CHLORHEXIDINE/LIDOCAINE DIAMED 2 mg/mL + 0.5 mg/mL ORAL SPRAY, LEMON FLAVOR

Introduction

Package Leaflet: Information for the User

Chlorhexidine/Lidocaine Diamed 2 mg/ml + 0.5 mg/ml oral spray, menthol flavor

Chlorhexidine/Lidocaine Diamed 2 mg/ml + 0.5 mg/ml oral spray, lemon flavor

chlorhexidine digluconate/lidocaine hydrochloride monohydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the Package Leaflet

1. What is Chlorhexidine/Lidocaine Diamed and what is it used for
2. What you need to know before you start using Chlorhexidine/Lidocaine Diamed
3. How to use Chlorhexidine/Lidocaine Diamed
4. Possible side effects
5. Storage of Chlorhexidine/Lidocaine Diamed
6. Contents of the pack and other information

1. What is Chlorhexidine/Lidocaine Diamed and what is it used for

This medicine contains the active substances chlorhexidine digluconate and lidocaine hydrochloride monohydrate. It is a throat preparation that combines an antiseptic (kills microorganisms) and an anesthetic (relieves pain).

This medicine is used in adults, adolescents, and children over 6 years old to treat the symptoms of sore throat.

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before you start using Chlorhexidine/Lidocaine Diamed

Do not use Chlorhexidine/Lidocaine Diamed

• if you are allergic to chlorhexidine, lidocaine, other local anesthetics similar to lidocaine, or any of the other components of this medicine (listed in section 6)
• in children under 6 years old
• if you are addicted to alcohol

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medicine

• if you have congestive heart failure
• if your liver is not functioning properly
• if you are taking medicines to treat heart rhythm problems (antiarrhythmics)
• if you have had a severe allergic reaction

Consult your doctor or pharmacist if your condition does not improve during the use of this medicine within 3 days of treatment or if you have a high fever.

Be careful not to get the solution in your eyes or ears or near them. If the solution gets in your eyes, you should rinse them with clean water for at least 15 minutes; during rinsing, the eyelids should be open.

This medicine should not be used less than 30 minutes before or during a meal or drink due to the risk of aspiration and localized burning from hot food/drink due to anesthesia of the throat and tongue.

This medicine is not compatible with some substances found in toothpastes. Therefore, you should wait at least half an hour after brushing your teeth before using this medicine.

The product should be administered with caution in patients with damage to the throat mucosa.

Children

This medicine should not be used in children under 6 years old.

Other Medicines and Chlorhexidine/Lidocaine Diamed

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

As this medicine contains lidocaine, inform them especially if you are taking:

• neuromuscular blockers (used, for example, during anesthesia)
• medicines to treat epilepsy (hydantoins)
• a medicine to treat sudden, severe allergic reactions (epinephrine)
• strong painkillers (opioids)
• beta-blockers (used for hypertension and certain heart problems)
• cimetidine (a medicine that reduces the amount of acid in the stomach, used, for example, for heartburn)
• mexiletine and other antiarrhythmic medicines.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

The use of this medicine may be considered during pregnancy or breastfeeding if necessary.

Driving and Using Machines

This medicine has no or negligible influence on the ability to drive and use machines.

Chlorhexidine/Lidocaine Diamed menthol flavor contains alcohol (ethanol) and sodium

This medicine contains 140 mg of alcohol (ethanol) in each dose of 5 sprays (adolescents over 12 years old and adults) or 84 mg of alcohol (ethanol) in each dose of 3 sprays (children between 6 and 12 years old). The amount of alcohol in a dose of this medicine is equivalent (in adolescents over 12 years old and adults) to less than 3.6 ml of beer or 1.4 ml of wine or (in children between 6 and 12 years old) to less than 1.4 ml of beer or 0.9 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

Chlorhexidine/Lidocaine Diamed lemon flavor contains alcohol (ethanol) and propylene glycol

This medicine contains 100 mg of alcohol (ethanol) in each dose of 5 sprays (adolescents over 12 years old and adults) or 60 mg of alcohol (ethanol) in each dose of 3 sprays (children between 6 and 12 years old). The amount of alcohol in a dose of this medicine is equivalent (in adolescents over 12 years old and adults) to less than 2.5 ml of beer or 1.0 ml of wine or (in children between 6 and 12 years old) to less than 1.6 ml of beer or 0.6 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains 85 mg of propylene glycol in each dose of 5 sprays (adolescents over 12 years old and adults) or 51 mg in each dose of 3 sprays (children between 6 and 12 years old).

3. How to Use Chlorhexidine/Lidocaine Diamed

Follow exactly the administration instructions of this medicine described in this leaflet or as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you are not sure.

Adults and Adolescents Over 12 Years Old

The recommended dose is 3-5 consecutive sprays, 6 to 10 times a day.

The maximum single dose is 5 sprays.

The maximum daily dose is 50 sprays.

Children Between 6 and 12 Years Old

The recommended dose is 2-3 consecutive sprays, 3 to 5 times a day.

The maximum single dose is 3 sprays.

The maximum daily dose is 15 sprays.

Do not take two doses less than 4 hours apart.

Children Under 6 Years Old

Do not administer this medicine to children under 6 years old.

Method of Administration

Oral use.

