Echinamed Hot Drink concentrate for oral solution
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 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. Information for the patient
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
EchinaMed Hot Drink, oral solution concentrate
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 10 days.
Leaflet contents:
- What EchinaMed Hot Drink is and what it is used for
- What you need to know before taking EchinaMed Hot Drink
- How to take EchinaMed Hot Drink
- Possible side effects
- How to store EchinaMed Hot Drink
- Contents of the pack and other information
1. What EchinaMed Hot Drink is and what it is used for
EchinaMed Hot Drink is a traditional herbal medicinal product used to relieve symptoms of the common cold and influenza, based exclusively on its traditional use.
2. What you need to know before starting to take EchinaMed Hot Drink
Do not take EchinaMed Hot Drink if you:
- Are allergic to plants from the Asteraceae (Compositae) family, or to any of the components of the product.
- Suffer from a progressive systemic disease (e.g. tuberculosis or sarcoidosis).
- Suffer from an autoimmune disease (such as multiple sclerosis, collagenosis).
- Have 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 develop allergies with symptoms such as 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 develops during treatment, 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
Use is not recommended for children under 12 years of age.
Taking EchinaMed Hot Drink with other medicines:
Do not use simultaneously with immunosuppressive drugs such as cyclosporine or methotrexate.
Pregnancy and breastfeeding
As a precautionary measure and due to insufficient data, use during pregnancy and breastfeeding is not recommended without medical supervision.
Driving and use of machinery:
No studies have been conducted on the effects of EchinaMed Hot Drink on the ability to drive vehicles or operate machinery.
EchinaMed Hot Drink contains sucrose.
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 4.12 g of sucrose per 5 ml dose.
EchinaMed Hot Drink contains a 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 elderly:
From day 1 to day 3, take 5 ml diluted in hot water, 5 times a day.
From day 4 to day 10, take 5 ml diluted in hot water, 3 times a day.
EchinaMed Hot Drink is a medicine taken by oral route.
Treatment should begin as soon as the first cold symptoms appear. The recommended duration of treatment is 10 days.
The medicine bottle should be shaken well before use.
The medicine must be diluted in hot water before drinking.
Do not exceed the recommended dose.
If symptoms persist for more than 10 days or worsen, consult your 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 due to an overdose, consult your doctor. Taking more than the recommended amount is unlikely to be harmful.
In case of overdose or accidental ingestion, go to a medical center or contact the Toxicology Information Service, telephone 91 562 0420, stating the medicine and the amount ingested.
If you forget to take EchinaMed Hot Drink
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everybody will experience them.
Make sure you have read section 2 of this leaflet.
Do not take EchinaMed Hot Drink if you are allergic to plants of the Asteraceae (Compositae) family, or to any of the components of the product.
Discontinue 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 accumulation
- Facial swelling (angioedema, 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 of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.
By reporting adverse 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, keep refrigerated.
Discard after one month from first opening.
Do not use EchinaMed Hot Drink after the expiry date stated on the container.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Information for the patient
A 5 ml dose of EchinaMed Hot Drink contains the following active substances:
1140 mg of extract (as tincture) from the fresh aerial parts of Echinacea purpurea (L.) Moench. Extraction solvent: ethanol 65% V/V (57% m/m)
60 mg of extract (as tincture) from the fresh root of Echinacea purpurea (L.) Moench. Extraction solvent: ethanol 65% V/V (57% m/m)
The other components are excipients:
Sucrose
Purified water
Concentrated elderberry juice
Citric acid monohydrate
Medium-chain triglycerides
Potassium sorbate
Pregelatinized corn starch (E1450)
Ethanol
Pack size
Bottle containing 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 - The Netherlands
This patient information leaflet has been approved in: January 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/