CRATAESOR 400 MG CAPSULES

Introduction

PACKAGE LEAFLET: Information for the user.

Crataesor 400 mg capsules

Crataegus oxyacanthoides Thuill.

Contents of the package leaflet:

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

1. What is Crataesor and what is it used for

It is a traditional herbal medicine to relieve nervousness with an exaggerated perception of heartbeats (palpitations) and in case of difficulty sleeping, based exclusively on its traditional use.

2. What you need to know before taking Crataesor

Do not take Crataesor

If you are allergic to the active substance or to any of the other components of this medicine (included in section 6).

Warnings and precautions

If the symptoms persist after 2 weeks of taking this medicine, consult your doctor or pharmacist.

This medicine is intended for the relief of palpitations of nervous origin, provided that a cardiac pathology has been ruled out.

Children and adolescents

It is not recommended for use in children and adolescents under 18 years of age, as there is not enough information on safety in this population.

Taking Crataesor with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Taking Crataesor with food, drinks, and alcohol

The influence of food and drinks on the effect of the medicine has not been described.

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 is not well established. In the absence of sufficient information, its use during pregnancy and breastfeeding is not recommended.

It is not known if this medicine has any effect on fertility.

Driving and using machines

No effect on the ability to drive and use machines has been described.

3. How to take Crataesor

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults: 2 capsules, 3 times a day with a glass of water.

This medicine is for oral use.

Use in children and adolescents

Its administration is not recommended for children under 18 years of age.

If you take more Crataesor than you should

Overdose cases have not been described.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Crataesor

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

4. Possible side effects

They have not been described.

Like all medicines, Crataesor can cause side effects, although not everyone gets them.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Crataesor

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

This medicine does not require special storage conditions.

Keep it in the original package.

Do not use this medicine after the expiration date that appears on the package after Cad. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Crataesor

Composition per capsule:

• The active substance is 400 mg of powder of leaves and flowers of Crataegus oxyacanthoides Thuill. (Content in flavonoids (expressed as hyperoside) ≥ 6 mg/capsule).
• The other components are hypromellose, carrageenan, potassium acetate, and water. ((capsule coating).

Appearance of the product and package contents

It is presented in a cardboard box containing 48 capsules of 400 mg in a PVC/PVDC/AL blister.

The capsules are transparent and contain a yellowish-green powder.

Marketing authorization holder and manufacturer:

SORIA NATURAL S.A.

Polígono La Sacea nº 1.

Garray. (42162). Soria.

Tel: 975252046

Fax: 975252267

e-mail: [email protected]

Date of the last revision of this leaflet:July 2019

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/