Deratin Complex lozenges honey-lemon flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Deratin complex honey-lemon flavoured lozenges
dihydrochloride chlorhexidine / benzocaine / enoxolone
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor, pharmacist or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You must consult a doctor if your condition worsens or if you do not improve within 2 days.
Contents of the leaflet
- What Deratin complex is and what it is used for
- What you need to know before taking Deratin complex
- How to take Deratin complex
- Possible adverse effects
- How to store Deratin complex
- Contents of the pack and other information
1. What Deratin complex is and what it is used for
The active ingredients in Deratin complex work by complementing the antiseptic action of chlorhexidine with the anti-inflammatory action of enoxolone on the oropharyngeal mucosa, and the local anesthetic action of benzocaine, thereby suppressing the typical discomfort caused by local throat irritation.
Deratin complex is indicated for the local, symptomatic, and temporary treatment of mild infectious and inflammatory conditions of the mouth and throat: oral aphthae, throat irritation, or hoarseness accompanied by pain and without fever, in adults and children over 6 years of age.
You should consult a doctor if symptoms worsen or do 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 medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking Deratin complex:
- If you are intolerant to other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).
- If you have a severe or extensive injury in the mouth.
- If you suffer from periodontitis (gum disease), as chlorhexidine may increase supragingival calculus formation.
- If you have hypertension or fluid retention, as enoxolone may worsen these conditions.
- It is recommended to maintain proper oral hygiene to reduce tartar buildup and possible tooth staining 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 of age without first consulting a doctor. Children may be more sensitive to benzocaine, as may elderly patients and debilitated patients.
Patients over 65 years of age
Using this medicine at high doses or for prolonged treatment may cause hypertension.
Elderly patients and debilitated patients may be more sensitive to benzocaine.
Taking Deratin complex with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Although interactions have not been reported under recommended conditions of use, this medicine should not be used with other oral or throat medications without consulting your doctor or pharmacist.
This is especially important in the case of:
- Other antiseptics for the mouth or throat.
- Cholinesterase inhibitor medicines (used for Alzheimer's disease).
- Sulfonamides (used for infections).
Anionic compounds and suspending agents, common components of toothpastes, reduce the effectiveness of chlorhexidine; therefore, the mouth should be thoroughly rinsed after using toothpaste.
Interference with diagnostic tests
If you are scheduled for any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may alter test results.
Deratin complex may interfere with the pancreatic function test using bentiromide. Do not take this medicine 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported with this medicine.
Deratin complex contains sorbitol (E420), sodium, and butylated hydroxyanisole (E320)
Sorbitol
This medicine contains 1000 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, consult your doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".
Butylated hydroxyanisole (E320)
This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylated hydroxyanisole.
3. How to take Deratin complex
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Children over 6 years
1 tablet every 4-5 hours, up to a maximum of 6 tablets per day.
Adults and children over 12 years
1 lozenge every 2-3 hours, up to a maximum of 8 lozenges per day.
Use in children
Administration of this medicine is not recommended for children under 6 years of age.
Children between 6 and 12 years: 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 oropharyngeal use.
The lozenges should be slowly dissolved in the mouth without chewing or swallowing them, as their action is local and only becomes evident when 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 occur, consult your doctor as soon as possible.
If you take more Deratin complex than you should
If you have taken an overdose of this medicine, you may experience: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or seizures, tinnitus (ringing in the ears), increased sweating and/or low blood pressure. Because this medicine contains enoxolone, symptoms such as hypertension (high blood pressure) and edema (swelling due to fluid retention) may also occur.
Additionally, since this medicine contains benzocaine, methemoglobinemia may occur (difficulty breathing, dizziness, fatigue, tiredness, weakness).
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Deratin complex can cause adverse effects, although not everyone will experience them.
Rarely, generalized allergic reactions and gastrointestinal disturbances may occur. With high doses and prolonged treatment, oedema (swelling caused by fluid retention) and hypertension may develop.
Discoloration of the teeth may occur, especially in individuals who have accumulations of dental tartar. This tooth discoloration is not permanent and can be removed by dental cleaning. The colour of dental fillings may also be altered; in such cases, the discoloration may be permanent.
Alteration in taste perception may occur.
In some cases, Deratin complex may cause mouth irritation or irritation of the tip of the tongue, which are usually temporary, as well as allergic reactions to chlorhexidine or benzocaine.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System of Pharmacovigilance for Human Medicines (Website: www.notificaram.es).
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Deratin complex
Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Deratin complex
- The active substances are chlorhexidine dihydrochloride, 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), povidone, sodium saccharin (E-954), magnesium stearate, honey flavour and lemon flavour (containing butylated hydroxyanisole (E-320)).
Appearance of the product and contents of the pack
Deratin complex are white or almost white, round tablets, with a "D+" on one side and a honey-lemon flavour.
They are available in packs containing 30 tablets.
Other presentations
Deratin complex mint-flavoured lozenges.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)
Date of the most recent review of this leaflet: September 2022
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/