ACTION AND MECHANISM

- Expectorant, antispasmodic. Thyme helps thin bronchial secretions by irritating the bronchial epithelium, increasing secretion production.

The expectorant effect could be facilitated by relaxing activity of the bronchial smooth muscle and stimulation of the movements of the bronchial cilia, as seen in in vitro tests.

SPECIAL WARNINGS

<?xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" />- If during treatment symptoms worsen or persist, or if symptoms such as fever, dyspnea or purulent sputum occur, patients should consult a doctor.
- The recommended duration of treatment is 5 days, after which the patient should consult a doctor if there has been no significant improvement.

SENIORS

No specific problems have been described in the elderly that require dosage adjustment.

COMPOSITION

Per tablet: 59.5 mg of dry extract of Thymus vulgaris or Thymus Zygis (thyme leaves and flowers), drug-extract ratio (DER) = 7-13: 1, extraction solvent: water.

Excipients with known effect: Fructose 300 mg. Sorbitol 523 mg

PATIENT ADVICE

- The recommended duration of treatment is 5 days.
- Consult your doctor if there is no significant improvement after 5 days of treatment. Consult your doctor if the patient's condition worsens or does not improve during treatment, or if they experience fever, difficulty breathing, or purulent phlegm.

CONTRAINDICATIONS

- Hypersensitivity to thyme, other components of the Lamiaceae or labiatae family (basil, spearmint, lemon balm, mint, oregano, rosemary, sage) or any other component of the medication.

PREGNANCY

There are no adequate and well-controlled studies in pregnant women, so the use of thyme during pregnancy at doses higher than those used in food is only acceptable if, in the absence of safer therapeutic alternatives, the benefits outweigh the potential risks.

INDICATIONS

- For [PRODUCTIVE COUGH] associated with a cold and to soothe a sore throat.
Traditional herbal medicine; based exclusively on its traditional use.

INTERACTIONS

No interaction studies have been performed.

LACTATION

It is unknown whether thyme components are excreted in breast milk, and what consequences this could have for the infant, is unknown. It is advisable to discontinue breastfeeding or avoid using thyme in doses higher than those used in breastfeeding.

CHILDREN

Safety and efficacy have not been evaluated in children under 6 years of age, so it is recommended to avoid its use.

RULES FOR CORRECT ADMINISTRATION

- Soft tablets should be sucked until they dissolve in the mouth.

POSOLOGY

- Adults and adolescents > 12 years, oral: 1-2 tablets/4 hours (4 times a day). Maximum dose: 12 tablets/day.
- Children 6 – 12 years, oral: 1 tablet 3 times a day.
- Children < 6 years: safety and efficacy have not been evaluated.
Treatment duration: 5 days. If there is no significant improvement during this period, it is advisable to consult your doctor.

PRECAUTIONS

- If during treatment at the recommended doses of this medicine, symptoms worsen or persist, or if symptoms such as [FEVER], [DYSPNEA] or [PURULENT SPUTUM] occur, patients should consult a doctor.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains fructose. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medicine.

ADVERSE REACTIONS

Thyme is generally well tolerated. The following adverse reactions have been reported:
- Digestive. Nonspecific gastric disorders.
- Allergic/dermatological. Allergic reactions have been reported, including one case of anaphylaxis and another of Quincke's edema.
In addition to these adverse reactions, other possible adverse reactions have been recorded in the FEDRA database (Spanish Pharmacovigilance, Adverse Reaction Data) of the Spanish Pharmacovigilance System, although a cause-effect relationship with thyme has not been demonstrated:
- Digestive. Anorexia.
- Cardiovascular. Tachycardia.
- Neurological/psychological. Vertigo.
- Allergic/dermatological. Erythema and maculopapular rash.

OVERDOSE

Symptoms: There is no clinical experience with overdose with thyme.
However, it should be noted that its essential oil, and especially thymol, are toxic substances when ingested in high doses, and can cause nausea, vomiting, stomach pain, headache, dizziness, seizures, and in severe cases, coma and death.
Treatment: Symptomatic treatment is recommended. Internal use of the essential oil as is is not recommended.
In case of overdose or accidental ingestion, go to a medical center or consult the Poison Control Center, indicating the product and the amount ingested.

COMPOSITION

THYME: 59.5 MILLIGRAMS - DRY EXTRACT
FRUCTOSE (EXCIPIENT): 300 MILLIGRAMS
SORBITOL (E-420) (EXCIPIENT): 523 MILLIGRAMS