Echinamed Junior tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
EchinaMed Junior, tablets
PACKAGE LEAFLET: Information for the user
Read this entire leaflet carefully as it contains important information for you.
This medicine is available without a prescription for the treatment of minor conditions without the intervention of a doctor. However, to achieve the best results, it must be used carefully.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist beyond ten days, you should consult a doctor.
- If you consider any of the side effects you experience to be severe or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What EchinaMed Junior is and what it is used for
- Before taking EchinaMed Junior
- How to take EchinaMed Junior
- Possible side effects
- How to store EchinaMed Junior
- Further information
1. What EchinaMed Junior is and what it is used for
EchinaMed Junior tablets are a traditional herbal medicinal product used to relieve symptoms of cold and flu, based solely on long-standing traditional use.
2. Before taking EchinaMed Junior
Do not take EchinaMed Junior if you:
- Are allergic to plants of the Asteraceae (Compositae) family, or to any of the components of the product.
- Have tuberculosis or sarcoidosis.
- Have an autoimmune disease.
- Have conditions that reduce your resistance to infection (e.g., AIDS).
- Are undergoing treatment with immunosuppressants.
- Suffer from diseases characterized by a low white blood cell count, such as agranulocytosis or leukemia.
- Have a tendency to develop allergies with symptoms such as urticaria, eczema, or asthma.
This medicine must not be given to children under 1 year of age.
Take special care with EchinaMed Junior:
- If your symptoms worsen or you develop high fever during treatment, consult a doctor or pharmacist.
- There is a possible risk of anaphylactic reaction in atopic patients, who should consult their doctor before taking this medicine.
- This medicine contains sorbitol. If you have been advised by your doctor that you have an intolerance to certain sugars, consult him/her before taking this medicine.
Taking other medicines:
It is not recommended to take this medicine concomitantly with immunosuppressants such as cyclosporine and methotrexate.
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 dangerous for the embryo or fetus and should be under medical supervision.
Driving and using machines:
No studies have been conducted on the effects of EchinaMed Junior on the ability to drive vehicles or operate machinery.
3. How to take EchinaMed Junior
Adolescents over 12 years of age
Take 2 tablets, 3 to 5 times daily.
Children from 6 to 12 years of age
Take 1 tablet, 3 to 5 times daily.
EchinaMed Junior is a medicine taken orally.
Treatment should begin as soon as the first cold symptoms appear. The recommended duration of treatment is 10 days.
The tablets should be taken with water or allowed to dissolve in the mouth, before meals.
Do not exceed the recommended dose.
If symptoms persist for more than 10 days, consult your doctor or pharmacist.
Not recommended for children under 6 years of age.
Contraindicated in children under 1 year of age.
If you take more EchinaMed Junior than you should
If you feel unwell due to an overdose, inform your doctor. An overdose is unlikely to be harmful.
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 medicine and the amount ingested.
If you forget to take EchinaMed Junior
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 EchinaMed Junior if you are allergic to plants from the Asteraceae (Compositae) family, or to any of the components of the product.
Like all medicines, EchinaMed Junior may have adverse effects. Discontinue treatment and consult your doctor if allergic reactions occur, such as:
- Skin rash
- Urticaria
- Inflammatory skin disorders (Stevens-Johnson syndrome)
- Skin swelling due to fluid accumulation
- Facial swelling (Quincke's edema)
- Reduced airflow to the lungs (bronchospasm)
- Asthma and severe allergic reactions (anaphylactic shock)
Echinacea may trigger allergic reactions in atopic patients.
The use of Echinacea purpurea preparations has been associated with the onset of autoimmune diseases such as disseminated encephalitis, erythema nodosum, immunothrombocytopenia, Evans' syndrome, Sjögren's syndrome with renal tubular dysfunction.
The frequency of these adverse effects is unknown.
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it involves possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of EchinaMed Junior
Keep in the original container to protect from moisture. Store at room temperature.
Keep out of the reach and sight of children.
Do not use EchinaMed Junior after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Additional Information
One tablet of EchinaMed Junior contains the following active substances:
380 mg of tincture (as dry extract) from the fresh aerial parts of Echinacea purpurea (L.) MOENCH
20 mg of tincture (as dry extract) from the fresh root of Echinacea purpurea (L.) MOENCH
The other components are excipients:
Sorbitol
Betacyclodextrin
Anhydrous colloidal silica
Vegetable magnesium stearate
Orange flavoring.
Pack size
Bottle with 120 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
www.avogel.es
Manufacturer
- VOGEL B.V.
J.P. Broekhovenstraat 16
ELBURG - The Netherlands
This leaflet was approved in: January 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/