Leaflet: information for the user

EchinaMed plus spray, oral spray solution.

Read this leaflet carefully before you start using this medicine

because it contains important information for you.

This medicine can be obtained without a prescription. However, to achieve the best

results, it must be used properly.

Follow exactly the administration instructions for the medicine contained in

this leaflet or those indicated by your doctor or pharmacist.

- 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 side effects, consult your doctor, pharmacist or nurse,

even if they are not described in this leaflet.

- You should consult a doctor if you get worse, or if you do not improve after 7 days of

treatment.

1. What isEchinaMed plus sprayand what it is used for

2. What you need to know before starting to useEchinaMed plus spray

3. How to useEchinaMed plus spray

4. Possible side effects

5. Storage ofEchinaMed plus spray

6. Contents of the pack and additional information

EchinaMed plus spray is a traditional herbal medicine for the relief of pharyngitis

(sore throat) associated with catarrh, colds, and flu, based on traditional use.

No use EchinaMed plus sprayif you:

• Are allergic to plants of the Asteraceae (Compositae) family, to sage, or

to any of the components of the product.

• Have an autoimmune disease (multiple sclerosis, collagenosis)
• Have conditions that reduce your resistance to infection.
• Are undergoing immunosuppressive treatment (cancer treatments with

cytostatics or post-transplant)

• Have diseases characterized by a low white blood cell count

such as agranulocytosis or leukemia.

Warnings and precautions

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

should consult a doctor or pharmacist.

• There is a possible risk of anaphylactic reaction in atopic patients. If you

have urticaria, atopic dermatitis, or asthma, you should consult your doctor

before using this medication.

• This medication contains 40-47% V/V of ethanol equivalent to 163mg per

dose (81mg per spray), equivalent for example to: 3.7 ml of beer per dose

(1.85 ml of beer per spray), equivalent for example to: 1.5 ml of wine per

dose (0.77 ml of wine per spray)

• It is harmful to alcoholics and should be monitored during pregnancy, lactation,

in children, and in high-risk groups such as patients with liver disease or

epileptics.

• This medication contains sorbitol. If your doctor has told you that you have

intolerance to certain sugars, you should consult your doctor before using this

medication.

• This medication contains saccharose. Patients with fructose intolerance, glucose

malabsorption, or galactosemia, or saccharase-isomaltase deficiency, should not

take this medication.

• This medication contains soy lecithin and should not be used by patients with

known allergy to peanuts or soy.

Children and adolescents

Do not administer to minors under 18 years old.

Use of EchinaMed plus spray with other medications:

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

Pregnancy and Lactation

As a precaution and in the absence of sufficient data, use during pregnancy and

lactation is not recommended without medical supervision.

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

harmful to 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 and operate machinery. However, based on its activity, it is

unlikely that EchinaMed plus spray will affect this ability.

Follow the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your pharmacist or doctor..

The recommended dose is:

Adults and seniors: 2 sprays, 6 to 10 times a day.

Start treatment with the first symptoms.

You can find the instructions for assembling the sprayer at the end of this leaflet..

EchinaMed plus spray is a medication for exclusive buccal and pharyngeal use.

Do not use more than the recommended dose.

Duration of use

Do not use EchinaMed plus spray continuously for more than 2 weeks.

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

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

If you take more EchinaMed plus spray than you should:

In case of excessive intake, symptoms may occur in accordance with the amount of ethanol (alcohol) ingested.

In case of overdose or accidental ingestion, go to a medical center or consult the Toxicological Information Service, phone 91 562 0420, indicating the medication and the amount used.

Like all medications, EchinaMed plus spray may have adverse effects, although not everyone may experience them.

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

• Eruption

• 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.

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

Reporting Adverse Effects:

Ifyouexperienceanytypeofadverseeffect,consultyourdoctororpharmacistornurse,evenifitispossibleadverseeffectsthatdonotappearinthisprospectus.YoucanalsoreportthemdirectlythroughtheSpanishSystemof

Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

Byreportingadverseeffects,youcancontributetoprovidingmoreinformationonthesafetyofthismedication.

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

Store at room temperature.

Do not use EchinaMed plus spray 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 containers and medicines you no longer need. This will help protect the environment..

One milliliter of EchinaMed plus spray contains as active principles:

• 863.3 mg of fresh aerial part extract ofEchinacea purpurea
• 45.5 mg of fresh root extract ofEchinacea purpurea
• 430 mg of fresh leaf extract ofSalvia officinalis

The other components are excipients:

Sucrose laurate (vegetal origin)

Soja lecithin (vegetal origin)

94% (m/m) ethanol

Mint oil

Sorbitol (liquid)

Appearance of the product and content of the container

EchinaMed plus is a translucent, brown to yellowish green liquid with

aromatic mint odor and a fresh, slightly bitter alcoholic taste.

It is presented in 30 ml bottles

For buccal and pharyngeal application.

Instructions for the assembly of the sprayer

Holder of the marketing authorization and responsible manufacturer

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Tel 93 201 99 22

Fax 93 209 03 19

Manufacturer

A. VOGEL B.V.

J.P. Broekhovenstraat 16, Elburg

Netherlands

Last review date of this leaflet: January 2020

Detailed and updated information on this medication is available on the

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

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