Stimol®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STIMOL® (STIMOL®)

Composition:

Active substance: citrulline malate;

1 sachet contains citrulline malate 1 g;

Excipients: natural orange sangria flavour solution, concentrated sodium hydroxide solution, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: colourless or yellowish liquid with an orange odour.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolic processes. Amino acids and their derivatives. ATC code A16AA.

Pharmacological properties.

Pharmacodynamics.

Citrulline malate is an equimolar mixture of malate and L-citrulline.

Malate stimulates the Krebs cycle and activates cellular energy production mechanisms, reduces lactate levels in blood and tissues, prevents the development of lactic acidosis, and increases ATP levels. Citrulline is one of the amino acids involved in the urea cycle, promoting the formation and excretion of urea from the body.

Pharmacokinetics.

Citrulline malate is rapidly absorbed in the intestine. Maximum concentration is reached within 45 minutes, exceeding baseline levels by 6–15 times, and returns to baseline after 5–6 hours.

Clinical characteristics.

Indications.

Symptomatic treatment of functional asthenia:

− physical asthenia;

− psychic asthenia;

− post-infectious asthenia;

− postoperative asthenia;

− asthenia in elderly patients;

− asthenia in athletes;

− vegetovascular dystonia of the hypotonic type;

− alcohol withdrawal syndrome;

− sexual asthenia.

The drug is indicated for asthenia symptoms: general weakness, emotional lability, chronic fatigue, low work capacity, drowsiness.

The drug is indicated for muscle pain and cramps caused by lactate accumulation after physical exertion. Recommended during the convalescence period in diseases leading to the development of asthenovegetative syndrome.

Contraindications.

Hypersensitivity to any component of the drug. Gastric or duodenal ulcer.

Interaction with other medicinal products and other forms of interaction.

Not known.

Special precautions for use.

One sachet of Stimol® contains approximately 30 mg (1.3 mmol) of sodium used to adjust the solution pH to 3.3. This should be taken into account when administering the drug to patients on a salt-free diet.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

No influence.

Dosage and Administration.

Orally, after dissolving the contents of the sachet in 100 mL of water or a sweetened beverage. Take during meals.

Adults: 1 sachet 3 times daily.

Children aged 6 years and older: 1 sachet 2 times daily.

Recommended duration of treatment: 4 weeks.

Children. The efficacy and safety of the drug in children under 6 years of age have not been sufficiently studied. The drug should be used in children aged 6 years and older.

Overdose. Not reported.

Side effects.

In individual cases, mild epigastric pain and allergic reactions are possible.

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging. 10 ml in a sachet. 18 sachets in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

BIODEX.

Manufacturer's location and address of business activity.

Manufacturing address: 1 Avenue Blaise Pascal, 60000 Beauvais, France / 1 avenue Blaise Pascal, 60000 Beauvais, France.