Armaya Fuerte 120 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Armaya Fuerte 120 mg hard capsules

Polypodium leucotomos L. extract

Read the entire leaflet carefully before starting to take this medicine, because

it contains important information for you.

Follow exactly the instructions for use of this medicine provided in this leaflet or those given 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 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 your condition worsens, or if you do not improve after 7 days.

Contents of the 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 adverse effects
5. How to store Armaya Fuerte
6. Contents of the pack and other 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 skin conditions, based exclusively on its traditional use.

You should consult a doctor if your condition 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 leucotomos L. or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

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

If you have fever, infectious diseases, hypertension, or heart failure, consult your doctor before taking this medicine.

Use in children and adolescents

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

Children aged 6 to 12 years: Consult your doctor before starting treatment so that your clinical condition can be assessed.

Taking Armaya Fuerte with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking Armaya Fuerte with food, drinks, and alcohol

Armaya Fuerte should be taken 30 minutes before meals. Avoid ingesting food or medicines that reduce stomach acidity or alcoholic beverages at the same time, as they could reduce its effectiveness.

Pregnancy, breastfeeding, and fertility

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

Safety during pregnancy and breastfeeding has not been established. As a precautionary measure, administration of this medicine is not recommended to women who are pregnant or breastfeeding.

Driving and using machines

The effect of Armaya Fuerte on the ability to drive and use machines is none or negligible.

Armaya Fuerte contains maize starch and lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Armaya Fuerte

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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 leucotomos extract daily.

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

The recommended duration of treatment is 4 weeks. After this period, consult your doctor regarding the advisability of continuing treatment.

Use in children aged 6 to 12 years:

The recommended dose is 1 capsule, 2 times a day, equivalent to 240 mg of Polypodium leucotomos extract daily.

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

Method of administration

Armaya Fuerte is administered orally.

Take the capsules whole, 30 minutes before each of the main meals, with a drink.

If you take more Armaya Fuerte than you should

If you have taken more Armaya Fuerte than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very rarely (up to 1 in 10,000 people), stomach discomfort, skin rash, and itching may occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Armaya Fuerte

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, following EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your usual pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Armaya Fuerte

• The active substance is Polypodium leucotomos L. extract. Each hard capsule contains 120 mg of dry extract from the rhizome of Polypodium leucotomos L. (native DER 4-6:1), equivalent to 2.5 - 6.25 mg of quinic acid. Extraction solvent: ethanol 12.5% V/V.

The other components (excipients) are:

• Capsule contents: corn starch, 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 pack contents

Armaya Fuerte is presented as hard gelatin capsules with red cap and body, packed in PVC-aluminum blisters, in containers containing 24 or 96 capsules.

Marketing Authorization Holder and Manufacturer

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006, Alicante,

Spain

Telephone: +34 965 28 67 00

Fax: +34 965 28 64 34

Email: [email protected]

Date of the most recent review of this leaflet: November 2017.

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