ARGOTONE 1% + 0,9% Nasal drops, solution

Зміст інструкції

1. ARGOTONE 1%/0,9% nasal drops, solution
   1. What is ARGOTONE and what is it used for
   2. What you need to know before using ARGOTONE
   3. How to use ARGOTONE
   4. Possible side effects
   5. How to store ARGOTONE
   6. Package Contents and Other Information

ARGOTONE 1%/0,9% nasal drops, solution

Silver proteinate/Efedrine 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 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 get worse.

Contents of this leaflet:

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

1. What is ARGOTONE and what is it used for

ARGOTONE contains the active ingredients vitelline silver, responsible for the antiseptic action, and ephedrine hydrochloride, responsible for the nasal decongestant action, and belongs to the group of nasal decongestants for topical (local) use.
ARGOTONE, therefore, acts as an antiseptic and nasal decongestant.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using ARGOTONE

Do not use ARGOTONE

• if you are allergic to vitelline silver, ephedrine hydrochloride, sympathomimetic amines in general or to any of the other components of this medicine (listed in paragraph 6).
• If the patient is a child under 12 years of age
• If you suffer from heart disease and severe high blood pressure.
• If you suffer from glaucoma (increased pressure inside the eye).
• If you suffer from prostatic hypertrophy (increased volume of the prostate).
• If you suffer from hyperthyroidism (increased thyroid function).
• If you suffer from pheochromocytoma (adrenal gland tumor)

Do not administer during or within two weeks following therapy with monoamine oxidase inhibitors (MAOIs), medicines used to treat depression.

Warnings and precautions
Consult your doctor or pharmacist before using ARGOTONE.
In patients with cardiovascular disease, and in hypertensive patients, the use of nasal decongestants must in any case be subject to the doctor's judgment.
Cardiovascular effects may be observed with the use of Argotone; rare cases of myocardial ischemia have been reported in association with the use of beta agonists.
Prolonged use of vasoconstrictors, i.e. medicines capable of inducing a narrowing of the blood vessels, with a consequent increase in blood pressure, can alter the normal function of the nasal and paranasal sinus mucosa, also inducing drug habituation. Repeating applications for longer periods than recommended may, therefore, be harmful.
Use with caution in diabetics and, due to the risk of urinary retention, in the elderly.
Consult your doctor if you experience symptoms such as chest pain and difficulty breathing.
The use, especially if prolonged, of topical products can lead to sensitization phenomena; in this case it is necessary to interrupt the treatment and, if necessary, institute suitable therapy. In the absence of a complete therapeutic response within a few days, consult your doctor; in any case, the treatment should not be prolonged for more than a week.
Strictly adhere to the recommended doses. The medicine, if accidentally ingested or if used for a long period at excessive doses, can determine toxic phenomena.
The medicine must not be used orally
Avoid contact of the liquid with the eyes
“Attention for those who play sports: the medicinal product contains substances prohibited for doping. Taking it differently from the dosage scheme and route of administration is prohibited.”
Ephedrine can be a substance subject to abuse.

Children and adolescents
The medicine cannot be taken by children under 12 years of age (see paragraph “Do not use Argotone”).

