TIP LOZENGES HONEY-LEMON FLAVOR

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Honey-Lemon Flavor Sucking Tablets

Read the entire leaflet carefully before starting to take the medicine

Keep this leaflet. You may need to read it again.

If you have any questions, ask your doctor or pharmacist.

This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Honey-Lemon Flavor Sucking Tablets are and what they are used for
2. Before taking Honey-Lemon Flavor Sucking Tablets
3. How to take Honey-Lemon Flavor Sucking Tablets
4. Possible side effects
5. Storage of Honey-Lemon Flavor Sucking Tablets
6. Additional information

1. What Honey-Lemon Flavor Sucking Tablets are and what they are used for

Honey-Lemon Flavor Sucking Tablets are yellowish, round tablets with a medicinal odor and honey-lemon flavor. They come in packs of 12 and 24 sucking tablets.

Dextromethorphan is a cough suppressant (cough medicine) indicated for the symptomatic treatment of all forms of cough that are not accompanied by expectoration (irritative cough, nervous cough).

2. BEFORE TAKING Honey-Lemon Flavor Sucking Tablets

Do not take Honey-Lemon Flavor Sucking Tablets:

• if you are allergic or hypersensitive to dextromethorphan or any of the components of this specialty.
• if you have respiratory failure.
• if you have asthmatic cough or cough with expectoration.
• If you are being treated with certain antidepressant medications, monoamine oxidase inhibitors (MAOIs) (see section "Taking other medications").
• If you are taking other medications such as antidepressants or antipsychotics, Honey-Lemon Flavor Sucking Tablets may interact with these medications, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

This medication may cause dependence. Therefore, treatment should be short-term.

Be careful with Honey-Lemon Flavor Sucking Tablets:

• if you have persistent or chronic cough, such as that caused by smoking, asthma, or emphysema, or when the cough is accompanied by abundant secretions.
• If you have any liver disease, consult your doctor before taking this medication.
• There have been reports of abuse with medications containing dextromethorphan in adolescents; therefore, this possibility should be taken into account, as serious side effects can occur (see section "If you take more Honey-Lemon Flavor Sucking Tablets than you should").

Taking other medications:

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Honey-Lemon Flavor Sucking Tablets should not be administered with certain antidepressant medications (MAOIs), furazolidone, or procarbazine, as they can cause severe toxic reactions characterized by excitement, hypertension, and hyperpyrexia.

Taking Honey-Lemon Flavor Sucking Tablets with food and beverages

Alcoholic beverages should not be consumed during treatment.

Pregnancy and breastfeeding:

Consult your doctor before taking this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Women who are breastfeeding should consult their doctor or pharmacist before taking this medication.

Driving and using machines:

During treatment with Honey-Lemon Flavor Sucking Tablets, a decrease in reaction capacity or drowsiness may occur, which should be taken into account when driving vehicles or operating hazardous machinery.

Important information about some of the components of Honey-Lemon Flavor Sucking Tablets:

This medication contains 1161.7 mg of sucrose and 1188 mg of glucose per tablet, which should be taken into account in patients with hereditary fructose intolerance, glucose/galactose absorption problems, saccharase-isomaltase deficiency, and diabetic patients.

3. HOW TO TAKE Honey-Lemon Flavor Sucking Tablets

Follow the administration instructions for Honey-Lemon Flavor Sucking Tablets exactly as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

Adults and children over 12 years old

Dissolve one tablet in the mouth when cough appears, up to a maximum of 2 tablets every 4-6 hours. Do not exceed 12 tablets per day.

If symptoms worsen or persist after 7 days, consult a doctor.

If you take more Honey-Lemon Flavor Sucking Tablets than you should:

If you have taken more Honey-Lemon Flavor Sucking Tablets than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you take more Honey-Lemon Flavor Sucking Tablets than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, consciousness disorders, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may include: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms. Accidental ingestion of very high doses can cause a state of drowsiness or gait disturbances in children.

There have been reports of abuse with medications containing dextromethorphan in adolescents, which can lead to serious side effects, such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

If you forget to take Honey-Lemon Flavor Sucking Tablets:

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, Honey-Lemon Flavor Sucking Tablets can have side effects, although not everyone experiences them.

The following side effects may occur:

Rare(at least 1 in 10,000 patients): Drowsiness or gastrointestinal discomfort. In this case, it is advisable to reduce the dosage.

The simultaneous consumption of alcohol during treatment can exacerbate the appearance of side effects. Do not consume alcoholic beverages during treatment.

If you observe these or any other reaction not described in this leaflet, consult your doctor or pharmacist.

5. Storage of Honey-Lemon Flavor Sucking Tablets

Keep Honey-Lemon Flavor Sucking Tablets out of the reach and sight of children.

Keep them in the original package.

Do not use Honey-Lemon Flavor Sucking Tablets after the expiration date shown on the package after "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packages and medications that are no longer needed. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Honey-Lemon Flavor Sucking Tablets

The active ingredient is dextromethorphan hydrobromide.

The other components are: sucrose, glucose, sodium saccharin, citric acid monohydrate, and honey and lemon flavors.

Appearance of the product and package contents

Yellow, round tablets with a honey and lemon odor and flavor.

The tablets come in packs of 12 and 24 units.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

FARMALIDER S.A.

C/Aragoneses 15,

28108-Alcobendas (Madrid)

Spain

Manufacturer:

FARMALIDER S.A.

C/La Vega, nº 6

45532 Carriches (Toledo)

Spain

This leaflet was approved in April 2020