VITANGO FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Vitango®film-coated tablets

Extract of Rhodiola roseaWS® 1375

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, 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 package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 14 days.

Contents of the Package Leaflet

1. What is Vitango and what is it used for
2. What you need to know before taking Vitango
3. How to take Vitango
4. Possible side effects
5. Storage of Vitango
6. Contents of the pack and further information

1. What is Vitango and what is it used for

Therapeutic IndicationsIt is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress, such as fatigue and weakness. Based exclusively on traditional use.

2. What you need to know before taking Vitango:

Do not take Vitango:If you are allergic (hypersensitive) to the extract of Rhodiola roseaor to any of the other components of this medicine (listed in section 6). Warnings and PrecautionsConsult your doctor or pharmacist before starting to take Vitango. If symptoms persist after two weeks of treatment, you should consult your doctor. After 2 months of treatment, you should consult your doctor about the convenience of continuing with it. Children and AdolescentsThe use of Vitango is not recommended in children and adolescents under 18 years of age. Other Medicinesand VitangoNo interactions are known to date. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Pregnancy and BreastfeedingIf you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The use of the medicine during pregnancy or breastfeeding is not recommended. Driving and Using MachinesNo studies have been conducted on how this medicine affects the ability to drive or use hazardous machinery.

3. How to Take Vitango

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

Vitango are film-coated tablets for oral use.

The recommended dose, unless your doctor has prescribed a different one, is as follows:

Adults and adolescents over 18 years: Take two tablets a day (one before breakfast and one before lunch).

It is recommended to take the tablets with a glass of water. Use in Children and AdolescentsThe use of Vitango is not recommended in children and adolescents under 18 years of age, as there are not enough data on its use in this age group. If you take more Vitango than you shouldNo cases of overdose have been reported. If you forget to take VitangoDo not take a double dose to make up for the forgotten doses. If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Frequency not known (cannot be estimated from the available data):

• Mild headache
• Mild gastrointestinal disorders
• Mild hypersensitivity reactions.

Reporting of Side Effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vitango

No special storage conditions are required.

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP:. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Vitango:The active ingredient is: 200 mg of dry extract of Rhodiola rosea root (1.5-5:1) (WS® 1375).

The extraction agent is ethanol 60% (m/m). The other ingredients (excipients) are microcrystalline cellulose, sodium croscarmellose, precipitated silica, magnesium stearate, hypromellose, stearic acid, red iron oxide (III), titanium dioxide, anti-foam emulsion (simeticone, methylcellulose, sorbic acid). Appearance of the Product and Contents of the Pack:Vitango are round, red, film-coated tablets.

Vitango is available in packs of 15, 20, 30, 40, and 60 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Str. 4

D-76227 Karlsruhe

GERMANY

You can request more information about this medicine by contacting the local representative of the Marketing Authorisation Holder:

SCHWABE FARMA IBÉRICA, S.A.U.

Avenida de la Industria, 4. Edificio 2, escalera 1, 2ª planta.

28108 Alcobendas, Madrid.

Date of the Last Revision of this Package Leaflet:March 2023

Other Sources of Information

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