Label: information for the user

Farinstop oral spray for buccal administration

Amilmetacresol/2,4-dichlorobenzoic acid alcohol/Lidocainehydrochloride monohydrate

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

?Keep this label, as you may need to refer to it again.
?If you need advice or more information, consult your pharmacist.
?If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this label, see section 4.
?You should consult a doctor if it worsens or does not improve after 3 days.

Farinstopspraycontains amylmetacresol and 2,4-dichlorobenzylic alcohol, both antiseptics, and lidocaine hydrochloride monohydrate, a local anesthetic for the throat.

It is indicated for the symptomatic relief of mild infections of the mouth and throat associated with pain and without fever in adults and adolescents over 12 years old.

Consult a doctor if it worsens or does not improve after 3 days.

No useFarinstopspray

Warning and Precautions

Consult your doctor or pharmacist before usingFarinstopspray.

You should inform your doctor if you:

• Have asthma.

The anesthetics contained in this medication may cause aspiration (coughing during meals or sensation of asphyxia) while eating. Do not ingest food directly after using this medication.

This medication may cause your tongue to become numb and may increase the risk of trauma from biting. Therefore, be careful when eating and drinking hot foods.

Follow the indicated doses: if taken in large quantities or frequently, this medication may affect the heart or nervous system, potentially causing seizures..

Older people or severely ill or frail individuals are more sensitive to possible adverse reactions to this medication, and should consult their doctor before using it..

Do not use this medication in the mouth and throat if you have extensive wounds there.

Children and Adolescents

This medication is not recommended for children under 12 years old.

Use ofFarinstopspraywith Other Medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications.

Consult especially with your doctor or pharmacist if you are taking any of the following medications, as it may be necessary to adjust the dose:

• Beta-blockers (used to treat heart failure or vascular diseases)
• Medications containing cimetidine (used to treat stomach ulcers).
• Other local anesthetics (amides).
• Medications used to treat heart diseases, such as mexiletine or procainamide.
• Medications like fluvoxamine (used to treat depression).
• Antibiotics, such as erythromycin or itraconazole.

Although interactions are not usually produced, do not use other oral or throat antiseptics while using Farinstop spray.

Administration of Farinstopspraywith Food, Drinks, and Alcohol

Do not take this medication just before meals or before drinking.

Pregnancy and Breastfeeding

Pregnancy:

This medication is not recommended duringpregnancy.

Breastfeeding:

This medication is not recommended during breastfeeding.

Driving and Operating Machines

This medication has no influence -or the influence is insignificant- on the ability to drive and operate machines.

Farinstop spraycontains sorbitol (E-420)

This medication contains 33.80 mg of sorbitol in each dose. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare disease by which a person is unable to metabolize fructose, speak with your doctor before you (or your child) take or receive this medication. As it may cause severe adverse effects.

Farinstop spraycontains ethanol

This medication contains 84.03 mg of alcohol (ethanol) in each dose. The amount in each dose of this medication is equivalent to less than 2.10 ml of beer or 0.84 ml of wine.

The small amount of alcohol contained in this medication does not produce any perceptible effect.

Farinstop spray: contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose, that is, it is essentially "sodium-free"

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended doses are:

• Adults and adolescents 15 years of age and older: one dose of 2 sprays in the mouth and/or throat, 1 to 6 times a day.

• Adolescents 12 to 15 years of age: one dose of 2 sprays in the mouth and/or throat, 1 to 4 times a day.

Use in children and adolescents

This medicine is not recommended for children under 12 years of age.

For buccal use only

Do not inhale when spraying

If symptoms do not improve after 3 days, worsen, or if you have a fever, yellow-green mucus, or difficulty swallowing, consult your doctor or pharmacist.

This medicine should not be used for more than 5 days, as it may alter the natural microbial balance of the throat.

Usage instructions:

1. Release the spray valve.
2. Insert the spray valve into your mouth and aim at the treated area. Press the spray head with your index finger.

Before using Farinstop spray for the first time, press the spray head several times aiming at another direction, until the spray is uniform.

Hold your breath while performing the spray.

If you use more Farinstop spray than you should

Events that may occur in case of incorrect use or overdose: excessive anesthesia (loss of sensitivity) of the upper digestive and respiratory tracts, insomnia, restlessness, excitement, respiratory depression (slow breathing). It may also cause shortness of breath, headache, fatigue, intolerance to exercise, dizziness, and loss of consciousness, due to a condition called methemoglobinemia. Seek immediate medical help or call the Toxicological Information Service, phone 91 562 04 20, specifying the medicine and the amount ingested.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them. During the use period, the following adverse reactions have been described for the combination of active substances in this medication:

Stop using Farinstopsprayand consult a doctor immediately if you experience symptoms ofangioedema, such as

• inflamed face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing

Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions (burning, itching), symptoms of anaphylactic shock, angioedema, sore throat, and unpleasant taste.

Very rare (may affect up to 1 in 10,000 people): gastrointestinal discomfort

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the box afterCAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store the bottle in the outer packaging to protect it from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and the
medicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines that you no longer need. In this way, you will help protect the environment..

Composition of Farinstop spray

The active principles are, per 100 ml:

Amilmetacresol……………………………………………………………………………0.223 g

2,4-Dichlorobenzylic alcohol ……………………………………………………………..0.446 g

Lidocaine hydrochloride monohydrate……………………………………0.690 g (equiv. to 0.600 g of lidocaine)

20 ml = 76 doses = 153 pulsations.

The other ingredients are:

96% Ethanol

Liquid non-crystallizing Sorbitol (E 420)(E 420)

Erythrosine (E127)(E127):Erythrosine, moisture, sodium chloride, and sodium sulfate

Sodium saccharin (E 954)

Citric acid monohydrate

Glycerol (E 422)

Levomenthol

Mint flavor:L-Menthol, isomenthol, menthyl acetate, isopulegol, propylene glycol (E 1520), Neomenthol, L-menthol, pulegone, and piperitone

Anise flavor:propylene glycol (E 1520), ethanol, anethol, and natural flavorings

Sodium hydroxide (for pH adjustment)

Purified water

Appearance of the product and contents of the container

The oral spray solution is transparent and red with anise and mint flavor and odor.

Farinstop sprayis presented in a high-density polyethylene (HDPE) bottle or in a type III glass bottle, equipped with a mechanical spray pump.

Each bottle contains 20 ml of solution that provides 153 pulsations

Holder of the marketing authorization and Responsible for the manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for the manufacturing:

Laboratories CHEMINEAU

93, route de la Monnaie

Vouvray 37210, France

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: GEISERSPRAY Spray for application in the oral cavity, solution

Slovakia: SERSPARY oral solution aerosol

Spain: Farinstop sprayoral spray solution

France: AMYLMETACRESOL/ALCOOL DICHLOROBENZYLIQUE/LIDOCAINE BIOGARAN CONSEIL 223 mg/ 446 mg/ 600 mg, solution for oral spray

Poland: LABIPRAY spray

Czech Republic: CRISTISOL

Date of the last review of this leaflet: June 2020

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