Echinamed junior comprimidos

EchinaMed Junior, tablets

PROSPECTO: information for the user

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

2. Before taking EchinaMed Junior

3. How to take EchinaMed Junior

4. Possible adverse effects

5. Storage of EchinaMed Junior

6. Additional information

EchinaMed Junior tablets, is a traditional herbal medicine to relieve symptoms of the common cold and flu, based exclusively on its traditional use.

Do not take EchinaMed Junior if you:

• Are allergic to plants of the Asteraceae family (Compositae), 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. HIV).
• 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.

Do not administer to children under 1 year old.

Be especially careful with EchinaMed Junior

• If during the use of the medication, symptoms worsen or high fever occurs, 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.

Interactions with other medications:

Do not take this medication with immunosuppressants such as ciclosporin and methotrexate.

Pregnancy and Breastfeeding

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

IMPORTANT FOR WOMEN

If you are pregnant or believe you may be, 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 operating machinery:

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

Teenagers 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 an oral medication.

Treatment should start as soon as the first symptoms of the cold appear. The recommended treatment duration 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, consult a doctor or pharmacist.

Not recommended for children under 6 years old.

Contraindicated in children under 1 year old.

If you take more EchinaMed Junior than you should

If you feel unwell due to excessive intake, inform your doctor. Excessive intake is unlikely to be harmful.

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

If you forgot to take EchinaMed Junior

Do not take a double dose to compensate for the missed doses.

Please ensure you have read section 2 of this prospectus

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

Like all medications, EchinaMed Junior may have adverse effects. Discontinue treatment and consult your doctor if you experience allergic reactions such as:

• Skin rash

• Urticaria

• Inflammatory skin disorders (Stevens-Johnson Syndrome)

• Skin swelling due to fluid

• 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 linked to the development of autoimmune diseases such as disseminated encephalitis, erythema nodosum, immunothrombocytopenia, Evans Syndrome, and 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 or pharmacist or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep in the original packaging 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 packaging.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

A EchinaMed Junior tablet contains the following active principles:

380 mgof fresh aerial part extract (as dry extract) ofEchinacea purpurea(L.) MOENCH

20 mgof fresh root extract (as dry extract) ofEchinacea purpurea(L.) MOENCH

The other components are excipients:

Sorbitol

Betaciclodextrin

Anhydrous colloidal silica

Vegetal origin magnesium stearate

Orange flavoring.

Package size

Bottle with 120 tablets

Oral use

Manufacturer

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Tel 93 201 99 22

Fax 93 209 03 19

www.avogel.es

Responsible for Manufacturing

A. VOGEL B.V.

J.P. Broekhovenstraat 16

ELBURG - Netherlands

This prospectus has been approved in: January 2020

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Products (AEMPS) http://www.aemps.gob.es/