DELTARINOLO 0.5% + 0.125% Назальный спрей, раствор

Содержание инструкции

1. DELTARINOLO 5 mg/ml + 1,25 mg/ml nasal spray, solution
   1. What is Deltarinolo and what is it used for?
   2. What you need to know before using Deltarinolo
   3. How to use Deltarinolo
   4. Possible side effects
   5. How to store Deltarinolo
   6. Contents of the pack and other information

DELTARINOLO 5 mg/ml + 1,25 mg/ml nasal spray, solution

ephedrine and naphazoline

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 would like 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 4 days of treatment.

Contents of this leaflet:

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

1. What is Deltarinolo and what is it used for?

Deltarinolo is a nasal medicine containing two active ingredients: ephedrine and naphazoline,
which belong to the category of nasal decongestants, used to reduce or eliminate
swelling of the nasal mucous membranes (decongest)..
This medicine is indicated to clear (decongest) a blocked nose.
Consult your doctor if you do not feel better or if you feel worse after 4 days of treatment.

2. What you need to know before using Deltarinolo

Do not use Deltarinolo

• if you are allergic to ephedrine, naphazoline or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from any of the following conditions: heart disease, high blood pressure (severe arterial hypertension), eye disease with increased pressure inside the eye (acute angle-closure glaucoma), excessive production of thyroid hormones (hyperthyroidism), enlarged prostate (prostatic hypertrophy), a tumor of an internal organ called the adrenal gland (pheochromocytoma), diabetes mellitus;
• if you are under 12 years of age (see “Children and adolescents”);
• if you are undergoing treatment with antidepressant medications or are within the two weeks

following discontinuation of antidepressant treatment;

• if you are pregnant and/or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using Deltarinolo:

• if you suffer from kidney failure (reduced kidney function);
• if you are an elderly person, due to the risk of urinary retention;
• if you suffer from cardiovascular diseases (diseases affecting the heart and/or blood vessels);
• if you suffer from hypertension (high blood pressure) even if not severe.

Prolonged use of medicines that constrict blood vessels, such as Deltarinolo, (vasoconstrictor
medicines) can alter the normal function of the nasal mucosa and nasal cavities (paranasal
sinuses), also inducing habituation to the medicine (reduction in effectiveness). Repeating the
assumptions for long periods can be harmful.
Use, especially if prolonged, of products administered locally on the mucous membranes can
cause an allergic reaction (sensitization); in this case, stop treatment and
consult your doctor. However, in the absence of complete therapeutic response within a few days,
consult your doctor.
In patients with cardiovascular diseases (diseases affecting the heart and/or blood vessels),
especially in hypertensive patients (patients with high blood pressure), the use of nasal decongestants
must always be subject to medical judgment. Be careful and
immediately inform your doctor if you experience difficulty breathing and chest pain.
The medicine should not be used orally: accidental oral use can cause
toxic effects. Avoid contact of the liquid with the eyes. Long-term use at
excessive doses can cause toxic effects.

Attention for athletes:the medicine contains substances prohibited for doping. It is
forbidden to take it differently, for dosage regimen and route of administration, than those
indicated (see “How to use Deltarinolo”).

Children and adolescents
The medicine is contraindicated in children under 12 years of age (see “Do not use
Deltarinolo”). Accidental ingestion in children can cause excessive sedative
effect (marked sedation).

Other medicines and Deltarinolo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
Do not use Deltarinolo if you are taking antidepressant medications, and not even within the two weeks
following discontinuation of antidepressant therapy (see “Do not use Deltarinolo”).
Take particular care if you are taking the following medicines at the same time:

Antihypertensives(used for high blood pressure): the ephedrine contained in Deltarinolo
may reduce the effectiveness of some of these medicines; instead, when associated with clonidine (an
antihypertensive), it can cause an increase in blood pressure.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):association with ephedrine may promote
the onset of lesions to the gastric mucosa.

Corticosteroids (drugs similar to cortisone):ephedrine may reduce the effectiveness of these
drugs. If you suffer from asthma and are being treated with corticosteroids, avoid taking medicines
containing ephedrine.

