Patient Information Leaflet

Regender 120 mg Hard Capsules

Extract ofPolypodium leucotomosL.

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained 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 more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist, even if they are not listed in this leaflet. See section 4.

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

1. What is Regender and what it is used for

2. What you need to know before starting to take Regender

3. How to take Regender

4. Possible side effects

5. Storage of Regender

6. Contents of the pack and additional information

Regender is a traditional herbal medicine for the relief of symptoms associated with mild to moderate skin inflammatory 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 Regender

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Regender.

Before taking the medication, consult your doctor if you have a fever, infectious diseases, hypertension, or heart failure.

Children and adolescents

Do not recommend the use of the medication in children under 6 years old due to insufficient 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.

Other medications and Regender

Use or taking 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 Regender with food, drinks, and alcohol

Regender should be taken 30 minutes before meals, avoiding the ingestion of foods 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 Regender on the ability to drive and operate machinery is negligible.

Regender contains lactose and cornstarch

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

Use in adults and adolescents

The recommended dose is 1 capsule 3 times a day, which is equivalent to 360 mg ofPolypodium leucotomosLextract 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 treatment.

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 leucotomosLextract per day.

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

Administration form

Regender is administered orally.

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

If you take more Regender than you should

If you have taken more Regender than you should, consult your doctor or pharmacist or go to the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Regender

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

If you interrupt treatment with Regender

If you have any other doubts 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 (may affect 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 or pharmacist, 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 for Pharmacovigilance of Medicinal Products for Human Use:http://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

Container, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash.Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Regender

• The active principle is the extract ofPolypodium leucotomosL.Each hard capsule contains

120 mg of dried rhizome extract ofPolypodium leucotomosL.(DERnative4-6:1) corresponding to 2.5 - 6.25 mg of quinic acid. Extraction solvent: Ethanol 12.5% V/V.

The other components are:

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

Appearance of the product and content of the packaging

Regender is presented in the form of hard gelatin capsules with a red-colored cap and body,

packaged in PVC-aluminum blisters, in containers that contain 24 or 96 capsules.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006, Alicante,

Spain

Email:[email protected]

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]

This leaflet was approved in January 2017.

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