Apogar 5 mg/5 mg sucking tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Apogar 5 mg/5 mg lozenges

Chlorhexidine dihydrochloride / Benzocaine

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

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet.
• You should consult your doctor if your condition worsens or if you do not improve after 2 days.

Leaflet Contents

1. What Apogar is and what it is used for
2. What you need to know before taking Apogar
3. How to take Apogar
4. Possible side effects
5. How to store Apogar
6. Contents of the pack and other information

1. What Apogar is and what it is used for

The active ingredients in this medicine combine the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medicine is used for the local and temporary symptomatic relief of mild infections of the mouth and throat that cause pain but are not accompanied by fever, such as: sore throat irritation, hoarseness, and minor mouth ulcers, in individuals aged 6 years and older.

2. What you need to know before starting to take Apogar

Do not take apogar

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you do not tolerate other local anaesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes),
• if you are an elderly patient or have a weakened immune system, you may require lower doses; in case of doubt, consult a doctor,
• if you have a severe or extensive injury in the mouth,
• if you suffer from periodontitis (gum disease), since chlorhexidine may increase supragingival calculus formation,
• it is recommended to maintain adequate oral hygiene to reduce tartar buildup and possible tooth staining that chlorhexidine may cause,
• do not take doses higher than those recommended in section 3. (How to take Apogar).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Although interactions have not been reported under recommended conditions of use, this medicine should not be used with other oral or throat medications without consulting your doctor or pharmacist.

This is especially important in the case of:

• Other mouth or throat antiseptics.
• Cholinesterase inhibitor medicines (medicines for Alzheimer's disease).
• Sulfonamides (used for infections).

Anionic compounds and suspending agents, common components of toothpastes, reduce the effectiveness of chlorhexidine; therefore, the mouth should be thoroughly rinsed after using toothpaste.

Interference with diagnostic tests

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

Children and adolescents

This medicine should be administered to children over 6 years of age. For administration instructions in children over 6 years, see section 3 below.

How to take Apogar

Use with caution, as methemoglobinemia may occur (difficulty breathing, dizziness, fatigue, tiredness, weakness).

Pregnancy and breastfeeding

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

Taking medicines during pregnancy can be harmful to the embryo or fetus, and should be monitored by your doctor.

Driving and using machines

There have been no reported cases of effects on the ability to drive or operate machinery.

3. How to take Apogar

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults, adolescents and children over 6 years of age

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

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

Slowly dissolve the lozenge in the mouth without chewing or swallowing it.

Elderly patients

Elderly and debilitated patients may be more sensitive to benzocaine, so lower concentrations of this medicine may be required.

This medicine is intended for oropharyngeal use; therefore, the lozenges must be slowly dissolved in the mouth without chewing or swallowing, as its action is local and only becomes evident when the product is in direct contact with the affected area.

Always use the lowest effective dose.

If you notice that symptoms worsen or persist for more than 2 days after starting treatment, or if fever, headache, nausea, or vomiting occur, consult your doctor as soon as possible.

If you take more Apogar than you should

Signs of overdose include: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or seizures, ringing in the ears, and increased sweating. A decrease in blood pressure may also occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Apogar

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

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

4. Possible adverse effects

Like all medicines, Apogar may cause adverse effects, although not everyone experiences them.

The most characteristic adverse reactions due to benzocaine are:

Discoloration of teeth may occur, especially in people who have plaque and tartar buildup on their teeth. This tooth discoloration is not permanent and can be removed by professional oral cleaning. Discoloration of dental fillings may also occur, in which case the discoloration may be permanent.

Altered taste perception may occur.

Irritation in the mouth or irritation of the tip of the tongue, or tongue numbness, which are usually temporary, loss of sensitivity in the mouth, stomatitis (inflammation of the oral mucosa), mucosal desquamation, burning sensation in the mucosa, altered taste perception, discoloration of teeth, tongue, fillings, and dentures, increased tartar buildup, 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.

Parotid gland inflammation has also been reported.

There have been cases of methemoglobinemia caused by benzocaine, whose symptoms include difficulty breathing, cyanosis (bluish discoloration of the skin and mucous membranes), altered mental state, headache, fatigue, difficulty exercising, dizziness, and loss of consciousness.

In some cases, this medicine may cause irritation in the mouth or irritation of the tip of the tongue, which are usually temporary, as well as allergic reactions to chlorhexidine or benzocaine.

Reporting of adverse effects

If you experience any of the adverse effects, consult your doctor or pharmacist, even if they are effects 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.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Apogar

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Apogar

The active substances are dihydrochloride of chlorhexidine and benzocaine.

Each lozenge contains 5 mg of chlorhexidine dihydrochloride 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), menthol flavour, and orange flavour.

Appearance of the medicinal product and contents of the pack

Apogar lozenges are orange-flavoured, yellowish-white, round, bevelled tablets, scored on one side.

Aluminium blister coated with PVDC and laminated with PVC/PE/PVDC. Packaged in containers of 20 lozenges.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. De Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Date of the most recent revision of this leaflet: June 2025

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