Active ingredients: Oxymetazoline (Oxymetazoline hydrochloride)
ACTIFED NASAL 0.5 mg / ml nasal spray, solution
Why is Actifed Nasale used? What is it for?
WHAT IS IT
Oxymetazoline is an effective decongestant, active for topical use, which causes prolonged relief from nasal obstruction.
WHY IT IS USED
Decongestant of the nasal mucosa (frees the blocked nose), especially in case of colds.
Contraindications When Actifed Nasale should not be used
ACTIFED NASAL should not be used in cases of known hypersensitivity to oxymetazoline or other components of the product, prostatic hypertrophy (enlarged prostate), heart disease and severe arterial hypertension. Glaucoma, hyperthyroidism.
The drug can not be taken by children under the age of 12
Do not administer during and in the two weeks following therapy with antidepressant drugs.
Precautions for use What you need to know before taking Actifed Nasale
In patients with cardiovascular diseases (heart and circulation diseases), especially in hypertensive patients (high blood pressure), the use of nasal decongestants must in any case be subjected to the judgment of the doctor from time to time.
It is also advisable to consult your doctor in cases where these disorders have occurred in the past.
Use with caution in the first months of pregnancy and, due to the danger of urinary retention, in the elderly
Interactions Which drugs or foods can modify the effect of Actifed Nasale
Do not administer during and in the two weeks following therapy with antidepressant drugs. 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
During pregnancy, use the product only after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
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 applications for long periods can be harmful.
The use, especially prolonged, of products for topical use can give rise to sensitization phenomena, in this case stop the treatment and consult the doctor to establish a suitable therapy. However, in the absence of a complete therapeutic response within a few days, consult the doctor; in any case, treatment should not be continued for more than 4 days.
It must not be used by mouth. The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena. It should be kept out of the reach of children, as accidental ingestion can cause marked sedation. Avoid contact of the liquid with the eyes.
Attention for those who carry out sporting activities: the product contains substances prohibited for doping. It is forbidden to "take a different dose, by dosage and by route of administration, from those reported.
The medicine is not contraindicated for people with celiac disease.
Dosage and method of use How to use Actifed Nasale: Dosage
Warning: do not exceed the indicated doses without medical advice.
Like
To use, remove the plastic cap, insert the end of the bottle into the nostril and press with a quick and firm motion, breathing deeply through the nose.
How many
Adults and children over 12 years: One mist (spray) per nostril every 612 hours, as needed.
How long
Do not exceed 4 days of treatment unless otherwise indicated by the doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Overdose What to do if you have taken too much Actifed Nasale
In case of accidental intake of an excessive dose of the medicine, notify your doctor immediately or go to the nearest hospital. In these cases, arterial hypertension (increased blood pressure), tachycardia (rapid heartbeat), photophobia (painful sensation caused by light), severe headache (intense headache), chest tightness and, in children, hypothermia (excessive lowering body temperature) and severe depression of the central nervous system with marked sedation, which require the adoption of adequate emergency measures.
Side Effects What are the side effects of Actifed Nasale
The product can locally determine phenomena of sensitization and congestion of the rebound mucous membranes. For rapid absorption of oxymetazoline through the inflamed mucous membranes, systemic (general) effects may occur, consisting of arterial hypertension, reflex bradycardia (reduced heart rate), headache (headache), disturbances in urination.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist. It is important to inform the doctor or pharmacist of any undesirable effects not described in the package leaflet.
Expiry and Retention
Do not refrigerate.
Do not disperse in the environment after use.
Warning: do not use the medicine after the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Keep this medicine 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.
COMPOSITION
1 ml contains:
Active ingredient: 0.5 mg oxymetazoline hydrochloride (= 0.05 mg / 0.10 ml per spray. Total 7.5 mg per bottle)
Excipients: Sorbitol, monobasic potassium phosphate, dibasic sodium phosphate, chlorhexidine acetate, purified water.
HOW IT LOOKS
Nasal spray solution.
The contents of the package are one bottle of 15 ml.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
ACTIFED NASAL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution contain:
Oxymetazoline hydrochloride 0.050 g (0.50 mg / ml)
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Nasal Spray Solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Decongestant of the nasal mucosa (frees the blocked nose), especially in case of colds.
04.2 Posology and method of administration
Dosage
Adults and children over the age of twelve
One spray per nostril every 6-12 hours, if necessary.
Do not exceed 4 days of treatment unless otherwise indicated by the doctor. Do not exceed the recommended dose.
Pediatric population
The drug is contraindicated in children under 12 years of age.
Method of administration
To use, remove the plastic cap, insert the end of the bottle into the nostril and press with a quick and firm motion, breathing deeply through the nose.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 prostatic hypertrophy,
heart disease and severe arterial hypertension.
Glaucoma,
hyperthyroidism.
Do not administer during and in the two weeks following therapy with antidepressant drugs.
Children under the age of 12.
04.4 Special warnings and appropriate precautions for use
In patients with cardiovascular diseases, especially those with hypertension, the use of nasal decongestants must in any case be subjected to the judgment of the physician from time to time.
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 applications for long periods can be harmful.
Use with caution in the first months of pregnancy and, due to the danger of urinary retention, in the elderly.
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.
If there is no complete therapeutic response within a few days, consult your doctor; in any case, the treatment must not be continued for more than 4 days.
Follow the recommended doses scrupulously.
The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena.It should be kept out of the reach of children, as accidental ingestion can cause severe sedation. It must not be used orally. Avoid contact of the liquid with the eyes.
Attention for those who carry out sporting activities: the product contains substances prohibited for doping. It is forbidden to "take a different dose, by dosage and by route of administration, from those reported.
04.5 Interactions with other medicinal products and other forms of interaction
Do not administer during and in the two weeks following therapy with antidepressant drugs.
04.6 Pregnancy and lactation
Use with caution in the first months of pregnancy
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
The product can locally determine phenomena of sensitization and congestion of the rebound mucous membranes. Due to the rapid absorption of oxymetazoline through the inflamed mucous membranes, systemic effects may occur, consisting of arterial hypertension, reflex bradycardia, headache, urination disturbances.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
In case of overdose, arterial hypertension, tachycardia, photophobia, intense headache, chest tightness and, in children, hypothermia and severe depression of the central nervous system with marked sedation may appear, which require the adoption of adequate emergency measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC: R01AA05 - Nasal decongestants and other preparations for topical use - Sympathomimetics, not associated
Oxymetazoline is an effective decongestant, active for topical use, which determines a prolonged relief in affections characterized by nasal obstruction.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sorbitol, Monobasic potassium phosphate, Dibasic sodium phosphate, Chlorhexidine acetate, Purified water
06.2 Incompatibility
Not known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Do not refrigerate
06.5 Nature of the immediate packaging and contents of the package
Bottle of 15 ml. Price
06.6 Instructions for use and handling
See section "Posology and method of administration".
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Johnson & Johnson SpA Via Ardeatina km 23,500 - 00071 Santa Palomba - Pomezia ROME
08.0 MARKETING AUTHORIZATION NUMBER
AIC N. 028139032
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: March 1992
Latest renewal date: March 2007
-nelle-carni-di-maiale.jpg)
