Sensigel (Gel) Instructions for Use

Marketing Authorization Holder

Pierre Fabre Médicament, CJSC (Russia)

Manufactured By

Pierre Fabre Medicament (France)

ATC Code

A01AD11 (Other drugs)

Dosage Form

Sensigel

Tooth gel: tube 50 ml

Dosage Form, Packaging, and Composition

50 ml – plastic tubes (1) – cardboard packs.

Therapeutic Category

Preparation for the prevention and treatment of dental hyperesthesia

Pharmacotherapeutic Group

Therapeutic and prophylactic dental agent

Indications

• Sensigel gel is indicated for the treatment and prevention of dental hyperesthesia, a condition characterized by sharp, transient pain arising from exposed dentin in response to various stimuli.
• It is specifically formulated to manage sensitivity triggered by thermal stimuli (such as hot or cold foods and beverages), tactile stimuli (for example, during toothbrushing or dental probing), chemical stimuli (including sweet or acidic substances), and evaporative stimuli (like a blast of air).
• The gel is intended for use in patients with exposed dentin at the necks of teeth, which can occur due to gingival recession, abrasive tooth wear, or erosive lesions.
• It serves a dual purpose as a therapeutic agent for active sensitivity and a prophylactic measure to prevent its recurrence or worsening, making it suitable for long-term oral hygiene management in individuals prone to dentinal hypersensitivity.

Contraindications

• Sensigel is contraindicated in patients with a known hypersensitivity to fluorinol, potassium nitrate, or any of the excipients listed in the product composition. Hypersensitivity reactions may manifest as localized irritation, swelling, or other allergic responses.
• Its use is strictly contraindicated in cases of significant oral mucosal ulcerations or erosive lesions of unknown origin, as the product may cause stinging or discomfort on compromised soft tissues.
• The gel should not be used by individuals diagnosed with severe renal impairment, due to the potential for systemic absorption of potassium and the associated risk of hyperkalemia, although this risk is generally low with topical use.
• It is also contraindicated in patients with widespread dental caries or active, untreated periodontal disease, as these conditions require specific professional intervention and the use of this gel alone is not sufficient for their management.

Dosage Regimen

For the effective management of dental hyperesthesia, apply a pea-sized amount (approximately 1-1.5 cm strip) of Sensigel gel to a soft-bristled toothbrush.

Brush teeth thoroughly for two minutes, twice daily, typically during the morning and evening oral hygiene routine, ensuring that the gel is applied directly to the sensitive areas, particularly the cervical regions of the teeth.

After brushing, expectorate the excess gel and foam; do not swallow. For maximum therapeutic effect, avoid rinsing the mouth, eating, or drinking for at least 30 minutes after application to allow prolonged contact of the active ingredients with the tooth surface.

The duration of use should be based on therapeutic response; continuous use for several weeks is often necessary to achieve a significant reduction in sensitivity. The gel can be used as part of a long-term maintenance regimen to prevent the recurrence of symptoms.

Adverse Reactions

Adverse reactions associated with Sensigel are generally mild and transient, primarily localized to the oral cavity. The most commonly reported reactions include minor oral mucosal irritation, a temporary alteration in taste perception (dysgeusia), and mild gingival irritation or redness.

In rare instances, localized allergic contact stomatitis or hypersensitivity reactions such as itching or swelling of the oral tissues may occur, particularly in individuals with a predisposition to allergies. Discontinuation of the product is recommended if such reactions are observed.

With prolonged and excessive use beyond recommended guidelines, there is a potential risk of dental fluorosis, a condition characterized by mottling of the tooth enamel, especially in children under the age of 12. Therefore, adult supervision and adherence to dosage are critical.

Systemic adverse effects are exceedingly rare due to minimal absorption; however, accidental ingestion of large quantities could potentially lead to gastrointestinal discomfort, including nausea or abdominal pain.

Drug Interactions

While systemic drug interactions are unlikely due to topical application and minimal absorption, there is a theoretical potential for interaction with other topical fluoride products, such as high-concentration fluoride gels, varnishes, or rinses prescribed by a dentist.

Concurrent use could lead to an increased cumulative fluoride exposure, elevating the risk of dental fluorosis. It is advisable to inform your dentist or physician about all oral care products you are using.

No specific pharmacokinetic interactions with systemically administered drugs have been identified. However, patients using drugs that can cause dry mouth (xerostomia) may experience a slightly altered retention time of the gel in the oral cavity, which could theoretically affect its efficacy.

As a precaution, a time interval of at least 30 minutes should be maintained between using Sensigel and applying other oral care products, such as whitening toothpastes or antimicrobial mouthwashes, to prevent any potential chemical incompatibility or reduction in the efficacy of either product.

Overdose

Acute overdose from topical oral use is improbable. The primary concern arises from accidental ingestion of a large volume of the gel. Symptoms of acute fluoride overdose, stemming from the fluorinol component, may include gastrointestinal distress such as nausea, vomiting, abdominal cramps, and diarrhea.

In severe cases of massive ingestion, particularly in small children or individuals with renal compromise, symptoms could progress to salivation, lacrimation, and neurological manifestations like headache, tremors, or paresthesia. Excessive potassium intake from potassium nitrate, though unlikely, could theoretically contribute to hyperkalemia in susceptible individuals.

In case of suspected overdose, immediately contact a poison control center or seek emergency medical attention. Do not induce vomiting unless instructed by a healthcare professional. Treatment is typically supportive and symptomatic, and may include the administration of calcium (e.g., milk, calcium gluconate) to bind fluoride ions and alleviate symptoms.

To prevent accidental overdose, especially in households with children, store the product in its original packaging and out of reach. Use only the recommended pea-sized amount for each application.

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.