Crataesor 400 mg capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: Information for the user.
Crataesor 400 mg capsules
Crataegus oxyacanthoides Thuill.
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you. Always follow exactly the instructions for use of this medicine as contained in this leaflet or as advised by your doctor or pharmacist.
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Package leaflet:
- What Crataesor is and what it is used for
- What you need to know before taking Crataesor
- How to take Crataesor
- Possible side effects
- How to store Crataesor
- Contents of the pack and other information
1. What Crataesor is and what it is used for
Crataesor is a traditional herbal medicinal product used to relieve nervousness associated with an exaggerated awareness of heartbeats (palpitations) and in cases of sleep difficulties, based exclusively on its traditional use.
2. What you need to know before starting to take Crataesor
Do not take Crataesor
If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
If 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 cardiac pathology has been ruled out.
Children and adolescents
Use is not recommended in children and adolescents under 18 years of age, as there is insufficient information on safety in this population.
Taking Crataesor with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Crataesor with food, beverages and alcohol
The influence of food and beverages on the effect of this medicine has not been reported.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Safety during pregnancy and breastfeeding has not been well established. In the absence of sufficient data, use during pregnancy and breastfeeding is not recommended.
It is unknown whether this medicine has any effect on fertility.
Driving and using machines
No effects on the ability to drive and use machines have been reported.
3. How to take Crataesor
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults: 2 capsules, 3 times a day with a glass of water.
This medicine is for oral use.
Use in children and adolescents
Administration is not recommended for children under 18 years of age.
If you take more Crataesor than you should
Cases of overdose have not been reported.
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 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 missed doses.
4. Possible adverse effects
Not described.
Like all medicines, Crataesor may produce adverse effects, although not everyone will experience them.
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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Crataesor Storage
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Store in the original container.
Do not use this medicine after the expiry date stated on the packaging following Exp. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Crataesor
Composition per capsule:
- The active substance is 400 mg of powder from leaves and flowers of Crataegus oxyacanthoides Thuill. (Flavonoid content (expressed as hyperoside) ≥ 6 mg per capsule).
- The other components are hypromellose, carrageenan, potassium acetate and water (capsule shell).
Appearance of the product and contents of the pack
Presented in a cardboard pack containing 48 capsules of 400 mg in PVC/PVDC/Al blisters.
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 most recent revision of this leaflet: July 2019
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS)
http://www.aemps.gob.es/