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DENTISSIN

Topical anaesthetic treatment for tooth eruption and oral inflammation.

Active substances:

lidocaine 5 mg/g

Patient information

Dentissin

Overview

Gingival gel, 5 mg/g

COMPOSITION

Each gram of gel contains the active substance lidocaine hydrochloride 5 mg, together with dry extracts of chamomile and thyme (natural components with a soothing effect).

Excipients: liquid sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol, carbomer, disodium edetate, sodium saccharin, polysorbate 20, sodium hydroxide, purified water.

WHAT IT IS USED FOR

A local anaesthetic gingival gel to relieve pain caused by:

•

teething in infants (from approximately 5 months of age) and wisdom tooth eruption in adults;

•

inflammatory conditions of the oral mucosa and gums.

HOW IT WORKS

Lidocaine temporarily blocks the transmission of pain impulses from the nerve endings of the oral mucosa and gums. The anaesthetic effect begins within 1–5 minutes of application and lasts approximately 15–30 minutes. The chamomile and thyme extracts contribute to a local soothing effect.

HOW TO USE

Apply locally to the gums or oral mucosa. Apply a pea-sized drop of gel to the painful area using a clean finger or a clean cotton swab, massaging gently.

Repeat 3 times a day, preferably after meals and before bedtime, no more than 6 times a day. Do not use for more than 7 days. If the gel is spat out, swallowed or vomited, do not repeat the dose immediately; the dose may be repeated after 3 hours if necessary.

WHEN IT SHOULD NOT BE USED

•

hypersensitivity to lidocaine, to other local anaesthetics of the amide group, or to any of the excipients;

•

trophic changes, swelling or ulceration of the oral mucosa or gums.

Important to know

The medicine contains sorbitol (E420): do not use if you have hereditary fructose intolerance. It contains parabens (E218 and E216), which may cause allergic reactions (even delayed ones), and propylene glycol, which may cause local irritation. Use with caution in patients with a history of neurological disorders and in those with heart failure.

Tell your doctor if you take class IB antiarrhythmics, other local anaesthetics, MAO inhibitors, tricyclic antidepressants or anticoagulants. The gel may cause anaesthesia of the taste buds (altered taste perception) and may reduce the gag reflex. During pregnancy and breast-feeding, use with caution, only after weighing the benefit against the risk. Read the package leaflet carefully before use.

Possible side effects

Rare: allergic reactions (urticaria, swelling at the application site), altered taste perception, reduced gag reflex.

If applied to severely damaged mucosa or in case of overdose: dizziness, perioral paraesthesia, blurred vision, tinnitus, nausea, vomiting, low blood pressure.

If side effects occur, stop using the product and consult a doctor or pharmacist.

STORAGE

Store below 25 °C. Keep out of the reach of children. Shelf life: 36 months.

PACK SIZE

10 g of gel in an aluminium tube; 1 tube together with the package leaflet in a carton box.

QUESTIONS AND CONTACTS

For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.