Echinamed gotas orales en solucion

Label: information for the user

EchinaMed oral drops in solution

Read this label carefully because it contains important information for you.

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

- Keep this label, 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 severe or if you notice any effect not mentioned in this label, inform your doctor or pharmacist.

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

2. Before taking EchinaMed drops

3. How to take EchinaMed drops

4. Possible adverse effects

5. Storage of EchinaMed drops

6. Additional information

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

Do not take EchinaMed dropsif you:

• Are allergic to plants in the Asteraceae (Compositae) family, or to any of the product's components.
• Have tuberculosis or sarcoidosis.
• Have an autoimmune disease.
• Have conditions that reduce your resistance to infection (e.g. HIV).
• Are undergoing immunosuppressive treatment.
• Have diseases characterized by a low white blood cell count, such as agranulocytosis or leukemia.
• Tend to have allergies with symptoms of urticaria, eczema, or asthma.

Do not administer to children under 1 year old.

Be especially careful with EchinaMed drops

• If during 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 65% V/V of 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 in

pregnancy, lactation, in children, and in high-risk groups such as patients

with liver disease or epileptics.

Interactions with other medications:

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

This medication contains alcohol, do not take it simultaneously with other medications that have been described to interact with alcohol (e.g. metronidazole)

Pregnancy and Lactation

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

IMPORTANT FOR WOMEN

If you are pregnant or believe 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.

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

Driving and operating machinery:

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

EchinaMed drops is a medication that is administered orally.

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

The drops should be taken with a little water. Treatment should begin 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 symptoms persist for more than 10 days, consult a doctor or pharmacist.

This medication is not recommended for children under 12 years old.

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

If you take more EchinaMed drops than you should:

In case of excessive intake, symptoms may occur according to the amount of alcohol ingested.

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 drops

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

Like all medicines, EchinaMed drops 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)

• Severe allergic reactions (anaphylactic shock) and asthma

Echinacea may trigger allergic reactions in atopic patients.

There have been reported associations with autoimmune diseases such as:

• Inflammation of the brain and spinal cord (disseminated encephalitis)

• Painful nodules on the shin (erythema nodosum)

• Decreased platelets (immunothrombocytopenia)

• Destruction of blood cells by antibodies (Evans syndrome)

• Dry eyes and mouth with renal tubular dysfunction (Sjögren's syndrome)

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

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 to the Spanish System of Pharmacovigilance for Medicinal Products for Human Use:https://www.notificaram.es..

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store at room temperature.

Keep out of reach and sight of children.

Do not use EchinaMed drops 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.

One milliliter of EchinaMed drops contains as active principles:

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

purpurea

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

The other components are excipients:

94% (m/m) ethanol

Purified water

Container size

Bottle with 50 ml

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

Detailed and updated information about this medication is available on the

website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

(http://www.aemps.gob.es/)