Digesmint Tisana
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Digesmint Herbal Tea
Mentha x piperita L, Pimpinella anisum L, Glycyrrhiza glabra L
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects 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.
Contents of the leaflet:
- What Digesmint is and what it is used for
- What you need to know before taking Digesmint
- How to take Digesmint
- Possible adverse effects
- How to store Digesmint
- Contents of the pack and other information
1. What Digesmint is and what it is used for
A traditional herbal medicinal product for the symptomatic relief of digestive disorders such as dyspepsia and flatulence, based solely on long-standing use.
You should consult a doctor if symptoms worsen or do not improve after 14 days.
2. What you need to know before starting to take Digesmint
Do not take Digesmint
If you are allergic to the active substances 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, 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 (acid reflux) should avoid preparations containing peppermint leaf, as they may increase acidity.
Patients with gallstones or any biliary disorders should use preparations containing peppermint leaf cautiously.
If symptoms worsen during treatment with this 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Excessive consumption of licorice root causes hypokalemia (reduced levels of circulating potassium in the blood), which may potentiate the effects of cardiac glycosides, interact with antiarrhythmic drugs or other drugs that induce hypokalemia (e.g. thiazide diuretics or loop diuretics, adrenocorticosteroids, stimulant laxatives), and worsen electrolyte imbalance.
Taking Digesmint with food, drinks, and alcohol
Not known.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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, administration is not recommended.
Driving and using machines
No studies have been conducted on the effects of this medicine on the ability to drive vehicles or operate machinery.
3. How to take Digesmint
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and children over 12 years of age: one infusion, 3 times daily.
Method and route of administration
For oral use. To prepare the infusion, pour approximately 200 ml (one glass) of boiling water over one tea bag/filter. Let it steep for 10 minutes. Remove the tea bag.
Do not use this medicine for longer 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
Not recommended for children under 12 years of age.
If you take more Digesmint than you should
Cases of overdose with Digesmint have not been reported.
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 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 missed dose.
Take Digesmint as soon as possible, continuing treatment as prescribed. If the next dose is due soon, it is better to wait and take the next dose at the scheduled time.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Allergic reactions (hypersensitivity) to anise have been reported, although the frequency of occurrence is unknown.
Due to the presence of peppermint, gastroesophageal reflux may worsen.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the package and other information
Composition of Digesmint
The active ingredients per tea bag/filter are:
- 0.608 g of Leaves of Mentha x piperita L (Peppermint).
(Essential oil content > 9 ml/kg)
- 0.496 g of Fruits of Pimpinella anisum L (Anise).
(Essential oil content > 20 ml/kg)
- 0.496 g of Root of Glycyrrhiza glabra L (Liquorice).
(Glycyrrhizic acid content > 4.0%)
Appearance of the medicinal product and contents of the pack:
This medicine comes in a cardboard package containing 20 tea bag/filters for infusion, packed 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: [email protected]
Date of the most recent review of this leaflet: March 2019
"Detailed information on this medicine is available on the website of the
Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/"