NOTICE
ANSM - Updated on : 14/10/2022
Name of medicinal product
YERBALAXA, herbal tea in dose sachet
Senna (leaf), Mallow (leaf)
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 7 days.
What does this leaflet contain?
1. What is YERBALAXA herbal tea in a sachet and what is it used for?
2. What do I need to know before taking YERBALAXA, herbal tea in a sachet?
3. How should I take YERBALAXA herbal tea in a sachet?
4. What are the possible side effects?
5. How to store YERBALAXA, herbal tea in a sachet?
6. Package contents and other information.
1. WHAT IS Yerbalaxa, herbal tea in a sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: stimulant laxative. ATC code: A06AB06.
YERBALAXA, herbal tea in sachet is a herbal medicine indicated for the short-term treatment of occasional constipation.
YERBALAXA herbal tea is indicated for adults.
You should consult your doctor if you do not feel any improvement or if you feel less well after 7 days.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING Yerbalaxa herbal tea in a sachet?
Never take YERBALAXA, herbal tea in a sachet:
- if you are allergic to senna, mallow or any of the other ingredients listed in section 6.
- in case of certain bowel and colon diseases,
- abdominal pain (stomach ache),
- chronic constipation (long-term constipation),
- in cases of severe dehydration,
- pregnant or breast-feeding women,
- children and adolescents under 18.
Warnings and Precautions
Consult your doctor or pharmacist before using YERBALAXA, herbal tea in a sachet.
- Medical advice should be sought in association with antiarrhythmic drugs, cardiac glycosides, drugs likely to cause torsades de pointes, diuretics, corticosteroids and licorice root products.
- Medical advice should be sought if you suffer from acute or persistent gastrointestinal pain, faecal retention, nausea and vomiting, as these symptoms may indicate intestinal obstruction.
- If you suffer from kidney disease, electrolyte imbalance is possible.
- In incontinent people, diapers will need to be changed more often to avoid prolonged skin contact with stool.
Special warnings :
Do not exceed 1 week's treatment. If the effect of treatment is insufficient, do not increase the dose or prolong the use of the drug, but ask your doctor or pharmacist for advice.
Occasional constipation:
This may be related to a recent change in lifestyle (travel). The drug can be used as a short-term treatment. Any recent constipation unexplained by a change in lifestyle, or any constipation accompanied by pain, fever or swelling of the abdomen, should be discussed with your doctor.
Chronic constipation (long-term constipation):
It should not be treated with a stimulant laxative. There are two possible causes:
- either bowel disease, which requires medical attention,
- or an imbalance in intestinal function due to dietary and lifestyle habits.
Anthracene laxatives, also known as stimulant laxatives, should be taken after all other forms of laxative (such as ballast laxatives) have been used, and after hygienic and dietary measures have been implemented.
If it becomes necessary to take laxatives on a daily basis, the causes of the constipation should be investigated.
Hygienic and dietary measures include :
- increasing dietary intake of plant-based products (green vegetables, raw vegetables, wholemeal bread, fruit),
- increasing consumption of water and fruit juices,
- increased physical activity (sport, walking, etc.),
- re-education of the defecation reflex,
- sometimes, adding bran to food.
Children and adolescents
This drug is contraindicated in children and adolescents under 18 years of age.
Other medicinal products and YERBALAXA, herbal tea sachet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This medicine should be avoided in association with antiarrhythmic drugs causing serious heart rhythm disorders (amiodarone, cibenzoline, diltiazem, disopyramide, dronedarone, flecainide, hydroquinidine, lidocaine, mexiletine, propafenone, quinidine, sotalol, verapamil).
Combination with diuretics, corticosteroids and licorice root products may increase mineral and electrolyte (potassium) imbalance.
YERBALAXA herbal tea sachet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
YERBALAXA herbal tea is contraindicated during pregnancy and lactation.
Driving and use of machinery
Not applicable.
YERBALAXA herbal tea contains lanis (fruit).
3. HOW TO TAKE Yerbalaxa, herbal tea in a sachet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults:
1 sachet-dose per day as an infusion, to be taken at bedtime.
Children and teenagers
Use in children and adolescents under 18 is contraindicated.
Method of administration
Take orally.
Bring water to the boil and pour into a cup containing the sachet, cover and leave to infuse for 5-10 minutes, then remove the sachet. The tea should be prepared just before use.
Duration of treatment
Treatment should not exceed one week.
Taking it up to two or three times during this week is generally sufficient.
If symptoms persist during treatment, consult your doctor or pharmacist.
If you have taken more YERBALAXA herbal tea than you should have
The main symptoms of overdose are as follows:
- abdominal cramps,
- severe diarrhoea, which may lead to significant loss of fluids and electrolytes.
Treatment should be symptomatic and consist of administering a large volume of fluids rich in minerals and electrolytes. Potassium levels, particularly in the elderly, should be monitored.
Chronic ingestion of drugs containing excessive doses of anthracene derivatives may lead to liver toxicity.
In the event of overdose, consult your doctor.
If you forget to take YERBALAXA, herbal tea sachet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking YERBALAXA, herbal tea in a sachet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
The following side effects may occur:
- Allergic reactions:
o pruritus, urticaria, local or generalized rash.
- Gastrointestinal disorders :
o abdominal pain, spasms, diarrhea, particularly in subjects suffering from irritable bowel syndrome. However, these symptoms may also occur following an overdose. In this case, dosage should be reduced.
- Kidney and urine symptoms:
o hydroelectrolytic imbalance, leading to the presence of albumin and blood in the urine,
o yellow or red-brown discoloration of the urine without clinical significance.
The frequency of this type of reaction is unknown.
If you experience any side effects not mentioned above, please consult your doctor or a qualified healthcare professional.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE Yerbalaxa, herbal tea in sachet-dose?
Keep out of sight and reach of children.
Store at temperatures not exceeding 25°C.
Do not use this medicine after the expiration date indicated on the packaging {DLU month/year}. The expiration date refers to the last day of that month.
Do not dispose of any medicine in the garbage . Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What YERBALAXA, herbal tea in a sachet, contains
- The active ingredients are :
Senna(Senna alexandrina Mill. or Cassia angustifolia Vahl) (leaf) ....800.0 mg to 1,100.0 mg
Quantity corresponding to 25 mg anthracene heterosides expressed as sennosides B.
Mallow(Malva sylvestris L.) (leaf)..800.0 mg
For one sachet.
- Other excipient: anise (fruit).
What YERBALAXA herbal tea is and what it contains
This medicine comes in the form of a herbal blend in a 2 g sachet.
Box of 10 sachets.
Marketing authorization holder
LABORATOIRES IPHYM
2053 AVENUE HENRI SCHNEIDER
69330 JONAGE
Marketing authorization holder
LABORATOIRES IPHYM
2053 AVENUE HENRI SCHNEIDER
69330 JONAGE
Manufacturer
LABORATOIRES IPHYM
2053 AVENUE HENRI SCHNEIDER
69330 JONAGE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Not applicable.