Leaflet: information for the patient

Deratin complex lozenges with peppermint flavor

dihydrochloride of chlorhexidine / benzocaine / enoxolone

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 adverse 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.

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

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

3. How to take Deratin complex

4. Possible adverse effects

5. Storage of Deratin complex

6. Contents of the pack and additional information

The active ingredients of Deratin complex act by complementing the antisepsis action of chlorhexidine, with the anti-inflammatory action of enoxolone on the buccal and pharyngeal mucosa and the local anesthetic action of benzocaine, thereby suppressing the typical discomfort caused by local irritation of the throat.

Deratin complex is indicated for the symptomatic and temporary local treatment of mild infectious and inflammatory processes of the mouth and throat: oral ulcers, throat irritation or hoarseness that are accompanied by 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.

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 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.
• If you have hypertension or fluid retention, as enoxolone may exacerbate these symptoms.
• It is recommended to maintain good oral hygiene to reduce the accumulation of plaque and the possible discoloration of teeth that chlorhexidine may cause.
• 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 your doctor. Children may be more sensitive to benzocaine, just like elderly patients and those with weakened health.

People over 65 years old

The use of this medication at high doses or for prolonged periods may cause hypertension.

Elderly patients and those with weakened health may be more sensitive to benzocaine.

Use of Deratin complex with other medications

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

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

This is especially important in the case of:

• Other mouth or throat antiseptics.
• Medications that inhibit cholinesterase (medications for Alzheimer's disease).
• Sulfonamides (used for infections).

Ionogenic 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

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

Deratin complex may interact with the pancreatic function test 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No effects on the ability to drive or operate machinery 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) suffer from an intolerance to certain sugars, or if 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; it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in 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 lozenge to suck every 2-3 hours, up to a maximum of 8 lozenges per day.

Use in children

Do not administer this medication to 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 buccal use.

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

Always use the lowest effective dose.

The normal duration of treatment is 2 days.

If symptoms worsen or persist for more than 2 days after starting treatment, or if fever, headache, nausea, or vomiting appear, 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 experience: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating, and/or low blood pressure. Due to the presence of enoxolona in this medication, symptoms such as high blood pressure and edema may occur.

Additionally, as this medication contains benzocaine, symptoms such as methemoglobinemia (difficulty breathing, dizziness, fatigue, weakness, and debility) may appear.

In case of overdose or accidental ingestion, immediately go to a medical center or call the Toxicological 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.

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

Exceptionally, generalized allergic reactions and gastrointestinal disturbances. At high doses and prolonged treatments, it may produce edema (swelling caused by fluid retention) and hypertension.

It may appear tooth discoloration, especially in people who have accumulations of tartar deposits 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.

It may appear alteration in the perception of taste.

In some cases, Deratin complex may present 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 (Website: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.

Store below 30 °C.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

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

Composition of Deratin complex

• The active principles 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), polyvidone, sodium saccharin (E-954), magnesium stearate, and peppermint aroma.

Appearance of the product and contents of the packaging

Deratin complex are white or almost white, round tablets, with a D+ on one of its faces and a peppermint flavor.

It is presented in packaging containing 30 tablets.

Other presentations

Deratin complex chewable tablets, lemon-honey flavor.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet:September 2022

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