Vicks for sore throat
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Vicks Gola Menthol 5/1 mg tablets, Lemon 5/1 mg tablets, Strawberry 5/1 mg tablets, Honey 5/1 mg tablets
chlorhexidine dihydrochloride / lidocaine hydrochloride monohydrate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your condition worsens after 3 days.
Contents of this leaflet
- What Vicks Gola is and what it is used for
- What you need to know before using Vicks Gola
- How to use Vicks Gola
- Possible side effects
- How to store Vicks Gola
- Contents of the pack and other information
1. WHAT VICKS GOLA IS AND WHAT IT IS USED FOR
Vicks Gola contains the active substances chlorhexidine dihydrochloride and lidocaine hydrochloride monohydrate. It is a throat preparation combining an antiseptic (which kills microorganisms) with an anaesthetic (which relieves pain).
Vicks Gola is used in adults, adolescents and children over 6 years of age for the treatment of sore throat symptoms.
Consult your doctor if you do not notice improvement or if you notice worsening after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE USING VICKS GOLA
Do not use Vicks Gola
- If you are allergic to chlorhexidine, lidocaine, other local anaesthetics similar to lidocaine, or to any of the other ingredients of this medicine (listed in section 6).
- In children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Vicks Gola
- If you have congestive heart failure,
- If your liver is not functioning properly,
- If you are taking medicines for heart rhythm disorders (antiarrhythmics),
- If you have previously experienced severe allergic reactions.
Contact your doctor or pharmacist if your condition does not improve during treatment with Vicks Gola within 3 days or if you develop a high fever.
Vicks Gola must not be used during or within 30 minutes before or after a meal or drinking, due to the risk of aspiration and localized burns from food or drinks that are too hot, caused by anaesthesia of the throat and tongue.
This medicine is incompatible with certain substances commonly found in toothpastes. Therefore, wait at least half an hour after brushing your teeth before using this medicine.
This product should be administered with caution in patients with non-intact oral mucosa.
Children
Vicks Gola must not be used in children under 6 years of age.
Other medicines and Vicks Gola
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Since Vicks Gola contains lidocaine, specifically inform them if you are taking:
- Neuromuscular blocking agents (e.g. used during anaesthesia),
- Medicines used to treat epilepsy (hydantoins),
- A medicine used to treat severe and sudden allergic reactions (epinephrine),
- Strong opioid painkillers (opiates),
- Beta-blockers (used for hypertension and certain heart conditions),
- Cimetidine (a medicine that reduces stomach acid, used for example in heartburn),
- Mexiletine and other antiarrhythmic medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Vicks Gola may be considered during pregnancy or breastfeeding if necessary.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machinery.
Vicks Gola Menthol contains sorbitol
This medicine contains 1.2 g of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine. Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
Vicks Gola Lemon contains sorbitol, aspartame, benzyl alcohol, and sodium
This medicine contains 1.2 g of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine. Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
This medicine contains 5 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.
This medicine contains 0.0009 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease, because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".
Vicks Gola Strawberry contains sorbitol and sodium
This medicine contains 1.2 g of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine. Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".
Vicks Gola Honey contains sorbitol, sulphites, and sodium
This medicine contains 1.2 g of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine. Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
This medicine contains sulphites. These may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".
3. HOW TO USE VICKS GOLA
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
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 in 24 hours.
Children aged 6 to 12 years
The recommended dose is one lozenge 3 to 5 times a day. The maximum dose is 5 lozenges in 24 hours.
Children < 6 years
Do not administer this medicine to children under 6 years of age.
Method of administration
For oral mucosa use. Allow the lozenge to dissolve slowly in the mouth.
To avoid local irritation, move the Vicks Gola lozenge around inside the mouth while sucking.
Vicks Gola must not be used during or within 30 minutes before or after a meal or drink, due to the risk of aspiration and localized burns from food or beverages that are too hot, caused by anaesthesia of the throat and tongue.
This medicine is incompatible with certain substances commonly found in toothpastes. Therefore, wait at least half an hour after brushing your teeth before using this medicine.
Duration of treatment
Do not use Vicks Gola for more than 3 consecutive days.
Consult your doctor if you do not feel better or if you feel worse during treatment with Vicks Gola, or if you develop a high fever.
If you use more Vicks Gola than you should
Excessive doses (more than 20 lozenges per day) may cause difficulty in swallowing (reduced swallowing reflex).
Other symptoms of chlorhexidine overdose may include: swelling of the airways, vomiting, extreme happiness (euphoria), blurred vision and loss of taste (which may last several hours), oesophageal, gastric and/or duodenal ulcers, and elevated liver enzymes (which can only be detected by blood tests).
