Amidrin 1 mg/ml nasal spray solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
AMIDRIN 1 mg/ml nasal spray solution
Xylometazoline hydrochloride
Read this entire leaflet carefully before you start using this medicine,
because it contains important information for you.
Always follow exactly the instructions for use provided in this
leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any side effects, consult your doctor or pharmacist, even if
they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days.
Contents of the leaflet:
- What Amidrin is and what it is used for
- What you need to know before using Amidrin
- How to use Amidrin
- Possible side effects
- How to store Amidrin
- Contents of the pack and other information
1. What Amidrin is and what it is used for
This medicine belongs to a group of medicines called sympathomimetics. It is a nasal decongestant.
It contains xylometazoline as the active substance. Xylometazoline, administered as a nasal spray, 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 adolescents aged 12 years and older.
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 Amidrin
Do not use Amidrin
-
If you are allergic to xylometazoline, to other nasal decongestants, or to any of the
other components of this medicine (listed in section 6). -
If you have recently undergone brain surgery through the nose or mouth.
Warnings and precautions
Consult your doctor or pharmacist before using this medicine if:
-
You are being treated with antidepressant medicines, phenothiazines (tranquilizers), or
methyldopa (for lowering 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).
-
Any heart or circulatory system disease.
-
Any prostate disease with difficulty in urination (prostatic hypertrophy).
-
Any thyroid disease (hyperthyroidism).
-
If you have ever experienced insomnia or dizziness while being treated with
other sympathomimetic medicines, such as those used, among others,
for treating heart diseases, hypotension (low blood pressure), or asthma.
-
In rare cases, xylometazoline, due to its temporary effects and prolonged use, may increase nasal congestion instead of reducing it; this is known as rebound effect.
Rarely, insomnia may occur after using the medicine. If this happens, avoid using it late in the afternoon or at night.
Do not exceed the recommended dose stated in section “3. How to use Amidrin”.
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 12 years of age without consulting a doctor.
Children may be especially prone to adverse effects from this medicine.
Patients over 65 years old
Consult your doctor or pharmacist, as elderly patients are more sensitive to the adverse effects of this medicine.
Use of Amidrin 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 any of the following medicines during the past 2 weeks, as it may cause an increase in blood pressure:
- Medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)).
- A medicine used to lower blood pressure called methyldopa.
It should also not be used if you are being treated with phenothiazines (tranquilizers) or medicines for treating asthma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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.
Amidrin contains benzalkonium chloride
This medicine may cause inflammation of the nasal mucosa, especially with prolonged treatment, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medicine not containing this excipient should be used whenever possible.
3. How to use Amidrin
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and older:
1 - 2 sprays into each nostril every 8 – 10 hours (up to 3 times daily).
Use in children
This medicine should not be used in children under 12 years of age without consulting a doctor.
Patients over 65 years of age
Should consult their 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 administration, clear any existing nasal secretions by thoroughly blowing your nose.
The solution should be administered with the head held upright.
Remove the protective cap from the container.
Insert the upper end of the container vertically into the nostril. Briefly and firmly squeeze the sides of the bottle while inhaling through the nose. Remove the container without releasing pressure. Repeat the procedure in the other nostril. To prevent infection, after each use and before closing the container, clean the applicator tip with a clean, damp cloth. Additionally, each container should only be used by one person. If symptoms worsen or do not improve after 3 days of treatment, discontinue use and consult your doctor.
If you use more Amidrin than you should
If excessive or prolonged doses are administered, or in case of accidental ingestion, 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 number 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, Amidrin may produce adverse effects, although not everyone experiences them.
Uncommon side effects, which may affect up to 1 in 100 patients, are:
Burning sensation, dryness and itching in the nose and throat, sneezing, nausea, headache, and nasal bleeding.
Rare side effects, which may affect up to 1 in 1,000 patients, are:
Anxiety, restlessness, transient visual disturbances, sleep disorders, tachycardia, palpitations, increased blood pressure, and rash (skin redness).
Like other nasal decongestants, excessive or prolonged use of this medicine may lead to rebound nasal congestion.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Amidrin
This medicine does not require any special storage conditions.
Keep out of the sight and reach of children.
Do not use Amidrin after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via the sewage system or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Additional Information
Composition of Amidrin
- The active substance is Xylometazoline hydrochloride 1 mg/ml.
- The other components (excipients) are: glycerol (E422), benzalkonium chloride, Niaouli essence, disodium phosphate, monosodium phosphate, and purified water.
Appearance of the product and contents of the container
Amidrin is supplied in a carton containing a polyethylene spray bottle with 10 ml of nasal spray solution.
Marketing Authorization Holder and Manufacturer
Laboratorio de Aplicaciones Farmacodinámicas, S.A.
Grassot, 16 - 08025 Barcelona (Spain)
FARDI Logo
Date of the most recent revision of this leaflet: July 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/