Label: Information for the User

EchinaMed Hot Drink, Oral Solution Concentrate

Read this label carefully before starting to take this medication as it contains important information for you.

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

2. What you need to know before starting to take EchinaMed Hot Drink

3. How to take EchinaMed Hot Drink

4. Possible adverse effects

5. Storage of EchinaMed Hot Drink

6. Contents of the container and additional information

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

Do not take EchinaMed Hot Drinkif you:

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

?Have a progressive systemic disease (tuberculosis or sarcoidosis).

?Have an autoimmune disease (such as multiple sclerosis, collagenosis).

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

?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

Warnings and precautions

Consult your doctor or pharmacist before startingto take EchinaMed Hot Drink

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

?Start treatment with the first signs of a cold.

Children and adolescents

Not recommended for use in children under 12 years.

EchinaMed Hot Drink use with other medications:

Do not use simultaneously with immunosuppressive medications such as ciclosporin or methotrexate

Pregnancy and breastfeeding

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

Driving and operating machinery:

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

EchinaMed Hot Drink contains sucrose.

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

Patients with diabetes mellitus should note that this medication 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.

The recommended dose is:

Adolescents over 12 years, adults, and seniors:

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

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

EchinaMed Hot Drink is a medication administered orally.

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

The medicine bottle should be shaken well before use,

The medicine should be diluted in warm water before being consumed.

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.

Do not administer to children under 1 year.

If you take more EchinaMed Hot Drink than you should

If, as a result of excessive intake, you feel unwell, consult a 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 Hot Drink

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Make sure you have read section 2 of this prospectus.

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

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 frequency of these adverse effects is unknown.

Reporting Adverse Effects

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 about the safety of this medication.

Keep this medication 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 indicated on the packaging.

Medicines should not be disposed of through drains or in the trash.Deposit empty containers and unused medicines at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment.

A 5 ml dose of EchinaMed Hot Drink contains the following active principles:

1140 mgof extract (as a tincture) from the fresh aerial part ofEchinacea purpurea(L.) Moench. Solvent for extraction: ethanol 65%V/V (57%m/m)

60 mgof extract (as a tincture) from the fresh root ofEchinacea purpurea(L.) MOENCH.Solvent for extraction: ethanol 65%V/V (57% m/m)

The other components are excipients:

Sucrose

Purified water

Concentrated elderberry juice.

Monohydrate of citric acid

Medium-chain triglycerides

Potassium sorbate

Pregelatinized cornstarch (E1450)

Ethanol

Container size

Bottle with 100 ml

Oral route

Manufacturer

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Tel 93 201 99 22

Fax 93 209 03 19

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 on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/