Sebidin Intensive

Package Leaflet: Information for the Patient

Sebidin Intensive, 5 mg + 5 mg, Sucking Tablets

Chlorhexidine dihydrochloride + Benzocaine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Sebidin Intensive and what is it used for
• 2. Important information before taking Sebidin Intensive
• 3. How to take Sebidin Intensive
• 4. Possible side effects
• 5. How to store Sebidin Intensive
• 6. Package contents and other information

1. What is Sebidin Intensive and what is it used for

Sebidin Intensive is a medicine used to treat symptoms such as throat pain and irritation, hoarseness, accompanying infections of the mouth and throat without fever. Additionally, it can be used to treat inflammatory conditions of the mucous membrane characterized by small ulcers of the mucous membrane (aphthae). If after 5 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Sebidin Intensive

When not to take Sebidin Intensive:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• in children under 12 years of age;
• in patients with methemoglobinemia (a blood disease related to the formation of abnormal hemoglobin that is unable to bind and transport oxygen. The most common symptom is cyanosis, resulting from tissue hypoxia) or a history of methemoglobinemia.

Warnings and precautions

Before taking Sebidin Intensive, you should discuss it with your doctor, pharmacist, or nurse. You should be particularly careful in the case of patients:

• with intolerance to ester-type local anesthetics (especially para-aminobenzoic acid derivatives, PABA), parabens, or p-phenylenediamine, as they may be hypersensitive to benzocaine.
• with breathing problems, such as asthma, bronchitis, or emphysema.
• with heart disease.
• smokers, as they are more prone to complications related to methemoglobinemia.
• with certain enzyme deficiencies, such as glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, NADH-methemoglobin reductase deficiency (diaphorase 1), and pyruvate kinase deficiency, who may also be more prone to developing methemoglobinemia.
• elderly, seriously ill, or weakened patients, due to the increased risk of systemic side effects of benzocaine.
• with severe oral mucosa injury, due to increased absorption of the anesthetic.
• with periodontal disease, due to increased deposition of dental plaque.
• in whom the tooth filling is rough or has uneven edges, due to the possibility of its discoloration.

Children and adolescents

Do not use in children under 12 years of age.

Sebidin Intensive and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Do not use Sebidin Intensive with:

• other medicines containing bactericidal substances (e.g., sulfonamides);
• cholinesterase inhibitors (medicines used to treat cognitive disorders).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Due to limited data on the safety of use in pregnant and breastfeeding women, it is not recommended to use Sebidin Intensive in this patient group.

Driving and using machines

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

Sebidin Intensive contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Sebidin Intensive

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The recommended dose for adults and children over 12 years of age: 1 tablet every 2 hours. You can take a maximum of 8 tablets in 24 hours.

Method of administration

Administration to the oral mucosa. The tablet should be slowly sucked in the mouth. Sucking tablets should not be chewed or swallowed. If symptoms worsen or persist for more than five days, or if they are accompanied by high fever, headache, nausea, or vomiting, you should contact your doctor.

Use in children and adolescents

Do not use in children under 12 years of age.

Taking a higher dose of Sebidin Intensive than recommended

Due to the small amount of active substances in one dose, the risk of overdose is low. If you experience any symptoms of poisoning, you should stop using the product immediately. In case of overdose, you should contact your doctor, as treatment may be necessary.

Missing a dose of Sebidin Intensive

Do not take a double dose to make up for a missed dose. If you have any further doubts about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Uncommon side effects (affecting 1 to 10 in 10,000 patients):

• irritation of the tongue tip and oral mucosa.

Side effects whose frequency cannot be estimated from the available data:

• methemoglobinemia (a blood disease related to the formation of abnormal hemoglobin);
• hypersensitivity, allergic reactions of the skin and mucous membrane;
• loss of appetite;
• taste disorders (rarely persistent);
• breathing difficulties, nasal mucosa congestion, throat irritation;
• brown discoloration of teeth, tongue, nausea, indigestion, abdominal pain, diarrhea, dry mouth, tongue burning, tongue tingling, increased deposition of dental plaque;
• rash, urticaria, contact dermatitis, allergic dermatitis;
• brown discoloration of dental fillings, dental prostheses, and other appliances used in the mouth.

Brown discolorations may be more pronounced in patients with dental plaque and usually appear after one week of treatment. Tongue discoloration is not harmful and usually resolves on its own. Tooth discoloration is not permanent and can be removed during oral hygiene. Discoloration of dental fillings may be permanent.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sebidin Intensive

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sebidin Intensive contains

• The active substances of the medicine are chlorhexidine dihydrochloride and benzocaine. One tablet contains 5 mg of chlorhexidine dihydrochloride and 5 mg of benzocaine.
• The other ingredients are: mannitol, microcrystalline cellulose (PH 101), povidone K29/32, magnesium stearate, sodium cyclamate (E 952), sodium saccharin (E 954), peppermint flavor 611072E, orange flavor 90103-71.

What Sebidin Intensive looks like and what the package contains

Sebidin Intensive sucking tablets are round with a notch on one side, white-yellow in color. Blister pack of PVC/PE/PVDC/Aluminum, in a cardboard box. The package contains 20 sucking tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder: Perrigo Poland Sp. z o.o.[+logo] ul. Domaniewska 48 02-672 Warsaw tel.: +48 (22) 852 55 51 Manufacturer: LABORATORIOS ALCALÁ FARMA, S.L. Avenida de Madrid, 82 28802 Alcalá de Henares (Madrid) Spain Date of last revision of the leaflet:August 2024