NOTICE
ANSM - Updated on: August 18, 2025
Drug Name
VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin-sodium-sweetened oral spray solution
Chlorhexidine digluconate/Lidocaine hydrochloride monohydrate
Box
Please read this package insert carefully before taking this medication, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
· Keep this package insert. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See Section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse after 3 days.
What is in this package insert?
1. What is VORJA MENTHOL 2 mg/0.5 mg per mL, oral spray solution sweetened with sodium saccharin, and what is it used for?
2. What should you know before using VORJA MENTHOL 2 mg/0.5 mg per mL, oral spray solution sweetened with sodium saccharin?
3. How should you use VORJA MENTHOL 2 mg/0.5 mg per mL, a sodium saccharin-sweetened oral spray solution?
4. What are the possible side effects?
5. How should you store VORJA MENTHOL 2 mg/0.5 mg per mL, a sodium saccharin-sweetened oral spray solution?
6. Package contents and other information.
1. WHAT IS VORJA MENTHOL 2 mg/0.5 mg per mL, sodium saccharin-sweetened oral spray solution, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Throat preparations, antiseptics (in combination with anesthetics) ATC code: R02AA05
VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin sodium-sweetened oral spray solution contains the active ingredients chlorhexidine digluconate and lidocaine hydrochloride monohydrate. This is a throat preparation that combines an antiseptic (which kills microorganisms) and an anesthetic (which relieves pain).
VORJA MENTHOL 2 mg/0.5 mg per mL, a sodium saccharin-sweetened oral spray solution, is used in adults, adolescents, and children over 6 years of age to treat the symptoms of a sore throat.
You should consult your doctor if you do not feel any improvement or if you feel worse after 3 days.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE USING VORJA MENTHOL 2 mg/0.5 mg per mL, oral spray solution sweetened with sodium saccharin?
Never use VORJA MENTHOL 2 mg/0.5 mg per mL, sodium saccharin-sweetened oral spray solution:
· If you are allergic to chlorhexidine, lidocaine, other anesthetics similar to lidocaine, or any other ingredient in this medication (listed in Section 6).
· In children under 6 years of age.
· If you are dependent on alcohol.
Warnings and Precautions
Consult your doctor or pharmacist before taking VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin-sweetened oral spray solution.
· If you have congestive heart failure,
· If your liver is not functioning properly,
· If you are taking medications to treat heart rhythm disorders (antiarrhythmics),
· If you have ever had severe allergic reactions.
Tell your doctor or pharmacist if your condition does not improve within 3 days of treatment while using VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin-sweetened oral spray solution, or if you have a high fever.
Be careful not to spray the solution near your eyes, into your eyes, or into your ears. If the solution comes into contact with your eyes, you must rinse them with plain water for at least 15 minutes while keeping your eyelid open.
VORJA MENTHOL 2 mg/0.5 mg per mL, oral spray solution sweetened with sodium saccharin, should not be used within 30 minutes before or during a meal or while drinking due to the risk of choking and localized burns caused by food orhot beverages due to numbness of the throat and tongue.
This medication is not compatible with certain substances commonly found in toothpaste. For this reason, you must wait at least half an hour after brushing your teeth before taking this medication.
This medication should be used with caution in patients with damaged throat mucosa.
Children
Do not use VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin sodium-sweetened oral spray solution in children under 6 years of age.
Other Medications and VORJA MENTHOL 2 mg/0.5 mg per mL, Oral Spray Solution Sweetened with Sodium Saccharin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
VORJA MENTHOL 2 mg/0.5 mg per mL, sodium saccharin-sweetened oral spray solution contains lidocaine; be sure to inform them, especially if you are taking:
· neuromuscular blockers (used, for example, during anesthesia),
· neuromuscular blockers (used, for example, during anesthesia),
· a medication to treat sudden and severe allergic reactions (epinephrine),
· strong pain relievers (opioids),
· beta-blockers (used to treat high blood pressure and certain heart conditions),
· cimetidine (a medication that reduces stomach acid, used, for example, to treat heartburn),
· mexiletine and other antiarrhythmic medications.
VORJA MENTHOL 2 mg/0.5 mg per mL, oral spray solution sweetened with sodium saccharin—with food, beverages, and alcohol
Not applicable.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning to become pregnant, consult your doctor or pharmacist before taking this medication.
