SALVIAMED TABLETS

Introduction

Package Leaflet: Information for the User

Salviamed, Tablets

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

This medicine can be obtained without a prescription for the treatment of minor conditions, without the intervention of a doctor. Nevertheless, to obtain the best results, it should be used properly.

Follow the administration instructions of the medicine contained in

this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 8 weeks of treatment, you should

consult a doctor

• If you experience side effects, consult your doctor, pharmacist, or nurse,

even if they are side effects not described in this package leaflet.

Contents of the Package Leaflet:

1. What SalviaMed tablets are and what they are used for
2. Before taking SalviaMed tablets
3. How to take SalviaMed tablets
4. Possible side effects
5. Storage of SalviaMed tablets
6. Additional information

1. What SalviaMed tablets are and what they are used for

SalviaMed tablets are a traditional herbal medicinal product used for the relief of menopausal hot flashes, night sweats, and excessive sweating, based exclusively on traditional use.

2. Before taking SalviaMed tablets

Do not take SalviaMed tabletsif you:

• Are allergic to sage (Salvia officinalis)or to any of the other

components of this medicine.

• If you are under 18 years of age.
• If you are pregnant or breastfeeding.

Be cautious with SalviaMed tablets

• If symptoms worsen or do not improve after 8 weeks of treatment, you should consult a doctor.

This medicine contains sucrose. If your doctor has told you that you have intolerance to certain sugars, you should consult your doctor before using this medicine.

Taking other medicines:

If you are being treated with anxiolytic medicines such as benzodiazepines or barbiturates, consult your doctor before using this medicine.

Pregnancy and Breastfeeding

As a precautionary measure and in the absence of sufficient data, use during pregnancy and breastfeeding is not recommended.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The consumption of medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machinery:

Based on current knowledge, the ability to drive vehicles and use machinery is not affected.

3. How to take SalviaMed tablets

The recommended dose is: adults (over 18 years), take one

tablet per day.

SalviaMed tablets are a medicine that is administered orally.

This product is not indicated for patients under 18 years of age.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

If symptoms worsen or do not improve after 8 weeks of treatment, you should consult a doctor.

If you take more SalviaMed tablets than you should:

It is unlikely that symptoms or toxicity will occur.

In case of overdose or accidental ingestion, go to a medical center or consult the Toxicology Information Service, phone 91 562 0420, indicating the medicine and the amount used.

If you forget to take Salviamed tablets

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

4. Possible side effects

Make sure you have read section 2 of this package leaflet.

Do not take SalviaMed tablets if you are allergic to sage (Salvia officinalis)or

to any of the other components of this medicine.

No side effects have been reported with the use of sage extract products.

If you experience side effects, consult your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of SalviaMed tablets

• Keep this medicine out of the sight and reach of children
• Do not use SalviaMed tablets after the expiration date indicated on the packaging.
• Use it within 8 months after opening.
• No special storage conditions are required.
• Do not use the medicine if you notice changes in its appearance. SalviaMed tablets are yellowish-brown, oblong tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

One SalviaMed tablet contains as an active ingredient:

51 mg of dry extract of fresh leaves of Salvia officinalisL, corresponding to 3400 mg of extract (as tincture)

Equivalent in dry plant: 200 mg per tablet

The other components are excipients: Microcrystalline cellulose

Sucrose laurate

Sodium croscarmellose

Colloidal silica

Glycerol distearate

Package size

Ambber glass bottle with 30 tablets. Oral use.

Marketing authorization holder

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Phone 93 201 99 22

Fax 93 209 03 19

Manufacturer

A.VOGEL B.V.

J.P. Broekhovenstraat 16 ELBURG - Netherlands

Date of the last revision of this package leaflet: December 2022

“ Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products

(AEMPS)http://www.aemps.gob.es/”