LIZIPAINA CHLORHEXIDINE 5 mg/BENZOCAINE 2.5 mg LOZENGES

Introduction

Package Leaflet: Information for the User

Lizipaina Chlorhexidine 5 mg/Benzocaine 2.5 mg Lozenges

Chlorhexidine Dihydrochloride/Benzocaine

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 2 days of treatment.

Contents of the Package Leaflet

1. What is Lizipaina and what is it used for
2. What you need to know before taking Lizipaina
3. How to take Lizipaina
4. Possible side effects
5. Storage of Lizipaina
6. Package Contents and Additional Information

1. What is Lizipaina and what is it used for

The active ingredients of this medication work by combining the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medication is used for the symptomatic local and temporary relief of mild mouth and throat infections with pain and without fever, such as throat irritation, hoarseness, and small mouth ulcers, for adults, adolescents, and children 6 years of age or older.

You should consult a doctor if your symptoms worsen or do not improve after 2 days.

2. What you need to know before taking Lizipaina

Do not take Lizipaina

• if you are allergic to the active ingredients or to 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 do not tolerate other local anesthetics like para-aminobenzoic acid (PABA), parabens, or para-phenylenediamine (a component of hair dye)
• if you have a severe or extensive injury in the mouth
• if you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus
• if you have fillings on your front teeth and if the surface of the filling or its edges are rough, as chlorhexidine can cause a permanent discoloration.

Anaphylactic Reactions

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

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

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

Stop taking this medication and go to your doctor immediately if you or a child in your care develop pale, gray, or blue skin, lips, or nail beds, headache, dizziness, difficulty breathing, fatigue, and rapid heartbeat.

Do not take this medication if you have sores and ulcers in your mouth and throat.

Do not take more than the recommended dose in section 3 (How to take Lizipaina)

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

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

Use under adult supervision in small children and in individuals with aspiration and swallowing problems, as the lozenges are a potential choking hazard.

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 of age without consulting a doctor first.

Children may be more sensitive to benzocaine, as are elderly people and debilitated patients.

Special Populations

Elderly people and debilitated patients may be more sensitive to benzocaine.

Other Medications and Lizipaina

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

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

Anionic compounds and suspending agents, common components of toothpastes, decrease the effectiveness of chlorhexidine, so the mouth should be rinsed well after using toothpaste.

Using Lizipaina with Food and Drinks

Avoid eating or drinking immediately after taking this medication.

Pregnancy and Breastfeeding

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.

Taking medications during pregnancy can be hazardous to the embryo, fetus, or breastfeeding child and should be monitored by your doctor.

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

Driving and Using Machines

It is unknown whether the combination of benzocaine and chlorhexidine affects the ability to drive or operate machinery.

Interference with Analytical Tests

If you are going to undergo any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medication, as it may alter the results. This medication may interact with tests of pancreatic function using 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 lozenge; that is, it is essentially "sodium-free".

3. How to Take Lizipaina

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of 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 should be dissolved slowly in the mouth, without chewing or swallowing, as their action is local and only occurs when the product is in direct contact with the affected area. The lozenges should not be chewed or swallowed.

Always use the smallest effective dose.

If you notice that your symptoms worsen or persist for more than 2 days after starting treatment, or if you develop a fever, headache, nausea, or vomiting, you should 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Signs of overdosing include: slurred speech, numbness, stumbling gait, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, increased sweating, decreased oxygen in the blood (pale, gray, or blue skin, lips, and nail beds, difficulty breathing, fatigue, confusion, headache, feeling of dizziness, and rapid heartbeat) and death in severe cases. A decrease in blood pressure may also occur.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been observed, whose frequency cannot be estimated from the available data.

In some cases, irritation in the mouth or on the tip of the tongue or numbness of the tongue may occur, which are usually transient; lack of sensitivity in the mouth; stomatitis (inflammation of the oral mucosa); desquamation of the mucosa; burning sensation in the mucosa; change in taste perception; discoloration of teeth, tongue, fillings, and dentures; increased tartar; anaphylactic shock and anaphylactic reactions (e.g., urticaria, angioedema, and rash).

Inflammation of the parotid gland has also been reported.

Discoloration of the teeth may occur, especially in people with tartar buildup on their teeth. This alteration of tooth color is not permanent and can be removed by a dental cleaning. The alteration of the color of the fillings can be permanent. The alteration of the color of the tongue disappears spontaneously and is not dangerous.

A change in taste perception may occur.

Some cases of methemoglobinemia caused by benzocaine have been reported, 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 before. Stop using the product and seek medical attention immediately if you or a child in your care experience: difficulty breathing, cyanosis (bluish discoloration of the skin and mucous membranes), altered mental state, headache, fatigue, difficulty exercising, rapid heartbeat, dizziness, or loss of consciousness.

Reporting Side Effects

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

5. Storage of Lizipaina

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

This medication should not be stored at a temperature above 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Lizipaina Composition

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

Product Appearance and Package Contents

White, round, flat, and beveled lozenges.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer

Laboratorios Alcalá-Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

or

Temmler Pharma GmbH

Temmlerstraße 2

35039 Marburg Germany

Date of the Last Revision of this Package Leaflet:April 2020.

You can access detailed and updated information about this medication by scanning the QR code included in the package 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es