CHLORHEXIDINE/LIDOCAINE DIAMED 5 mg/1 mg LOZENGES MENTHOL FLAVORED

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

This medication contains the active ingredients chlorhexidine dihydrochloride 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 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.

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 treatment with this medication within 3 days or if you have a high fever.

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 oral mucosa damage.

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 might 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 stomach acid, 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 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 have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

Chlorhexidine/Lidocaine Diamed lemon flavor contains sorbitol, aspartame, benzyl alcohol, and sodium

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 have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medication contains 5 mg of aspartame per lozenge. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it properly.

This medication contains 0.0009 mg of benzyl alcohol per lozenge.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (metabolic acidosis).

This medication contains less than 1 mmol of sodium (23 mg) per lozenge, i.e., it is essentially "sodium-free".

Chlorhexidine/Lidocaine Diamed strawberry flavor contains sorbitol and sodium

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 have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medication contains less than 1 mmol of sodium (23 mg) per lozenge, i.e., it is essentially "sodium-free".

Chlorhexidine/Lidocaine Diamed honey flavor contains sorbitol, sulfites, and sodium

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 have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medication contains sulfites. It may rarely cause severe hypersensitivity reactions and bronchospasm.

This medication contains less than 1 mmol of sodium (23 mg) per lozenge, i.e., it is essentially "sodium-free".

3. How to take Chlorhexidine/Lidocaine Diamed

Follow the instructions for administration of 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 one lozenge 6 to 10 times a day.

The maximum dose is 10 lozenges every 24 hours.

Children between 6 and 12 years old

The recommended dose is one lozenge 3 to 5 times a day.

The maximum dose is 5 lozenges every 24 hours.

Children under 6 years old

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

Method of administration

Oral use. Let the lozenge dissolve slowly in the mouth.

To avoid local irritation, this medication should be moved around the mouth while sucking.

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.

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 treatment with this medication or if you have a high fever.

If you take more Chlorhexidine/Lidocaine Diamed than you should

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, 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 rhythmic eye movements, muscle contractions, psychosis, spasms, respiratory arrest, epileptic coma, decreased level of consciousness, sudden drop in blood pressure, slow heart rate, and heart rhythm problems.

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 further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everybody 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 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 that spreads across the body (urticaria) (very rare, may affect less than 1 in 10,000 people)

Other possible adverse effects

Common (may affect up to 1 in 10 people)

• nausea, vomiting, abdominal pain
• allergic skin reactions

Uncommon (may affect up to 1 in 1,000 people)

• localized itchy rash after contact with the medication

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 blue-tinged 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 blue-tinged 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 twitches (tremor)
• 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 of adverse effects

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. You can also report them directly through the Spanish Medicines Surveillance System for Human Use http://www.notificaram.es By reporting adverse 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 blister/packaging after "EXP". The expiration date is the last day of the month indicated.

Store below 25°C.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Chlorhexidine/Lidocaine Diamed

• The active ingredients are chlorhexidine dihydrochloride and lidocaine hydrochloride monohydrate. Each lozenge contains 5 mg of chlorhexidine dihydrochloride (corresponding to 4.37 mg of chlorhexidine) and 1 mg of lidocaine hydrochloride monohydrate (corresponding to 0.81 mg of lidocaine).

• The other ingredients are:

Chlorhexidine/Lidocaine Diamed menthol flavor: sorbitol (E420), magnesium stearate (E572), anhydrous citric acid (E330), levomenthol.

Chlorhexidine/Lidocaine Diamed lemon flavor: sorbitol (E420), magnesium stearate (E572), aspartame (E951), acesulfame potassium (E950), lemon flavor (contains benzyl alcohol, corn maltodextrin, alpha-tocopherol, and sodium).

Chlorhexidine/Lidocaine Diamed strawberry flavor: sorbitol (E420), magnesium stearate (E572), anhydrous citric acid (E330), levomenthol, sucralose (E955), strawberry flavor (contains sodium, corn maltodextrin, and triacetin (E1518)).

Chlorhexidine/Lidocaine Diamed honey flavor: sorbitol (E420), magnesium stearate (E572), anhydrous citric acid (E330), stevia, honey flavor (contains corn maltodextrin, modified corn starch (E1450), triacetin (E1518), sulfites, and sodium).

Appearance of the product and package contents

Chlorhexidine/Lidocaine Diamed are lozenges, round, white to off-white, slightly speckled, with a diameter of approximately 16 mm and a thickness of 5 mm.

They are packaged in Al-PVC/PCTFE or Al-PVC/PE/PVDC blisters or single-dose pre-cut blisters in packs of 12, 24, or 36 lozenges.

Only some pack sizes may be marketed.

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 under the following names:

Spain Chlorhexidine / lidocaine Diamed 5 mg/1 mg lozenges

Date of the last review of this prospectus: October 2024

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