Echinamed Plus spray solution for oral use

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EchinaMed plus spray, solution for oral spray.

Read the entire leaflet carefully before you start using this medicine

because it contains important information for you.

This medicine is available without prescription. However, to achieve the best results, it must be used correctly.

Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days of treatment.

Contents of the leaflet:

1. What EchinaMed plus spray is and what it is used for
2. What you need to know before using EchinaMed plus spray
3. How to use EchinaMed plus spray
4. Possible side effects
5. How to store EchinaMed plus spray
6. Contents of the pack and other information

1. What EchinaMed Plus Spray is and what it is used for

EchinaMed Plus Spray is a traditional herbal medicinal product for the relief of pharyngitis (sore throat) associated with colds, colds and flu, based on its traditional use.

2. What you need to know before using EchinaMed Plus Spray

Do not use EchinaMed Plus Spray if you:

• Are allergic to plants from the Asteraceae (Compositae) family, sage, or any of the product's components.
• Have an autoimmune disease (e.g. multiple sclerosis, collagenosis).
• Have conditions that reduce your resistance to infection.
• Are undergoing treatment with immunosuppressants (e.g. oncological treatments with cytostatics or due to organ transplant).
• Suffer from diseases characterized by low white blood cell count, such as agranulocytosis or leukemia.

Warnings and precautions

• If your symptoms worsen during use of the medicine or you develop high fever, you should consult a doctor or pharmacist.
• There is a possible risk of anaphylactic reaction in atopic patients. If you suffer from urticaria, atopic dermatitis, or asthma, consult your doctor before using this medicine.
• This medicine contains 40–47% V/V ethanol, equivalent to 163 mg per dose (81 mg per spray), which corresponds, for example, to: 3.7 ml of beer per dose (1.85 ml of beer per spray), or 1.5 ml of wine per dose (0.77 ml of wine per spray).
• It is harmful for alcoholics and its use should be monitored during pregnancy, breastfeeding, in children, and in high-risk groups such as patients with liver disease or epilepsy.
• This medicine contains sorbitol. If your doctor has informed you of an intolerance to certain sugars, consult your doctor before using this medicine.
• This medicine contains sucrose. Patients with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency must not take this medicine.
• This medicine contains soya lecithin and must not be used by patients with known allergy to peanuts or soya.

Children and adolescents

Do not administer to individuals under 18 years of age.

Use of EchinaMed Plus Spray with other medicines:

There is no evidence that extracts of echinacea or sage interact with other medicines.

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.

If you are pregnant or think you might be, consult your doctor before taking this medicine. The use of medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery:

No studies have been conducted on the effects of EchinaMed Plus Spray on the ability to drive vehicles or operate machinery. However, based on its known activity, it is unlikely that EchinaMed Plus Spray impairs such ability.

3. How to use EchinaMed Plus Spray

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your pharmacist or doctor.

Recommended dose:

Adults and elderly: 2 sprays, 6 to 10 times daily.

Begin treatment at the first signs of symptoms.

At the end of this leaflet you can find instructions for assembling the spray pump.

EchinaMed Plus Spray is a medicine intended for exclusive oropharyngeal use.

Do not use more than the recommended dose.

Duration of use

Do not use EchinaMed Plus Spray continuously for longer than 2 weeks.

If symptoms persist for more than 7 days, consult your doctor or pharmacist.

Do not use a double dose to make up for a missed dose.

If you use more EchinaMed Plus Spray than you should:

In case of overdose, symptoms related to the amount of ingested ethanol (alcohol) may be expected.

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 quantity used.

4. Possible adverse effects

Like all medicines, EchinaMed plus spray may have adverse effects, although not everyone experiences them.

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

• 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.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

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 through 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 Plus Spray

Keep this medicine out of the sight and reach of children.

Store at room temperature.

Do not use EchinaMed Plus Spray after the expiry date stated on the container.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the pack and other information

One ml of EchinaMed plus spray solution contains the following active substances:

• 863.3 mg of extract from the fresh aerial parts of Echinacea purpurea
• 45.5 mg of extract from the fresh root of Echinacea purpurea
• 430 mg of extract from the fresh leaves of Salvia officinalis

The other components are excipients:

Sucrose laurate (vegetable origin)
Soybean lecithin (vegetable origin)
Ethanol 94% (m/m)
Peppermint oil
Sorbitol (liquid)

Appearance of the product and contents of the container

EchinaMed plus is a translucent liquid, brown to yellowish-green in color, with an aromatic peppermint odor and a fresh, slightly bitter, alcoholic taste.

Supplied in 30 ml bottles.

For oropharyngeal use.

Instructions for assembling the spray

Marketing Authorization Holder and Manufacturer

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

Date of the most recent review of this package leaflet: January 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/