Hibitane 5 mg/5 mg lozenges, orange flavour

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HIBITANE 5mg/5mg Sucking Tablets ORANGE FLAVOUR

hydrochloride dihydrate chlorhexidine / benzocaine

Read the entire leaflet carefully before you start taking this medicine because 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or do not improve after 2 days.

Contents of the leaflet:

1. What Hibitane is and what it is used for

2. What you need to know before taking Hibitane

3. How to take Hibitane

4. Possible adverse effects

5. How to store Hibitane

6. Contents of the pack and other information

1. What Hibitane is and what it is used for

The active ingredients in this medicine combine the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medicine is used for the local and temporary symptomatic relief of mild infections of the mouth and throat that cause pain and are not accompanied by fever, such as: sore throat irritation, hoarseness, and minor mouth ulcers.

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

Do not take Hibitane

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Hibitane:

• If you are intolerant to other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).
• If you have a severe or extensive oral lesion.
• If you suffer from periodontitis (gum disease), as chlorhexidine may increase supragingival calculus formation.
• Do not take doses higher than those recommended in section 3. (How to take Hibitane).

It is recommended to maintain proper oral hygiene to reduce tartar buildup and possible tooth staining that chlorhexidine may cause.

Other medicines and Hibitane:

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

Although interactions have not been reported under recommended conditions of use, Hibitane should not be used together with other medicines intended for oral use without first consulting your doctor or pharmacist.

Drug interactions may be especially important with:

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

Anionic compounds and suspending agents, which are common ingredients in toothpastes, reduce the effectiveness of chlorhexidine; therefore, the mouth should be thoroughly rinsed after using toothpaste.

Interference with diagnostic tests:

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Use in patients over 65 years of age:

Elderly and debilitated patients may be more sensitive to benzocaine.

Use in children:

This medicine should not be administered to children under 6 years of age without prior medical advice. Children may be more sensitive to benzocaine, as are elderly and debilitated patients.

Driving and operating machinery:

There have been no reported cases affecting the ability to drive or operate machinery.

Hibitane contains:

• Sodium: this medicine contains less than 23 mg of sodium (1 mmol) per lozenge, i.e., essentially "sodium-free".

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

This medicine 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 exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

If you feel that the effect of Hibitane is too strong or too weak, inform your doctor or pharmacist.

This medicine is intended for oropharyngeal use; therefore, the lozenges must be slowly dissolved in the mouth without chewing or swallowing, as its action is local and only becomes effective when the product is in direct contact with the affected area.

Normal dosage:

Adults and children over 6 years of age:

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

Do not exceed 8 lozenges in 24 hours (1 day).

Slowly dissolve the lozenge in the mouth without chewing or swallowing.

Always use the lowest effective dose.

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

If you take more Hibitane than you should:

If you have taken more than the recommended amount, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 915 62 04 20, indicating the medicine and the amount taken.

Signs of overdose may include: slurred speech, drowsiness, unsteady gait, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, and increased sweating. A decrease in blood pressure may also occur.

4. Possible adverse effects

Like all medicines, this medicine may have adverse effects, although not everyone will experience them.

Discoloration of the teeth may occur, especially in people who have plaque or tartar buildup on their teeth. This change in tooth color is not permanent and can be removed by dental cleaning. The color of dental fillings may also be altered; in such cases, this discoloration may be permanent.

Altered taste perception may occur.

In some cases, this medicine may cause irritation in the mouth or irritation of the tip of the tongue, which are usually temporary, 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 a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hibitane

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of unused medicines and containers. This will help protect the environment.

6. Additional Information

Composition of Hibitane:

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

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

Appearance of the medicinal product and contents of the pack:

Hibitane are orange-flavoured lozenges. This medicine is available in packs 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 most recent revision of this leaflet: September 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/