NOTICE
ANSM - Updated: 08/03/2018
Name of the drug
HERBESAN, plant mix for herbal tea, sachets
Senna (leaf of)
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 if you feel worse after 10 days.
What does this booklet contain ?
1. What is HERBESAN, herbal mixture for herbal sachets-dose and in what cases is it used?
2. What information do you need to know before taking HERBESAN, herbal tea mix, dose sachets?
3. How to take HERBESAN, herbal mixture for herbal tea, sachets-dose?
4. What are the possible side effects?
5. How to store HERBESAN, herbal mixture for herbal tea, sachets-dose?
6. Contents of the package and other information.
1. WHAT IS HERBESAN, Herbal Mix for herbal tea-bags AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: stimulant laxative - ATC code: A06AB06
Herbal drug used in the short-term treatment of occasional constipation.
2. WHAT YOU NEED TO KNOW BEFORE TAKING HERBESAN, herbal mixture for herbal sachet-dose?
Do not take HERBESAN in the following cases:
· if you are allergic to Senna or any of the other ingredients of this medicine, listed in section 6.
· Some diseases of the bowel and colon,
· In case of abdominal pain (stomach pain),
· In case of chronic constipation (long-term constipation)
· In children under 12 years old.
This medicine is generally not recommended unless advised by your doctor:
· in combination with certain diuretics or heart medications (Other medicines and HERBESAN ).
Warnings and precautions
Talk to your doctor or pharmacist before taking HERBESAN .
Occasional constipation:
It may be related to a recent lifestyle change (travel). The drug can be a help in short treatment. Any recent constipation unexplained by the change of lifestyle, any constipation accompanied by pains, fever, swelling of the belly must seek the advice of the doctor.
Chronic constipation (long-term constipation):
It should not be treated with a stimulant laxative.
It can be related to 2 causes:
- is a disease of the intestine that requires treatment by the doctor
- an imbalance of bowel function due to dietary habits and lifestyle.
The treatment includes among others:
- an increase in dietary intake of plant products (green vegetables, raw vegetables, wholemeal bread, fruit ...),
- an increase in the consumption of water and fruit juice,
- an increase in physical activity (sport, walking ...),
- a reeducation of the defecation reflex,
- sometimes, the addition of sound to the diet.
It is helpful to consult your doctor or pharmacist.
This medicine may cause a loss of potassium. The combination with other diuretics or heart medications can be dangerous.
children
In children, the treatment of constipation is based on lifestyle and dietary measures, including the use of the right amount of water with infant milk powders, a diet rich in plant products , addition of fruit juice.
Treatment with a stimulant laxative without medical advice may be contraindicated (regular laxative intake at a young age may hinder the normal functioning of the defecation reflex).
Other medicines and HERBESAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including amiodarone, astemizole, bepridil, bretylium, disopyramide, erythromycin IV, halofrantrine, pentamidine, quinidine, sparfloxacin, sotalol, sultopride, terfenadine, vincamine.
HERBESAN with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of this drug is not recommended during pregnancy and lactation.
Driving and using machines
Not applicable.
HERBESAN contains:
Not applicable.
3. HOW TO TAKE HERBESAN, herbal mixture for herbal sachets-dose?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage :
Adults and adolescents
A bag to be taken in the evening 2 hours after the meal.
Use in children
This medication is contraindicated in children under 12 years of age.
Mode of administration :
Oral way.
In a cup, pour boiling water over the bag and let steep for 5 minutes. Remove the bag, sugar or flavor according to your taste.
Herbal tea should be prepared at the time of use and swallowed immediately.
Duration of treatment :
The treatment should not exceed 8 to 10 days.
If symptoms persist while using this medicine, consult your doctor.
If you take more HERBESAN than you should
Consult your doctor or your pharmacist.
If you forget to take HERBESAN
Do not take a double dose to make up for the dose you forgot to take
If you stop taking HERBESAN
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?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· You may experience nausea, vomiting, stomach pain, or diarrhea: stop treatment and tell your doctor;
· Rarely allergy reactions such as urticaria, edema (swelling), or feeling sick and hypotensive;
· There is a risk of decreased potassium in the blood;
· Abnormal staining of the urine is possible.
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 on the safety of the medicine.
5. HOW TO STORE HERBESAN, herbal mixture for herbal sachets-dose?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month.
Store at a temperature not exceeding 25 ° C, away from moisture.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What HERBESAN contains
· The active substance is:
Senna ( Cassia senna L. or C. angustifolia Vahl) (sheet of) .................................. ........................ 0,80g
Corresponding amount of anthracene glycosides expressed as sennosides B at ......... .. 18-25 mg
for a bag of 2 g
· The other components are:
Aniseed fruits, peppermint leaves, quackgrass rhizomes.
What HERBESAN looks like and contents of the pack
This medicine is in the form of a tea bag. Box of 10.
Marketing Authorization Holder
SUPER DIET LABORATORIES
8 STREET CHRISTOPHE COLOMB
75008 PARIS
Operator of the marketing authorization
SUPER DIET LABORATORIES
RUE VICTOR HUGO - BP 70010
59721 DENAIN CEDEX
Maker
SUPER DIET LABORATORIES
RUE VICTOR HUGO - BP 70010
59721 DENAIN CEDEX
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
October 2017
Other
Detailed information on this medicine is available on the ANSM website ( www.ansm.sante.fr ).