REDSENG 300 mg CAPSULES

Introduction

Package Leaflet: Information for the User

REDSENG 300 mg Capsules

Panax ginsengC.A. Meyer

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

This medication can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

Follow the administration instructions of 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.
• You should consult a doctor if your condition worsens or does not improve after 2 months of treatment.

Contents of the Package Leaflet:

1. What is Redseng and what is it used for
2. What you need to know before taking Redseng
3. How to take Redseng
4. Possible side effects
5. Storage of Redseng
6. Package Contents and Additional Information

1. What is Redseng and what is it used for

Traditional herbal medicinal product used in cases of fatigue, physical or intellectual exhaustion, and weakness, based exclusively on its traditional use.

2. What you need to know before taking Redseng

Do not take Redseng

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

• If you have arterial hypertension, cardiac arrhythmias, anxiety, nervousness, or excitability.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Redseng.

This medication may cause hypertension, anxiety, and increased nervousness, irritability, and insomnia.

Children and Adolescents

Children and adolescents under 18 years of age should not use this medication.

Taking Redseng with Other Medications

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

Before taking this medication, consult your doctor if you are being treated with digoxin or anticoagulant therapy, such as warfarin, as ginseng may alter the effects of your usual treatment. Consult your doctor if you are being treated with MAOIs (monoamine oxidase inhibitors) such as phenelzine, as it may potentiate the appearance of side effects (tremors, insomnia, irritability, etc.). Diabetic patients should be especially careful, as they may need to adjust their insulin dose, as this medication may reduce blood glucose levels.

Taking Redseng with Food, Beverages, and Alcohol

The consumption of caffeinated beverages should be limited, as it may increase the risk of nervousness, irritability, and insomnia.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. No studies have been conducted to establish the safety of using this medication during pregnancy or breastfeeding, so its administration is not recommended in these circumstances.

Driving and Using Machines

No effects on the ability to drive and use machines have been described.

3. How to Take Redseng

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults: Take 3 to 5 capsules per day.

This medication is for oral use.

Do not use this medication for more than 2 months without consulting your doctor or pharmacist.

Use in Children and Adolescents

The administration of this medication is not recommended for children and adolescents under 18 years of age.

If You Take More Redseng Than You Should

In case of overdose, the side effects described may be potentiated. In case of accidental ingestion, consult your pharmacist or doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If You Forget to Take Redseng

In case of forgetting a dose, take the medication as soon as possible, continuing the treatment as prescribed. However, if the next dose is near, it is best not to take the forgotten dose and wait for the next one. In no case should you take a double dose to compensate for the forgotten dose.

4. Possible Side Effects

Like all medications, Redseng can cause side effects, although not everyone will experience them.

Excitement, insomnia, nervousness, diarrhea, headache, arterial hypertension, or skin rashes may occur; the frequency of these effects is unknown.

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

5. Storage of Redseng

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated 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 unused medications at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Redseng

Each capsule contains as an active ingredient: 300 mg of Panax ginsengC.A. Meyer (Korean red ginseng, 6-year-old root).

The other components are the excipients: gelatin (capsule shell), glycerol, and acetic acid.

Appearance of the Product and Package Contents

The medication consists of transparent capsules containing a beige powder, packaged in blister packs and containers containing 30, 50, or 100 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

LABORATORIOS SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

This package leaflet was approved in April 2012

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/