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ECHINAMED ORAL DROPS IN SOLUTION

ECHINAMED ORAL DROPS IN SOLUTION

Ask a doctor about a prescription for ECHINAMED ORAL DROPS IN SOLUTION

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 ORAL DROPS IN SOLUTION

Introduction

Leaflet: information for the user

EchinaMed oral drops in solution

Read this 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 get 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 the 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 EchinaMed drops are and what they are used for
  2. Before taking EchinaMed drops
  3. How to take EchinaMed drops
  4. Possible side effects
  5. Storage EchinaMed drops
  6. Additional information

1. What EchinaMed drops are and what they are used for

EchinaMed drops are a plant-based medication indicated for the treatment of symptoms of the common cold in adults, adolescents, and children over 12 years old.

2. Before taking EchinaMed drops

Do not take EchinaMed dropsif you:

  • Are allergic to plants of the Asteraceae family (Composites), or to any of the components of the product.
  • Suffer from tuberculosis or sarcoidosis
  • Suffer from an autoimmune disease.
  • Suffer from 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 drops

  • If during the use of the medication, the 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 65% V/V ethanol (alcohol) equivalent to 458

mg of alcohol per dose of 25 drops equivalent to about 13 ml of beer or about 5 ml of

wine.

  • This medication is harmful to alcoholics and should be monitored during pregnancy, breastfeeding, in children, and in high-risk groups such as patients

with liver disease or epileptics.

Taking other medications:

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

This medication contains alcohol and should not be taken simultaneously with other medications that have described interactions with alcohol (e.g., metronidazole)

Pregnancy and Breastfeeding

As a precautionary measure and in the absence of sufficient data, use during pregnancy and breastfeeding is not recommended without medical supervision.

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 dangerous for the embryo or fetus and should be monitored by your doctor.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women.

Driving and using machinery:

No studies have been conducted on the effects of EchinaMed drops on the ability to drive vehicles and use machinery. However, based on its activity, it is unlikely that EchinaMed drops will alter this ability.

3. How to take EchinaMed drops

EchinaMed drops are a medication that is administered orally.

The recommended daily dose for adults, adolescents, and children over 12 years old is 25 drops 3 to 5 times a day.

The drops should be taken with a little water. Treatment should be started when the first symptoms of a cold are detected.

Do not use more than the recommended dose.

Do not take this medication for more than 10 days.

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

It is not recommended to use in children under 12 years old.

It is contraindicated to use in children under 1 year old.

If you take more EchinaMed drops than you should:

In case of excessive intake, symptoms can be expected according to the amount of alcohol ingested.

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 drops

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 drops if you are allergic to plants of the Asteraceae family (Composites), or to any of the components of the product.

Like all medications, EchinaMed drops can have side effects.

Interrupt treatment and consult your doctor if allergic reactions occur

such as:

  • Skin rash (rash)
  • Urticaria
  • Inflammatory skin disorders (Stevens-Johnson syndrome)
  • Swelling of the skin due to fluid
  • Swelling of the face (Quincke's edema)
  • Reduction of air passage to the lungs (bronchospasm)
  • Asthma and severe allergic reactions (anaphylactic shock)

Echinacea may trigger allergic reactions in atopic patients.

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)
  • decrease in platelets (immunothrombocytopenia)
  • destruction of blood cells by antibodies (Evans syndrome)
  • dryness of the 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 experience any type of side effect, consult your doctor or pharmacist

or nurse, even if it is a possible side effect that does not appear in this

leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance 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 drops

Store at room temperature.

Keep out of the reach and sight of children.

Do not use EchinaMed drops after the expiration date indicated on the packaging.

Medications should not be thrown away through drains or into the trash.

Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

One ml of EchinaMed drops contains as active ingredients:

  • 860 mg of extract (as tincture) of the fresh aerial part of Echinacea

purpurea

  • 45 mg of extract (as tincture) of the fresh root of Echinacea purpurea

The other components are excipients:

94% (m/m) ethanol

Purified water

Package size

Bottle with 50 ml

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/

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