Vicks Sinex - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Oxymetazoline

Vicks Sinex 0.05% Nasal Spray Solution

Why is Vicks Sinex used? What is it for?

WHAT IS IT

VICKS SINEX NASAL SPRAY SOLUTION is a nasal decongestant for local use, ie it frees the blocked nose.

WHY IT IS USED

VICKS SINEX NASAL SPRAY SOLUTION is used to relieve the unpleasant symptoms associated with congestion of the nasal mucosa (stuffy nose) typical of colds and flu.

Contraindications When Vicks Sinex should not be used

Hypersensitivity (allergy) to the components of the product. Prostatic hypertrophy (swelling of the prostate), heart disease and severe arterial hypertension (high blood pressure), glaucoma (high pressure in the eye), hyperthyroidism (increased activity of the thyroid). Do not administer during and in the two weeks following therapy with antidepressant drugs (MAOIs). Inflammation or lesions of the oral mucosa or skin around the nostrils. The drug can not be taken by children under the age of 12. It is also advisable to consult your doctor in cases where these disorders have occurred in the past.

Precautions for use What you need to know before taking Vicks Sinex

IT IS IMPORTANT TO KNOW THAT

Use with caution in the first months of pregnancy and, due to the danger of urinary retention (difficulty urinating), in the elderly. Use with caution even in patients with angina and diabetes. However, in the absence of a complete therapeutic response within a few days, consult your doctor; in any case, the treatment must not be continued for more than 4 consecutive days to avoid a rebound effect and phenomena of rhinitis induced by the drug. In this case it is necessary to interrupt the treatment and institute a suitable therapy. Strictly follow the recommended doses. The product should be kept out of the reach and sight of children, as accidental ingestion can cause severe sedation. It must not be used orally. Avoid contact of the liquid with the eyes.

Benzalkonium chloride (BAC) contained as a preservative in VICKS SINEX 0.05% NASAL SPRAY solution, especially when used for long periods, can cause swelling of the nasal mucosa. If such a reaction (persistent nasal congestion) is suspected, a BAC-free nasal medicine should be used if possible. If such nasal medications without BAC are not available, another pharmaceutical form should be considered.

It can cause bronchospasm.

Attention for those who carry out sports activities: the product contains substances prohibited for doping. It is forbidden to take a different intake, for dosage schedule and route of administration, from those reported.

WHEN IT CAN ONLY BE USED AFTER CONSULTING YOUR DOCTOR

In patients with cardiovascular diseases, and especially in hypertensive patients (patients with high blood pressure). In patients suffering from angina, diabetes (raised blood glucose), hyperthyroidism (increased thyroid activity), narrow angle glaucoma Patients treated with antidepressant drugs (anti-MAO) and antiparchinsonian drugs.

If you need to take the medicine for more than 4 days. If you have not observed any positive effects after using VICKS SINEX NASAL SPRAY SOLUTION. If symptoms persist or worsen while using VICKS SINEX NASAL SPRAY SOLUTION.

Interactions What medications or foods may change the effect of Vicks Sinex

There is the possibility of interaction between sympathomimetic amines such as oxymetazoline with antidepressant drugs (anti-MAO), so use during or in the two weeks following treatment with these drugs is not recommended.

Oxymetazoline may reduce the effectiveness of beta blocker drugs, methyl dopa, or other antihypertensive drugs.

There may be a possible risk of increased hypertension (high blood pressure) and arrhythmias (irregular heartbeats) when tricyclic antidepressants are given with sympathomimetic drugs such as oxymetazoline. Increased cardiovascular toxicity may occur when sympathomimetic drugs are administered concomitantly with antiparchinsonian drugs such as bromocriptine.

If you are using other medicines ask your doctor or pharmacist for advice.

Warnings It is important to know that:

WHAT TO DO DURING PREGNANCY AND BREASTFEEDING

Use with caution in the first months of pregnancy, so it is advisable to consult your doctor if you suspect a pregnancy or wish to plan a maternity leave.

DRIVING VEHICLES AND USING MACHINERY

No effects on the ability to drive and use machines have been observed.

Dosage and method of use How to use Vicks Sinex: Dosage

HOW MUCH: Adults and children over 12 years of age: 1-2 sprays per nostril.

WHEN AND FOR HOW LONG: every 6-8 hours. Do not use for more than 4 days, in the absence of complete therapeutic response within this period, consult your doctor.

HOW: Hold the bottle upright, insert the end of the nebulizer into the nostril and press the nebulizer with a quick and firm motion. After nebulization, inhale deeply with your mouth closed.

The empty space above the liquid is necessary to obtain the best atomization.

Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.

Warning: do not exceed the indicated doses without medical advice.

Overdose What to do if you have taken too much Vicks Sinex

Treatment must be symptomatic. In more serious cases, intubation and artificial respiration are required.

