Deratin 5 mg comprimidos para chupar

Patient Information Leaflet: Package Insert

Deratin 5 mg Lozenges

chlorhexidine dihydrochloride

Read this leaflet carefully before you start to take this medicine,because it contains important information for you

Follow exactly the administration instructions for 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 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 it worsens or does not improve after 2 days.

Deratin is a buco-pharyngeal antiseptic.

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

Consult a doctor if symptoms worsen or do not improve after 2 days of treatment.

Do not use Deratin:

• if you are allergic to chlorhexidine or any of the other ingredients 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), as chlorhexidine may cause an increase in supragingival calculus.
• 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 use doses higher than those recommended in section 3.

Children and adolescents

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

Use of Deratin with other medicines

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

Do not use it together with other medicines that contain antiseptics.

Taking Deratin Tablets with food and drinks

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

Pregnancy and breastfeeding

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

Do not use during pregnancy or breastfeeding unless your doctor tells you to.

Driving and operating machinery

The influence of Deratin on the ability to drive and use machines is negligible or insignificant.

Deratin contains sorbitol (E-420) and sodium.

Sorbitol

This medicine contains 1000 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a condition where you cannot tolerate 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 (or your child) before taking this medicine.

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Sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 it slowly in the mouth, up to a maximum of 6 lozenges per day.

Adults and adolescents 12 years old and above:

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

Always use the lowest effective dose.

Leave the lozenge to dissolve slowly in the mouth. The lozenges should not be chewed or swallowed as their action is entirely local and their activity only manifests when the product is in direct contact with the affected area.

If it worsens or if symptoms persist after 2 days of treatment or 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 unsteady gait).

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

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

During the period of use of chlorhexidine, the following adverse effects have occurred, whose frequency has not been established with precision:

Most frequent incidence:change in sense of taste, increase in dental plaque, tooth discoloration, mouth discoloration, dental fillings, and dentures or other oral prostheses visible one week after starting treatment. Tooth filling discoloration may be permanent.

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

Rare incidence:local irritative reactions and rarely severe allergic reactions, which include nasal congestion, sensation of lack of air or difficulty breathing, skin eruption, itching, facial swelling. In case of appearance, treatment should be suspended and a doctor consulted.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is 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: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store below 25 °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 thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Deratin

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

Appearance of the product and content of the packaging

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

It is presented in packaging that contains 20 tablets, packaged in aluminum/PVC blister.

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: December 2021

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