ANGINOVAG ORAL SPRAY SOLUTION

Introduction

Leaflet:information for the patient

Anginovag oral spray solution

Decualinium chloride/enoxolone/hydrocortisone acetate/tyrothricin/lidocaine hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• 1. If you have any doubts, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Anginovag is and what it is used for
2. What you need to know before starting to use Anginovag
3. How to use Anginovag
4. Possible side effects

5 Conservation of Anginovag

1. Contents of the package and additional information

1. What Anginovag is and what it is used for

The active ingredients of this medication work by complementing the antiseptic, antimicrobial, and antifungal action of decualinium chloride, with the bactericidal antibiotic action of tyrothricin, the anti-inflammatory action of enoxolone and hydrocortisone acetate, and the local anesthetic action of lidocaine hydrochloride.

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

2. What you need to know before starting to use Anginovag

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 mouth mucosa.

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 alteration of the oral microbial 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 doping test.

Children and adolescents

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

Using Anginovag withother medications

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

Avoid simultaneous administration of Anginovag with other topical anesthetics.

Pregnancy andbreastfeeding

No data are available on the use of Anginovag in pregnancy.

Lidocaine is excreted in breast milk.

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

Driving and using machines

The influence of Anginovag on the ability to drive and use machines is nil 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 people with alcoholism.

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

3. How to use Anginovag

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

Anginovag is for buccopharyngeal use.

Instructions for correct administration of the preparation:

Open your mouth wide. Direct the inhaler nozzle towards the affected area (throat, mouth, tongue, etc., as needed).

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

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

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

Use in children and adolescents

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

If you use more Anginovag than you should

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

If you forget to use Anginovag

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Anginovag

If you have any other doubts 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 will experience them.

Rare side effects(may affect up to 1 in 1,000 people): blurred vision.

Side effects with unknown frequency(cannot be estimated from available data): hypersensitivity, allergy (itching, redness, rash, spots, or swelling of the skin, inflammation).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Anginovag

No special storage conditions are required.

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

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of Anginovag

• The active ingredients are: decualinium chloride, enoxolone, hydrocortisone acetate, tyrothricin, and lidocaine hydrochloride.
• The other components are: sodium saccharin, propylene glycol, pineapple flavor, and 89.385% ethanol v/v

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Date of the last revision of thisleaflet: August 2019

Other sources of information

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