ECHINAMED JUNIOR Tablets

Introduction

EchinaMed Junior, tablets

PACKAGE LEAFLET: information for the user

Read the entire leaflet carefully because it contains important information for you.

This medication can be obtained without a prescription, for the treatment of minor conditions without the intervention of a doctor. However, to obtain the best results, it should be used with care.

• 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 ten days, you should consult a doctor.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What is EchinaMed Junior and what is it used for
2. Before taking EchinaMed Junior
3. How to take EchinaMed Junior
4. Possible side effects
5. Storage EchinaMed Junior
6. Additional information

1. What is EchinaMed Junior and what is it used for

EchinaMed Junior tablets are a traditional herbal medicinal product to relieve the symptoms of the common cold and flu, based exclusively on its 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 product's components.
• Suffer from tuberculosis or sarcoidosis
• Suffer from 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 have allergies with symptoms of urticaria, eczema, or asthma.

It should not be administered to children under 1 year of age

Be careful with EchinaMed Junior

• If during the use of the medication, symptoms worsen or there is a high fever, you should consult a doctor or pharmacist.
• There is a possible risk of anaphylactic reaction in atopic patients, who should consult their doctor before taking this medication.
• This medication contains sorbitol. If you have been informed by your doctor that you have an intolerance to certain sugars, consult with them before taking this medication.

Taking other medications:

It is not recommended to take this medication along with immunosuppressants such as cyclosporine and methotrexate.

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 medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machinery:

No studies have been conducted on the effects of EchinaMed Junior on the ability to drive vehicles and use machinery.

3. How to take EchinaMed Junior

Adolescents over 12 years old

Take 2 tablets, 3 to 5 times a day.

Children from 6 to 12 years old

Take 1 tablet, 3 to 5 times a day.

EchinaMed Junior is a medication that is administered orally.

Treatment should begin as soon as the first symptoms of the cold appear. The recommended duration of treatment is 10 days.

Tablets should be taken with water or dissolved in the mouth, before meals.

Do not use more than the recommended dose

If symptoms persist for more than 10 days, you should consult a doctor or pharmacist.

It is not recommended for children under 6 years old.

It is contraindicated for use in children under 1 year of age.

If you take more EchinaMed Junior than you should

If, as a result of excessive intake, you feel unwell, tell your doctor. An overdose is unlikely to be harmful.

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

If you forget to take EchinaMed Junior

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 leaflet

Do not take EchinaMed Junior if you are allergic to plants of the Asteraceae (Compositae) family, or to any of the product's components.

Like all medications, EchinaMed Junior can have side effects. Interrupt treatment and consult your doctor if allergic reactions occur, such as:

• Skin rash
• Urticaria
• Inflammatory skin disorders (Stevens-Johnson syndrome)
• Fluid-induced skin swelling
• 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 purpureapreparations 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 side effects is unknown.

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of EchinaMed Junior

Keep in the original package to protect it from moisture. Store at room temperature.

Keep out of the reach and sight of children

Do not use EchinaMed Junior after the expiration date indicated on the package.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Additional information

One EchinaMed Junior tablet contains as active ingredients:

380 mgof tincture (as dry extract) of the fresh aerial part of Echinacea purpurea(L.) MOENCH

20 mgof tincture (as dry extract) of the fresh root of Echinacea purpurea(L.) MOENCH

The other components are excipients:

Sorbitol

Betacyclodextrin

Colloidal anhydrous silica

Vegetable magnesium stearate

Orange flavoring.

Package size

Bottle with 120 tablets

Oral use

Holder

Bioforce Spain 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 - Netherlands

This leaflet was approved in: January 2020

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