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ECHINAMED TABLETS

ECHINAMED TABLETS

Ask a doctor about a prescription for ECHINAMED TABLETS

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use ECHINAMED TABLETS

Introduction

Package Leaflet: Information for the User

EchinaMed Tablets

Read this package leaflet carefully, as 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. Nevertheless, to achieve the best results, it should

be used with caution.

  • 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 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 package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

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

1. What is EchinaMed and what is it used for

It is indicated for the treatment of the common cold.

EchinaMed belongs to a group of medications called

Immunostimulants of plant origin. It acts by stimulating the body's defenses.

2. Before taking EchinaMed

Do not take EchinaMedif you:

?Are allergic to plants of the Asteraceae family (Composites) or to any of the product's components.

?Have tuberculosis.

?Have a tendency to have allergies with symptoms of urticaria, eczema, or asthma.

?Suffer from an autoimmune disease.

?Have conditions that reduce your resistance to infection (e.g., AIDS)

?Are undergoing treatment with immunosuppressants (e.g., treatment to prevent organ rejection after a transplant)

?Are receiving treatment that reduces your response to infections (e.g., chemotherapy or radiotherapy for cancer treatment)

?Suffer from diseases characterized by a low white blood cell count, such as agranulocytosis.

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

Be careful with EchinaMed

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. They should consult their doctor before taking this medication.

It is not recommended for administration to children under 12 years of age, as its efficacy

has not been sufficiently proven.

This medication contains sucrose. Patients with known hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medication.

This medication contains sorbitol. Patients with hereditary problems of fructose intolerance should not take this medication.

Pregnancy and Breastfeeding

No studies have been conducted during pregnancy or breastfeeding with this

medication, so its administration is not recommended, except under medical discretion.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Driving and Using Machines

No studies have been conducted on the effect of EchinaMed on the ability to drive vehicles and use machinery; however, based on its activity, it is unlikely to be altered.

Taking Other Medications

There is no evidence that extracts of Echinacea purpureainteract with other medications; however, due to its activity, it is not recommended to take this medication with immunosuppressants such as cyclosporine and methotrexate.

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

3. How to Take EchinaMed

Follow these instructions unless your doctor has given you different instructions. Remember to take your medication.

EchinaMed is a medication that is administered orally.

The recommended daily dose for adults, the elderly, and children over 12

years is 1 tablet 3 times a day.

The tablets should be taken with water before the main meals or can also be dissolved in the mouth.

Start treatment at the first symptom of a cold. Do not take this medication for more than 10 days.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more EchinaMed than you should:

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

If you forget to take EchinaMed:

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

4. Possible Side Effects

VERY IMPORTANT, make sure you have read section 2. Before Taking EchinaMed, of this package leaflet, before reading this section 4.

EchinaMedmay have side effects, as with all medications. Interrupt treatment and consult your doctor if any of the following effects occur:

Allergic reactions such as:

? 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)

This medication may trigger allergic reactions in patients who have a tendency to have allergies.

A relationship has been reported with autoimmune diseases such as:

? inflammation of the brain and spinal cord (disseminated encephalitis)

? painful lumps on the shin (erythema nodosum)

? decreased platelet count (immune thrombocytopenia)

? destruction of blood cells by antibodies (Evans Syndrome)

? dry eyes and mouth with tubular kidney damage (Sjögren's Syndrome)

Leukopenia may occur with long-term use (more than 8 weeks)

The frequency of these side effects is unknown.

If you consider that any of the effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform 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 not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: 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

This medication does not require special storage conditions.

It should be stored in the original packaging.

Keep out of the reach and sight of children.

Do not use EchinaMedafter the expiration date indicated on the packaging.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need.

In this way, you will help protect the environment.

6. Additional Information

One EchinaMed tablet contains as active ingredients:

  • 17.7 mg of dry extract of the fresh aerial part of Echinacea purpureaequivalent to 1140 mg of hydroethanolic extract.
  • 0.9 mg of dry extract of the fresh root of Echinacea purpureaequivalent to 60 mg of hydroethanolic extract.

Extraction solvent: ethanol at 57.3% (m/m)

The other components are excipients:

Mannitol (E 421)

Medium-chain triglycerides

Sucrose esters of fatty acids (E 473)

Sorbitol (E 420)

Croscarmellose sodium

Magnesium stearate (of vegetable origin)

Package Size

Package containing 30 tablets.

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

  • VOGEL B.V.

J.P.Broekhovenstraat 16, Elburg

Netherlands

This package leaflet was approved in: July 2023

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/

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