STIMOL 1 g ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

STIMOL 1g Oral Solution

Citrulline Malate

Read this package leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine 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 it worsens or does not improve after 7 days.

Contents of the Package Leaflet

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

1. What Stimol Oral Solution is and what it is used for

It contains citrulline as the active ingredient, which is a non-essential amino acid that intervenes in protein formation and may help in situations of muscle fatigue.

Stimol is indicated for: Symptomatic relief of asthenic states (temporary fatigue) that could benefit from the intake of a non-essential amino acid (which intervenes in protein formation).

2. What you need to know before taking Stimol Oral Solution

Do not take Stimol:

• If you are allergic to citrulline or any of the other components of this medicine (listed in section 6).
• If you have severe kidney or liver disease.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Stimol 1g Oral Solution.

Children and Adolescents

Do not administer to children under 6 years of age, as there are no data available for this age group.

For use in children from 6 to 12 years, consult a doctor.

Taking Stimol with Other Medicines

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

No interaction studies have been conducted.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Since there are no data available, do not take Stimol Oral Solution during pregnancy or breastfeeding.

Driving and Using Machines

The influence of Stimol on the ability to drive and use machines is nil or insignificant.

Stimol 1g Oral Solution contains Sodium

Patients on low-sodium diets should note that this medicine contains 30mg (1.3mmol) of sodium per sachet.

3. How to Take Stimol Oral Solution

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Oral.

Adults: 3 sachets per day, taking one sachet during main meals.

Use in Children

Children from 6 to 12 years, under medical supervision: 2 sachets per day, divided between meals and dinner.

Do not administer to children under 6 years of age.

Treatment should be of short duration (12 days).

The oral solution should be taken with the help of a glass of water: dilute the contents of the sachet in a glass of water (approx. 150ml) or other cold or hot liquid (milk, juice, etc.).

If symptoms worsen or persist after 1 week, consult a doctor.

If you take more Stimol Oral Solution than you should

If you take Stimol in large doses, you may experience gastrointestinal discomfort, such as nausea, vomiting, or diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to a medical center, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Stimol Oral Solution

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Short-term stomach pain and, rarely, nervousness have been reported in some cases.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects 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 medicine.

5. Storage of Stimol Oral Solution

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection 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 Stimol 1g Oral Solution

• The active ingredient is citrulline malate. Each sachet contains 1g of citrulline malate.
• The other ingredients (excipients) are: orange essence aroma, sodium hydroxide (E524), and purified water.

Appearance of the Product and Package Contents

Stimol is an oral solution, a yellowish liquid.

It is presented in sachets containing 1g of active ingredient.

Each package contains 18 sachets.

Marketing Authorization Holder and Manufacturer

Biocodex

22 rue des Aqueducs

94257 Gentilly - FRANCE

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Laboratorios Pérez Giménez

Phone: 957 271100

Date of the last revision of this package leaflet: December 2015.

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