Label:Information for the Patient

Anginovag Oral Spray Solution

Decqualine Chloride/Enoxolone/Acetate of Hydrocortisone/Tyrothricin/Lidocaine Hydrochloride

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

• Keep this label, as you may need to read it again.
• 1. If you have any questions, consult yourdoctor,pharmacistor nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

1.What is Anginovag and how is it used

2.What you need to knowbeforestarting touse Anginovag

3.How to use Anginovag

4.Possible adverse effects

5Storage of Anginovag

6.Contents of the package and additional information

The active principles of this medication act by complementing the antisepsis, antimicrobial, and antifungal action of chlorquinaldol, with the bactericidal antibacterial action of tyrothricin, the anti-inflammatory action of enoxolone and hydrocortisone acetate, and the local anesthetic action of lidocaine hydrochloride.

Anginovag is a mouth spray solution for the treatment of mild throat afflictions without fever accompanied by pain, itching, and/or irritation in adults and children and adolescents over 12 years old.

Do not use Anginovag:

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you have severe lesions in the mucous membrane of the mouth.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Anginovag.

Prolonged use of Anginovag for more than 10 days should be avoided due to the possibility of altering the oral bacterial flora.

Contact your doctor if you experience blurred vision or other visual disturbances.

Those who engage in competitive sports should be aware that the use of this medication may result in a positive test for doping.

Children and adolescents

Anginovag should not be used in children and adolescents under 12 years old.

Use of Anginovag with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Avoid simultaneous administration of Anginovag with other topical anesthetics.

Pregnancy and breastfeeding

No data is available on the use of Anginovag during pregnancy.

Lidocaine is excreted in breast milk.

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

Driving and operating machinery

The influence of Anginovag on the ability to drive and operate machinery is negligible or insignificant.

Anginovag contains ethanol and propylene glycol

This medication contains 93.33 mg of propylene glycol per ml.

This medication contains 89.385% ethanol, which corresponds to an approximate amount of 75 mg per application, equivalent to 2 ml of beer or 1 ml of wine.

This medication is harmful to individuals with alcoholism.

The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk populations, such as patients with liver disease, epilepsy, brain damage, and patients with alcoholism.

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

Anginovag is for buccal and pharyngeal use.

Instructions for correct administration of the preparation:

Open your mouth wide. Direct the inhaler nozzle towards the affected area (throat, mouth, tongue, etc., depending on the case).

Press the top of the capsule from top to bottom until it reaches the top, keeping the bottle in a vertical position.

Discard the first sprays if the container is new or has not been used for several days.

In adults and adolescents over 12 years old, it is recommended to start with 1-2 applications of Anginovag every 2 or 3 hours, switching to one application every 6 hours when symptoms start to decrease.

Use in children and adolescents

Anginovag should not be used in children and adolescents under 12 years old.

If you use more Anginovag than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Anginovag

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Anginovag

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

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

Rare Adverse Effects(may affect up to1 in every 1,000 people): blurred vision.

Adverse Effects of Unknown Frequency(cannot be estimated from available data): hypersensitivity, allergy (itching, redness, rash, spots or swelling on the skin, inflammation).

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:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This does not require special conditions for conservation.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the labelafter CAD.The expiration date is the last day of the month indicated.

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

Composition of Anginovag

• The active principles are: decqualinio chloride, enoxolone, acetate of hydrocortisone, thyrotropin-releasing hormone and lidocaine hydrochloride.
• The other components are:sodium saccharin, propylene glycol, pineapple essence and ethanol 89.385% v/v

Appearance of the product and contents of the packaging

Polyethylene bottle with a dosing valve. The bottle contains 20 ml of oral spray solution.

Holder of the marketing authorization and responsible for manufacturing

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Date of the last review of this prospectus: August 2019

Other sources of information

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