ARMAYA FUERTE 120 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Armaya Fuerte 120 mg Hard Capsules

Extract of Polypodium leucotomosL.

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

Keep this package leaflet, as you may need to read it again.

If you need advice or more information, consult your pharmacist.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Armaya Fuerte is and what it is used for
2. What you need to know before taking Armaya Fuerte
3. How to take Armaya Fuerte
4. Possible side effects
5. Storage of Armaya Fuerte
6. Contents of the pack and further information

1. What Armaya Fuerte is and what it is used for

Armaya Fuerte is a traditional herbal medicinal product for the relief of symptoms associated with mild to moderate inflammatory processes of the skin, based exclusively on its traditional use.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Armaya Fuerte

Do not take Armaya Fuerte:

If you are allergic to the extract of Polypodium leucotomosL. or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Armaya Fuerte.

In case of fever, infectious diseases, hypertension, or heart failure, consult your doctor before taking the medication.

Use in children and adolescents

The use of the medication is not recommended in children under 6 years of age, as there is insufficient clinical information to support its safe and effective use.

Children from 6 to 12 years:Consult your doctor before starting treatment so that they can assess the clinical situation.

Taking Armaya Fuerte with other medications

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

Taking Armaya Fuerte with food, beverages, and alcohol

Armaya Fuerte should be taken 30 minutes before meals, avoiding the ingestion of food or medications that reduce stomach acidity or alcoholic beverages at the same time, as they may decrease its effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Safety during pregnancy and breastfeeding has not been established. As a precautionary measure, its administration is not recommended in women during pregnancy or breastfeeding.

Driving and using machines

The effect of Armaya Fuerte on the ability to drive and use machines is nil or insignificant.

Armaya Fuerte contains cornstarch and lactose.

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

3. How to take Armaya Fuerte

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

Dosage

Use in adults and adolescents:The recommended dose is 1 capsule, 3 times a day, equivalent to 360 mg of Polypodium leucotomosextract per day.

If necessary, an additional capsule may be administered, preferably at night.

The recommended treatment duration is 4 weeks. After this period, consult your doctor about the convenience of continuing it.

Use in children from 6 to 12 years:

The recommended dose is 1 capsule, 2 times a day, equivalent to 240 mg of Polypodium leucotomosextract per day.

If symptoms persist or worsen two weeks after starting treatment, consult your doctor.

Method of administration

Armaya Fuerte is administered orally.

Take the capsules 30 minutes before each main meal, whole, with the help of some liquid.

If you take more Armaya Fuerte than you should

If you have taken more Armaya Fuerte than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Armaya Fuerte

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

With a very rare frequency (up to 1 in 10,000 people), stomach discomfort, skin rash, and itching may appear.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Armaya Fuerte

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Armaya Fuerte

• The active ingredient is the extract of Polypodium leucotomosL. Each hard capsule contains 120 mg of dry extract of Polypodium leucotomosL. rhizome (native DER 4-6:1) corresponding to 2.5 - 6.25 mg of quinic acid. Extraction solvent: Ethanol 12.5% V/V.

The other components (excipients) are:

• Capsule content: cornstarch, magnesium stearate (E-572), and anhydrous lactose.
• Capsule shell: titanium dioxide (E-171), erythrosine (E-127), gelatin, and red iron oxide (E-172).

Appearance of the product and contents of the pack

Armaya Fuerte is presented in the form of hard gelatin capsules, with a red cap and body, packaged in PVC-aluminum blisters, in packs containing 24 or 96 capsules.

Marketing authorization holder and manufacturer

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006, Alicante,

Spain

Phone: +34 965 28 67 00

Fax: +34 965 28 64 34

Email: [email protected]

Date of the last revision of this package leaflet: November 2017.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/