Acetazolamide(diuretic), antacids, ammonium chlorideand sodium bicarbonate:are
drugs that slow down the elimination of ephedrine through the urine.

Digoxin(heart medicine), cyclopropane(a medicine for inducing anesthesia), phenylpropanolamineand pseudoephedrine(nasal decongestants): simultaneous
administration with ephedrine increases the risk of adverse effects on the heart and/or
blood vessels.

Reserpine(antihypertensive and antipsychotic): may reduce the effectiveness of ephedrine.

Theophylline(used for respiratory diseases): concomitant use of ephedrine may cause a
greater incidence of gastrointestinal and nervous system side effects.

Caffeine:association with ephedrine may potentiate some effects on the nervous system (sympathomimetic
effects) of ephedrine.

Pregnancy and breastfeeding
Do not use Deltarinolo during pregnancy and breastfeeding. Avoid using
the medicine even if you suspect you are pregnant or wish to plan a pregnancy.

Driving and operating machinery
Deltarinolo does not impair the ability to drive vehicles or operate machinery.

Deltarinolo contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate (parabens)
which may cause allergic reactions (even delayed) and, exceptionally, bronchospasm
(narrowing of the bronchi with severe difficulty breathing).

3. How to use Deltarinolo

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 one spray every 3-4 hours, up to 4 times a day.
Spray once inside the nostrils.

Warning:strictly adhere to the recommended doses. A higher dosage of the medicine,
even if taken nasally and for a short period of time, can lead to serious
effects on the body.
Do not prolong the treatment for more than 4 days.
Use only for short periods of treatment: long-term use at excessive doses can
determine toxic effects.
For correct use of the nebulizer, follow the instructions below:

For nebulizations
Without tilting your head back, insert
the cone of the nebulizer into the nostril and press
on the central part of the side walls of the
bottle with rapid and energetic bursts.
The Deltarinolo bottle contains 15 ml of liquid.
The air space above the liquid is absolutely necessary for perfect functioning of the
bottle.

To open the bottle

Tear off the tab (1).
Press the cap and simultaneously rotate
counterclockwise (2).

If you use more Deltarinolo than you should
If you have taken a much higher dose than recommended, you may experience arterial hypertension
(high blood pressure), tachycardia (palpitations), photophobia (sensitivity to light),
severe headache, chest tightness, psychiatric reactions, and in children, hypothermia
(lowering of body temperature) and severe depression of the central nervous system with
marked sedation: in case of ingestion or accidental intake of an excessive dose of the
medicine, immediately notify your doctor or go to the nearest hospital.

If you forget to use Deltarinolo
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.
The medicine may facilitate the onset of local allergies (sensitization phenomena) and
worsen nasal mucosal congestion.
After administration of Deltarinolo, the following side effects may occur:

• fast heartbeat (tachycardia),
• anxiety,
• restlessness,
• insomnia.
• nausea,
• headache,
• dizziness,
• tremors,
• dry mouth,
• urinary disorders,
• alterations of blood circulation at the level of the limbs,
• high blood pressure (arterial hypertension),
• slow heartbeat (bradycardia),
• irregular heartbeat (cardiac arrhythmias).

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
contribute to providing more information on the safety of this medicine.

5. How to store Deltarinolo

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. The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
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 Deltarinolo contains

• The active ingredients are ephedrine hydrochloride and naphazoline nitrate. 100 ml of solution contain 500 mg of ephedrine hydrochloride and 125 mg of naphazoline nitrate.
• The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium edetate, sodium monobasic phosphate, sodium phosphate, sodium hydroxide, purified water.

Description of the appearance of Deltarinolo and contents of the pack
Nasal spray, solution.
The pack contains a nasal spray bottle containing 15 ml of solution. The bottle is made of
plastic and is equipped with a nebulizer.

Marketing Authorisation Holder
VEMEDIA MANUFACTURING B.V.
Verrijn Stuartweg 60, 1112 – AX DIEMEN (Netherlands)

Manufacturer
Unither Liquid Manufacturing
1-3 Allée de la Neste; Z.I. d’en Sigal
Colomiers (France)