Leaflet: information for the user

REDSENG 300 mg tablets

Panax ginsengC.A. Meyer

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

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this leaflet.
• You should consult a doctor if you get worse or do not improve after 2 months of treatment.

1. What isRedsengand what it is used for

2. What you need to know before starting to takeRedseng

3. How to takeRedseng

4. Possible side effects

5. Storage ofRedseng

6. Contents of the pack and additional information

Traditional medication based on plants used in states of fatigue, physical or intellectual exhaustion, and weakness, based exclusively on its traditional use.

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 high blood pressure, cardiac arrhythmias, anxiety, nervousness, or excitability.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Redseng.

This medication may cause high blood pressure, anxiety, and increased nervousness, irritability, and insomnia.

Children and adolescents

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

Taking Redseng with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, 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 modify 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 adverse effects (tremors, insomnia, irritability, etc.). Diabetic patients should be especially careful as they may need to adjust their insulin dose because this medication may reduce blood glucose levels.

Taking Redseng with food, drinks, and alcohol

You should limit the consumption of caffeine-containing beverages, 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 it is not recommended for use in these circumstances.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

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.

The recommended dose is:

Adults: Take 3 to 5 tablets per day.

This medication is used orally.

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

Use in children and adolescents

This medication is not recommended for children and adolescents under 18 years old.

If you take more Redseng than you should

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

If you forgot to take Redseng

In case of forgotten dose, take the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the forgotten dose and wait for the next one. Never take a double dose to compensate for the forgotten dose.

Like all medications, Redseng can produce adverse effects, although not all people will experience them.

Excitement, insomnia, nervousness, diarrhea, headache, high blood pressure, or skin eruptions may occur, the frequency of these effects is unknown.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the 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 Redseng

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

Appearance of the product and contents of the packaging

The medication are biconvex beige-colored tablets in packaging containing 30 or 200 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for manufacturing

LABORATORIOS SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

This leaflet was approved in April 2012

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