Leaflet: information for the user

Lizipaina chlorhexidine 5 mg/benzocaine 2.5 mg lozenges

Chlorhexidine digluconate/Benzocaine

Read this leaflet carefully before you start to take 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 2 days of treatment.

1. What is Lizipaina and what it is used for

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

3. How to take Lizipaina

4. Possible adverse effects

5. Storage of Lizipaina

6. Contents of the pack and additional information

The active ingredients 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 and without fever, such as sore throat, hoarseness, and small mouth ulcers, for adults, adolescents, and children 6 years of age or older.

You should consult a doctor if it worsens or does not improve after 2 days.

Do not take Lizipaina

• 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 Lizipaina:

• if you cannot tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye)
• 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
• if you have fillings in your incisors and the surface of the filling or its margins are rough, as chlorhexidine may cause permanent discoloration.

Anaphylactic reactions

Rare but serious allergic reactions, including fatal anaphylaxis, have been reported associated with the use of topical and oral chlorhexidine.

Lizipaina chlorhexidine 5 mg / benzocaine 2.5 mg should not be used if there have been previous hypersensitivity reactions to chlorhexidine (including allergic reactions after the use of mouthwashes, during the insertion of chlorhexidine-coated urinary or venous catheters, and pre-surgical skin washes or preparatory showers).

If symptoms of allergic reactions occur during the use of Lizipaina chlorhexidine 5 mg / benzocaine 2.5 mg, treatment should be stopped immediately and the patient should seek medical attention.

Stop taking this medication and seek immediate medical attention if you or a child in your care develop pale or grayish-blue skin, lips, or nail coverings, headache, dizziness, difficulty breathing, fatigue, and tachycardia (rapid heartbeats).

Do not take this medication if you develop mouth and throat ulcers and lesions.

Do not take doses higher than those recommended in section 3 (How to take Lizipaina)

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

Due to the local anesthetic action of benzocaine, avoid eating or drinking directly after taking a tablet.

Use with adult supervision in young children and individuals with swallowing and aspiration problems, as the tablets are a potential risk of asphyxiation.

If symptoms persist or worsen, or if new symptoms appear, stop using this medication and consult your doctor.

Children

This medication should not be administered to children under 6 years old without consulting a doctor first.

Children may be more sensitive to benzocaine, just like older adults and debilitated patients.

Special populations

Older adults and debilitated patients may be more sensitive to benzocaine.

Other medications and Lizipaina

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

Although no interactions have been described in the recommended conditions of use, Lizipaina should not be used at the same time as other medications applied to the mouth without consulting a doctor or pharmacist. This is especially important in the case of mouth and throat antisetics, sulfamides (medications used to treat some infections), and medications that inhibit cholinesterase (such as medications for Alzheimer's disease).

Anionic 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.

Use of Lizipaina with food and drinks

Avoid eating or drinking immediately after taking this medication.

Pregnancy and breastfeeding

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

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

If you are pregnant or breastfeeding, consult with your doctor before using this medication.

Driving and operating machinery

The combination of benzocaine and chlorhexidine is unknown to affect the ability to drive or operate machinery.

Interference with diagnostic tests

If you are to undergo any diagnostic tests (including blood, urine, skin tests that use allergens, etc.) inform your doctor that you are using this medication, as it may alter the results. This medication may interact with pancreatic function tests that use bentiromide. Do not use this medication at least 3 days before the test and inform your doctor.

Lizipaina contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

The recommended dose is:

Adults, adolescents, and children 6 years of age or older: 1 lozenge every 2 or 3 hours, dissolving it slowly in the mouth.

Do not take more than 8 lozenges per day.

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. The lozenges should not be chewed or swallowed.

Always use the lowest effective dose.

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

If you take more Lizipaina than you should

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.

The signs of overdose manifest as: mumbling speech, drowsiness, staggering gait, blurred or double vision, dizziness, excitement, or convulsions, tinnitus, increased sweating, decreased oxygen levels in the blood (pale, gray, or blue skin, lips, and nail beds, difficulty breathing, fatigue, confusion, headache, feeling of drowsiness, and rapid heart rate, and death in the most severe cases). A decrease in blood pressure may also occur.

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

The following adverse effects have been observed, but their frequency cannot be estimated from the available data.

Some cases may present with irritation in the mouth or at 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); mucosa peeling; sensation of burning in the mucosa; change in the perception of taste; discoloration of teeth, tongue, fillings, and dentures; increased tartar; anaphylactic shock and anaphylactic reactions (for example, urticaria, angioedema, and rash).

There have also been reports of parotid gland inflammation.

Teeth discoloration is mainly seen in people who have accumulations of tartar on their teeth. This alteration in tooth color is not permanent and can be eliminated by means of oral hygiene. The alteration in the color of fillings may be permanent. The alteration in tongue color disappears spontaneously and is not hazardous.

There may be an alteration in the perception of taste.

There have been cases of methemoglobinemia caused by benzocaine, a serious condition that must be treated immediately because it reduces the amount of oxygen in the blood. This can occur even if you have used this product previously. Stop using the product and seek immediate medical attention if you or a child under your care experience: difficulty breathing, cyanosis (blue discoloration of the skin and mucous membranes), altered mental state, headache, fatigue, difficulty exercising, rapid heart rate, dizziness, or loss of consciousness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication should not be stored at a temperature above 86°F (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 the packaging and medications you no longer need at theSIGREcollection point at the pharmacy.En case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment..

Composition of Lizipaina

• The active principles are dihydrochloride of chlorhexidine and benzocaine.
• The other components are mannitol (E-421), microcrystalline cellulose, povidone, magnesium stearate, sodium cyclamate (E-952), sodium saccharin (E-954), and menthol aroma.

Appearance of the product and content of the packaging

White, round, flat, and bisected lozenges.

It is presented in a container with 20 lozenges in a low-density polyethylene tube and a polypropylene cap.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Grupo Sanofi

Responsible for manufacturing

Laboratorios Alcalá-Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

or

Temmler Pharma GmbH

Temmlerstraße 2

35039 Marburg Germany

Last review date of this leaflet:April 2020.

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/12055/P_12055.html

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