Leaflet: information for the user

STIMOL 1g oral solution

Citrulline malate

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

Follow exactly the administration instructions contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 7 days.

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

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

3. How to take Stimol oral solution

4. Possible side effects

5. Storage of Stimol oral solution

6. Contents of the pack and additional information

It contains citrulline as the active ingredient, which is an essential amino acid that is involved in the formation of proteins and may help in situations of muscle fatigue.

Stimol is indicated for: Symptomatic relief of asthenia (temporary fatigue) that may benefit from the intake of an essential amino acid (involved in protein formation).

Do not take Stimol:

- If you are allergic to citrulline or any of the other components of this medication (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 old, as there is no data available for this age group.

For use in children aged 6 to 12 years, consult your doctor.

Taking Stimol with other medications

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

No interaction studies have been conducted.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Since there is no data available, do not take Stimol oral solution during pregnancy or breastfeeding.

Driving and operating machinery

The influence of Stimol on the ability to drive and operate machinery is negligible or insignificant.

Stimol 1 g oral solution contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Oral administration.

Adults:3 packets per day, administering one packet during main meals.

Use in children

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

Do not administer to children under 6 years.

Treatment should be of short duration (12 days).

The oral solution should be taken with the help of a glass of water: dissolve the contents of the packet in a glass of water (approx. 150 ml) or another 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 or go to a medical center, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested

If you forgot to take Stimol oral solution

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es

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

This product does not require special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Stimol 1g oral solution

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

Appearance of the product and contents of the packaging

Stimol is an oral solution, a yellowish liquid.

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

Each package contains 18 sachets.

Holder of the marketing authorization and responsible for manufacturing

Biocodex

7, avenue Gallieni

94257 Gentilly - FRANCE

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

Laboratorios Pérez Giménez

Telephone: 957 271100

Date of the last review of this leaflet: December 2015.

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.