information

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

Phenylephrine hydrochloride

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.

• Keep this leaflet. You may need to read it again.
• If you want 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.
• See a doctor if you do not feel better or if your symptoms worsen after 5 days. Contents of this leaflet:
• 1. What NASOMIXIN C.M. is and what it is used for
• 2. What you need to know before using NASOMIXIN C.M.
• 3. How to use NASOMIXIN C.M.
• 4. Possible side effects
• 5. How to store NASOMIXIN C.M.
• 6. Contents of the pack and other information

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

This medicine contains the active ingredient phenylephrine hydrochloride, which belongs to a group of
medicines called nasal decongestants.
NASOMIXIN C.M. is used to clear a blocked nose by local application.
See your doctor if you do not feel better or if you 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 condition or if you suffer from high blood pressure (severe arterial hypertension);
• if you have a serious problem with your thyroid (hyperthyroidism);
• if you have an eye disorder, characterized by increased pressure in the eye (closed-angle glaucoma);
• if you are taking or have taken in the two weeks prior medicines used for depression or Parkinson's disease (monoamine oxidase inhibitors) (See section “Other medicines and NASOMIXIN C.M.”);
• if the person who needs to use this medicine is a child under the age of 12 years.

Warnings and precautions
Consult your doctor or pharmacist before using NASOMIXIN C.M..
Use this medicine with caution and under the supervision of your doctor if:

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

Use NASOMIXIN C.M. at the recommended doses, as it may cause “rebound” congestion, which
can lead to using this medicine in excessive quantities.
This medicine, if used for long periods of time, can cause:

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

Other medicines and NASOMIXIN C.M.
Tell 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 for the treatment of depression (tricyclic antidepressants), as they may increase the effects on blood pressure of NASOMIXIN C.M..

Do not use this medicine if you are taking or have taken in the two weeks prior medicines used for
depression or Parkinson's disease (monoamine oxidase inhibitors), as serious
side effects may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine with caution and under the direct
supervision of your doctor.

Driving and operating machinery
NASOMIXIN C.M., when used at the recommended doses, does not affect the ability to drive vehicles or operate
machinery. However, this medicine used at high doses can cause dizziness, difficulty concentrating and
drowsiness (sedation). Therefore, if this happens to you, avoid driving vehicles or operating machinery.

NASOMIXIN C.M. contains benzalkonium chloride
This medicine contains benzalkonium chloride which can cause bronchospasm.

3. How to use NASOMIXIN C.M.

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Instructions for opening the bottle:press and simultaneously unscrew while keeping the bottle resting on a base. Screw back on to close the bottle.

Instructions for use:insert the drops into each nostril with your head turned to the side and lowered. The recommended dose is 1-2 drops in each nostril, up to 3-4 times a day, to be repeated if necessary. Do not use higher doses than recommended and do not use NASOMIXIN C.M. for more than 5 days.

Use in the elderly
The doctor will determine the dose and assess whether to reduce the dosage.

If you use more NASOMIXIN C.M. than you should
Following accidental ingestion of this medicine or use of an excessive amount, toxic effects may occur. If you take excessive doses of this medicine, you may experience increased blood pressure (arterial hypertension), increased heart rate (tachycardia), light sensitivity (photophobia), severe headache and a feeling of tightness in the chest and, in particular, in children, a reduction in body temperature (hypothermia) and severe depression of the central nervous system with strong sedation. In case of accidental ingestion/use of an excessive dose of this medicine, inform 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 a missed dose. If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following the use of this medicine, especially for periods longer than 5 days, the following side effects may occur:

• 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 decreased blood pressure (rebound hypotension), sweating, decreased heart rate (bradycardia), paler skin color (pallor);
• stimulation of the nervous system: headache, sleep disturbance (insomnia), tremors, dizziness, restlessness. Reporting of side effects If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Keep the bottle tightly closed and protected from light.
Do not use this medicine if you notice a 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 unused medicine must be
discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NASOMIXIN C.M. contains

• The active ingredient is phenylephrine hydrochloride: 1 ml of solution contains 2.5 mg of phenylephrine hydrochloride.
• The other ingredients 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 a 15 ml bottle with dropper.
The bottle has a safety closure to make it difficult for children to open.

Marketing Authorisation Holder
TEOFARMA S.r.l. - via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l. - Viale Certosa 8/A - Pavia.