The use of VORJA MENTHOL 2 mg/0.5 mg per mL, oral spray solution sweetened with sodium saccharin, may be considered during pregnancy or breastfeeding if necessary.
Driving and Operating Machinery
This medication has no or negligible effect on the ability to drive or operate machinery.
VORJA MENTHOL 2 mg/0.5 mg per mL, oral spray solution sweetened with sodium saccharin, contains alcohol and sodium
This medication contains 140 mg of alcohol (ethanol) in each dose of 5 sprays (adolescents > 12 years and adults) or 84 mg of alcohol (ethanol) in each dose of 3 sprays (children aged 6 to 12 years). The amount in a single dose of this medication is equivalent (for adolescents > 12 years of age and adults) to less than 3.6 mL of beer, or 1.4 mL of wine, or (for children ≥ 6 years of age and ≤ 12 years of age), less than 1.4 mL of beer or 0.9 mL of wine. The small amount of alcohol in this medication is not likely to cause any noticeable effects.
This medication contains less than 1 mmol of sodium (23 mg) per dose, meaning it is essentially “sodium-free.”
3. HOW TO USE VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin-sweetened oral spray solution?
Always use this medication exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you have any questions.
Adults and adolescents over 12 years of age
The recommended dose is 3 to 5 consecutive sprays, 6 to 10 times a day.
The maximum dose per administration is 5 sprays.
The maximum daily dose is 50 sprays.
Children 6 to 12 years of age
The recommended dose is 2 to 3 consecutive sprays, 3 to 5 times a day.
The maximum dose per use is 3 sprays.
The maximum daily dose is 15 sprays.
Do not take two doses less than 4 hours apart.
Children under 6 years of age
Do not give this medication to children under 6 years of age.
Route of administration
For oral use.
VORJA MENTHOL 2 mg/0.5 mg per mL, a saccharin-sodium-sweetened oral spray solution, should not be used within 30 minutes before or during a meal or while drinking a beverage due to the risk of choking and localized burns caused by food orhot beverages, due to numbness of the throat and tongue.
This medication is not compatible with certain substances commonly found in toothpastes. You must therefore wait at least half an hour after brushing your teeth before using this medication.
One bottle is for use by a single patient only.


1. Rotate the spray nozzle before use so that it is perpendicular to the bottle.
2. Open your mouth wide, aim the spray nozzle toward the back of your throat, and press the tip. Hold your breath while spraying.
When using the spray for the first time, you must prime the pump until only liquid is dispensed (usually 6 to 7 times). This may also be necessary if the product has not been used for a while.
If you do not use this medication for a while, it is recommended that you clean the spray after the last use, following the procedure below:
· Hold the spray bottle upside down and press the spray tip until no more liquid comes out (the solution no longer flows from the spray nozzle).
· Remove the sprayer from the spray pump and place it in a bath of hot water for a few minutes.
· Remove the spray nozzle from the water and let it dry.
· Replace the spray nozzle on the spray pump by turning it downward so that it locks onto the spray pump.
Duration of Treatment
Do not use VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin-sweetened oral spray solution for more than three consecutive days.
Consult a doctor if you do not feel better or if your condition worsens while using VORJA MENTHOL 2 mg/0.5 mg per mL, sodium saccharin-sweetened oral spray solution, or if you have a high fever.
If you have taken more VORJA MENTHOL 2 mg/0.5 mg per mL, sodium saccharin-sweetened oral spray solution than you should have
Overdoses (more than one bottle per day) may cause difficulty swallowing (reduced swallowing reflex).
Other symptoms of chlorhexidine overdose may include: swelling of the airways, vomiting, intense joy (euphoria), blurred vision, and loss of taste (which may last several hours), esophageal, gastric, and/or duodenal ulcers, and elevated liver enzyme levels (which can only be determined by a blood test).
Other symptoms of lidocaine overdose may include: headache, paranoia, hallucinations, dizziness, lightheadedness, drowsiness, agitation, ringing in the ears, unpleasant sensations on the skin (e.g., cramps, tingling), speech or hearing difficulties, a metallic taste, numbness around the mouth, acidosis (with symptoms such as rapid breathing, confusion, and fatigue), blurred vision, involuntary rhythmic eye movements, muscle contractions, psychosis, spasms, respiratory arrest, epileptic coma, decreased level of consciousness, sudden drop in blood pressure, slow heart rate, heart rhythm disturbances, and cardiac arrest.
