Deratin Complex lozenges mint flavour

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Deratin complex effervescent tablets with mint flavour

dihydrochloride chlorhexidine / benzocaine / enoxolone

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as given by your doctor, pharmacist or nurse.

• 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 a doctor if your condition worsens or if you do not improve after 2 days.

Leaflet contents

1. What Deratin complex is and what it is used for
2. What you need to know before taking Deratin complex
3. How to take Deratin complex
4. Possible side effects
5. How to store Deratin complex
6. Contents of the pack and other information

1. What Deratin complex is and what it is used for

The active ingredients in Deratin complex work by combining the antiseptic action of chlorhexidine with the anti-inflammatory action of enoxolone on the oropharyngeal mucosa and the local anesthetic action of benzocaine, thereby suppressing the typical discomfort caused by local throat irritation.

Deratin complex is indicated for the local and temporary symptomatic treatment of mild infectious and inflammatory conditions of the mouth and throat: oral aphthae, throat irritation, or hoarseness accompanied by pain and without fever, in adults and children over 6 years of age.

You should consult a doctor if symptoms worsen or do not improve after 2 days, or if you have constipation that does not improve.

2. What you need to know before starting to take Deratin complex

Do not take Deratin complex

• if you are allergic to chlorhexidine, benzocaine, glycyrrhizic acid (enoxolone), or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Deratin complex:

• 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 any severe or extensive injury in the mouth.
• If you have periodontitis (gum disease), as chlorhexidine may increase supragingival calculus formation.
• If you have hypertension or fluid retention, as glycyrrhizic acid (enoxolone) may worsen these symptoms.
• It is recommended to maintain adequate oral hygiene to reduce tartar buildup and possible tooth staining that chlorhexidine may cause.
• Doses higher than those recommended in section 3 must not be taken.

Children and adolescents

Do not use Deratin complex in children under 6 years of age without first consulting a doctor. Children may be more sensitive to benzocaine, as may elderly patients and debilitated patients.

Patients over 65 years

The use of this medicine at high doses or for prolonged treatments may cause hypertension.

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

Use of Deratin complex with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Although no interactions have been reported under the recommended conditions of use, this medicine should not be used with other oral or throat medications without consulting your doctor or pharmacist.

This is especially important in the case of:

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

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

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may alter test results.

Deratin complex may interfere with the pancreatic function test using bentiromide. Do not take this medicine at least 3 days before the test and inform your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported with this medicine.

Deratin complex contains sorbitol (E-420) and sodium

Sorbitol (E-420)

This medicine contains 1000 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has advised you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor (or your child's doctor) before taking this medicine.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".

3. How to take Deratin complex

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Children over 6 years of age

1 tablet every 4–5 hours, up to a maximum of 6 tablets per day.

Adults and children over 12 years of age

1 lozenge every 2–3 hours, up to a maximum of 8 tablets per day.

Use in children

Administration of this medicine is not recommended for children under 6 years of age.

Between 6 and 12 years of age: 1 tablet every 4–5 hours, up to a maximum of 6 tablets per day.

Administer under adult supervision.

How to use

Deratin complex is intended for oropharyngeal use.

The lozenges should be slowly dissolved in the mouth without chewing or swallowing them, as their action is local and only becomes effective when the product is in direct contact with the affected area.

Always use the lowest effective dose.

The usual duration of treatment is 2 days.

If your condition worsens or symptoms persist for more than 2 days after starting treatment, or if fever, headache, nausea, or vomiting occur, you should consult your doctor as soon as possible.

If you take more Deratin complex than you should

If you have taken an overdose of this medicine, you may experience: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or seizures, tinnitus (ringing in the ears), increased sweating and/or low blood pressure. Because this medicine contains enoxolone, symptoms such as hypertension (high blood pressure) and edema (swelling due to fluid retention) may occur.

Additionally, since this medicine contains benzocaine, methemoglobinemia may occur (difficulty breathing, dizziness, fatigue, tiredness, weakness).

In case of overdose or accidental ingestion, seek immediate medical attention at a healthcare center or call the Toxicology Information Service. Telephone: 915 620 420, indicating the medicine and the amount ingested.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Deratin complex may produce adverse effects, although not everyone will experience them.

Rarely, generalized allergic reactions and gastrointestinal disturbances may occur. With high doses and prolonged treatment, oedema (swelling caused by fluid retention) and hypertension may develop.

Discoloration of the teeth may appear, especially in individuals who have accumulations of dental plaque. This tooth discoloration is not permanent and can be removed by professional oral cleaning. The colour of dental fillings may also be altered; in such cases, this discoloration may be permanent.

Altered taste perception may occur.

In some cases, Deratin complex 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 of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (Website: www.notificaram.es).

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Deratin complex

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

Store below 30 ºC.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Deratin complex

• The active substances are chlorhexidine dihydrochloride, benzocaine and enoxolone. Each tablet contains 5 mg of chlorhexidine dihydrochloride, 4 mg of benzocaine and 3 mg of enoxolone.
• The other components (excipients) are: sorbitol (E-420), povidone, sodium saccharin (E-954), magnesium stearate and mint flavouring.

Appearance of the product and contents of the pack

Deratin complex are white or almost white, round tablets with a "D+" on one side and a mint taste.

They are presented in packs containing 30 tablets.

Other presentations

Deratin complex honey-lemon flavoured lozenges.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the most recent revision of this leaflet: September 2022

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