FARINSTOP SPRAY ORAL SPRAY SOLUTION

Introduction

Prospectus: Information for the User

Farinstop Spray Solution for Oral Spraying

Amilmetacresol/2,4-Dichlorobenzyl Alcohol/Lidocaine Hydrochloride Monohydrate

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

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist exactly.

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

Contents of the Prospectus

1. What Farinstop Spray is and what it is used for.
2. What you need to know before using Farinstop Spray.
3. How to use Farinstop Spray.
4. Possible side effects.
5. Storage of Farinstop Spray.
6. Package Contents and Additional Information.

1. What is Farinstop Spray and what is it used for

Farinstop Spray contains amilmetacresol and 2,4-dichlorobenzyl alcohol, both antiseptics, and lidocaine hydrochloride monohydrate, a local anesthetic for the throat.

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

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before using Farinstop Spray

Do not useFarinstop

• If you are allergic to lidocaine hydrochloride monohydrate or other local anesthetics of the amide type, to amilmetacresol, to 2,4-dichlorobenzyl alcohol, or to any other ingredient of this medication (see list in section 6).

Warning and Precautions

Consult your doctor or pharmacist before using Farinstop Spray.

You must inform your doctor if you:

• Suffer from asthma.

The anesthetics contained in this medication can cause aspiration (coughing during meals or feeling of suffocation) while eating. Do not eat food directly after using this medication.

This medication can 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 too frequently, this medication can affect the heart or nervous system, potentially causing convulsions.

The elderly or seriously ill or fragile individuals are more sensitive to the possible adverse reactions of this medication and should consult their doctor before using it.

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

Children and Adolescents

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

Use ofFarinstop

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

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

• Betablockers (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 such as 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.

Taking Farinstop Spraywith Food, Drinks, and Alcohol

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

Pregnancy and Breastfeeding

Pregnancy:

This medication is not recommended during pregnancy.

Breastfeeding:

This medication is not recommended during breastfeeding.

Driving and Using Machines

This medication has no influence - or the influence is insignificant - on the ability to drive and use 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 an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare disease where a person is unable to metabolize fructose, talk to your doctor before you (or your child) take or receive this medication. As it can cause serious side 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 in this medication does not produce any noticeable effect.

Farinstop Spray: contains Sodium

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

3. How to use Farinstop Spray

Take this medication exactly as described in this prospectus or following the instructions of your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended doses are:

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

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

Use in Children and Adolescents

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

For oral use only

Do not inhale when spraying

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

This medication is not recommended for use for more than 5 days, as it may alter the natural microbial balance of the throat.

Instructions for use:

1. Lift 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 to the side, until the spray is uniform.

Hold your breath while spraying.

If you use more Farinstop Spraythan you should

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them. During the use period, the following adverse reactions have been described for the combination of active substances of this medication:

Stop taking FarinstopSpray and consult a doctor immediately if you experience symptoms ofangioedema, such as

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

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

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

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that are not listed in this prospectus.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that are not listed in this prospectus.

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

5. Storage of Farinstop Spray

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 after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Farinstop Spray

The active ingredients are, per 100 ml:

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

2,4-Dichlorobenzyl Alcohol ……………………………………………………………..0.446 g

Lidocaine Hydrochloride Monohydrate……………………………………0.690 g (equiv. to 0.600 g of lidocaine)

20 ml = 76 doses = 153 sprays.

The other ingredients are:

96% Ethanol

Non-crystallizing Liquid Sorbitol (E 420)

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

Sodium Saccharin (E 954)

Citric Acid Monohydrate

Glycerol (E 422)

Levomenthol

Peanut Oil: L-Menthol, Isomenthol, Menthyl Acetate, Isopulegol, Propylene Glycol (E 1520), Neomenthol, L-Menthol, Pulegone, Piperitone

Anise Flavor: Propylene Glycol (E 1520), Ethyl Alcohol, Anethole, and Natural Flavoring Substances

Sodium Hydroxide (for pH adjustment)

Purified Water

Appearance of the Product and Package Contents

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

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

Each bottle contains 20 ml of solution that provides 153 sprays

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Laboratories CHEMINEAU

93, route de la Monnaie

Vouvray 37210, France

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

Germany: GEISERSPRAY Spray zur Anwendung in der Mundhöhle, Lösung

Slovakia: SERSPARY orálna roztoková aerodisperzia

Spain: Farinstop spray solución para la pulverización bucal

France: AMYLMETACRESOL/ALCOOL DICHLOROBENZYLIQUE/LIDOCAINE BIOGARAN CONSEIL 223 mg/ 446 mg/ 600 mg, solution pour pulvérisation buccale

Poland: LABIPRAY spray

Czech Republic: CRISTISOL

Date of the last revision of this prospectus: June 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es