Other medicines and ARGOTONE
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Ephedrine reduces the plasma half-life of corticosteroids. Asthmatic patients undergoing treatment with these drugs should therefore avoid taking products based on ephedrine.
Ephedrine contained in ARGOTONE can interact negatively with monoamine oxidase inhibitors (MAOIs). It is consequently contraindicated to administer the product during or within two weeks following antidepressant drug therapy.
Ephedrine can reduce the pharmacological effectiveness of antihypertensive drugs (medicines used to treat high blood pressure); when associated with clonidine (an antihypertensive), it can cause an increase in norepinephrine levels and increased blood pressure with an increased risk of arrhythmias.
The urinary excretion of ephedrine is pH dependent; acetazolamide (a medicine used as a diuretic), antacids, ammonium chloride and sodium bicarbonate are able to alkalize the urine, and consequently slow down the elimination of ephedrine.
The simultaneous association of ephedrine with digoxin (a medicine that stimulates the heart), phenylpropanolamine (a nasal decongestant), cyclopropane (used to induce anesthesia) and pseudoephedrine (a nasal decongestant) is associated with a greater risk of cardiovascular events (increased risk of arrhythmias).
Reserpine (a medicine used as an antihypertensive and antipsychotic), by causing depletion of norepinephrine, can reduce the effectiveness of ephedrine.
Theophylline can cause a greater incidence of central and gastrointestinal side effects that manifest following the administration of ephedrine.
Thyroid hormones: caution is required when using sympathomimetics and thyroid hormones concomitantly.
Volatile anesthetics: ephedrine should be avoided in patients undergoing anesthetic treatment with halogenated anesthetics.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
It is advisable not to use the medicine during pregnancy or while breastfeeding.

Driving and operating machinery
No effects on the ability to drive and operate machinery are known

3. How to use ARGOTONE

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For adults and children over 12 years of age, the recommended dose is 3 drops in each nostril 2-3
times a day.
Treatment should not be prolonged for more than 7 days.
Strictly adhere to the recommended doses. A higher dosage of the product, even if taken locally and for a short period of time, may lead to serious systemic (general) effects.

If you use more ARGOTONE than you should
In case of accidental intake of an excessive dose of ARGOTONE, immediately notify your doctor
or go to the nearest hospital.
In case of overdose (e.g., accidental oral intake), central depression (depression of the central nervous system) and sedation may occur in children, or episodes of excitement with
agitation, hypertensive crises and facial congestion.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The medicine may locally determine sensitization phenomena or congestion of the mucous membranes, a
rebound phenomenon, that is, the opposite of the desired effect.
The following side effects have been reported with the use of ephedrine systemically and may
occur following the use of ephedrine-based nasal drops.
The following side effects have been reported in post-marketing experience. Frequencies are defined
as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare
(≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated based on
available data).

Nervous system disorders
Not known: Headache, restlessness, insomnia, tolerance

Cardiac disorders
Not known: Tachycardia (increased heart rate), palpitations, myocardial ischemia

Vascular disorders
Not known: Hypertension (increased blood pressure)

Respiratory, thoracic and mediastinal disorders
Not known: Dyspnea (difficulty breathing)

Renal and urinary disorders
Not known: Nocturia (frequent urination during the night) in patients with prostatic hyperplasia
(increased prostate volume), urinary retention (difficulty in urination)

Skin and subcutaneous tissue disorders
Not known: Hyperhidrosis (excessive sweating), rash (temporary skin eruption)

Immune system disorders
Not known: Hypersensitivity

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ARGOTONE

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.
The expiry date indicated refers to the product in intact packaging, correctly stored.
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.
Stains from Argotone on handkerchiefs will be easily removed by washing them in lukewarm water with any
type of detergent. Boiling water should not be used as it would make the stains permanent.

6. Package Contents and Other Information

What ARGOTONE contains

• The active ingredients are colloidal silver and ephedrine hydrochloride
• 100 ml of solution contains 1.0 g of colloidal silver and 0.9 g of ephedrine hydrochloride.
• The other ingredients are sodium chloride, purified water, anhydrous sodium thiosulfate.

Description of the appearance of ARGOTONE and package contents
20 ml glass bottle.
ARGOTONE is packaged in a child-resistant container. Therefore, TO OPEN THE
BOTTLE, PRESS THE CAP AND SIMULTANEOUSLY UNSCREW IT. To reclose it, simply
screw it on tightly.

Marketing Authorisation Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milan

Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - Quinto de' Stampi - Rozzano(MI)
Zeta Farmaceutici spa Via Galvani, 10 – 36066 Sandrigo (VI)