Package Insert: Information for the Patient

AMIDRIN 1 mg/ml Nasal Spray Solution

Xilometazoline hydrochloride

Read this entire package insert carefully before starting to use this medication,

because it contains important information for you.

Follow exactly the administration instructions of the medication contained in this

package insert or those indicated by your doctor, or pharmacist.

- Keep this package insert, as you may need to refer to it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any adverse effects, consult your doctor, or pharmacist even if they

are not listed in this package insert. See section 4.

- You should consult a doctor if your condition worsens or does not improve after 3 days.

This medication belongs to a group of medications known as sympathomimetics. It is a nasal decongestant medication.

It contains xylometazoline as the active ingredient. Xylometazoline administered in the form of a nasal spray, produces local vasoconstriction, 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 above.

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

Do not use Amidrin

- If you are allergic to xylometazoline, other nasal decongestants, or any of the

other components of this medication (listed in section 6).

- If you have recently undergone any surgery in the brain through the nose ormouth

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication if:

- You are being treated with antidepressant medications, phenothiazine (tranquilizer), or

methyldopa (to lower blood pressure).

- You have experienced or have, although only once, any of the following diseases or

symptoms:

- If you have high blood sugar levels (diabetes mellitus).

- If you have high blood pressure (hypertension).

- If you have any heart or circulatory system disease.

- If you have any prostate disease with difficulty urinating (prostatic hypertrophy).

- If you have any thyroid disease (hyperthyroidism).

- If you have ever experienced insomnia or dizziness when treated with other

sympathomimetic medications, such as those used to treat heart disease, low blood

pressure, or asthma.

Adverse reactions

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 medication. If this happens, avoid using

it in the late afternoon or at night.

Do not exceed the recommended dose in the section “3. How to use Amidrin”.

To prevent contagion, the medication should not be used by more than one person and

the applicator should be cleaned with a clean, damp cloth after each use.

Children

Do not use in children under 12 years old without consulting a doctor.

Children may be especially prone to adverse effects of this medication.

People over 65 years old

Consult your doctor or pharmacist as older people are more sensitive to the adverse

effects of this medication.

Use of Amidrin with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may have to

use any other medication.

This medication should not be used by people taking or having taken during the last

two weeks the following medications, as it may cause an increase in blood pressure:

• medications used to treat depression (tricyclic antidepressants or monoamine oxidase
• inhibitors (MAOIs)
• a medication used to lower blood pressure called methyldopa.

This medication should also not be used in case of treatment with phenothiazine

(tranquilizer) or medications to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend tobecomepregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machinery

Although problems are not expected, if you experience drowsiness or dizziness, do not

drive or operate hazardous machinery.

Amidrin contains benzalkonium chloride

This medication may cause nasal mucosa inflammation, especially with long-term

use, 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.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older:

1 - 2 applications in each nasal cavity every 8 –10 hours (up to 3 times a day).

Use in children

This medication should not be used in children under 12 years without consulting a doctor.

Individuals 65 years and older

They should consult their doctor or pharmacist as older individuals are more sensitive to the adverse effects of this medication.

How to use

This medication is used via the nasal route.

Before application, eliminate any existing nasal secretions by blowing your nose well.

The solution is applied while keeping the head straight.

Remove the protective cap from the container.

Insert the top of the container into the nasal opening in a vertical position. Press the container walls briefly and firmly while inhaling through the nose. Remove the container without stopping the pressure. Repeat the procedure in the other nasal opening. To prevent contamination, 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 1 person. If it worsens or does not improve after 3 days of treatment, discontinue and consult your doctor.

If you use more Amidrin than you should

In case of excessive or very frequent dosing or 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, Amidrin may produce adverse effects, although not all people will experience them.

The rare adverse effects that may affect up to 1 in 100 patients are:

Itching, dryness, and burning in the nose and throat, sneezing, nausea, headache, and nasal bleeding.

The rare adverse effects that may affect up to 1 in 1,000 patients are: Anxiety, restlessness, transient visual disturbances, sleep disorders, tachycardia, palpitations, increased blood pressure, exanthema (skin redness).

Like other nasal decongestants, excessive or prolonged use of this medication may lead to nasal congestion due to rebound effect.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not require special conditions for conservation.

Keep out of sight and reach of children.

Do not use Amidrin after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Amidrin

• The active ingredient is Xilometazolina hydrochloride 1 mg/ml,
• The other components (excipients) are: glycerol (E422), benzalkonium chloride, Niauli essence, disodium phosphate, monosodium phosphate, and purified water.

Appearance of the product and contents of the package

Amidrin is presented in a case containing a polyethylene spray bottle with 10 ml of nasal spray solution.

Holder of the marketing authorization and responsible for manufacturing

Laboratory of Pharmacodynamic Applications, S.A.

Grassot, 16 - 08025 Barcelona (Spain)

Logo FARDI

Last review date of this leaflet: July 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/