Interfrin 0.5 mg/ml nasal spray solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
INTERFRIN 0.5 mg/ml solution for nasal spray
Oxymetazoline hydrochloride
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days of treatment.
Contents of this leaflet:
- What INTERFRIN is and what it is used for
- What you need to know before using INTERFRIN
- How to use INTERFRIN
- Possible side effects
- How to store INTERFRIN
- Contents of the pack and other information
1. What INTERFRIN is and what it is used for
This medicine belongs to a group of medicines called sympathomimetics. It is a nasal decongestant containing oxymetazoline as the active substance. When administered through the nose, oxymetazoline produces local constriction of blood vessels, thereby decongesting the nasal mucosa.
It is indicated for the local and temporary relief of nasal congestion in adults and children from 6 years of age.
You should consult a doctor if symptoms worsen or do not improve after 3 days of treatment.
2. What you need to know before using INTERFRIN
Do not use INTERFRIN
- If you are allergic to oxymetazoline, to other nasal decongestants, or to any of the other ingredients of this medicine (listed in section 6).
- If you have recently undergone head surgery (if you have had cranial, transnasal, or transoral surgery).
Warnings and precautions
Inform your doctor or pharmacist before starting to use INTERFRIN if:
- You are being treated with antidepressant medicines, phenothiazines (tranquilizers), or methyldopa (to lower blood pressure).
- You have had or currently have, even if only once, any of the following conditions or symptoms:
- High blood sugar levels (diabetes mellitus)
- High blood pressure (hypertension)
- Heart or circulatory system disorders
- Prostate disease with difficulty urinating (prostatic hypertrophy)
- Thyroid disease (hyperthyroidism)
- If you have ever experienced insomnia or dizziness while being treated with other sympathomimetic medicines, such as those used to treat heart conditions, hypotension (low blood pressure), or asthma.
In rare cases, oxymetazoline, due to its temporary effects and prolonged use, may increase nasal congestion instead of reducing it; this is known as rebound effect.
Insomnia may rarely occur after using the medicine. If this happens, avoid using it late in the afternoon or at night.
Do not exceed the recommended dose indicated in section 3 HOW TO USE INTERFRIN.
To prevent transmission of infections, the medicine must not be used by more than one person, and the applicator should always be cleaned after each use with a clean, damp cloth.
Children
Do not use in children under 6 years of age.
Children may be especially susceptible to adverse effects of this medicine.
Use of INTERFRIN with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This medicine must not be used by people who are taking or have taken, within the last 2 weeks, medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors [MAOIs]), or the antihypertensive medicine called methyldopa.
It should also not be used if you are being treated with phenothiazines (tranquilizers) or medicines for asthma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy or breastfeeding.
Driving and using machines
Although problems in this regard are not expected, if you experience drowsiness or dizziness, do not drive or operate dangerous tools or machinery.
INTERFRIN contains benzalkonium chloride
This medicine may cause inflammation of the nasal mucosa, especially with long-term treatment, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), whenever possible, a nasal medicine not containing this ingredient should be used.
3. How to use INTERFRIN
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults and children over 6 years
1 spray into each nostril no more than 2 times in 24 hours.
Use in children
This medicine must not be used in children under 6 years of age.
Children may be especially prone to experiencing adverse effects with this medicine.
Patients over 65 years
Consult your doctor or pharmacist, as elderly individuals are more sensitive to the adverse effects of this medicine.
How to use
This medicine is for nasal use.
Before applying the medicine, clear any existing nasal secretions by thoroughly blowing your nose.
Insert the tip of the bottle into the nostril and press the pump firmly and quickly once into each nostril, keeping your head upright and inhaling deeply while pressing the spray.
To prevent infection, after each use and before closing the container, clean the applicator tip with a clean, damp cloth. Additionally, each container must be used by only one person.
If symptoms worsen or do not improve after 3 days of treatment, stop treatment and consult your doctor.
If you use more INTERFRIN than you should
With excessive or prolonged dosing, you may experience: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91.5620420, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, INTERFRIN may have adverse effects, although not everyone experiences them.
During the period of use of oxymetazoline, the following adverse effects have been observed, although their frequency could not be precisely established:
The most frequently occurring adverse effects are:
Burning at the application site, dryness, itching of the nasal mucosa, or sneezing.
Adverse effects that may occur rarely are:
Anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disturbances in children. Tachycardia, palpitations, increased blood pressure. Headache, nausea, exanthema (skin redness).
Excessive or prolonged use of this medicine may lead to nasal congestion.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Storage of INTERFRIN
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of INTERFRIN
The active substance is oxymetazoline. Each ml of nasal spray solution contains 0.5 mg of oxymetazoline.
The other components (excipients) are benzalkonium chloride, glycine, povidone, sorbitol (E-420), and purified water.
Appearance of the product and contents of the pack
This medicine is a nasal spray solution.
It is presented in a box containing a 15 ml plastic bottle with a screw cap.
Marketing Authorization Holder and Manufacturer:
INTERPHARMA, S.A.
Santa Rosa, 6. Santa Coloma de Gramenet (Barcelona) - 08921, Spain
Date of the most recent revision of this leaflet: February 2013.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/