Leaflet: information for the user

Apogar 5 mg /5 mg lozenges

Dihydrochloride of chlorhexidine/Benzocaine

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult your doctor if it worsens or does not improve after2 days.

1. What isApogarand for what it is used

2. What you need to know before starting to takeApogar

3. How to takeApogar

4. Possible side effects

5. Storage ofApogar

6. Contents of the package and additional information

The active principles of this medication act by combining the antisepsis and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medication is used for the symptomatic relief of mild infections of the mouth and throat that are accompanied by pain, but not fever, such as: sore throat, hoarseness, small mouth ulcers, from 6 years old.

Do not take Apogar

• if you are allergic to the active ingredients or any of the other components of this medication listed in section 6.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication,

• if you cannot tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a hair dye component),
• if you are an elderly patient or your immune system is weakened, you may need lower doses, in case of doubt, consult a doctor,
• if you have any severe or extensive injuries in the mouth,
• if you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus,
• do not take doses higher than recommended in section 3 (How to take Apogar).

Interference with diagnostic tests

This medication may interact with the pancreatic function test that uses bentiromide. Do not take this medication at least three days before the test and inform your doctor.

It is recommended to maintain good oral hygiene to reduce the accumulation of plaque and the possible discoloration of the teeth that may be caused by chlorhexidine.

Children and adolescents

This medication should be administered to children over 6 years old. For the administration method in children over 6 years old, see section 3

How to take Apogar.

It should be used with caution as it may cause methemoglobinemia (difficulty breathing, dizziness, fatigue, tiredness, weakness).

Use of Apogar with other medications

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

Although not described in the recommended conditions of use, it should not be used with other medications applied to the mouth without consulting a doctor or pharmacist.

This is especially important in the case of:

• Other mouth or throat disinfectants.
• Medications that inhibit cholinesterase (medications for Alzheimer's disease).
• Sulfonamides (used for infections).

Ionizable compounds and suspending agents, common components of toothpaste, reduce the effectiveness of chlorhexidine, so it is recommended to rinse your mouth well after using toothpaste.

Pregnancy and breastfeeding

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

The consumption of medications during pregnancy can be hazardous to the embryo or fetus, and should be monitored by your doctor.

Driving and operating machines

No cases have been described that affect the ability to drive or operate machines.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

This medication is for buccal use, so the lozenges must be dissolved slowly in the mouth without chewing or swallowing them, as their action is local and only manifests when the product is in direct contact with the affected area.

Always use the smallest effective dose.

If you observe that the symptoms worsen or persist for more than 2 days after starting treatment or a fever, headache, nausea, or vomiting appears, you must consult your doctor as soon as possible.

The recommended dose is:

Adults, adolescents, and children over 6 years old:

1 lozenge every 2 or 3 hours, dissolving it slowly in the mouth.

Do not take more than 8 lozenges in 24 hours (1 day).

Dissolve the lozenge slowly in the mouth without chewing or swallowing.

Older adults

Older adults and more debilitated patients may be more sensitive to benzocaine, so lower concentrations of this medication may be needed.

If you take more Apogar than you should

The signs of overdose are: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement, or convulsions, tinnitus, increased sweating. Hypotension may also occur.

In case of overdose or accidental ingestion, consult your 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 take Apogar

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

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

Like all medications, Apogar may produce adverse effects, although not all people may experience them.

Discoloration of the teeth may appear, especially in people who have accumulations of tartar on their teeth. This alteration in tooth color is not permanent and can be eliminated through oral hygiene. The color of fillings may also be altered, in which case, this discoloration may be permanent.

Alteration in the perception of taste may appear.

Irritation in the mouth or irritation of the tip of the tongue or numbness of the tongue, which are usually temporary, lack of sensitivity in the mouth, stomatitis (inflammation of the oral mucosa), peeling of the mucosa, sensation of burning in the mucosa, change in the perception of taste; discoloration of teeth, tongue, fillings, and dentures; increase in tartar, as well as hypersensitivity reactions such as urticaria, angioedema (swelling of certain areas of the skin), anaphylactic reaction or anaphylactic shock, mainly due to chlorhexidine

Also, inflammation of the parotid gland has been reported.

Some cases of methemoglobinemia caused by benzocaine have been reported, whose symptoms are difficulty breathing, cyanosis (blue discoloration of the skin and mucous membranes), alteration of mental state, headache, fatigue, difficulty exercising, dizziness, and loss of consciousness.

Reporting Adverse Effects

If you experience any of these adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed 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.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Apogar

The active principles are dihydrochloride of chlorhexidine and benzocaine.

Each lozenge contains 5 mg of dihydrochloride of chlorhexidine and 5 mg of benzocaine.

The other components (excipients) are: mannitol (E-421), microcrystalline cellulose (E-460), povidone, magnesium stearate, sodium cyclamate, sodium saccharin (E-954), peppermint aroma and orange aroma.

Appearance of the product and contents of the packaging

Apogar are lozenges, with an orange flavor, white-yellowish in color, rounded, beveled and scored on one side.

Aluminum blister coated with PVDC and stratified PVC/PE/PVDC. It is presented in packs of 20 lozenges.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Tel: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Revision date of this leaflet: March 2020

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