NOTICE
ANSM - Updated: 24/09/2013
Name of the drug
CLIMAXOL oral 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. WHAT CLIMAXOL, oral solution AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE TAKING CLIMAXOL, oral solution?
3. HOW TO TAKE CLIMAXOL, oral solution?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CLIMAXOL oral solution?
6. ADDITIONAL INFORMATION
1. WHAT CLIMAXOL, oral solution AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Herbal medicine.
Therapeutic indications
Traditional herbal medicine used in:
· disorders of venous circulation
· the fragility of small vessels.
2. WHAT YOU NEED TO KNOW BEFORE TAKING CLIMAXOL, oral solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take CLIMAXOL, oral solution:
· If you are allergic (hypersensitive) to any of the ingredients in CLIMAXOL, oral solution.
Precautions for use; special warnings
Special warnings
20 drops of solution contain 0.25 g of ethanol
This medicine contains 69% ethanol (alcohol), i.e. up to 340 mg per dose, equivalent to 8.5 ml of beer, 3.4 ml of wine per dose. 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.
Precautions for use
· Venous circulation disorders :
This drug has all its effectiveness when it is associated with a healthy lifestyle.
o Avoid exposure to the sun, heat, prolonged standing, excess weight.
o Walking and possibly wearing adapted stockings promote blood circulation.
· If discomfort and fragility of vessels increase (bruises and bruises spread), CHECK YOUR DOCTOR IMMEDIATELY.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking 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
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
There is insufficient data on taking this medication during pregnancy and lactation. Therefore, as a precaution, it is best not to take CLIMAXOL oral solution without medical advice.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Ethanol (alcohol)
3. HOW TO TAKE CLIMAXOL, oral solution?
Instructions for a good use
To take in a little water, before meals.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Venous circulation disorders: 20 to 25 drops, 2 times daily
Fragility of small vessels: 20 drops, 3 times a day.
Method and route of administration
Oral way
Frequency of administration
Not applicable.
Duration of treatment
Not applicable.
Symptoms and instructions in case of overdose
If you take more CLIMAXOL, oral solution than you should:
Consult your doctor or your pharmacist.
Instructions for omitting one or more doses
If you forget to take CLIMAXOL, oral solution:
Do not take a double dose to make up for the dose you forgot to take. Continue your treatment normally.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, CLIMAXOL oral solution can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CLIMAXOL oral solution?
Keep out of the reach and sight of children.
Expiration date
Do not use CLIMAXOL oral solution after the expiry date which is stated on the package. The expiry date refers to the last day of the month.
Storage conditions
Not applicable.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away to the sewer 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 CLIMAXOL, oral solution contain?
The active substances are:
Tincture of witch hazel 1/10 .......................................... .................................................. ................... 28 ml
Tincture of thorny fragon 1/10 .......................................... .................................................. ........... 28 ml
Tincture of horse chestnut at 1/10 ........................................ .................................................. ............... 28 ml
Tincture of hydrastis 1/10 .......................................... .................................................. ....................... 8 ml
Tincture of Viburnum 1/10 ........................................... .................................................. .................... 8 ml
For 100 ml of oral solution.
Pharmaceutical form and content
What is CLIMAXOL oral solution and contents of the pack?
60 ml oral solution with dropper.
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 Saint Beard
exploiting
LEHNING Laboratories
1,3 rue du Petit-Marais
57640 SAINTE BARBE
Maker
LEHNING Laboratories
1,3 rue du Petit-Marais
57640 SAINTE BARBE
Names of the drug in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names:
In accordance with the regulations.
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 (www.ansm.sante.fr).
Information reserved for health professionals
Not applicable.
Other
Not applicable.