CHLORHEXIDINE/LIDOCAINE DIAMED 2 mg/mL + 0.5 mg/mL ORAL SPRAY SOLUTION MENTHOL FLAVORED

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this package 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 Chlorhexidine/Lidocaine Diamed is and what it is used for
2. What you need to know before taking Chlorhexidine/Lidocaine Diamed
3. How to take Chlorhexidine/Lidocaine Diamed
4. Possible side effects
5. Storage of Chlorhexidine/Lidocaine Diamed
6. Package contents and additional information

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

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

This medication 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 taking 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 medication (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 medication

• if you have congestive heart failure
• if your liver is not functioning properly
• if you are taking medications 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 medication 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 medication 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 medication is not compatible with some substances commonly found in toothpastes. Therefore, you should wait at least half an hour after brushing your teeth before using this medication.

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

Children

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

Other Medications and Chlorhexidine/Lidocaine Diamed

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and Using Machines

This medication has no effect or has a negligible influence on the ability to drive and use machines.

Chlorhexidine/Lidocaine Diamed Menthol Flavor Contains Alcohol (Ethanol) and Sodium

This medication 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 medication 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 medication does not produce any noticeable effect.

This medication 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 medication 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 medication 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 medication does not produce any noticeable effect.

This medication 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 the administration instructions for this medication described in this package leaflet or as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

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 medication to children under 6 years old.

Method of Administration

Oral use.

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

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 sprayer. Hold your breath while activating the mechanism.

On first use, the pump must 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 medication for a while, it is recommended to clean the sprayer after the last use, according to the following procedure:

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

Duration of Treatment

Do not use this medication 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 medication 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 (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 can last several hours), esophageal, gastric, or duodenal ulcers, and elevated liver enzyme concentrations (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, epileptic coma, decreased level of consciousness, sudden drop in blood pressure, slow heartbeats, 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 medication and the amount ingested/used.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

• 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 rash with itching that spreads across your 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 rash with itching after contact with the medication

Frequency Not Known (cannot be estimated from 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 or tooth 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 tremors
• general body weakness and lack of energy (asthenia), transient problems with taste or burning sensation in the tongue, sensation of heat or cold in the mouth

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Chlorhexidine/Lidocaine Diamed

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

Do not use this medication after the expiration date stated on the bottle/box after "EXP". The expiration date is the last day of the month indicated.

Store below 25°C.

Chlorhexidine/Lidocaine Diamed Menthol Flavor: The validity period after first opening is 3 months.

Chlorhexidine/Lidocaine Diamed Lemon Flavor: The validity period after first opening is 6 months.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Chlorhexidine/Lidocaine Diamed

• The active ingredients 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 components 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 Package Contents

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 package 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 Medication is Authorized in the Member States of the European Economic Area with the Following Names:

Date of the Last Revision of this Package Leaflet: October 2024.

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