Other symptoms of lidocaine overdose may include: headache, paranoia, hallucinations, dizziness, vertigo, drowsiness, agitation, ringing in the ears, unpleasant skin sensations (e.g. tingling, "pins and needles"), speech or hearing disturbances, metallic taste, numbness of the mouth, acidosis (with symptoms such as rapid breathing, confusion, fatigue), blurred vision, rhythmic involuntary eye movements, muscle twitching, psychosis, spasms, respiratory arrest, epileptic coma, reduced consciousness, sudden drop in blood pressure, slowed heart rate, heart rhythm problems and cardiac arrest.
Seek immediate medical advice from your doctor or pharmacist if you (or your child) experience any of these symptoms.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following symptoms, stop taking the medicine immediately, contact your
doctor or go to the nearest hospital emergency department:
- Severe allergic reactions (rare; may affect up to 1 in 1,000 people), such as:
- swelling of the arms, legs, ankles, face, or eyes;
- swelling of the lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing;
- dizziness or fainting (loss of consciousness).
- Widespread itchy, raised rash (urticaria) (very rare, may affect less than 1 in 10,000 people).
Other possible side effects
Common (may affect up to 1 in 10 people)
- Nausea, vomiting, abdominal pain;
- skin allergic reactions.
Rare (may affect up to 1 in 1,000 people)
- Localized itchy rash after contact with the medicine.
Frequency not known (cannot be estimated from the available data)
- Lack of energy or weakness, and blood disorders with symptoms such as headache, dizziness, fatigue, breathing difficulties, and bluish skin (methemoglobin in the blood);
- increased sensitivity to sunlight (delayed), or other skin or dental reactions;
- anxiety, restlessness, extreme happiness (euphoria);
- drowsiness, dizziness, disorientation, confusion (including confused speech), vertigo, chills, psychosis, nervousness, tingling, numbness, spasms, loss of consciousness, coma;
- vision disturbances (blurred or double vision);
- ringing in the ears (tinnitus);
- asthma, breathing difficulties (dyspnea), rapid and shallow breathing with dizziness and bluish skin (respiratory distress syndrome and respiratory depression), sudden inability to breathe (respiratory arrest);
- difficulty swallowing, mouth ulcers or skin rashes in the oral mucosa;
- peeling of the oral mucosa, swelling of the salivary glands;
- muscle contractions or tremors;
- general physical weakness or lack of energy (asthenia), temporary taste disturbances or burning sensation of the tongue, sensation of cold or heat in the mouth.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. HOW TO STORE VICKS GOLA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack/box after "Exp".
The expiry date refers to the last day of that month.
Store below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Vicks Gola contains
The active substances are chlorhexidine dihydrochloride and lidocaine hydrochloride monohydrate. Each tablet 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).
- Other components are: Vicks Gola Menthol: sorbitol (E420), magnesium stearate (E572), anhydrous citric acid (E330), levomenthol. Vicks Gola Lemon: sorbitol (E420), magnesium stearate (E572), aspartame (E951), acesulfame potassium (E950), lemon flavour (contains benzyl alcohol, maize maltodextrin, alpha tocopherol, and sodium). Vicks Gola Strawberry: sorbitol (E420), magnesium stearate (E572), anhydrous citric acid (E330), levomenthol, sucralose (E955), strawberry flavour (contains sodium, maize maltodextrin and glyceryl triacetate (E1518)). Vicks Gola Honey: sorbitol (E420), magnesium stearate (E572), anhydrous citric acid (E330), stevia, honey flavour (contains maize maltodextrin, modified maize starch (E1450), glyceryl triacetate (E1518), sulphites and sodium).
Description of the appearance of Vicks Gola and contents of the package The Vicks
Gola tablets are round, white or almost white, slightly speckled, with a diameter of
approximately 16 mm and a thickness of 5 mm.
They are available in Al-PVC/PCTFE or Al-PVC/PE/PVDC blisters or perforated unit-dose blisters, in pack sizes of 12, 24 or 36 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Procter & Gamble S.r.l. – Viale Giorgio Ribotta 11, 00144 Roma
Manufacturer
Laboratoria Qualiphar
Rijksweg 9
Bornem
Antwer 2880
Belgium
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France VORJA 5 mg/1 mg, comprimé à sucer
Germany Chlorhexidin/Lidocain Diamed 5 mg /1 mg Lutschtabletten, gepresst
Netherlands Oraliv 5 mg/1 mg zuigtabletten
Spain AngiStop 5 mg/1 mg comprimidos para chupar
Italy Vicks Gola 5/1 mg pastiglie