Neo-Synephrine

Patient Information Leaflet

NEO-SYNEPHRINE 2.5 mg/ml nasal drops, solution

Phenylephrine hydrochloride
Please read all of 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.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

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

1. What NEO-SYNEPHRINE is and what it is used for

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

2. What you need to know before using NEO-SYNEPHRINE

Do not use NEO-SYNEPHRINE

• 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 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 NEO-SYNEPHRINE”);
• if the person who is to use this medicine is a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using NEO-SYNEPHRINE.
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 enlarged prostate (prostatic hypertrophy).

Use NEO-SYNEPHRINE at the recommended doses, as prolonged use may cause rebound congestion, which could 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).

Children over 12 years of age
This medicine should be used with great caution in children over 12 years of age, as in this population it may increase the risk of adverse effects.
Other medicines and NEO-SYNEPHRINE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 NEO-SYNEPHRINE 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 may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are in the first months of pregnancy or if you are breastfeeding, use this medicine only under direct medical supervision.
Driving and using machines
NEO-SYNEPHRINE, when used at the recommended doses, does not affect the ability to drive vehicles or operate machinery.
NEO-SYNEPHRINE contains benzalkonium chloride
This medicine contains benzalkonium chloride which may cause bronchospasm.

3. How to use NEO-SYNEPHRINE

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1–2 drops into each nostril, up to 3–4 times daily, if necessary.
Do not use higher doses than those recommended and do not use NEO-SYNEPHRINE for more than 5 days.
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 tilted downward.
If you use more NEO-SYNEPHRINE 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 or overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to use NEO-SYNEPHRINE
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 everyone will experience them.
The following side effects may occur after using this medicine for periods longer than 5 days:

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

The use of high doses and for prolonged periods (beyond the recommended limit) may lead to the following side effects:

• effects due to stimulation of the cardiovascular system: increased blood pressure (hypertension) followed by reduction in blood pressure (rebound hypotension), sweating, reduced heart rate (bradycardia), paleness of the skin (pallor);
• effects due to 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, please contact your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEO-SYNEPHRINE

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.
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 below 25 °C.
Use this medicine within 30 days of first opening the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NEO-SYNEPHRINE 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, 2-phenoxyethanol, benzalkonium chloride, anhydrous citric acid, purified water.

Description of the appearance of NEO-SYNEPHRINE and contents of the pack
Pack containing a 15 ml bottle with dropper.
The bottle has a child-resistant cap 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.