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Crataesor 400 mg capsulas

About the medicine

How to use 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.

  • Keep this package insert, as you may need to read it again.
  • If you need advice or more information, consult your pharmacist.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are not described in this package insert. See section 4.
  • You should consult a doctor if it worsens, or if it does not improve after 2 weeks.

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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