Anginovag solution for oral spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Anginovag oral spray solution
Dequalinium chloride/enoxolone/hydrocortisone acetate/tyrothricin/lidocaine hydrochloride
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Anginovag is and what it is used for
- What you need to know before using Anginovag
- How to use Anginovag
- Possible side effects
- Storage of Anginovag
- Contents of the pack and other information
1. What Anginovag is and what it is used for
The active ingredients in this medicine work synergistically, combining the antiseptic, antimicrobial, and antifungal action of dequalinium chloride with the bactericidal antibiotic action of tyrothricin, the anti-inflammatory effects of enoxolone and hydrocortisone acetate, and the local anesthetic action of lidocaine hydrochloride.
Anginovag is a solution for oral spray used to treat mild throat conditions without fever that are accompanied by pain, soreness, and/or irritation, in adults and children and adolescents over 12 years of age.
2. What you need to know before using Anginovag
Do not use Anginovag:
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
- if you have severe lesions on the oral 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 disruption of the oral microbial flora.
Contact your doctor if you experience blurred vision or other visual disturbances.
Athletes should be aware that the use of this medicine may result in a positive doping test.
Children and adolescents
Anginovag must not be used in children and adolescents under 12 years of age.
Use of Anginovag with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Avoid simultaneous administration of Anginovag with other topical anesthetics.
Pregnancy and breastfeeding
There are no data available on the use of Anginovag during pregnancy.
Lidocaine is excreted in breast milk.
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
The effect of Anginovag on the ability to drive and operate machinery is negligible or none.
Anginovag contains ethanol and propylene glycol
This medicine contains 93.33 mg of propylene glycol per ml.
This medicine contains 89.385% ethanol, corresponding to an approximate quantity of 75 mg per dose, equivalent to 2 ml of beer or 1 ml of wine.
This medicine is harmful for individuals suffering from alcoholism.
The alcohol content should be taken into account in pregnant women or those who are breastfeeding, children, and high-risk populations such as patients with liver disease, epilepsy, brain injury, and patients with alcoholism.
3. How to use Anginovag
Follow exactly the instructions for drug administration provided in this leaflet or as directed by your physician. If in doubt, consult your doctor or pharmacist.
Anginovag is for oropharyngeal use.
Instructions for correct administration of the preparation:
Open your mouth widely. Direct the spray nozzle toward the affected area (throat, mouth, tongue, etc., as applicable).
Press down firmly on the top of the capsule from top to bottom until fully depressed, keeping the bottle in an upright 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 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 as symptoms begin to improve.
Use in children and adolescents
Anginovag must 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 a doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.
If you forget to use Anginovag
Do not take a double dose to make up for missed doses.
If you stop using Anginovag
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare adverse effects (may affect up to 1 in 1,000 people): blurred vision.
Adverse effects with unknown frequency (cannot be estimated from available data): hypersensitivity, allergy (itching, redness, rash, spots or swelling of the skin, inflammation).
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Anginovag
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.
6. Contents of the container and other information
Composition of Anginovag
- The active substances are: dequalinium chloride, enoxolone, hydrocortisone acetate, tyrothricin and lidocaine hydrochloride.
- The other components are: sodium saccharin, propylene glycol, pineapple flavoring and ethanol 89.385% v/v.
Appearance of the product and contents of the container
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 most recent review of this summary: August 2019
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)