Leaflet: information for the user

HIBITANE 5mg/5mg Lozenges, lemon flavor

chlorhexidine dihydrochloride/benzocaine

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

- 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. See section 4.

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

1. What is Hibitane and what it is used for

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

3. How to take Hibitane

4. Possible side effects

5. Storage of Hibitane

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 temporary relief of local symptoms of mild throat infections that are not accompanied by fever, such as: sore throat, irritation, hoarseness.

Do not take Hibitane

- If you are allergic (hypersensitive) to chlorhexidine, benzocaine, 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 Hibitane:

- 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.

- Do not take doses higher than recommended in section 3 (How to take Hibitane).

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

Other medications and Hibitane

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

Although not described in the recommended conditions of use, do not use with other mouth or throat medications without consulting your doctor or pharmacist.

Medication interactions may be especially important with:

- Other mouth or throat antiseptics.

- Medications that inhibit cholinesterase (medications for Alzheimer's disease).

- Sulfonamides (used for infections).

The 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.

Interference with diagnostic tests

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Important for women

If you are pregnant, breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before taking this medication.

Use in people over 65 years

Older people and those who are debilitated may be more sensitive to benzocaine.

Use in 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 people and those who are debilitated.

Driving and operating machinery

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

Hibitane contains:

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

- Sulfur dioxide (E-220): this medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains sulfur dioxide (as part of the fragrances).

- Sucrose:This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

- Butylhydroxyanisole (E-320): this medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole.

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

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

Follow the administration instructions exactly as stated in this leaflet or as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

If you think the effect of Hibitane is too strong or too weak, inform 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.

The normal dose is as follows:

Adults and children over 6 years:

1 lozenge to be dissolved slowly in the mouth every 2 or 3 hours.

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 lowest effective dose.

If you observe that the symptoms worsen or persist for more than 2 days after starting treatment, or if you experience fever, headache, nausea, or vomiting, consult your 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 Toxicological Information Service, telephone 915 62 04 20, stating the medication and the amount taken.

The main symptoms of overdose are: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating. A decrease in blood pressure may also occur.

Like all medications, this medication may have adverse effects, although not everyone may experience them.

During the period of use of medications containing chlorhexidine and benzocaine, the following adverse effects have been observed, whose frequency has not been established with precision.

Discoloration of the teeth may appear. This staining or discoloration may be more pronounced in people who have tartar buildup on their teeth. This alteration of the color of the teeth is not permanent and can be eliminated through a dental cleaning. The color of the fillings may also be altered, in which case, this discoloration may be permanent.

Alteration in the perception of taste may appear.

In some cases, this medication may produce 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 of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://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.

Do not store at a temperature above 25 °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.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.In 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.

Hibitane Composition

Each lozenge contains:

- As active principles: Chlorhexidine dihydrochloride 5 mg and benzocaine 5 mg.

- The other components (excipients) are: mannitol (E-421), microcrystalline cellulose (E-460), povidone, magnesium stearate, sodium cyclamate, sodium saccharin (E-954), menthol aroma (contains citronellol, d-limonene, sodium and sulfur dioxide (E-220)) and lemon-lime aroma (contains citral, citronellol, d-limonene, geraniol, linalool, sodium, sulfur dioxide (E-220), saccharose and butylhydroxyanisole (E-320)).

Product Appearance and Packaging Content

They are lemon-flavored lozenges. This medication is presented in packs of 20 lozenges.

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder:

IONFARMA s.l.u.

Perú, 228

08020 Barcelona, Spain

Responsible Manufacturer

Laboratorios Alcalá-Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares

Madrid, Spain

Last Review Date of this Leaflet:September 2021

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