FRUIT SALT ENO EFFERVESCENT POWDER

Introduction

Package Leaflet: Information for the User

Fruit Salt ENO Effervescent Powder

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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
• Keep this 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 it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

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

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

Fruit Salt ENO is a medicine with antiacid 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 it worsens or does not improve after 7 days.

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

Do not take Fruit Salt ENO

• If you are allergic to sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium carbonate, or any of the other components of this medicine (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

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

Do not use for more than 7 consecutive days. If after this period the symptoms persist, stop taking the medicine 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 medicine.

Children

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

Use of Fruit Salt ENO with other medicines

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

In general, the intake of any antiacid should be separated by a minimum of 1 or 2 hours from the administration of any other medicine.

Consult your doctor or pharmacist before using this medicine 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 with food and drinks

The consumption of milk and dairy products should be done at different times from taking the medicine.

Do not take this medicine 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 medicine.

Driving and Using Machines

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

Fruit Salt ENO contains sodium

Patients on low-sodium diets should note that this medicine contains 852 mg (37 mmol) of sodium per 5g dose.

3. How to take Fruit Salt ENO

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 according to 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, obtaining a clear 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 overflow. 3. Pour the powder into a glass of water and stir until the effervescence stops.

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

Use in children under 12 years old: This medicine is not indicated for use in children under 12 years old.

If you take more Fruit Salt ENO 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. Phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fruit Salt ENO

This medicine does not require special storage conditions.

Keep out of sight and reach of children.

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

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

6. Package Contents and Additional Information

Composition of Fruit Salt ENO

The active ingredients are: each 5g of effervescent powder contains 2.319mg of sodium hydrogen carbonate, 2.181mg of anhydrous citric acid, and 500mg of anhydrous sodium carbonate. This medicine does not contain excipients.

Appearance of the Product and Package Contents

Fruit Salt ENO is a white 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 leaflet: December/2015

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