In the event of an overdose, mydriasis (enlargement of the pupil), nausea, cyanosis, fever, tachycardia (increased heart rate) arrhythmias (irregular heartbeats), hypertension (increased blood pressure), dyspnoea, cardiac arrest may occur , photophobia (light discomfort), headache (headache), severe chest tightness and, in children, severe central nervous system depression with symptoms such as decreased body temperature, bradycardia (decreased heart rate), hypotension (blood pressure low), apnea and loss of consciousness (fainting) which require the adoption of adequate emergency measures.In case of accidental ingestion / intake of an excessive dose of VICKS SINEX SPRAY NASAL SOLUTION, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Vicks Sinex

The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena. The product can locally determine sensitization phenomena and congestion of the rebound mucous membranes. In general, no severe undesirable effects were observed. Due to the rapid absorption of oxymetazoline through the inflamed mucous membranes, systemic effects can occur, divided as follows:

Rare:

Eye disorders: eye irritation, discomfort or redness;

Respirators: discomfort or irritation of the nose, mouth or throat; sneezing

Very rare:

Cardiovascular: tachycardia, palpitations, elevated blood pressure, reflex bradycardia

Central Nervous System: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache

Gastrointestinal: nausea

Urogenital system: urination disorders

The prolonged use of vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating the applications for long periods can be harmful. The use, especially if prolonged, of topical products can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.

Expiry and Retention

Expiry: see the expiry date on the package.

Warning: do not use the medicine after the expiry date indicated on the package.

The expiry date, shown on the external and internal label, refers to the product in intact packaging, correctly stored.

KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.

It is important to always have the information about the medicine available, so keep both the box and the package leaflet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition and pharmaceutical form

COMPOSITION

1 ml of product contains:

ACTIVE PRINCIPLE: Oxymetazoline hydrochloride 0.5 mg, for a total of 7.5 mg per bottle of 15 ml.

EXCIPIENTS: Levomenthol, Sodium citrate dihydrate, Tiloxapol, Anhydrous citric acid, Chlorhexidine gluconate, Benzalkonium chloride, Camphor, Ethylenediaminetetraacetic acid (disodium salt), Eucalyptol, Sodium hydroxide, Purified water.

HOW IT LOOKS

VICKS SINEX NASAL SPRAY SOLUTION comes in the form of a nasal solution, contained in a 15 ml plastic bottle with screw cap.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information about Vicks Sinex can be found in the "Summary of Features" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER O 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS AND QUALITY CONTROLS

01.0 NAME OF THE MEDICINAL PRODUCT

VICKS SINEX 0.05% NASAL SPRAY SOLUTION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active principle: oxymetazoline hydrochloride 0.0500% w / v

Excipients: levomentol, sodium citrate dihydrate, isoctyl polyoxyethylphenol polymer (tiloxapol), etc.

For the full list of excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Aqueous solution for topical nasal applications.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Decongestant of the nasal mucosa, especially in case of colds.

04.2 Posology and method of administration

Adults and children over 12 years: 1-2 sprays per nostril every 6-8 hours, unless otherwise indicated by the doctor. Hold the bottle upright, insert its tip into the nostril and press with a quick and firm motion. After application, inhale deeply with your mouth closed.

04.3 Contraindications

Known hypersensitivity to the components of the product, prostatic hypertrophy, heart disease and severe arterial hypertension. Glaucoma, hyperthyroidism. Do not administer during and in the two weeks following therapy with antidepressant drugs (MAOIs). Inflammation or lesions of the oral mucosa or skin around the nostrils.

The drug is contraindicated in children under 12 years of age.

04.4 Special warnings and appropriate precautions for use

Use with caution in the first months of pregnancy and, due to the danger of urinary retention, in the elderly.

Use with caution even in patients with angina and diabetes. However, in the absence of a complete therapeutic response within a few days, consult your doctor; in any case, the treatment must not be continued for more than 4 consecutive days to avoid a rebound effect and phenomena of rhinitis induced by the drug. Strictly follow the recommended doses. The product should be kept out of the reach and sight of children, as accidental ingestion can cause marked sedation.

It must not be used orally. Avoid contact of the liquid with the eyes.

04.5 Interactions with other medicinal products and other forms of interaction

There is the possibility of interaction between sympathomimetic amines such as oxymetazoline with anti-MAO drugs for which use is not recommended during or in the two weeks following treatment with anti-MAO drugs (see section 4.3).

Oxymetazoline may reduce the effectiveness of beta-blocking drugs, methyl dopa, or other antihypertensive drugs. Hypertension and arrhythmias may occur when tricyclic antidepressants are administered with sympathomimetic drugs such as oxymetazoline. An increase in cardiovascular toxicity may occur when sympathomimetic drugs are administered concomitantly with antiparchinsonian drugs such as bromocriptine.

