Leaflet: Information for the User

DigesmintTisana

Mentha x piperitaL,Pimpinella anisumL,Glycyrrhiza glabraL

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

Follow exactly the administration instructions for the medicine contained in this

leaflet or those 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 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 if you do not improve after 14 days.

1. What is Digesmint and what it is used for

2. What you need to know before starting to take Digesmint

3. How to take Digesmint

4. Possible side effects

5. Storage of Digesmint

6. Contents of the pack and additional information

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

Consult a doctor if it worsens or does not improve after 14 days.

Do not take Digesmint

If you are allergic to the active ingredients or to Apiaceas (Umbelliferas) (caraway, celery, coriander, dill, and fennel) or to menthol and anethol, or to any of the other components of this medication (listed in section 6).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Digesmint

Patients with gastroesophageal reflux (heartburn), should avoid preparations with peppermint leaf as it may increase heartburn.

Patients with gallstones and any biliary alteration, should be cautious when using preparations with peppermint leaf.

If symptoms worsen during use of the medication, consult a doctor or pharmacist.

Children and Adolescents

Do not administer this medication to children under 12 years old.

Other medications and Digesmint

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Excessive consumption of licorice root induces hypokalemia (decrease in the amount of potassium circulating 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 diuretics or loop diuretics, adrenocorticosteroids, stimulant laxatives) and exacerbate electrolyte imbalance.

Taking Digesmint with food, drinks, and alcohol

Unknown.

Pregnancy, breastfeeding, and fertility

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

No adequate and well-controlled studies have been conducted in pregnant women, or in breastfeeding women, therefore administration is not recommended.

Driving and operating machines

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

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

The recommended dose is:

Adults and children over 12 years: one infusion, three times a day.

Form and route of administration

Oral route. The infusion must be prepared by pouring 200 ml (one cup) of boiling water over a bag/filter. Leave to infuse for 10 minutes. Remove the bag.

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

If symptoms persist after 14 days of use of this medication, consult your doctor or pharmacist.

Use in children and adolescents

Do not administer to children under 12 years.

If you take moreDigesmintthan you should

No cases of overdosing with Digesmint have been described.

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

If you forgot to take Digesmint

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

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

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

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

The presence of mint may worsen gastroesophageal reflux.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly through theSpanish 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.

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.

Do not use this medication if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Digesmint Composition

The active principles are per each bag/filter:

• 0.608 g of Leaves ofMentha x piperitaL (Mint).

(Essential oil content > 9 ml/kg)

• 0.496 g of Fruits ofPimpinella anisumL (Anise)

(Essential oil content > 20 ml/kg)

• 0.496 g of Root ofGlycyrrhiza glabraL (Licorice).

(Glycyrrhizic acid content > 4.0 %)

Product appearance and packaging contents:

This medication is presented in a cardboard container containing 20 bag/filter for infusion in polypropylene sachets.

Marketing authorization holder and responsible manufacturer:

SORIA NATURAL S.A.

Polígono La Sacea nº 1.

Garray. (Soria).

Tel: 975252046

Fax: 975252267

e-mail: [email protected]

Last review date of this leaflet: March 2019

“Detailed information on this medication is available on the website of the

Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/”