NOTICE
ANSM - Last updated: 14/04/2015
Name of the medicinal product
TISANE PROVENCALE N ° 1, plants for herbal tea in sachet
Sene (sheet of)
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist after 8 to 10 days, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. What is PROVENCAL TISANE No. 1, herbal teas in sachets and in which case is it used?
2. What should be known before taking TISANE PROVENCALE N ° 1, herbal teas in sachets ?
3. How to take TISANE PROVENCALE N ° 1, herbal teas in sachet ?
4. What are the possible side effects?
5. How to store TISANE PROVENCALE N ° 1, herbal teas in sachets ?
6. Additional information.
1. WHAT IS PROVENCAL TISANE N ° 1, plants for herbal tea in sachets AND WHAT USES IS IT USED FOR?
Pharmacotherapeutic group
This medication is a stimulant laxative.
Therapeutic indications
It is recommended in the short-term treatment of occasional constipation.
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE TAKING PROVENCAL TISANE N ° 1, herbal teas in sachets?
List of information needed before taking the medication
Not applicable
Cons-indications
Never take TISANE PROVENCALE N ° 1, plants for herbal tea in sachets:
· in the case of certain diseases of the intestine and the colon,
· in case of abdominal pain (stomach pains),
· in case of chronic constipation (long-lasting constipation),
· during severe dehydration states,
· in children under 12 years of age.
This medication is GENERALLY NOT RECOMMENDED unless your doctor has advised otherwise:
· in combination with certain diuretics or certain heart medicines ( see Taking other medicines ),
Precautions for use; special warnings
Take special care with TISANE PROVENCALE N ° 1, plants for herbal tea in sachet:
· Do not exceed 8 to 10 days of treatment.
Occasional constipation :
It may be related to a recent change in lifestyle (travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-term constipation):
It should not be treated with a stimulant laxative.
It can be linked to two causes:
· a disease of the intestine that requires treatment by the physician,
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· an increase in dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruit ...),
· an increase in the consumption of water and fruit juices,
· an increase in physical activities (sports, walking ...),
· a rehabilitation of the defecation reflex,
· sometimes, the addition of sound to the diet.
It is helpful to seek advice from your doctor or pharmacist.
Special case of the child :
In children the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right quantities of water with infant milk powders, a diet rich in vegetable products, addition of juice of fruits.
Interaction with other medicines
Taking other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, including amiodarone, astemizole, bepridil, bretylium, disopyramide, erythromycin IV, halofantrine , pentamidine, quinidinic acid, sparfloxacin, sotalol, sultopride, terfenadine, vincamine, talk to your doctor or pharmacist.
Interactions with food and beverages
Food and drinks
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Use of this medication is not recommended during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Not applicable.
List of excipients with known effect
Not applicable
3. HOW TO TAKE PROVENCAL TISANE N ° 1, herbal teas in sachets?
Instructions for proper use
In a cup, pour boiling water over a sachet. Leave to infuse for 5 to 10 minutes.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Reserved for adults and adolescents over 12 years of age.
1 sachet to take infusion 1 to 2 times a day at the maximum.
Administration mode
Oral use.
Duration of treatment
This treatment should only be taken for a short period (maximum 8 to 10 days).
If the effect of the treatment is insufficient, do not increase the dose or prolong the use, but ask your doctor or pharmacist for advice.
Symptoms and Instructions for Overdose
If you have taken more PROVENCAL TISANE N ° 1, herbal teas in sachet you should not have:
Consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take TISANE PROVENCALE N ° 1, plants for herbal tea in sachet:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
If you stop taking TISANE PROVENCALE N ° 1, herbal teas in sachet:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, TISANE PROVENCALE N ° 1, plants for herbal tea in sachet is likely to have undesirable effects, although not everyone is subject to it.
· Nausea, vomiting, stomach pain or diarrhea may occur: stop treatment and tell your doctor;
· rarely allergic reactions to urticaria, edema (swelling) or feeling unwell and hypotension;
· there is a risk of decreased potassium in the blood;
· Abnormal staining of the urine is possible.
If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE PROVENCAL TISANE N ° 1, herbal teas in sachets?
Keep out of the reach and sight of children.
Expiration date
Do not use TISANE PROVENCALE N ° 1, plants for herbal tea in sachets after the expiry date stated on the box. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does TISANE PROVENCALE N ° 1 contain, herbal teas in sachets?
The active substance is:
SENE ( Cassia senna L.) (sheet of):
corresponding amount of anthracene heterosides expressed as sennoside B to 12.5 mg
For a bag of 1.7g
The other components are:
Aerial parts of marshmallow, yarrow yarrow, peppermint leaf, licorice root, rosemary leaf
Pharmaceutical form and content
What is TISANE PROVENCALE N ° 1, herbal teas in sachet and contents of the pack?
This medication is in the form of a tea bag. Box of 24.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
LABORATORY OF PROVENCAL TISANE
Chemin de Longuelance
13400 AUBAGNE - FRANCE
exploiting
LABORATORY OF PROVENCAL TISANE
Chemin de Longuelance
13400 AUBAGNE - FRANCE
Maker
LABORATORY OF PROVENCAL TISANE
Chemin de Longuelance
13400 AUBAGNE - FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet 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 for health professionals only
Not applicable.
Other
Not applicable.