Stimol 1 g oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

STIMOL 1g oral solution

Citric acid malate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for taking this medicine provided in this leaflet or those given 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the 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 adverse effects
5. How to store Stimol oral solution
6. Contents of the pack and other information

1. What Stimol oral solution is and what it is used for

Contains citrulline as the active substance, which is a non-essential amino acid involved in protein formation and may help in situations of muscle fatigue.

Stimol is indicated for: Symptomatic relief of asthenia (transient tiredness) that may benefit from supplementation with a non-essential amino acid (involved in protein formation).

2. What you need to know before starting to take 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 1 g oral solution.

Children and adolescents

Do not administer to children under 6 years of age, due to lack of data in this population.

For use in children aged 6 to 12 years, medical advice should be sought.

Taking Stimol with other medicines

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

No interaction studies have been conducted.

Pregnancy, breastfeeding and fertility

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

Due to lack of data, Stimol oral solution should not be taken during pregnancy or breastfeeding.

Driving and using machines

The effect of Stimol on the ability to drive and use machines is none or negligible.

Stimol 1 g oral solution contains sodium

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

3. How to take Stimol oral solution

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Oral use.

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

Use in children

Children aged 6 to 12 years, under medical supervision: 2 sachets per day, taken with lunch and dinner.

Do not administer to children under 6 years of age.

Treatment should be short-term (12 days).

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

If symptoms worsen or persist after 1 week, consult your 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, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Stimol oral solution

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

In some cases, short-lived stomach pains have been reported, and rarely, nervousness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse 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 EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Stimol 1 g oral solution

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

Appearance of the product and contents of the pack

Stimol is an oral solution, a yellowish liquid.

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

Each pack contains 18 sachets.

Marketing Authorization Holder and Manufacturer

Biocodex
22 rue des Aqueducs
94257 Gentilly - FRANCE

You may request further information about this medicinal product from the local representative of the Marketing Authorization Holder:

Laboratorios Pérez Giménez
Telephone: 957 271100

Date of the most recent review of this leaflet: December 2015.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.