04.6 Pregnancy and breastfeeding

There are no studies on the use of the product during pregnancy and lactation. Use with caution in the first months of pregnancy. Use the product only under medical supervision.

04.7 Effects on ability to drive and use machines

No effects on the ability to drive or use machines have been observed.

04.8 Undesirable effects

The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena. The product may locally determine sensitization phenomena, and congestion of the mucous membranes from rebound. In general, no severe undesirable effects have been observed. Due to the rapid absorption of oxymetazoline through the inflamed mucous membranes, systemic effects can occur, divided as follows:

Rare

Eye disorders: eye irritation, discomfort or redness.

Respiratory: discomfort or irritation of the nose, mouth or throat; sneezing.

Very rare

Cardiovascular: tachycardia, palpitations, rise in blood pressure, reflex bradycardia.

Central Nervous System: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache.

Gastrointestinal: nausea.

Urogenital system: urination disorders.

The prolonged use of vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating the applications for long periods can be harmful. The use, especially if prolonged, of topical products can result in to sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy.

04.9 Overdose

Symptoms

Symptoms due to moderate or acute overdose may include mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmias, hypertension, dyspnoea, cardiac arrest, photophobia, headache, severe chest tightness and, in children, severe CNS depression with symptoms such as decreased body temperature, bradycardia, hypotension, apnea and loss of consciousness which require the adoption of adequate emergency measures.

Treatment of overdose

Treatment must be symptomatic. In more serious cases, intubation and artificial respiration are required.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: decongestants and other nasal preparations for topical use, unassociated sympathomimetics.

ATC code: R01AA05

VICKS SINEX NASAL SPRAY is a drug based on the vasoconstrictive and decongestant properties of Oxymetazoline hydrochloride assisted by the well-known balsamic properties of Menthol, Camphor and Eucalyptol, and is used to relieve the unpleasant symptoms related to nasal mucosal congestion, such as stuffy nose and hypersecretion, typical of colds and flu.

The solution is administered without resorting to propellant gases, but through the simple mechanical action exerted by pressing on the container.

05.2 Pharmacokinetic properties

The route of administration through Nasal Spray, the small quantity administered with the single dose, and the fact that the dosage is repeated every 6-8 hours, mean that the levels of Oxymetazoline eventually absorbed and placed in circulation, rarely reach values ​​of significance. pharmacological. In any case, Oxymetazoline is immediately metabolized by enzymatic systems, in particular by Mono-Amino-Oxidase, then conjugated and inactivated in the liver, and, therefore, almost totally excreted by the kidney, in the form of metabolites, and, only minimally, unchanged.

05.3 Preclinical safety data

The toxicity of VICKS SINEX NASAL SPRAY is very low, so much so that oral DL 50 in mice and rats could not be determined. In fact, this LD 50 is greater than 5 ml / kg, which is the maximum dose practicable to the animal. This means that at this dose none of the animals died, and doses higher than it cannot be administered without causing death from mechanical causes. Chronic oral toxicity was determined in two animal species (rat and beagle dog) by administering to them as maximum dose, 0.132 ml / kg / day of VICKS SINEX NASAL SPRAY for the duration of 3 months. , which represent more than 10 times the human therapeutic dose, repeated for 90 days, showed no toxic effects. Another group for each of the two animal species (rats and dogs) was treated in the same way and with the same oral doses. for two months. The same animals were then treated by nasal inhalation of VICKS SINEX NASAL SPRAY nebulized for 15 minutes per day for a further 30 days. The behavior and growth of the animals of the first and second groups po were normal, the haematoserological tests provided normal data and, after sacrifice, no damage to the main organs was found during necropsy and histology.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Levomentol, sodium citrate dihydrate, isoctyl polyoxyethylphenol polymer (tiloxapol), anhydrous citric acid, chlorhexidine gluconate, benzalkonium chloride, camphor, ethylenediaminetetraacetic acid (disodium salt), eucalyptol, sodium hydroxide, purified water.

06.2 Incompatibility

No incompatibilities with other drugs have been reported.

06.3 Period of validity

48 months.

06.4 Special precautions for storage

None.

06.5 Nature of the immediate packaging and contents of the package

15ml spray plastic bottle, equipped with screw cap.

06.6 Instructions for use and handling

Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.

07.0 MARKETING AUTHORIZATION HOLDER

PROCTER & GAMBLE S.r.l. - Viale Giorgio Ribotta 11 - 00144 Rome.

08.0 MARKETING AUTHORIZATION NUMBER

AIC n. 023198017

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Date of first authorization: February 1975.

Renewal of the authorization: June 2010

10.0 DATE OF REVISION OF THE TEXT

April 2012

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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