REGENDER 120 mg HARD CAPSULES

Introduction

Patient Information Leaflet

Regender 120 mg hard capsules

Extract of Polypodium leucotomosL.

Read this leaflet 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 leaflet or as indicated 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 side effects, consult your doctor, pharmacist, even if it is a side effect not described in this leaflet. See section 4.

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

Contents of the Leaflet

1. What is Regender and what is it used for
2. What you need to know before taking Regender
3. How to take Regender
4. Possible side effects
5. Storage of Regender
6. Package contents and additional information

1. What is Regender and what is it used for

Regender is a traditional herbal medicine 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 if it does not improve after 7 days.

2. What you need to know before taking Regender

Do not take Regender

If you are allergic to the extract of Polypodium leucotomosL. 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 Regender.

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

Children and adolescents

The use of the medicine is not recommended in children under 6 years of age, as there is not sufficient 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.

Other medicines and Regender

Use or intake with other medicines. Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicine.

Taking Regender with food, drinks, and alcohol

Regender should be taken 30 minutes before meals, avoiding the intake of food or medicines 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 medicine.

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

Driving and using machines

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

Regender contains lactose and corn starch

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

3. How to take Regender

Follow exactly the administration instructions of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of 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 of Polypodium leucotomosL. extract 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, which is equivalent to 240 mg of Polypodium leucotomosL. extract per day.

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

Method of administration

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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Regender

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

If you stop taking Regender

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Reporting of side effects

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

5. Storage of Regender

No special storage conditions are required.

Keep out of sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Regender

• 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 are:

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

Appearance of the product and package contents

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

packaged in PVC-aluminum blisters, in packages containing 24 or 96 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006, Alicante,

Spain

Email: asacpharma@asac.net

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: asacpharma@asac.net

This leaflet was approved in January 2017.

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