Salviamed tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Salviamed, tablets
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
This medicine can be purchased without a prescription, for the treatment of minor conditions, without the intervention of a doctor. However, to obtain the best results, it must be used properly.
Follow exactly the instructions for use 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 symptoms worsen or persist after 8 weeks of treatment, you should consult a doctor.
- If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not described in this leaflet.
Leaflet contents:
- What SalviaMed tablets are and what they are used for
- Before taking SalviaMed tablets
- How to take SalviaMed tablets
- Possible adverse effects
- Storage of SalviaMed tablets
- Further 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 flushes, night sweats, and excessive sweating, based exclusively on its traditional use.
2. Before taking SalviaMed tablets
Do not take SalviaMed tablets if you:
- Are allergic to sage (Salvia officinalis) or to any of the other
components of this medicine.
- Are under 18 years of age.
- Are pregnant or breastfeeding.
Take special care with SalviaMed tablets
- If symptoms worsen or no improvement is seen after 8 weeks of treatment,
consult your doctor.
- This medicine contains sucrose. If your doctor has informed you of an intolerance
to certain sugars, 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 Breast-feeding
As a precautionary measure and in the absence of sufficient data, use during
pregnancy and breast-feeding is not recommended.
IMPORTANT FOR WOMEN
If you are pregnant or think you might be pregnant, consult your doctor before
taking this medicine. Taking medicines during pregnancy may be harmful to the
embryo or fetus and should be monitored by your doctor.
Driving and using machines:
Based on current knowledge, the ability to drive vehicles and use machines is not affected.
3. How to take SalviaMed tablets
Recommended dose: Adults (over 18 years of age), take one
tablet per day.
SalviaMed tablets are administered orally.
This product is not intended for patients under 18 years of age.
Follow the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist.
If symptoms worsen or no improvement is observed after 8 weeks of treatment, consult your 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 contact the Toxicology Information Service at telephone number 91 562 0420, indicating the medication and the amount taken.
If you forget to take SalviaMed tablets
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Make sure you have read section 2 of this leaflet.
Do not take SalviaMed tablets if you are allergic to sage (Salvia officinalis) or to any of the other components of this medicine.
Adverse effects have not been reported with the use of products containing sage extract.
If you experience any adverse effects, consult your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of SalviaMed tablets
- Keep this medicine out of sight and reach of children.
- Do not use SalviaMed tablets after the expiry date stated on the packaging.
- Use within 8 months of opening.
- No special storage conditions required.
- Do not use the medicine if you notice any changes in its appearance. SalviaMed tablets are yellowish-brown, oblong tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
One SalviaMed tablet contains the following active substance:
51 mg of dry extract from fresh leaves of Salvia officinalis L., equivalent 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 diestearate
Pack size
Amber glass bottle containing 30 tablets. Oral use.
Marketing Authorization Holder
Bioforce España A.Vogel, S.A.
Platón 6,
08021-Barcelona
Spain
Tel 93 201 99 22
Fax 93 209 03 19
Manufacturer
A.VOGEL B.V.
J.P. Broekhovenstraat 16 ELBURG - The Netherlands
Date of the most recent revision of this leaflet: December 2022
“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products
(AEMPS)http://www.aemps.gob.es/”