Regender 120 mg hard capsules
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
Regender 120 mg Hard Capsules
Polypodium leucotomos L. extract
Please read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided 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 further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the Leaflet
- What Regender is and what it is used for
- What you need to know before taking Regender
- How to take Regender
- Possible adverse effects
- How to store Regender
- Contents of the pack and other information
1. What Regender is and what it is used for
Regender is a traditional herbal medicinal product for the relief of symptoms associated with mild to moderate inflammatory skin conditions, based exclusively on its traditional use.
You should consult a doctor if symptoms worsen or do 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 leucotomos L. 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.
If you have fever, infectious diseases, hypertension, or heart failure, consult your doctor before taking this medicine.
Children and adolescents
The use of this medicine is not recommended in children under 6 years of age, as there is insufficient clinical information to support its safe and effective use.
Children aged 6 to 12 years: Consult your doctor before starting treatment, so your clinical condition can be assessed.
Other medicines and Regender
Use or intake with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Regender with food, drinks, and alcohol
Regender should be taken 30 minutes before meals, avoiding the intake of food or medications that reduce stomach acidity, or alcoholic beverages, at the same time, as they could reduce its effectiveness.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might 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, administration of this medicine is not recommended to women during pregnancy or breastfeeding.
Driving and use of machines
The effect of Regender on the ability to drive and use machines is none or negligible.
Regender contains lactose and maize starch
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Regeneder
Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use in adults and adolescents
The recommended dose is 1 capsule three times a day, equivalent to 360 mg of Polypodium leucotomos L. extract daily.
If necessary, an additional capsule may be taken, preferably at night.
The recommended duration of treatment is 4 weeks. After this period, consult your doctor regarding the need to continue treatment.
Use in children aged 6 to 12 years
The recommended dose is 1 capsule twice daily, equivalent to 240 mg of Polypodium leucotomos L. extract daily.
If symptoms persist or worsen two weeks after starting treatment, consult your doctor.
Method of administration
Regeneder is administered orally.
Take the capsules whole, 30 minutes before each main meal, with a drink.
If you take more Regeneder than you should
If you have taken more Regeneder 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Regeneder
Do not take a double dose to make up for missed doses.
If you stop Regeneder treatment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Very rare side effects (may affect up to 1 in 10,000 people) include stomach discomfort, skin rash, and itching.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the
packaging, after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Regender
- The active substance is Polypodium leucotomos L. extract. Each hard capsule contains:
120 mg of dry rhizome extract of Polypodium leucotomos L. (native DER 4-6:1), equivalent to 2.5 - 6.25 mg of quinic acid. Extraction solvent: ethanol 12.5% V/V.
The other components are:
- Capsule contents: corn starch, anhydrous lactose, and magnesium stearate (E-572).
- Capsule shell: gelatin, erythrosine (E-127), iron oxide red (E-172), and titanium dioxide (E-171).
Appearance of the product and contents of the container
Regender is presented as hard gelatin capsules with red cap and body,
packed in PVC-aluminum blisters, in packs 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: [email protected]
Manufacturer
Especialidades Farmacéuticas Centrum, S.A.
C/ Sagitario, 14
03006, Alicante,
Spain
Telephone: +34 965 28 67 00
Fax: +34 965 28 64 34
Email: [email protected]
This leaflet was approved in January 2017.
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/