Elgydium (Solution, Paste) Instructions for Use

ATC Code

A01AB03 (Chlorhexidine)

Active Substances

Calcium carbonate (Ph.Eur. European Pharmacopoeia)

Chlorhexidine (Rec.INN registered WHO)

Pharmacotherapeutic Group

Therapeutic and prophylactic dental agent

Indications

• For the treatment and prevention of gingivitis (inflammation of the gums) characterized by redness, swelling, and bleeding.
• As an adjunct in the management of periodontitis to reduce bacterial load in periodontal pockets.
• For post-surgical care following dental procedures such as scaling, root planing, and oral surgery to prevent infection and promote healing.
• For the management of oral candidiasis (fungal infections) and other mucosal infections where chlorhexidine’s broad-spectrum antimicrobial action is beneficial.
• As a preventive measure against dental plaque formation and to maintain oral hygiene in patients with physical limitations or temporary conditions that impede proper mechanical cleaning.
• For the disinfection of dentures and other oral appliances to prevent stomatitis and other related infections.

Contraindications

• Hypersensitivity to chlorhexidine digluconate, calcium carbonate, or any of the other excipients listed in the composition of the specific dosage form.
• Use in patients with a known history of allergic reactions to similar antiseptic agents, which may manifest as contact dermatitis, urticaria, or more severe systemic reactions.
• The mouthwash solution is contraindicated in children under 6 years of age due to the risk of ingestion and the presence of ethanol; the toothpaste should be used in children only under adult supervision to prevent swallowing.
• Should not be used on open body cavities, serous membranes, or the middle ear due to the risk of irritation and potential tissue damage.
• Avoid use in cases of severe traumatic injuries of the oral mucosa or extensive ulcerations, as it may delay healing or cause further irritation.

Dosage Regimen

For Elgydium Toothpaste: Brush teeth thoroughly for 1-2 minutes with approximately 1-1.5 grams of toothpaste (covering the brush head) two to three times daily, preferably after meals. Do not swallow the paste. After brushing, spit out the excess. To maximize the antiseptic effect, it is recommended to avoid rinsing the mouth with water immediately after brushing, allowing the active substances to remain on the teeth and gums.

For Elgydium Mouthwash Solution: Adults and children over 6 years of age should use 10-15 ml (approximately one capful) of the undiluted solution to rinse the mouth for 30 seconds to 1 minute. This should be repeated 2-3 times a day, preferably after meals. The solution should not be swallowed. To ensure optimal efficacy, it is advised to use the mouthwash at least 30 minutes after brushing with a standard toothpaste, as some anionic ingredients in toothpastes (like sodium lauryl sulfate) can inactivate chlorhexidine.

Duration of Treatment: The typical treatment course for therapeutic purposes is 2-4 weeks. For long-term preventive use, a regimen of 1-2 times per week may be sufficient, but this should be discussed with a dentist to assess individual risk and necessity. Prolonged continuous daily use of chlorhexidine-containing products can lead to tooth staining and taste disturbance.

Adverse Reactions

The most frequently reported adverse reactions are local effects in the oral cavity. Reversible brown staining of teeth, dental restorations, and the tongue is very common, particularly with prolonged use. This staining can usually be removed by professional dental prophylaxis. Alteration in taste perception (dysgeusia) and a burning sensation of the tongue are also common; these effects are typically transient and resolve after discontinuation of treatment.

Uncommon adverse reactions include superficial desquamation (peeling) of the oral mucosa and swelling of the parotid glands (parotitis). In rare cases, allergic reactions such as contact dermatitis, skin rashes, or generalized allergic reactions (anaphylaxis) may occur. Instances of increased tartar formation have also been reported with long-term use.

For the mouthwash solution containing ethanol, local irritation and a stinging sensation may occur, especially if the oral mucosa is compromised. Accidental ingestion of large amounts of the mouthwash can lead to systemic effects of ethanol intoxication, including dizziness, nausea, and in severe cases, central nervous system depression.

Drug Interactions

Chlorhexidine is incompatible with anionic compounds, which can neutralize its antimicrobial activity. Therefore, it is recommended to maintain an interval of at least 30 minutes between using Elgydium products and other oral care products containing sodium lauryl sulfate (a common foaming agent in most toothpastes) or other anionic surfactants.

Concomitant use with other topical antiseptics (e.g., hydrogen peroxide, povidone-iodine) is not recommended as it may lead to increased local irritation or chemical inactivation. While systemic interactions are unlikely due to minimal absorption, caution is advised when using the mouthwash solution in patients taking medications that can cause a disulfiram-like reaction (e.g., metronidazole), as the product contains ethanol.

There is a potential for chlorhexidine to inactivate certain topical antibiotics if applied to the same area concurrently. It is also advised to inform your dentist or physician if you are using any other prescription or over-the-counter oral medications or rinses.

Overdose

Accidental ingestion of the toothpaste in small amounts is unlikely to cause serious harm due to the low concentration of active ingredients and may result only in gastrointestinal discomfort. If a large amount is ingested, symptomatic treatment and medical observation are recommended.

Ingestion of the mouthwash solution is more concerning due to the ethanol content. Symptoms of overdose may include signs of alcohol intoxication such as dizziness, nausea, vomiting, slurred speech, central nervous system depression, and in severe cases, respiratory depression. If a significant quantity is ingested, seek immediate medical attention. Do not induce vomiting. Treatment is supportive and symptomatic; gastric lavage may be considered if performed shortly after ingestion.

There is no specific antidote for chlorhexidine. In case of topical overuse, excessive rinsing or brushing may lead to intensified local adverse effects like staining, mucosal irritation, and taste disturbance, which generally subside upon discontinuation of the product.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.