DERATIN COMPLEX lozenges mint flavored

Introduction

Patient Information Leaflet

Deratin Complex Sucking Tablets Mint Flavor

dihydrochloride of chlorhexidine / benzocaine / enoxolone

Read this leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the Leaflet

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. Storage of Deratin Complex
6. Package contents and additional information

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

The active ingredients of Deratin Complex work by complementing the antiseptic action of chlorhexidine, with the anti-inflammatory action of enoxolone in the buccopharyngeal mucosa and the local anesthetic action of benzocaine, thus suppressing the typical discomfort caused by local irritation of the throat.

Deratin Complex is indicated for the symptomatic local and temporary treatment of mild infectious and inflammatory processes of the mouth and throat: oral aphthae, throat irritation or aphonia with pain and without fever, for adults and children over 6 years old.

You should consult a doctor if it worsens or does not improve after 2 days or if you have constipation that does not improve.

2. What you need to know before taking Deratin Complex

Do not take Deratin Complex

• if you are allergic to chlorhexidine, benzocaine, enoxolone, 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 Deratin Complex:

• If you do not 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 injury in the mouth.
• If you suffer from periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus.
• If you suffer from hypertension or fluid retention, as enoxolone may increase these symptoms.
• It is recommended to maintain good oral hygiene to reduce the accumulation of tartar and possible tooth discoloration that may be caused by chlorhexidine.
• Do not take doses higher than those recommended in section 3.

Children and adolescents

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

Over 65 years old

The use of this medication at high doses or in prolonged treatments may produce hypertension.

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

Use of Deratin Complex with other medications

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

Although not described in the recommended conditions of use, do not use with other medications for oral application without consulting a doctor or pharmacist.

This is especially important in the case of:

• 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 analytical tests

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

Deratin Complex may interact with the test for determining pancreatic function that uses bentiromide. Do not take this medication 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

No effects on the ability to drive or use machines have been described due to the use of this medication.

Deratin Complex contains sorbitol (E-420) and sodium

Sorbitol (E-420)

This medication contains 1000 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sodium

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

3. How to take Deratin Complex

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

The recommended dose is:

Children over 6 years old

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

Adults and children over 12 years old

1 sucking tablet every 2-3 hours, up to a maximum of 8 tablets per day.

Use in children

Administration of this medication is not recommended for children under 6 years old.

Between 6 and 12 years old, 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 for buccopharyngeal use.

The sucking tablets should be dissolved slowly in the mouth without chewing or swallowing, as their action is local and only becomes apparent if the product is in direct contact with the affected area.

Always use the smallest effective dose.

The normal duration of treatment is 2 days.

If it worsens or symptoms 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 Deratin Complex than you should

If you have taken an overdose of this medication, you may notice: slurred speech, numbness, staggering gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating, and/or low blood pressure. Due to the fact that this medication contains enoxolone, symptoms such as hypertension (high blood pressure) and edema (swelling caused by fluid retention) may occur.

Also, as this medication contains benzocaine, methemoglobinemia (difficulty breathing, dizziness, fatigue, tiredness, weakness) may appear.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, Deratin Complex can cause side effects, although not everyone will experience them.

Exceptionally, generalized allergic reactions and gastrointestinal disorders. With high doses and continued treatment, edema (swelling caused by fluid retention) and hypertension may occur.

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 eliminated through a dental cleaning. The color of fillings may also be altered, in which case this discoloration may be permanent.

Alteration in 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (Website: www.notificaram.es).

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Deratin Complex

Keep this medication out of sight and reach of children.

Store below 30 ºC.

Do not use this medication after the expiration date shown on the box 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. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Deratin Complex

• The active ingredients are chlorhexidine dihydrochloride, benzocaine, and enoxolone, each tablet contains 5 mg of dihydrochloride of chlorhexidine, 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 flavor.

Appearance of the product and package contents

Deratin Complex are white or almost white, round tablets with a D+ on one of their faces and a mint flavor.

They are presented in packages containing 30 tablets.

Other presentations

Deratin Complex sucking tablets honey-lemon flavor.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this leaflet:September 2022

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