DIGESMINT TISANE (Herbal Tea)

Introduction

Leaflet: information for the user

Digesmint Tisane

Mentha x piperitaL, Pimpinella anisumL, Glycyrrhiza glabraL

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated 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 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 your symptoms worsen or do not improve after 14 days.

Contents of the leaflet:

1. What is Digesmint and what is it used for
2. What you need to know before taking Digesmint
3. How to take Digesmint
4. Possible side effects
5. Storage of Digesmint
6. Package contents and additional information

1. What is Digesmint and what is it used for

Traditional herbal medicine for the symptomatic relief of digestive disorders such as dyspepsia and flatulence, based exclusively on its traditional use.

You should consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Digesmint

Do not takeDigesmint

If you are allergic to the active ingredients or to Apiaceae (Umbelliferae) (caraway, celery, coriander, dill, and fennel) or to menthol and anethole, or to any of the other components of this medicine (listed in section 6).

In case of cardiovascular disorders such as hypertension, renal disorders, liver disorders (cholestatic or inflammatory), hypokalemia, and severe obesity.

Warnings and precautions

Consult your doctor or pharmacist before taking Digesmint.

Patient with gastroesophageal reflux (acidity) should avoid peppermint preparations as they may increase acidity.

Patient with bile stones and any biliary disorder should be cautious when using peppermint preparations.

If symptoms worsen during the use of the medicine, you should consult a doctor or pharmacist.

Children and Adolescents

This medicine is not recommended for children under 12 years of age.

Other medicines and Digesmint

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Excessive consumption of licorice root induces hypokalemia (decrease in the amount of circulating potassium in the blood), and this may potentiate the action of cardiac glycosides, interact with antiarrhythmic drugs or with other hypokalemia-inducing drugs (e.g., thiazide or loop diuretics, adrenocorticosteroids, stimulant laxatives), and worsen electrolyte imbalance.

Taking Digesmint with food, beverages, and alcohol

None known.

Pregnancy, breastfeeding, and fertility

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

There are no adequate and well-controlled studies in pregnant or breastfeeding women; therefore, its administration is not recommended.

Driving and using machines

No studies have been conducted on how this medicine affects the ability to drive vehicles and use machines.

3. How to take Digesmint

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years: one tisane, 3 times a day.

Form and route of administration

Oral route. The infusion should be prepared by pouring about 200 ml (one glass) of boiling water over a bag/filter. Let it rest for 10 minutes. Remove the bag.

Do not use this medicine for more than 14 days without consulting your doctor or pharmacist.

If symptoms persist after 14 days of using this medicine, consult your doctor or pharmacist.

Use in children and adolescents

This medicine is not recommended for children under 12 years of age.

If you take moreDigesmintthan you should

No cases of overdose with Digesmint have been reported.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Digesmint

Do not take a double dose to make up for the forgotten dose.

Take Digesmint as soon as possible, continuing the treatment as prescribed. If the next dose is near, it is better to wait for the next intake.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Allergic reactions (hypersensitivity) to anise have been described, although the frequency of occurrence is unknown.

Due to the presence of peppermint, it may worsen gastroesophageal reflux.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Digesmint

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Digesmint

The active ingredients are per bag/filter:

• 0.608 g of Mentha x piperitaL (Peppermint) leaves.

(Essential oil content > 9 ml/kg)

• 0.496 g of Pimpinella anisumL (Anise) fruits.

(Essential oil content > 20 ml/kg)

• 0.496 g of Glycyrrhiza glabraL (Licorice) root.

(Glycyrrhizic acid content > 4.0%)

Appearance of the product and package contents:

This medicine is presented in a cardboard package containing 20 bags/filters for infusion in polypropylene sachets.

Marketing authorization holder and manufacturer:

SORIA NATURAL S.A.

Polígono La Sacea nº 1.

Garray. (Soria).

Tel: 975252046

Fax: 975252267

e-mail: soria@sorianatural.es

Date of the last revision of this leaflet: March 2019

“Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/”