FRUIT SALT ENO LEMON FLAVORED EFFERVESCENT POWDER

Introduction

Package Leaflet: Information for the User

Fruit Salt ENO Lemon-Flavored Effervescent Powder

Sodium Hydrogen Carbonate, Anhydrous Citric Acid, Anhydrous Sodium Carbonate.

Read the entire package leaflet carefully before starting to take this medication because 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What Fruit Salt ENO Lemon is and what it is used for
2. What you need to know before taking Fruit Salt ENO Lemon
3. How to take Fruit Salt ENO Lemon
4. Possible side effects
5. Storage of Fruit Salt ENO Lemon
6. Package Contents and Additional Information

1. What Fruit Salt ENO Lemon is and what it is used for

Fruit Salt ENO Lemon is a medication with anti-acid action and is indicated for the relief and symptomatic treatment of heartburn and stomach acid in adults and adolescents over 12 years old.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Fruit Salt ENO Lemon

Do not take Fruit Salt ENO Lemon

• If you are allergic to sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium carbonate, or any of the other components of this medication (listed in section 6).
• In case of heart, liver, or kidney disease.
• In case of high blood pressure.
• If you are on a low-sodium diet.

Warnings and Precautions

Taking high amounts of this medication or for a long period may cause alkalosis (an alteration of the acid-base balance), so do not exceed the recommended dose.

Do not use for more than 7 consecutive days. If symptoms persist after this period, stop taking the medication and consult your doctor, as this could indicate a more serious illness.

If you have appendicitis or its symptoms (nausea, vomiting, cramps, abdominal pain), do not take this medication.

Children

Children under 12 years old: This medication is not indicated for use in children under 12 years old.

Using Fruit Salt ENO Lemon with Other Medications

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

In general, the intake of any anti-acid should be separated by at least 1 or 2 hours from the administration of any other medication.

Consult your doctor or pharmacist before using this medication if you are taking:

• Tetracyclines, used to treat some infections.
• Amphetamines, used as a stimulant for the nervous system.
• Quinidine, used to treat heart rhythm problems.
• Lithium carbonate, used to treat some psychiatric problems.
• Iron salts, used to treat iron deficiencies.
• Calcium supplements.

Taking Fruit Salt ENO Lemon with Food and Drinks

Consumption of milk and dairy products should be done at different times from taking the medication.

Do not take this medication immediately after excessive food and drink.

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.

Driving and Using Machines

No effects have been observed on the ability to drive or use machinery.

Fruit Salt ENO Lemon Contains Sodium

Patients on low-sodium diets should note that this medication contains 850 mg (37 mmol) of sodium per 5g dose.

3. How to Take Fruit Salt ENO Lemon

Adults and Children Over 12 Years Old:the recommended dose is one sachet or one internal measure of the bottle cap (5g of effervescent powder) dissolved in a glass of water when symptoms occur, preferably 1 to 3 hours after meals.

Do not take more than 2 doses in a 24-hour period.

{The mode of use will be adapted based on the presentation}

{for boxes with 10 sachets of 5g of effervescent powder}

Dissolve the contents of one sachet of effervescent powder in a glass of water. Stir until the effervescence stops, resulting in a pale green transparent solution.

{for bottles of 150g of effervescent powder}

1. Remove the bottle cap. 2. Pour the powder into the inner ring of the cap until it starts to spill over. 3. Pour the powder into a glass of water and stir until the effervescence stops.

If symptoms do not improve within 7 days, you should stop treatment and consult your doctor.

Use in Children Under 12 Years Old:This medication is not indicated for use in children under 12 years old.

If You Take More Fruit Salt ENO Lemon Than You Should

With high doses, there may be an increase in sodium in the blood and metabolic alkalosis, which manifests with the following symptoms: weakness, thirst, decreased saliva, dizziness, headache, decreased tension, and tachycardia (increased heart rate).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

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

The following side effects have been observed with an unknown frequency (cannot be estimated from the available data): mild stomach or intestine irritation, belching, flatulence (gas), and abdominal bloating.

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: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fruit Salt ENO Lemon

This medication does not require special storage conditions.

Keep out of sight and reach of children.

Do not use Fruit Salt ENO Lemon after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the Sigre point in the 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 Fruit Salt ENO Lemon

• The active ingredients are: each 5g of effervescent powder contains 2.288 mg of sodium hydrogen carbonate, 2.157 mg of anhydrous citric acid, and 500 mg of anhydrous sodium carbonate.

• The other components (excipients) are: lemon flavor, indigo carmine (E-132), quinoline yellow (E-104), sodium saccharin, and deterpenated lime flavor.

Appearance of the Product and Package Contents

Fruit Salt ENO Lemon is a pale green effervescent powder. It is presented in 150g bottles and boxes of 10 paper-polyethylene-aluminum-polyethylene sachets containing 5g of effervescent powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor - 28046 – Madrid – Spain

Manufacturer

Haleon Alcala, S.A.

Ctra. Ajalvir KM 2,500, 28806 Alcalá de Henares (Madrid).

Date of the Last Revision of this Package Leaflet: December/2015

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