NEO-SYNEPHRINE 2.5 mg/ml Назальные капли, раствор

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1. NEO-SYNEPHRINE 2,5 mg/ml nasal drops, solution
   1. What is NEO-SYNEPHRINE and what is it used for
   2. What you need to know before you use 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

NEO-SYNEPHRINE 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 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 is NEO-SYNEPHRINE and what is it used for

This medicine contains the active ingredient phenylephrine hydrochloride, which belongs to a group
of medicines called nasal decongestants.
NEO-SYNEPHRINE is used to clear a blocked nose through 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 you use 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 heart disease or if you suffer from high blood pressure (severe arterial hypertension);
• if you have a serious problem with your thyroid (hyperthyroidism);
• 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 NEO-SYNEPHRINE”);
• 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 NEO-SYNEPHRINE.
Use this medicine with caution and under the supervision of your doctor if:

• you suffer from high blood pressure (hypertension);
• you suffer from heart disease including heart rhythm disorders (arrhythmias);
• you suffer from thyroid diseases;
• you have diabetes mellitus;
• you have an enlarged prostate (prostatic hypertrophy).

Use NEO-SYNEPHRINE 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 (medicinal atrophic rhinitis);
• reduction of the effectiveness of the medicine (tachyphylaxis).

Children over the age of 12 years
This medicine should be used with great caution in children over the age of 12 years
because in this population it may increase the risk of undesirable 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 for the treatment of 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 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 may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
If you are in the first months of pregnancy or if you are breastfeeding, use this medicine only under the
direct supervision of your doctor.

Driving and using machines
NEO-SYNEPHRINE, when used at the recommended doses, does not affect the ability to drive vehicles or
use machines.

NEO-SYNEPHRINE contains benzalkonium chloride
This medicine contains benzalkonium chloride which may cause bronchospasm.

3. How to use NEO-SYNEPHRINE

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.
The recommended dose is 1-2 drops in each nostril, up to 3-4 times a day, if
necessary.
Do not use doses higher than those recommended and do not use NEO-SYNEPHRINE for more than 5 days.

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
low.

If you use more NEO-SYNEPHRINE than you should
Following accidental ingestion of this medicine or use of an excessive amount, you may
experience toxic effects.
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 decrease in body temperature (hypothermia) and severe depression of the central nervous system with strong sedation may occur.
In case of accidental ingestion/use of an excessive dose of this medicine, immediately notify your
doctor or go to the nearest hospital.

If you forget to use NEO-SYNEPHRINE
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.
Following the use of this medicine for periods longer than 5 days, the following side effects may occur:

• 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 from stimulation of the cardiovascular system: increased blood pressure (hypertension) followed by decreased blood pressure (rebound hypotension), sweating, decreased heart rate (bradycardia), paler skin color (pallor);
• effects from stimulation of the nervous system: headache (cephalalgia), sleep disturbance (insomnia), tremors, dizziness, restlessness.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 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.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NEO-SYNEPHRINE 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, 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 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.