HIBITANE 5mg/5mg LOZENGES ORANGE FLAVOR

Introduction

Prospect: Information for the user

HIBITANE 5mg/5mg Lozenges Orange Flavor

chlorhexidine dihydrochloride / benzocaine

Read the entire prospectus carefully before starting to take this medication because it contains important information for you.

• Keep this prospectus, 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 side effects that are not listed in this prospectus. See section 4.
• You should consult your doctor if it worsens or does not improve after 2 days

Contents of the prospectus:

1. What is Hibitane and what is it used for
2. What you need to know before taking Hibitane
3. How to take Hibitane
4. Possible side effects
5. Storage of Hibitane

1. Package contents and additional information

1. What is Hibitane 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 that occur with pain, and without fever, such as: throat irritation, hoarseness, small mouth sores.

2. What you need to know before taking Hibitane

N

• If you are allergic (hypersensitive) to chlorhexidine, benzocaine, or any of the other components of this medication (listed in section 6).

A

Consult your doctor or pharmacist before starting to take Hibitane:

• If you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a hair dye component).
• If you have any serious or extensive injury in the mouth.
• If you have periodontitis (gum disease), because chlorhexidine may cause an increase in supragingival calculus.
• Do not take higher doses than recommended in section 3. (How to take Hibitane).

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

Oibitane

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

Although they are not described in the recommended conditions of use, this medication should not be used with other medications for mouth application without consulting a doctor or pharmacist.

Medication interactions can be especially important with:

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

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

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.

Pregnancy and lactation:

Consult your doctor or pharmacist before using any medication.

Use inpeople over 65 years:

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

Use in children:

This medication should not be administered to children under 6 years without consulting a doctor first. Children may be more sensitive to benzocaine, just like the elderly and debilitated patients.

Driving and using machines:

No cases have been reported that affect the ability to drive or operate machinery.

Hibitane contains:

• Sodium: this medication contains less than 23 mg of sodium (1mmol) per lozenge, which is essentially "sodium-free".

• Sulfur dioxide (E-220): this medication may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfur dioxide (as part of the flavors).

This medication contains fragrances with citral, citronellol, D-limonene, geraniol, and linalool.

Citral, citronellol, D-limonene, geraniol, and linalool may cause allergic reactions.

3. How to take Hibitane

Follow the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

If you think the effect of Hibitane is too strong or too weak, tell your doctor or pharmacist.

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

The normal dose is:

Adults and children over 6 years:

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.

Always use the smallest effective dose.

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

If you take more Hibitane than you should:

If you have taken more than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

Signs of overdose manifest with: slurred speech, numbness, stumbling gait, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, increased sweating. There may also be a decrease in blood pressure.

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone experiences them.

Tooth discoloration may appear, especially in people who have tartar buildup on their teeth. This alteration of tooth color is not permanent and can be removed by a dental cleaning. The color of fillings may also be altered, in which case this discoloration can be permanent.

Alteration in taste perception may occur.

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

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 is not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hibitane

Keep this medication out of sight and reach of children.

Do not store at a temperature above 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition ofHibitane:

The active ingredients are: chlorhexidine dihydrochloride 5 mg, benzocaine 5 mg.

The other components are: mannitol (E-421), microcrystalline cellulose (E-460), magnesium stearate, sodium cyclamate, sodium saccharin (E-954), menthol flavor (contains citronellol, D-limonene, sulfur dioxide (E-220), and sodium) and orange flavor (contains citral, citronellol, D-limonene, geraniol, linalol, sodium, and sulfur dioxide (E-220)).

Appearance of the product and package contents:

Hibitane are orange-flavored lozenges. This medication is presented in packages of 20 lozenges.

Marketing authorization holder and manufacturer:

Holder:

IONFARMA s.l.u.

Perú, 228

08020 Barcelona, Spain

Manufacturer:

Laboratorios Alcalá-Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares

Madrid, Spain

Date of the last revision of this prospectus:September 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es