SANTAMED 01 Herbal mixture for infusion, slimming sachets 24Sachet

IN THIS ANNEX, THE TERMS "MARKETING AUTHORISATION" ARE UNDERSTOOD AS "REGISTRATION OF TRADITIONAL HERBAL MEDICINAL PRODUCT" AND THE TERM "AUTHORISATION" AS "REGISTRATION"

Blackcurrant (Ribes nigrum L.) (leaf of) ............................................................................................ 0,600 g

Ash (Fraxinus excelsior L.) (leaf of) ..................................................................................... 0,450 g

Green tea (Camellia sinensis L.) (leaf of)................................................................................... 0,375 g

For one sachet of 1,5 g.

Traditional herbal medicinal product used:

• As an adjuvant in minor urinary disorders by promoting diuresis.
• As a supplement to a hypocaloric diet to facilitate weight loss in overweight adults, provided that any serious pathology has been previously ruled out by a doctor.

Its use is restricted to the specified indication exclusively on the basis of long-standing use.

SANTAMED 01, mixture of plants for herbal tea in sachet is indicated in adults.

Dosage

Adults

1 to 4 sachets per day, preferably after meals.

Paediatric population

The use of SANTAMED 01, mixture of plants for herbal tea in sachet is not recommended in children and adolescents under 18 years (see section Warnings and precautions).

Method of administration

Oral use.

Use 1 sachet per cup of boiling water, as an infusion. Bring water to the boil and pour it over the sachet, cover and leave to infuse for 15 minutes then remove the sachet. The herbal tea must be prepared at the time of use.

Duration of ttreatment

• As an adjuvant in minor urinary disorders:

2 weeks.

If symptoms persist beyond 2 weeks of treatment, a doctor or pharmacist must be consulted.

• In addition to a low-calorie diet to facilitate weight loss.

1 month.

If after 1 month of treatment taking this medicine has not resulted in weight loss, a doctor or pharmacist must be consulted.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

Conditions for which it is recommended to reduce fluid intake (for example, serious heart or kidney diseases).

If symptoms persist or worsen while using the medicine, a doctor or pharmacist must be consulted.

If symptoms such as fever, painful urination, spasms or blood in the urine occur while using this medicine, a doctor or pharmacist must be consulted.

To ensure an increase in urine volume, sufficient water intake is necessary during treatment.

Paediatric population

The use in children and adolescents aged less than 18 years has not been established due to the absence of adequate data. Therefore, the use of SANTAMED 01, herbal tea mixture in sachets, is not recommended in children and adolescents under 18 years.

No interaction studies have been performed.

Pregnancy

Safety during pregnancy has not been established. In the absence of sufficient data, the use of this medicine is not recommended during pregnancy.

Breast-feeding

Safety during breastfeeding has not been established. In the absence of sufficient data, the use of this medicine is not recommended during breastfeeding.

Fertility

No data on fertility are available.

The effects on the ability to drive vehicles and use machines have not been studied.

No adverse effects have been described.

Reporting of suspected adverse reactions

Reporting of suspected adverse effects after the drug has been registered is important. It allows continuous monitoring of the benefit/risk profile of the drug. Health professionals report any suspected adverse effect through the national reporting system: the National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

No cases of overdose have been reported.

A genotoxicity study conducted in vitro with the infusions of the plants contained in the specialty SANTAMED 01, herbal tea mixture in sachets, did not show a mutagenic effect in the Ames test.

No carcinogenicity or reproductive toxicity studies have been carried out.

3 years.

Store protected from light and moisture.

No special requirements.