Package Leaflet

NTR

“nasal drops, solution” 15 ml bottle
“nasal spray, solution” 15 ml bottle
READ CAREFULLY ALL THE INFORMATION CONTAINED IN THIS LEAFLET BEFORE USE.
This is a SELF-MEDICATION medicine that you can use to treat mild and transient disorders which are easily recognizable and resolvable without medical intervention. It can be purchased without a prescription, but must be used correctly to ensure effectiveness and minimize adverse effects.

For further information and advice, consult your pharmacist.
Consult a doctor if symptoms do not resolve after a short period of treatment.

NAME OF THE MEDICINAL PRODUCT: NTR
WHAT NTR LOOKS LIKE.
NTR is available as nasal drops and nasal spray. The dropper bottle contains 15 ml of solution; the spray bottle contains 15 ml of solution.
WHAT IT IS.
NTR is a topical nasal decongestant; it is used to relieve nasal congestion through local application.
WHY IT IS USED.
NTR is used to relieve excessive nasal secretion due to the common cold.
WHEN IT MUST NOT BE USED.
Hypersensitivity to the active substances or to any of the excipients.
Severe heart disease and severe arterial hypertension, glaucoma, hyperthyroidism. Do not use in children under 12 years of age.
Do not administer during or within two weeks after treatment with antidepressant drugs.
Do not use during pregnancy or breastfeeding.
It is advisable to consult a doctor if you have previously experienced such conditions.

PREGNANCY AND BREASTFEEDING.
Ask your doctor or pharmacist for advice before taking any medicine.
NTR must not be used during pregnancy or breastfeeding.
Its use should also be avoided if you suspect you may be pregnant or are planning a pregnancy.
Effects on ability to drive vehicles and use machinery
No effects on the ability to drive vehicles or use machinery are known.

PRECAUTIONS FOR USE.
Avoid concomitant use of other vasoconstrictors such as oral or nasal decongestants due to the risk of vasoconstriction (see section WHICH MEDICINES OR FOODS CAN AFFECT THE EFFECT OF THE MEDICINE).
Children are more sensitive to the systemic effects of sympathomimetic vasoconstrictors; therefore, keep the product out of children's reach, as accidental ingestion may cause severe central nervous system depression with marked sedation (see section WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE OF THE MEDICINE).

WHICH MEDICINES OR FOODS CAN AFFECT THE EFFECT OF THE MEDICINE.
The effect of phenylephrine may be enhanced when used concomitantly with antidepressant drugs.
If you are taking other medicines, consult your doctor or pharmacist.

IMPORTANT INFORMATION.
Use with caution and under medical supervision due to the risk of urinary retention, especially in elderly patients and those with benign prostatic hyperplasia.
In patients with cardiovascular diseases, and particularly in hypertensive patients, the use of nasal decongestants should always be evaluated by a physician. Prolonged use of vasoconstrictors may alter the normal function of the nasal and paranasal sinus mucosa and may lead to drug dependence: repeated applications over a long period may be harmful.
Prolonged or frequent use of topical products may lead to sensitization reactions and cause adverse effects. In such cases, discontinue use immediately and consult your doctor, who may prescribe appropriate treatment if necessary.
Benzalkonium chloride (BAC), included as an active ingredient in NTR, may cause nasal mucosal swelling, especially when used over long periods. If such a reaction is suspected (persistent nasal congestion), another nasal preparation without BAC should be used, if possible. If a BAC-free nasal product is not available, consider using an alternative pharmaceutical form.
May cause bronchospasm.
The container of NTR drops is made of latex rubber. It may cause severe allergic reactions.

HOW TO USE THIS MEDICINE.
Warning: do not exceed the recommended doses without medical advice.
Use of the spray: For maximum convenience and ease of use, the product is contained in a plastic nasal spray device. For optimal effectiveness, blow your nose first, then press the spray nozzle while inhaling. The first spray reduces swelling in the lower nasal passages. Repeat the application after a few minutes to decongest deeper mucosal areas and open the nasal sinuses. Repeat every 3–4 hours, if needed.
Use of the dropper bottle: instill 2–3 drops of solution into each nostril after blowing your nose, ensuring deep penetration of the product, and repeating the procedure after about ten minutes if necessary.
If no complete therapeutic response occurs within a few days, consult your doctor; in any case, treatment should not exceed four days.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.

Instructions for use.
Dropper bottle:

To open the bottle, press down and simultaneously unscrew the cap. It is recommended to place the bottle on a stable surface.
To close the bottle, screw the cap back on normally.
For subsequent uses, follow instructions from point 1.
Spray bottle:
If the bottle is new, prime the pump by pressing it two to three times without inserting into the nostrils.

WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE OF THE MEDICINE.
In case of overdose, symptoms may include arterial hypertension, tachycardia, photophobia, severe headache, chest tightness, and in children, hypothermia and severe central nervous system depression with marked sedation, requiring immediate emergency measures. Accidental ingestion or prolonged use at excessive doses may lead to toxic effects.
Keep the medicine out of children's reach, as accidental ingestion may cause marked sedation.
In case of accidental ingestion or overdose of NTR, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of NTR, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS.
Like all medicines, NTR can cause adverse effects, although not everyone experiences them.
The medicine may cause local sensitization and rebound congestion of the mucous membranes. Due to rapid absorption of phenylephrine through inflamed mucosa, systemic effects such as arterial hypertension, reflex bradycardia, headache, and urinary disturbances may occur.
Following the instructions in this leaflet reduces the risk of adverse effects.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse effects, you help provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE.
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under recommended conditions.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store the bottle tightly closed and protected from light, as prolonged exposure to air or intense light may cause oxidation and some loss of efficacy. Discolored solutions, although harmless, should be discarded.
Store at a temperature not exceeding 25°C.
It is important to keep both the packaging and this leaflet for future reference.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This helps protect the environment.
Keep the medicine out of the sight and reach of children.

COMPOSITION: 1 ml contains:
ACTIVE SUBSTANCES: Phenylephrine hydrochloride 5 mg, Tenildiamine hydrochloride 1 mg, Benzalkonium chloride 200 micrograms.
EXCIPIENTS: Buffered aqueous solution composed of: Sodium citrate 2H₂O, Sodium chloride, 2-phenoxyethanol, Citric acid, Purified water.

MARKETING AUTHORISATION HOLDER:
TEOFARMA S.r.l. Via F.lli Cervi, 8 - Valle Salimbene (PV)
MANUFACTURER:
TEOFARMA S.r.l. Viale Certosa 8/A - Pavia.
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: