ECHINAMED HOT DRINK CONCENTRATED ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

EchinaMed Hot Drink, concentrate for oral solution

Read the entire package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult your doctor if your symptoms worsen or do not improve after 10 days.

Contents of the package leaflet:

1. What is EchinaMed Hot Drink and what is it used for
2. What you need to know before taking EchinaMed Hot Drink
3. How to take EchinaMed Hot Drink
4. Possible side effects
5. Storage of EchinaMed Hot Drink
6. Contents of the pack and further information

1. What is EchinaMed Hot Drink and what is it used for

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

2. What you need to know before taking EchinaMed Hot Drink

Do not take EchinaMed Hot Drinkif you:

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

Suffer from a progressive systemic disease (tuberculosis or sarcoidosis).

Suffer from an autoimmune disease (such as multiple sclerosis, collagenosis).

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.

Do not administer to children under 1 year of age

Warnings and precautions

Consult your doctor or pharmacist before starting to take EchinaMed Hot Drink

• If symptoms worsen or high fever occurs during the use of the medicine, consult a doctor or pharmacist.
• There is a possible risk of anaphylactic reaction in atopic patients, who should consult their doctor before taking this medicine.

Treatment should be started at the first signs of a cold.

Children and adolescents

Not recommended for use in children under 12 years of age.

Taking EchinaMed Hot Drink with other medicines:

Should not be used simultaneously with immunosuppressive medicines such as cyclosporine or methotrexate

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.

Driving and using machinery:

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

EchinaMed Hot Drink contains sucrose.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 4.12 g of sucrose per 5 ml dose.

EchinaMed Hot Drink containsa small amount of alcohol (ethanol),less than 100 mg per 5 ml dose.

3. How to take EchinaMed Hot Drink

The recommended dose is:

Adolescents over 12 years, adults, and the elderly:

From the first to the third day, take 5 ml diluted in hot water, 5 times a day

From the fourth to the tenth day, take 5 ml diluted in hot water, 3 times a day

EchinaMed Hot Drink is a medicine that is administered orally.

Treatment should be started as soon as the first symptoms of a cold are detected. The recommended duration of treatment is 10 days.

The medicine bottle should be shaken well before use,

The medicine should be diluted in hot water before being drunk.

Do not use more than the recommended dose.

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

Use in children:

Not recommended for children under 12 years of age.

Do not administer to children under 1 year of age.

If you take more EchinaMed Hot Drink than you should

If you feel unwell as a result of excessive intake, consult your doctor. Excessive intake 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 medicine and the amount ingested.

If you forget to take EchinaMed Hot Drink

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Make sure you have read section 2 of this package leaflet

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

Stop treatment and consult your doctor if allergic reactions occur, such as:

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

Echinacea may trigger allergic reactions in atopic patients.

The frequency of these side effects is unknown.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of EchinaMed Hot Drink

Keep this medicine out of the sight and reach of children

Store below 25°C. Once opened, store in the refrigerator.

Discard after one month from the first opening.

Do not use EchinaMed Hot Drink after the expiration date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

A 5 ml dose of EchinaMed Hot Drink contains as active ingredients:

1140 mgof extract (as tincture) of the fresh aerial part of Echinacea purpurea(L.) Moench. Extraction solvent: ethanol 65% V/V (57% m/m)

60 mgof extract (as tincture) of the fresh root of Echinacea purpurea(L.) MOENCH. Extraction solvent: ethanol 65% V/V (57% m/m)

The other ingredients are excipients:

Sucrose

Purified water

Concentrated elderberry juice

Citric acid monohydrate

Medium-chain triglycerides

Potassium sorbate

Pregelatinized corn starch (E1450)

Ethanol

Package size

Bottle with 100 ml

Oral use

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 January 2020

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