Novag Rino 35 micrograms/dose solution for nasal spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
NOVAG RINO 35 micrograms/dose nasal spray solution
Oxymetazoline hydrochloride
Read the entire leaflet carefully because it contains important information for you.
This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist after 3 days of treatment, you should consult a doctor.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What NOVAG RINO is and what it is used for
- Before you use NOVAG RINO
- How to use NOVAG RINO
- Possible side effects
- How to store NOVAG RINO
- Further information
1. What NOVAG RINO is and what it is used for
This medicine belongs to a group called Sympathomimetics. It is a medicine containing oxymetazoline as the active substance, which is a nasal decongestant. When administered into the nose, it produces nasal decongestion and improves nasal airflow.
This medicine is indicated for the local symptomatic relief of nasal congestion, as occurs in colds and rhinitis.
2. BEFORE USING NOVAG RINO
Do not use NOVAG RINO
If you are allergic (hypersensitive) to oxymetazoline, to other nasal decongestants, or to any of the other ingredients of the medicine.
If you have recently undergone head surgery.
Take special care with NOVAG RINO
Take special care with NOVAG RINO and consult your doctor before using this medicine if:
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You are being treated with antidepressant medications, phenothiazines (tranquilizers), or methyldopa (to lower blood pressure).
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You have had or currently have, even if only once, any of the following conditions or symptoms:
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If you have high blood sugar levels (diabetes mellitus)
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If you have high blood pressure (hypertension)
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If you have any heart or circulatory system disease
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If you have prostate disease with difficulty urinating (prostatic hypertrophy)
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If you have any thyroid disease (hyperthyroidism)
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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 may increase nasal congestion symptoms rather than reduce them; this is due to its temporary effects and prolonged use, which may lead to this outcome, known as rebound effect.
Do not exceed the recommended dose indicated in section 3. How to use NOVAG RINO.
To prevent infections, the medicine should not be used by more than one person, and the applicator must always be cleaned after each use with a clean, damp cloth.
Use with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines—even those obtained without a prescription.
This medicine must not be used by individuals who are taking or have taken, within the past two weeks, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) or methyldopa (a medicine to lower blood pressure).
It should also not be used if you are being treated with phenothiazines (tranquilizers) or medications for asthma.
Use of NOVAG RINO with food and drinks
The use of NOVAG RINO does not affect the effectiveness of this medicine.
Use in children
Do not use in children under 6 years of age without consulting a doctor.
Children may be especially prone to adverse effects from this medicine.
Use in people aged 65 years and older
Consult your doctor or pharmacist, as elderly individuals are more sensitive to the effects of this medicine.
Pregnancy and breastfeeding
This medicine must not be administered during pregnancy or breastfeeding.
Consult your doctor or pharmacist before using any medicine.
IMPORTANT FOR WOMEN If you are pregnant or think you might be pregnant, consult your doctor before taking this medication. Taking medications during pregnancy can be harmful to the embryo or fetus, and must be monitored by your doctor. |
Driving and operating machinery
Observe your response to the medication, as drowsiness has occurred in some cases at usual doses. In such cases, do not drive or operate dangerous machinery.
Important information about some of the components of NOVAG RINO
This medicine may cause inflammation of the nasal mucosa, particularly with prolonged treatment, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medication without this excipient should be used whenever possible.
3. HOW TO USE NOVAG RINO
Follow these instructions unless your doctor has given you different ones.
Consult your doctor or pharmacist if you have any doubts.
The usual dose is:
Adults and children over 6 years of age: Apply 1 spray into each nostril up to 2 times a day, once in the morning and once at night. If necessary, adults may administer a second spray into each nostril at each dose.
Children under 6 years of age: This medicine must not be used in children under 6 years of age.
This medicine is for nasal use.
If this is the first time the product is being used or if it has not been used for a long time, the spray must be primed. To do this, hold the container away from the body and press the spray pump several times until a fine mist is released.
Before applying, clear any existing nasal discharge by blowing your nose thoroughly.
To administer the spray, keep your head upright.
Insert the nozzle into the nostril in such a way that it does not completely block the opening. While pressing the nozzle, inhale gently to ensure the medicine spreads evenly throughout the nasal cavity.
To prevent contamination, after each use and before closing the container, clean the tip of the nozzle with a clean, damp cloth. In addition, each container must be used by only one person.
If symptoms worsen or persist for more than 3 days after starting treatment, discontinue treatment and consult your doctor.
If you use more NOVAG RINO than you should
If excessive or prolonged doses are used, you may experience headache, tremors, insomnia, excessive sweating, sleep disturbances, palpitations, or nervousness.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91.5620420, indicating the medicine and the amount ingested.
If you forget to use NOVAG RINO
Do not use a double dose to make up for missed doses.
If necessary, resume use as indicated in section 3. HOW TO USE NOVAG RINO.
4. Possible adverse effects
Like all medicines, NOVAG RINO 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 accurately determined:
The adverse effects that may occur more frequently are:
Burning sensation at the site of application, dryness, itching of the nasal mucosa, or sneezing.
The adverse effects that may occur very 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 increased nasal congestion.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
5. Storage of NOVAG RINO
Keep out of the reach and sight of children.
No special storage conditions are required.
Do not use this medicinal product after the expiry date stated on the packaging after: EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of NOVAG RINO
The active substance is: oxymetazoline hydrochloride. Each spray delivers 35 micrograms of oxymetazoline hydrochloride in 0.07 ml of nasal spray solution.
The other components (excipients) are: benzalkonium chloride (0.014 mg per spray), potassium dihydrogen phosphate (to adjust pH), anhydrous disodium hydrogen phosphate (to adjust pH), purified water.
Appearance of the product and contents of the container
It is a colourless, transparent liquid solution.
The container with the dosing pump is white and contains 15 ml of nasal spray solution.
Marketing Authorization Holder:
Tarbis Farma, S.L.U.
Gran Vía Carlos III, 94
08028 Barcelona
Spain
Manufacturer:
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid 82
28802 Alcalá de Henares (Madrid)
Spain
This leaflet was approved in August 2009