Patient Information Leaflet

Deratin complex lozenges, lemon-mint flavor

dihydrochloride of chlorhexidine / benzocaine / enoxolone

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

Follow exactly the administration instructions contained in this leaflet or those 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 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 you get worse or do not improve after 2 days.

1. What is Deratin complex 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. 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 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 a 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.

Older people 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, it should not be used with other mouth or throat medications without consulting a 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 analytical 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 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 (E420), sodium, and butylhydroxyanisole (E320)

Sorbitol

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 have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

Sodium

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

Butil hydroxyanisole (E-320)

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole.

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, tiredness, weakness) may appear.

In case of overdose or accidental ingestion, go immediately 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. With high doses and prolonged treatment, 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 oral hygiene. It may also alter the color of fillings, 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.

Medicines should not be disposed of through drains or in the 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. In this way, you will help protect the environment.

Composition of Deratin complex

• The active principles are dihydrochloride of chlorhexidine, 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), polyvidone, sodium saccharin (E-954), magnesium stearate, honey aroma and lemon aroma (contains butyl hydroxyanisole (E-320)).

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 honey-lemon flavor.

It is presented in packaging containing 30 tablets.

Other presentations

Deratin complex chewable tablets with a mint 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/