GEISIL 0.6 mg/1.2 mg LOZENGES MINT FLAVORED

Introduction

Package Leaflet: Information for the Patient

Geisil0.6 mg / 1.2 mg menthol-flavored lozenges

amilmetacresol / dichlorobenzyl alcohol

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

• 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult your doctor if your symptoms worsen or do not improve after 2 days, or if they are accompanied by high fever, headache, nausea, or vomiting.

Contents of the Package Leaflet

1. What Geisil lozenges are and what they are used for
2. What you need to know before taking Geisil lozenges
3. How to take Geisil lozenges
4. Possible side effects.
5. Storage of Geisil lozenges

1. Package Contents and Additional Information

1. What Geisil is and what it is used for

Geisil lozenges contain amilmetacresol and dichlorobenzyl alcohol. These ingredients are 2 mild antiseptics.

The action of sucking the lozenges allows the active ingredients to act on the area of discomfort and also helps to lubricate and soothe the painful area. This helps to relieve pain and discomfort in the mouth and throat.

Geisil is used for the local symptomatic relief of sore throat pain and irritation in adults and children from 6 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 2 days of treatment, or if they are accompanied by high fever, headache, nausea, or vomiting.

2. What you need to know before taking Geisil

Do not take Geisil

• if you are allergic (hypersensitive) to amilmetacresol, dichlorobenzyl alcohol, or any of the other ingredients of this medication (listed in section 6).
• if the patient is under 6 years of age
• if you have an intolerance to certain sugars, such as maltitol or isomalt

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Geisil if you:

• have or are suffering from any other throat problem

Children

Children under 6 years of age must not take this medication.

Taking Geisil with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

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.

• There is insufficient data on the safety of the combination of alcohol + 2,4-dichlorobenzyl amilmetacresol in pregnant or breastfeeding women. As a precautionary measure, its use is not recommended during pregnancy.

Driving and Using Machines

Geisil lozenges have a nil or negligible effect on the ability to drive or use machines.

Geisil contains maltitol liquid and isomalt

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may have a slight laxative effect because it contains 1.83 g of isomalt per lozenge.

Caloric value: 2.3 kcal/g of isomalt

3. How to take Geisil

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is for adults and adolescents from 12 years of age: 1 lozenge every 2 or 3 hours, as needed, up to a maximum of 8 lozenges in 24 hours.

Use in children from 6 to 11 years

Children from 6 to 11 years should take this medication only under adult supervision.

The recommended dose is: 1 lozenge every 2 or 3 hours, as needed, up to a maximum of 4 lozenges in 24 hours.

Children under 6 years of age must not take this medication.

How to take

Geisil is for buccopharyngeal use only.

Dissolve slowly in the mouth, do not swallow, chew, or bite.

Consult your doctor if you do not feel better or if you feel worse after 2 days of treatment or if you have a high fever, headache, nausea, or vomiting.

If you take more Geisil than you should

If you exceed the recommended dose, you may experience gastrointestinal discomfort. Stop taking it and consult your doctor or pharmacist.

If you have taken more than you should, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

4. Possible side effects

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

If you experience any episode of hypersensitivity to this medication, stop taking it and consult your doctor or pharmacist. If any of the side effects you suffer from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

The side effects that can occur are very rare and may affect up to 1 in 10,000 people:

Hypersensitivity reactions including skin rash, burning, itching, and swelling of the mouth or throat

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse. This includes any possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Geisil

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

Do not use this medication after the expiration date stated on the packaging. The expiration date corresponds to the last day of that month.

Do not dispose of medications through wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition

• The active ingredients are amilmetacresol 0.6 mg and dichlorobenzyl alcohol 1.2 mg.
• The other ingredients (excipients) are:

Geisil, menthol flavor:

Peppermint essential oil

Anise essential oil

Levomenthol

Indigo carmine colorant (E132)

Quinoline yellow (E104)

Sodium saccharin (E954)

Tartaric acid (E334)

Isomalt (E953)

Maltitol, liquid (E965)

Appearance of Geisil and package contents

PVC-PVDC/Aluminum blisters.

Each package contains 24 lozenges.

Marketing Authorization Holder

Geiser Pharma, S.L.

Camino Labiano 45B

31192 Mutilva Alta, Navarra

Spain

Manufacturer

LOZY'S PHARMACEUTICALS

Business Park

31795 Lekaroz (Navarra)

Spain

This package leaflet was last revised in: October 2020

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