If you (or your child) experience any of these symptoms, contact your doctor or pharmacist immediately.
If you forget to take VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin sodium-sweetened oral spray solution
Not applicable.
If you stop taking VORJA MENTHOL 2 mg/0.5 mg per mL, sodium saccharin-sweetened oral spray solution
Not applicable.
If you have any other questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, though not everyone gets them.
If you experience any of the following symptoms, stop taking this medication and contact your doctor immediately or go to the emergency room at the nearest hospital:
· Severe allergic reactions (rare, affecting up to 1 in 1,000 people), identified, for example, by:
o Swelling of the arms, legs, ankles, face, or eyes.
o Swelling of the lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing.
o Dizziness or fainting (loss of consciousness).
· Itchy rashes spreading over the body (hives) (Very rare, affecting up to 1 in 10,000 people).
Other possible side effects
Common (may affect up to 1 in 10 people)
· Nausea, vomiting, abdominal pain.
· Allergic skin reactions.
Rare (may affect up to 1 in 1,000 people)
· Localized itchy rash following contact with the medication.
Frequency unknown (frequency cannot be estimated based on available data)
· Weakness, loss of energy, and changes in blood accompanied by symptoms such as headache, dizziness, fatigue, difficulty breathing, and bluish skin (methemoglobinemia).
· Hypersensitivity to sunlight (delayed) or other reactions affecting the skin or teeth.
· Anxiety, agitation, or intense joy (euphoria).
· Drowsiness, dizziness, disorientation, confusion (including slurred speech), lightheadedness, tremors, psychosis, nervousness, tingling, numbness, spasms, loss of consciousness, coma.
· Vision problems (blurred or double vision).
· Ringing in the ears (tinnitus).
· Asthma, difficulty breathing (dyspnea), rapid and shallow breathing progressing to dizziness and blue skin , sudden inability to breathe (respiratory failure ).
· Difficulty swallowing, ulcers, or rashes in the mouth.
· Peeling of the skin inside the mouth, swelling of the salivary glands.
· Muscle contractions or twitching (tremors).
· General weakness and lack of energy (asthenia) ; temporary changes in taste or a burning sensation on the tongue; a feeling of cold or heat in the mouth.
Reporting Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package insert. You can also report side effects directly through the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers—Website: https://signalement.social-sante.gouv.fr/
By reporting side effects, you help provide more information on the safety of this medication.
5. HOW SHOULD VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin sodium-sweetened oral spray solution, BE STORED?
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date printed on the bottle/box after “EXP.” The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25 °C.
The shelf life after first opening is 3 months.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What VORJA MENTHOL 2 mg/0.5 mg per mL, saccharin sodium-sweetened oral spray solution contains
· The active ingredients are chlorhexidine digluconate and lidocaine hydrochloride monohydrate.
Each mL of solution contains 2 mg of chlorhexidine digluconate (equivalent to 1.15 mg of chlorhexidine) and 0.5 mg of lidocaine hydrochloride monohydrate (equivalent to 0.41 mg of lidocaine).
Each spray (85 microliters) contains 0.17 mg of chlorhexidine digluconate and 0.04 mg of lidocaine hydrochloride monohydrate.
· The other ingredients are: levomenthol, cineole, glycerol (E422), sodium saccharin (E954), citric acid monohydrate (E330), ethanol (96%), purified water.
What is VORJA MENTHOL 2 mg/0.5 mg per mL, oral spray solution sweetened with sodium saccharin, and contents of the outer packaging
VORJA MENTHOL 2 mg/0.5 mg per mL, sodium saccharin-sweetened oral spray solution is a clear, colorless solution.
It is available in a 30-mL brown glass bottle with a spray pump made of polypropylene, polyethylene, polyoxyethylene, and stainless steel. Each box contains one bottle.
Marketing Authorization Holder
Vicks Laboratories
163–165 Quai Aulagnier
92600 Asnière-sur-Seine
France
Marketing Authorization Holder
P&G Health France
18C, Boulevard Winston Churchill
21000 DIJON
France
Manufacturer
Laboratoria Qualiphar
Rijksweg 9
2880 Bornem
Belgium
Trade names of the drug in the Member States of the European Economic Area
This medicine is authorized in the Member States of the European Economic Area under the following names: In accordance with applicable regulations.
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The date this package insert was last revised is:
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Other
Detailed information about this medication is available on the ANSM (France) website.