Echinamed comprimidos
Introduction
Package Insert: Information for the User
EchinaMed Tablets
Read this package insert carefully because it contains important information for you.
This medication can be obtained without a prescription for the treatment of minor ailments
without the intervention of a doctor. Nevertheless, for the best results it should
be used with care.
- Keep this package insert, as you may need to read it again
- If you need advice or more information, consult your pharmacist.
- If symptoms worsen or persist after ten days, you should consult a
doctor.
- If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor
pharmacist.
1. What EchinaMed is and for what it is used
2. Before taking EchinaMed
3. How to take EchinaMed
4. Possible adverse effects
5. Storage of EchinaMed
6. Additional information
1. What is EchinaMed and what is it used for
It is indicated for the treatment of the common cold.
EchinaMed belongs to a group of medications known as
Plant-derived immunostimulants. It acts by stimulating the body's defenses.
The body's defenses.
2. Before taking EchinaMed
Do not take EchinaMedif you:
?Are allergic to plants of the Asteraceae (Compositae) family or to any of the product's components.
of the product's components.
?Have tuberculosis.
?Have a tendency to have allergies with symptoms of urticaria, eczema, or asthma..
?Suffer from an autoimmune disease.
?Have conditions that reduce your resistance to infection (e.g. HIV)
?Are undergoing treatment with immunosuppressants (e.g. treatment to prevent organ rejection after a transplant)
?Are receiving treatment that reduces your response to infections (e.g. chemotherapy or radiation therapy for cancer treatment)
?Suffer from diseases characterized by a low white blood cell count such as agranulocytosis.
Do not administer to children under 1 year.
Be especially careful with EchinaMed
If during the use of the medication, symptoms worsen or high fever occurs, you should
consult a doctor or pharmacist.
There is a possible risk of anaphylactic reaction in atopic patients. They should consult their doctor before taking this medication.
Do not recommend its administration to children under 12 years old since its efficacy
has not been sufficiently proven.
This medication contains saccharose. Patients with known hereditary intolerance to fructose, malabsorption of glucose or galactose, or saccharase-isomaltase deficiency should not take this medication.
This medication contains sorbitol. Patients with hereditary problems of intolerance to fructose should not take this medication.
Pregnancy and Lactation
No studies have been conducted during pregnancy or the lactation period with this
medication, so it is not recommended to administer it, unless a better medical opinion.
is available.
IMPORTANT FOR WOMEN
If you are pregnant or believe you may be, 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 effect of EchinaMed on the ability to
drive vehicles and operate machinery, however, based on its activity, it is
unlikely to be altered.
Concomitant use of other medications:
No evidence exists that extracts ofEchinacea purpureainteract with
other medications, however, due to its activity, it is not recommended to take
this medication with immunosuppressants such as ciclosporina and metotrexato
Inform your doctor or pharmacist if you are taking or have recently taken
any other medication, including those acquired without a prescription.
3. How to Take EchinaMed
Follow these instructions unless your doctor has given you different instructions. Remember to take your medication.
EchinaMed is a medication that is administered orally.
The recommended daily dose for adults, seniors, and children over 12 years old is 1 tablet 3 times a day
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4. Possible Adverse Effects
IMPORTANT, please ensure you have read section 2. Before Taking
EchinaMed, from this prospectus, before reading this section 4.
Do not take EchinaMed if you are allergic to plants of the Asteraceae family (composites)
Like all medicines, EchinaMed may have adverse effects. Discontinue treatment and consult your doctor if any of the following effects occur:
Allergic reactions such as:
Dermatitis
Urticaria
Inflammatory skin disorders (Stevens-Johnson Syndrome)
Swelling of the skin due to fluid
Angioedema of the face (Quincke's edema)
Reduced airflow to the lungs (bronchospasm)
Asthma and severe allergic reactions (anaphylactic shock)
This medicine may trigger allergic reactions in patients prone to allergies.
There have been reports of autoimmune diseases such as:
Disseminated encephalitis and myelitis
Painful nodules on the shin (erythema nodosum)
Decreased platelets (immunothrombocytopenia)
Cell destruction by antibodies (Evans Syndrome)
Dry eyes and mouth with renal tubular dysfunction (Sjögren's Syndrome)
Leucopenia may occur with long-term use (more than 8 weeks)
The frequency of these adverse effects is unknown.
If you consider any of the effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, report it to your doctor or pharmacist.
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 of Pharmacovigilance for Medicinal Products for Human Use: https://www.notificaram.es.
By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of EchinaMed
This medication does not require special conservation conditions.
It should be stored in the original packaging.
Keep out of the reach and sight of children.
Do not useEchinaMedafter the expiration date indicated on the packaging.
Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines.
By doing so, you will help protect the environment.
6. Additional Information
A EchinaMed tablet contains the following active principles:
- 17.7 mg of dry extract from the fresh aerial part ofEchinacea purpureaequivalent to 1140 mg of hydroethanolic extract.
- 0.9 mg of dry extract from the fresh root ofEchinacea purpureaequivalent to 60 mg of hydroethanolic extract.
Extraction solvent: ethanol at 57.3% (m/m)
The other components are excipients:
Manitol (E 421)
Medium-chain triglycerides
Sucroesters of fatty acids (E 473)
Sorbitol (E 420)
Sodium croscarmellose
Magnesium stearate (of vegetable origin)
Packaging size
Packaging containing 30 tablets.
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 leaflet was approved in: July 2023
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/
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