DERATIN 5 mg LOZENGES

Introduction

Package Leaflet: Information for the Patient

Deratin 5 mg Lozenges

chlorhexidine dihydrochloride

Read this package leaflet carefully before you start using this medicine, because it contains important information for you

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the Package Leaflet:

1. What is Deratin and what is it used for
2. What you need to know before taking Deratin
3. How to take Deratin
4. Possible side effects
5. Storage of Deratin
6. Package contents and additional information

1. What is Deratin and what is it used for

Deratin is a buccal-pharyngeal antiseptic.

Deratin is indicated for the local treatment of mild mouth and throat infections without fever, such as: mouth ulcers, sore throat, hoarseness, for adults and children over 6 years old.

You should consult a doctor if it worsens or does not improve after 2 days of treatment.

2. What you need to know before taking Deratin

Do not use Deratin:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Deratin.

• If you have periodontitis (gum disease), because chlorhexidine may cause an increase in supragingival calculus.
• It is recommended to maintain good oral hygiene to reduce the accumulation of tartar and the possible discoloration of teeth that may be caused by chlorhexidine.
• Doses higher than those recommended in section 3 should not be used.

Children and adolescents

Do not use Deratin in children under 6 years old without consulting a doctor first.

Using Deratin with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicine.

Deratin should not be used in conjunction with other medicines that contain antiseptics.

Taking Deratin lozenges with food and drinks

The action of chlorhexidine is reduced by the presence of food residue.

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 medicine.

Deratin should not be used during pregnancy or breastfeeding unless your doctor advises you to do so.

Driving and using machines

Deratin has no or negligible influence on the ability to drive and use machines.

Deratin contains sorbitol (E-420) and sodium.

Sorbitol

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

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Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per lozenge, which is essentially "sodium-free".

3. How to take Deratin

Follow the instructions for administration of the medicine contained in this package 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 lozenge every 4-5 hours, dissolving slowly in the mouth, up to a maximum of 6 lozenges per day.

Adults and adolescents from 12 years old:

1 lozenge every 2-3 hours, dissolving slowly in the mouth, up to a maximum of 8 lozenges per day.

Always use the lowest effective dose.

Let the lozenge dissolve slowly in the mouth. The lozenges should not be chewed or swallowed, as their action is totally local and their activity is only evident if the product is in direct contact with the affected area.

If it worsens or if symptoms persist after 2 days of treatment or if fever, headache, nausea, or vomiting appear, consult your doctor as soon as possible.

If you use more Deratin than you should

Consult your doctor or pharmacist immediately. Chlorhexidine intoxication is unlikely due to its poor absorption through the gastrointestinal membrane. In case of overdose, it is recommended to take milk, egg white, or gelatin. Especially in children, chlorhexidine overdose produces symptoms of alcohol intoxication (slurred speech, drowsiness, or stumbling gait).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service Tel. 91 562 04 20, indicating the product and the amount ingested.

4. Possible side effects

Like all medicines, Deratin can cause side effects, although not everybody gets them.

During the period of use of chlorhexidine, the following side effects have been reported, whose frequency could not be established with precision:

Most frequent incidence:change in taste, increase in tartar on the teeth, discoloration of the teeth, mouth, dental fillings, and dentures or other oral prostheses, which is visible a week after starting treatment. The discoloration of the fillings may be permanent.

Less frequent or rare incidence:irritation of the tip of the tongue; irritation of the mouth has been described in children from 10 to 18 years old, the lesions are transient and may not be painful.

Rare incidence:local irritative reactions and rarely extreme allergic reactions, which include nasal congestion, feeling of shortness of breath or difficulty breathing, skin rash, itching, swelling of the face. If it appears, treatment should be discontinued and your doctor consulted.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Deratin

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

Store below 25 ºC.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Deratin

• The active principle is: chlorhexidine dihydrochloride, each lozenge contains 5 mg of chlorhexidine dihydrochloride
• The other components (excipients) are: Sorbitol (E-420), povidone, sodium saccharin (E-954), magnesium stearate, and peppermint flavor.

Appearance of the product and package contents

Deratin are white or almost white, round lozenges, with a "D" on one of their faces.

They come in packages containing 20 lozenges, packaged in aluminum/PVC blisters.

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 package leaflet: December 2021

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