Patient Information

HIBITANE 5mg/5mg Lozenges Orange Flavor

chlorhexidine dihydrochloride/benzocaine

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, but not fever, such as: sore throat, hoarseness, small mouth ulcers.

No take Hibitane

• If you are allergic (hypersensitive) to chlorhexidine, benzocaineor to any of the other components of this medication (including 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 para-phenylenediamine (a component of hair dye).
• If you have any severe or extensive injury in the mouth.
• If you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus.
• Do not take doses higher than therecommended 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 medicines andHibitane:

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

Although not described in the recommended conditions of use, it should not be used with other mouth or throat medications without consulting a doctor or pharmacist.

Drug interactions may be especially important with:

• Other mouth or throat antisetics.
• Medicines that inhibit cholinesterase (medicines for Alzheimer's disease).
• Sulfonamides (used for infections).

Ionogenic compounds and suspending agents, common components of toothpaste, 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 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 anymedication.

Use inpeople over 65 years:

Older people and those who are debilitatedmay 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 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 (1mmol) per lozenge, which is essentially “sodium-free”.

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

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

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

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

If you estimate that the action ofHibitaneis too strong or weak, inform your doctor or pharmacist.

This medication is for buccal use, so the chewable tablets 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:

Adults and children over 6 years:

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

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

Dissolve the chewable tablet slowly in the mouth without chewing or swallowing.

Always use the lower dose that is effective.

If you observe that the symptoms worsen or persist for more than 2 days after starting treatment or fever, headache, nausea, or vomiting appear, you must 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, phone 915 62 04 20, indicating the medication and the amount taken.

The signs of overdose manifest with: slurred speech, numbness, staggering gait, blurred or double vision, dizziness, excitement, or convulsions, tinnitus, increased sweating. A decrease in blood pressure may also occur.

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

It may cause tooth discoloration, especially in people with dental plaque accumulations. This alteration of tooth color is not permanent and can be eliminated through oral hygiene.

It may also alter the perception of taste..

In some cases, this medication may presentmouth or tongue tip irritation, which are usually transient, as well as allergic reactions to chlorhexidine or benzocaine.

Reporting Adverse Effects

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

Keep this medication out of the 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofHibitane:

The active principles are: dihydrochloride of chlorhexidine 5 mg, benzocaine 5 mg.

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

Appearance of the product and contents of the packaging:

Hibitane are lozenges with an orange flavor. This medication is presented in packaging of 20 lozenges.

Holder of the marketing authorization and responsible for manufacturing:

Holder:

IONFARMA s.l.u.

Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing:

Laboratorios Alcalá-Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares

Madrid, Spain

Date of the last review of this leaflet:September2021

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/