NOTICE
ANSM - Updated on: August 18, 2025
Drug Name
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge
Chlorhexidine dihydrochloride/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 5 mg/1 mg, sorbitol-sweetened lozenge, and what is it used for?
2. What you should know before taking VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge
3. How should you take VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge?
4. What are the possible side effects?
5. How should you store VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge?
6. Package contents and other information.
1. WHAT IS VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Throat preparations, antiseptics (in combination with anesthetics) ATC code: R02AA05
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge contains the active ingredients chlorhexidine dihydrochloride and lidocaine hydrochloride monohydrate. It is a throat preparation that combines an antiseptic (which kills microorganisms) and an anesthetic (which relieves pain).
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge is used in adults, adolescents, and children over 6 years of age to treat 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 TAKING VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge?
Never take VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge:
· If you are allergic to chlorhexidine, lidocaine, other anesthetics similar to lidocaine, or any other ingredient in this medicine (listed in Section 6).
· In children under 6 years of age.
Warnings and Precautions
Consult your doctor or pharmacist before taking VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge.
· 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 5 mg/1 mg, sorbitol-sweetened lozenge, or if you have a high fever.
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge, should not be taken less than 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 in 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 oral mucosa.
Children
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge, should not be taken by children under 6 years of age.
Other Medications and VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge 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 for high blood pressure and certain heart conditions),
· cimetidine (a medication that reduces the amount of acid in your stomach, used, for example, to treat heartburn),
· mexiletine and other antiarrhythmic medications.
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge 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.
Taking VORJA MENTHOL 5 mg/1 mg, a sorbitol-sweetened lozenge, may be considered during pregnancy or while breastfeeding, if necessary.
Driving and Operating Machinery
This medication has no or negligible effect on the ability to drive or operate machinery.
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge contains sorbitol
This medication contains 1.2 g of sorbitol per lozenge. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before you (or your child) take or receive this medication. Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.
3. HOW TO TAKE VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge?
Be sure to always take 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 one lozenge 6 to 10 times a day.
The maximum dose is 10 lozenges per 24 hours.
Children 6 to 12 years of age
The recommended dose is one lozenge 3 to 5 times a day.
The maximum dose is 5 lozenges per 24 hours.
Children under 6 years of age
Do not give this medication to children under 6 years of age.
Directions for Use
For oral use. Allow the lozenge to dissolve slowly in the mouth.
To avoid local irritation, move the VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge around in your mouth while sucking on it.
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge, should not be taken within 30 minutes before or during a meal or while drinking a beverage due to the risk of choking and localized burning caused by food/hot beverages, due to numbness of the throat and tongue.
This medication is not compatible with certain substances commonly found in toothpaste. You should therefore wait at least half an hour after brushing your teeth before taking this medication.
Duration of Treatment
Do not take VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge, for more than 3 consecutive days.
Consult your doctor if you do not feel better, if you feel worse, or if you have a high fever while taking VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge.
If you have taken more VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenges than you should have
Overdoses (more than 20 lozenges 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: headaches, paranoia, hallucinations, dizziness, vertigo, 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 5 mg/1 mg, sorbitol-sweetened lozenge
Not applicable.
If you stop taking VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge
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, although 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 strength, 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, 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 discoloration of the skin (respiratory distress and depression), sudden inability to breathe (respiratory arrest).
· Difficulty swallowing, mouth ulcers, or skin 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, 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 adverse 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 5 mg/1 mg, sorbitol-sweetened lozenge, 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 blister pack or box after “EXP.” The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25 °C.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge contains
· The active ingredients are chlorhexidine dihydrochloride and lidocaine hydrochloride monohydrate.
Each lozenge contains 5 mg of chlorhexidine dihydrochloride (equivalent to 4.37 mg of chlorhexidine) and 1 mg of lidocaine hydrochloride monohydrate (equivalent to 0.81 mg of lidocaine).
· The other ingredients are: sorbitol (E420), magnesium stearate (E572), anhydrous citric acid (E330), levomenthol.
What is VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge, and contents of the outer packaging
VORJA MENTHOL 5 mg/1 mg, sorbitol-sweetened lozenge, is a round, white or nearly white tablet with slight mottling, approximately 16 mm in diameter and 5 mm thick.
They are available in blister packs or pre-cut single-dose blister packs made of (aluminum-PVC/PCTFE) or (aluminum-PVC/PE/PVDC), in boxes of 12, 24, or 36 lozenges. Not all presentations may be marketed.
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
Names of the drug in the Member States of the European Economic Area
This drug is authorized in the member states of the European Economic Area under the following names: In accordance with current 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.