NOTICE
ANSM - Updated: 17/12/2015
Name of the drug
CAROMINTHE, oral solution in drops
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· 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. See section 4.
· You should talk to your doctor if you do not feel better or feel worse after 3 or 4 days
Summary notice
What does this booklet contain :
1. What is CAROMINTHE, oral solution in drops and in which cases is it used?
2. What information do you need to know before using CAROMINTHE, oral solution in drops ?
3. How to use CAROMINTHE, oral drops solution ?
4. What are the possible side effects?
5. How to preserve CAROMINTHE, oral solution in drops ?
6. Additional information.
1. WHAT IS CAROMINTHE, oral drops solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
CAROMINTHE, oral solution in drops is a homeopathic medicine traditionally used in difficult digestion.
2. WHAT INFORMATION DO YOU KNOW BEFORE USING CAROMINTHE, oral solution in drops?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use CAROMINTHE, oral solution in drops:
· In the child.
· If you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine, listed in section 6.
Precautions for use; special warnings
Warnings and precautions for use
· This medicinal product contains a maximum of 39% ethanol (alcohol), that is to say up to 154 mg per dose (20 drops), which is equivalent to 3.8 ml of beer, 1.5 ml of wine.
The use of this drug is dangerous in alcoholic subjects and should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as hepatic insufficiency or epileptics.
· Given the presence of the strain PULSATILLA in the formula, this drug should not be used in cases of otitis or sinusitis without medical advice.
Interactions with other drugs
Other medicines and CAROMINTHE, oral drops solution:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with food and drinks
CAROMINTHE, oral drops solution with food and drinks.
This medication is best taken away from meals.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
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
Carominthe , oral drops solution contains ethanol.
3. HOW TO USE CAROMINTHE, oral solution in drops?
Instructions for a good use
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Medicine reserved for adults
Take 20 drops 4 times a day for 3 days then 2 times a day for 15 days.
Administration mode
Oral way
Hold the bottle vically.
Frequency of administration
Space the catches as soon as possible and stop the catches as soon as the symptoms disappear.
Duration of treatment
Treatment should not be continued beyond 3 to 4 days in the absence of improvement.
Symptoms and instructions in case of overdose
If you take more CAROMINTHE, oral solution in drops than you should:
Immediately consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take CAROMINTHE, oral solution in drops:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, this medicine 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 CAROMINTHE, oral solution in drops?
Keep this medicine out of the sight and reach of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the label, carton and vial.
The expiry date refers to the last day of this month .
Storage conditions
No special storage conditions.
Keep the bottle tightly closed.
If necessary, warn against some visible signs of deterioration
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What contains CAROMINTHE, oral solution in drops:
· The active substances are:
Absinthium 3DH ................................................ .................................................. .............................. 5.94 ml
Pulsatilla 4DH ................................................ .................................................. ................................. 5.94 ml
Collinsonia canadensis 3 DH .............................................. .................................................. .............. 5.94 ml
Nux vomica 4 DH .............................................. .................................................. .............................. 5.94 ml
Lupulinum 2 DH ............................................... .................................................. ............................... 5,94 ml
Mentha piperita TM ............................................... .................................................. .......................... 2.97 ml
Taraxacum dens leonis 2 DH ............................................. .................................................. ............. 29.70 ml
for a bottle of 90ml.
· The other components are:
Ethanol 39% (v / v), orange blossom water, caramel (E150).
Pharmaceutical form and content
Appearance of CAROMINTHE, oral drops solution and contents of the pack
Carominthe oral drops solution is in the form of oral solution packaged in yellow glass bottle of 90 ml with dropper, under a cardboard case.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Marketing Authorization Holder and Manufacturer
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 leaflet was last revised is <{MM / YYYY}> <{YYYY month}.>
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.