NOTICE
ANSM - Updated: 17/04/2014
Name of the drug
CRATAEGUS COMPLEX No. 15, oral drops solution
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If the symptoms get worse or persist, consult a doctor.
· If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
What does this booklet contain :
1. What is CRATAEGUS COMPLEX No. 15, oral solution drops and in which case is it used?
2. What information do you need to know before taking CRATAEGUS COMPLEX No. 15, oral drops solution ?
3. How to take CRATAEGUS COMPLEX No. 15, oral drops solution ?
4. What are the possible side effects?
5. How to store CRATAEGUS COMPLEX No. 15, oral drops solution ?
6. Additional information.
1. WHAT IS CRATAEGUS COMPLEX No. 15, oral drops solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Homeopathic medicine.
Therapeutic indications
CRATAEGUS COMPLEX No. 15, oral drops solution is a homeopathic medicine traditionally used in the treatment of palpitations and cardiovascular manifestations of nervousness, anxiety and insomnia.
2. BEFORE YOU TAKE CRATAEGUS COMPLEX No. 15, oral solution drops?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take CRATAEGUS COMPLEX NO. 15, oral drops solution:
· In the child.
· If you are allergic (hypersensitive) to any of the components.
Precautions for use; special warnings
Take special care with CRATAEGUS COMPLEX No. 15, oral drops solution:
This medicine contains 52% v / v of ethanol (alcohol) fl uid, i.e. up to 205 mg per dose (20 drops), which equals 5.1 ml of beer, 2.1 ml of wine per dose.
The use of this drug is dangerous in alcoholic subjects and should be considered in pregnant or breastfeeding women and high risk groups such as hepatic insufficiency or epileptics.
Interactions with other drugs
Taking or using other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Food and drinks
This medicine is to be taken in a little water, preferably outside meals.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Seek advice from your doctor or pharmacist before taking any medicine.
Due to the presence of alcohol, this medication is not recommended during pregnancy and lactation.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of CRATAEGUS COMPLEX No. 15, oral drops solution:
This medicine contains ethanol.
3. HOW TO TAKE CRATAEGUS COMPLEX NO. 15, oral solution in drops?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Medicine reserved for adults.
20 drops twice a day.
Administration mode
To take in a little water, preferably outside meals. Keep the medicine under the tongue before swallowing.
Sublingual route.
Hold the bottle vertically.
Frequency of administration
Space the catches as soon as possible and stop the catches as soon as the symptoms disappear.
Duration of the treatment
The duration of treatment should not exceed 3 weeks; beyond that a medical opinion is necessary.
Symptoms and instructions in case of overdose
If you have used more CRATAEGUS COMPLEX NO. 15, oral drops solution than you should have:
Consult your doctor or your pharmacist.
Instructions for omitting one or more doses
If you forgot to use CRATAEGUS COMPLEX NO. 15, oral drops solution:
Do not take a double dose to make up for the dose you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, CRATAEGUS COMPLEXE N ° 15 drops drops can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr. By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE CRATAEGUS COMPLEX NO. 15, oral solution in drops?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use CRATAEGUS COMPLEX No. 15, oral drops solution after the expiry date which is stated on the label and outer carton. The expiry date refers to the last day of the month.
Storage conditions
Keep the bottle tightly closed.
No special storage conditions.
If necessary, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does CRATAEGUS COMPLEX No. 15, oral drops solution contain?
The active substances are :
Crataegus oxyacantha TM ............................................... .................................................. .................... 9 ml
Arnica montana 2 DH .............................................. .................................................. ............................ 3 ml
Aconitum napellus 4 DH .............................................. .................................................. ........................ 3 ml
Nux vomica 4 DH .............................................. .................................................. .................................. 3 ml
Glonoinum 8 DH ............................................... .................................................. .................................. 3 ml
Cactus grandiflorus 2 DH .............................................. .................................................. ...................... 3 ml
Arsenicum album 4 DH .............................................. .................................................. .......................... 3 ml
Apocynum cannabinum 8 DH .............................................. .................................................. ................. 3 ml
for a 30 ml bottle.
The other components are :
Ethanol, purified water.
Pharmaceutical form and content
What is CRATAEGUS COMPLEX No. 15, oral drops solution and contents of the pack?
This medicine is in the form of oral solution drops, packaged in 30 ml bottle with dropper under a cardboard sleeve.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE BARBE
LA FRANCE
exploiting
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE BARBE
LA FRANCE
Maker
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE BARBE
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.