This medicine should not be used less than 30 minutes before or during a meal or drink due to the risk of aspiration and localized burning from hot food/drink due to anesthesia of the throat and tongue.

This medicine is not compatible with some substances found in toothpastes. Therefore, you should wait at least half an hour after brushing your teeth before using this medicine.

A bottle should only be used by one patient.

1. Turn the tube before use so that it is perpendicular to the bottle.
2. Open your mouth wide, direct the tube towards the throat, and press the spray. Hold your breath while activating the mechanism.

On first use, the pump needs to be primed until it only expels liquid (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 medicine for a while, it is recommended to clean the spray after the last use, according to the following procedure:

• Turn the spray upside down and press the spray head until no more liquid comes out (no solution is sprayed from the spray).
• Remove the spray from the spray head and place it in a bowl of warm water for a few minutes.
• Take the spray out of the water and let it dry.
• Place the dry spray on the spray head, turning it upside down so that it blocks the spray head.

Duration of Treatment

Do not use this medicine for more than three consecutive days.

You should talk to a doctor if you do not feel better or if you feel worse during the use of this medicine or if you have a high fever.

If You Take More Chlorhexidine/Lidocaine Diamed Than You Should

Overdoses (more than one bottle per day) can cause difficulty swallowing (reduction of the swallowing reflex).

Other symptoms of chlorhexidine overdose may include: swelling of the airways, vomiting, extreme happiness (euphoria), blurred vision, and loss of taste (which can last several hours), esophageal, gastric, or duodenal ulcers, and elevated liver enzyme levels (which can only be determined by blood tests).

Other symptoms of lidocaine overdose may include: headache, paranoia, hallucinations, dizziness, vertigo, drowsiness, agitation, ringing in the ears, unpleasant sensations on the skin (e.g., tingling), speech or hearing disturbances, metallic taste, numbness around the mouth, acidosis (with symptoms such as rapid breathing, confusion, fatigue), blurred vision, involuntary eye movements, muscle contractions, psychosis, spasms, respiratory arrest, coma, decreased level of consciousness, sudden drop in blood pressure, slow heart rate, heart rhythm problems, and cardiac arrest.

Contact your doctor or pharmacist immediately if you (or your child) develop any of these symptoms.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested/used.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you develop any of the following symptoms, stop using this medicine and inform your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (rare; may affect up to 1 in 1,000 people), which can be noticed, for example, by:
  • swelling of the arms, legs, ankles, face, or eyes
  • swelling of the lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing
  • dizziness or fainting (loss of consciousness)
  • raised itchy rash spreading across the body (urticaria) (very rare, may affect less than 1 in 10,000 people)

Other possible side effects

Frequent (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 after contact with the medicine

Frequency Not Known (cannot be estimated from the available data)

• lack or loss of strength and energy and changes in the blood with symptoms such as headache, dizziness, fatigue, difficulty breathing, and bluish skin (methemoglobinemia)
• hypersensitivity to the sun (delayed) or other skin reactions
• anxiety, agitation, extreme happiness (euphoria)
• drowsiness, vertigo, disorientation, confusion (also confused speech), dizziness, chills, psychosis, nervousness, tingling, numbness, spasms, loss of consciousness, coma
• vision disturbances (blurred or double vision)
• ringing in the ears (tinnitus)
• asthma, difficulty breathing (dyspnea), rapid and shallow breathing that progresses to dizziness and bluish skin (distress and respiratory depression), sudden inability to breathe (respiratory arrest)
• swallowing problems, ulcers, or rash in the mouth
• peeling of the skin inside the mouth, swelling of the salivary glands
• muscle contractions or twitching (tremor)
• general body weakness and lack of energy (asthenia), transient problems with the sense of taste or burning sensation in the tongue, feeling of heat or cold in the mouth

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Chlorhexidine/Lidocaine Diamed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle/carton after "EXP". The expiry date is the last day of the month stated.

Store below 25°C.

Chlorhexidine/Lidocaine Diamed menthol flavor: The shelf life after first opening is 3 months.

Chlorhexidine/Lidocaine Diamed lemon flavor: The shelf life after first opening is 6 months.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, consult your pharmacist on how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Chlorhexidine/Lidocaine Diamed

• The active substances are chlorhexidine digluconate and lidocaine hydrochloride monohydrate. Each ml of solution contains 2 mg of chlorhexidine digluconate (corresponding to 1.15 mg of chlorhexidine) and 0.5 mg of lidocaine hydrochloride monohydrate (corresponding 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:Chlorhexidine/Lidocaine Diamed menthol flavor: Levomenthol, cineole, glycerol (E422), sodium saccharin (E954), citric acid monohydrate (E330), ethanol (96%), purified water.Chlorhexidine/Lidocaine Diamed lemon flavor: Lemon flavor, glycerol (E422), propylene glycol (E1520), sucralose (E955), citric acid monohydrate (E330), ethanol (96%), purified water.

Appearance of the Product and Contents of the Pack

Chlorhexidine/Lidocaine Diamed oral spray is a clear, colorless solution. It comes in a 30 ml brown glass bottle with a spray pump made of polypropylene, polyethylene, polyoxethylene, and stainless steel. Each pack contains one bottle.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH

Am Mittelhafen 20

48155 Münster

Germany

Manufacturer

Laboratoria Qualiphar

Rijksweg 9

2880 Bornem

Belgium

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of This Leaflet: October 2024.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)