Prospect: Patient Information

Armaya Fuerte 120 mg Hard Capsules

Extract ofPolypodium leucotomosL.

Read this prospect carefully before starting to take this medicine, because

it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

?Keep this prospect, as you may need to read it again.

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

?If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects that do not appear described in this prospect.See section 4.

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

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

2. What you need to know before starting to take Armaya Fuerte

3. How to take Armaya Fuerte

4. Possible adverse effects

5. Storage of Armaya Fuerte

6. Contents of the package and additional information

Armaya Fuerte is a traditional herbal medicine for the relief of symptoms

associated with mild to moderate inflammatory skin processes, based exclusively on its traditional use.

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

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 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

Do not recommend the use of the medication in children under 6 years old due to a lack of sufficient clinical information to support its safe and effective use.

Children aged 6 to 12 years: Consult your doctor before starting treatment to assess the clinical situation.

Taking Armaya Fuerte with other medications

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

Taking Armaya Fuerte with food, drinks, 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 reduce its effect.

Pregnancy, breastfeeding, and fertility

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

The safety during pregnancy and breastfeeding has not been established. As a precaution, it is not recommended to administer this medication to women during pregnancy or breastfeeding.

Driving and operating machinery

The effect of Armaya Fuerte on the ability to drive and operate machinery is negligible or null.

Armaya Fuerte contains cornstarch and lactose.

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

Follow exactly the medication administration instructions contained in this leaflet or those 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, which is equivalent to 360 mg ofPolypodium 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.

Use in children aged 6 to 12 years:

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

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

Administration Form

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 Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Armaya Fuerte

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting Adverse Effects

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

No requires special conservation conditions.

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.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Armaya Fuerte

• The active principle is the extract of Polypodium leucotomos L. Each hard capsule contains 120 mg of dry extract of rhizome of Polypodium leucotomos L . (DER native 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:

• Content of the capsule : cornstarch, magnesium stearate (E-572) and anhydrous lactose.
• Capsule coating : titanium dioxide (E-171) , erythrosine (E-127), gelatin and iron oxide red (E-172).

Appearance of the product and content of the packaging

Armaya Fuerte is presented in the form of hard gelatin capsules, with cap and body of red color, packaged in PVC-aluminum blister, in containers that contain 24 or 96 capsules.

Holder of the marketing authorization and responsible 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]

Last review date of this prospectus: November 2017.

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/