NOTICE
ANSM - Updated on : 04/07/2017
IN THIS APPENDIX, THE TERM "MARKETING AUTHORIZATION" IS UNDERSTOOD TO MEAN "TRADITIONAL HERBAL MEDICINE REGISTRATION" AND THE TERM "AUTHORIZATION" IS UNDERSTOOD TO MEAN "REGISTRATION".
Product name
CARDIOCALM, film-coated tablet
Hawthorn (dried extract of hawthorn leaf and flower)
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as your doctor or pharmacist tells you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 2 weeks.
What does this leaflet contain?
1. What is CARDIOCALM, film-coated tablet and what is it used for?
2. What do I need to know before taking CARDIOCALM, film-coated tablet?
3. How do I take CARDIOCALM, film-coated tablet?
4. What are the possible side effects?
5. How should CARDIOCALM film-coated tablets be stored?
6. Package contents and other information.
1. WHAT IS CARDIOCALM, film-coated tablet AND WHAT IS IT USED FOR?
CARDIOCALM, film-coated tablet is a traditional herbal medicine used :
to relieve symptoms of temporary cardiac disorders of nervous origin (palpitations, exaggerated perception of heartbeat linked to mild anxiety), after any serious illness has been ruled out by a doctor.
in states of mild nervous tension and minor sleep disorders.
Its use is reserved for specified indications based exclusively on the length of time it has been used.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CARDIOCALM, film-coated tablet?
Never take CARDIOCALM, film-coated tablet :
- if you are allergic to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
If symptoms worsen during use, consult your doctor.
If you experience swelling of the ankles or legs, pain in the region of the heart, which may extend to the arms, upper abdomen or neck area, or respiratory distress (dyspnoea), consult your doctor or pharmacist immediately.
Children and adolescents
In case of temporary cardiac disorders
In children and adolescents under 18, cardiac disorders require medical diagnosis. This medicine is not recommended for children and adolescents under 18.
Nervous tension and sleep disorders
In the absence of data, this drug is not recommended for children and adolescents under 18 years of age.
Other medicines and CARDIOCALM, film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CARDIOCALM, film-coated tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
In the absence of sufficient data, the use of this drug is not recommended during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
CARDIOCALM, film-coated tablet contains
Not applicable.
3. HOW DO I TAKE CARDIOCALM, film-coated tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
For temporary heart problems and mild nervous tension
1 to 2 tablets per dose, up to 6 tablets per day.
For minor sleep disorders
1 tablet with the evening meal and 1 to 2 tablets at bedtime.
Use in children and adolescents
The use of this drug in children and adolescents under 18 years of age is not recommended.
Method of administration
Take by mouth. Swallow tablets with water.
Duration of treatment
If symptoms persist for more than 2 weeks, consult your doctor.
If you have taken more CARDIOCALM, film-coated tablet than you should have
Not applicable.
If you forget to take CARDIOCALM, film-coated tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking CARDIOCALM, film-coated tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
There are no known adverse effects to date. In case of side effects, please consult a doctor or a qualified health professional.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE CARDIOCALM, film-coated tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store at temperatures not exceeding 30°C, in its outer packaging, protected from moisture.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CARDIOCALM, film-coated tablet contains
- The active substance is :
Hawthorn(Crataegus laevigata Jacq. (Lindm.) or C. monogyna (Poir.) DC.) (dry leaf and flower extract d) 70 mg
Extraction solvent: 60% V/V ethanol
Drug/extract ratio: 4-7:1
For one film-coated tablet.
- Other components are :
Colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, Kollicoat Protect*, titanium dioxide (E171), talc, erythrosine (E127).
*Kollicoat Protect: graft copolymer of macrogol and polyvinyl alcohol, polyvinyl alcohol, silicon dioxide.
Extract additive: maltodextrin, anhydrous colloidal silica.
What CARDIOCALM, film-coated tablet is and what it contains
This medicine comes in the form of film-coated tablets. Each box contains 40 or 80 tablets.
Not all presentations may be marketed.
Marketing authorization holder
LABORATOIRE PHARMASTRA
2c RUE DU MARECHAL DE LATTRE DE TASSIGNY
67460 SOUFFELWEYERSHEIM
Marketing authorization holder
LABORATOIRE PHARMASTRA
2c RUE DU MARECHAL DE LATTRE DE TASSIGNY
67460 SOUFFELWEYERSHEIM
Manufacturer
LABORATOIRE PHARMASTRA
2c RUE DU MARECHAL DE LATTRE DE TASSIGNY
67460 SOUFFELWEYERSHEIM
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.