Crataesor 400 mg capsulas
Introduction
PACKAGE INSERT: Information for the user.
Crataesor 400 mg capsules
Crataegus oxyacanthoides Thuill.
Read this package insert carefully before starting to take this medicine, because it contains important information for you. Follow exactly the administration instructions of the medicine contained in this package insert or those indicated by your doctor or pharmacist.
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1. What is Crataesor and what is it used for
It is a traditional herbal medicine to alleviate 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 starting to take Crataesor
Do not take Crataesor
If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
Warnings and precautions
If symptoms persist after 2 weeks of taking this medication, consult your doctor or pharmacist.
This medication is intended for the relief of nervous origin palpitations, 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 the safety of use in this population.
Taking Crataesor with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Taking Crataesor with food, drinks, and alcohol
No information is available on the influence of food and drinks on the effect of the medication.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.
The safety during pregnancy and breastfeeding is not well established. In the absence of sufficient information, it is not recommended to use during pregnancy and breastfeeding.
No information is available on the effect of this medication on fertility.
Driving and operating machinery
No information is available on any effect on the ability to drive and operate machinery.
3. How to Take Crataesor
Follow exactly the medication administration instructions contained in this leaflet or those 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 medication is used orally.
Use in children and adolescents
It is not recommended for administration to children under 18 years old.
If you take more Crataesor than you should
No cases of overdose have been described.
In case of overdose or accidental ingestion, consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone 91.562.04.20 indicating the medication and the amount ingested.
If you forgot to take Crataesor
Do not take a double dose to compensate for the missed doses.
4. Possible Adverse Effects
No have been described.
Like all medications, Crataesor can produce adverse effects, although not all people will experience them.
Reporting Adverse Effects
If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Crataesor Storage
Keep this medication out of the sight and reach of children.
This medication does not require special storage conditions.
Store in the original packaging.
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.
Do not use this medication if you observe visible signs of deterioration.
Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Crataesor
Composition per capsule:
- The active principle is 400 mg of leaf and flower powder ofCrataegus 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 contents of the packaging
It is presented in a cardboard container containing 48 capsules of 400 mg in a PVC/PVDC/AL blister.
The capsules are transparent and contain a yellowish green powder.
Holder of the marketing authorization and responsible for manufacturing:
SORIA NATURAL S.A.
Polígono La Sacea nº 1.
Garray. (42162). Soria.
Tel: 975252046
Fax: 975252267
e-mail:[email protected]
Date of the last review of this leaflet:July 2019
Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)
http://www.aemps.gob.es/
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