Sebidin

Package Leaflet: Information for the User

Sebidin, 5 mg + 50 mg, Sucking Tablets

Chlorhexidine dihydrochloride + Ascorbic acid

Read the package leaflet carefully before using 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 your doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Sebidin and what is it used for

Sebidin, sucking tablets, is a medicine with a combined action of chlorhexidine dihydrochloride and vitamin C. Chlorhexidine dihydrochloride has antibacterial properties: it acts bacteriostatically and bactericidally against Gram-positive, Gram-negative bacteria, and Candida albicans yeast.
Vitamin C is involved in the process of collagen formation and tissue regeneration.
The medicine supplements the increased need for vitamin C that occurs in inflammatory conditions of the throat and tonsils.

Sebidin is indicated for:

• local treatment of symptoms of pharyngitis and tonsillitis.

2. Important information before taking Sebidin

When not to take Sebidin

• If the patient is allergic to chlorhexidine, vitamin C, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Before starting to take Sebidin, the patient should discuss it with their doctor or pharmacist.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.
• If the doctor recommends continuing treatment, the medicine should not be taken for more than 14 days without consulting a doctor again.
• The medicine may cause taste disturbances, which usually disappear within 4 hours of taking the medicine.
• During long-term use, tooth and tongue discoloration may occur, which disappears on its own or must be removed by a doctor.
• In individual cases, in patients with gastrointestinal and liver diseases, stomach and intestinal disorders such as nausea, vomiting, and belching may occur. In these cases, the use of the medicine should be discontinued.

Sebidin and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interaction between Sebidin and other medicines has been found.

Sebidin with food and drink

The medicine is recommended to be taken after a meal.

Pregnancy and breastfeeding

In pregnancy, breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking this medicine. If the patient is pregnant or breastfeeding, or suspects they may be pregnant, or is planning to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Sebidin contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine may have a harmful effect on teeth.

Sebidin contains the colorant - koszenil red (E124)

The medicine may cause allergic reactions.

3. How to take Sebidin

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose is 1 tablet 4 times a day (every 6 hours).

Use in children and adolescents from 12 years of age and adult patients

On the mucous membrane of the mouth. Suck 1 tablet 4 times a day (every 6 hours).
Due to the sucrose content, caution is advised when administering to patients with diabetes and those prone to tooth decay.
The medicine is recommended to be taken after a meal and after cleaning the teeth. For 2 hours after taking the medicine, it is not recommended to rinse the mouth or drink large amounts of fluids.

Taking a higher dose of Sebidin than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist.

Missing a dose of Sebidin

The patient should continue taking the medicine.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Sebidin

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Uncommon side effects may include:

• allergic reactions
• skin rashes
• superficial peeling of the mucous membrane of the mouth
• swelling of the parotid glands
• irritation or inflammation of the mucous membrane of the mouth
• stomach upset and diarrhea.

Taking the medicine for more than 7 days may cause side effects such as discoloration of the tongue back, tooth surfaces, and composite fillings, which disappear on their own.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sebidin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
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.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sebidin contains

• The active substances of the medicine are: chlorhexidine dihydrochloride and L-ascorbic acid (vitamin C). One tablet contains 5 mg of chlorhexidine dihydrochloride and 50 mg of ascorbic acid.
• The other ingredients are: sucrose, methylcellulose, talc, magnesium stearate, quinoline yellow (E104), koschenil red (E124), landryn flavor.

What Sebidin looks like and what the pack contains

Sebidin sucking tablets are pink-orange in color, in the shape of a flat disc with cut edges.
20 pieces, 1 blister pack of 20 pieces.
Blister pack of PVC/PVDC/Al in a cardboard box.

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:
Richard Bittner AG
Ossiacherstraße 7
9560 Feldkirchen
Austria
Date of last revision of the leaflet:August 2024