NOTICE
ANSM - Updated on : 26/01/2023
Product name
BOLDOFLORINE, film-coated tablet
Sidebar
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions, please ask your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult a doctor.
- If you notice any side effects not mentioned in this leaflet, or if you experience any of the effects mentioned as serious, please tell your doctor or pharmacist.
Contents leaflet
In this leaflet :
1. WHAT IS BOLDOFLORINE, film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT DO I HAVE TO KNOW BEFORE TAKING BOLDOFLORINE, film-coated tablet?
3. HOW DO I TAKE BOLDOFLORINE, film-coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW CAN I USE BOLDOFLORINE, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS BOLDOFLORINE, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
STIMULANT LAXATIVE.
Therapeutic indications
This medicine is a stimulant laxative (stimulates intestinal evacuation).
It is recommended for occasional constipation.
It usually takes effect within 8 to 12 hours.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING BOLDOFLORINE, film-coated tablet?
What you need to know before taking BOLDOFLORINE
Not applicable.
Contraindications
This drug MUST NOT BE USED in the following cases:
- certain diseases of the intestine and colon,
- in cases of abdominal pain,
- for chronic constipation (long-term constipation),
- in children under 12 without a doctor's prescription.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Warnings
Do not use for prolonged periods without medical advice.
Occasional constipation: This may be due 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 referred to your doctor.
Chronic constipation (long-term constipation): It should not be treated with a stimulant laxative.
There are two possible causes:
- or an intestinal disease requiring medical attention,
- or an imbalance in intestinal function due to eating habits and lifestyle.
Treatment includes
- increasing dietary intake of plant-based products (green vegetables, raw vegetables, wholemeal bread, fruit, etc.),
- increased consumption of water and fruit juices,
- increased physical activity (sports, walking, etc.),
- reeducate the defecation reflex,
- sometimes adding bran to the diet.
Consult your doctor or pharmacist for advice.
Particular case of children: In children, constipation treatment is based on lifestyle and dietary measures: in particular, using the right amount of water with infant milk powders, eating a diet rich in plant-based products, and adding fruit juices.
Treatment with stimulant laxatives without medical advice is contraindicated. (Regular use of laxatives at an early age can interfere with the normal functioning of the defecation reflex).
Precautions for use
Not recommended for nursing mothers.
This drug may cause potassium loss. Combination with other drugs (such as certain diuretics or heart medications) may be dangerous.
Interactions with other drugs
Taking other medications
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
In particular, if you are taking amiodarone, astemizole, bepridil, bretylium, disopyramide, erythromycin IV, halofantrine, pentamidine, quinidinics, sparfloxacin, sotalol, sultopride, terfenadine, vincamine.
Interactions with food and beverages
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breast-feeding
This medicine should only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether to continue treatment.
This drug should not be used during breast-feeding.
Sportsmen
Not applicable.
Effects on ability to drive vehicles or use machines
Not applicable.
List of excipients
Not applicable.
3. HOW DO I TAKE BOLDOFLORINE, film-coated tablet?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Adults: 1 to 3 tablets per day, after the evening meal.
Treatment should be short-term (8 to 10 days).
If the effect of treatment is insufficient, do not increase the dose or prolong use, but ask your doctor for advice.
IN ALL CASES, STRICTLY ADHERE TO YOUR DOCTOR'S PRESCRIPTION.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Do not take a double dose to make up for the one you missed. Continue your treatment as usual.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, BOLDOFLORINE, film-coated tablet is likely to have undesirable effects, although not everyone is subject to them:
Possible diarrhea, abdominal pain.
In this case, discontinue use and consult your doctor.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
5. HOW DO I USE BOLDOFLORINE, film-coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not exceed the expiration date clearly indicated on the packaging.
Storage conditions
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. FURTHER INFORMATION
Complete list of active substances and excipients
The active ingredients are:
Boldine ........................................................................................................................................ 0.740 mg
Senna (dried leaf extract) ..................................................................................................... 27,800 mg
Rosemary extract ..................................................................................................................... 12,000 mg
For one film-coated tablet.
The other constituents are:
Microcrystalline cellulose, corn starch, methylated casein*, magnesium stearate, hypromellose, titanium dioxide, propylene glycol, diethyl phthalate.
*Methylated casein is obtained by treating casein with formaldehyde.
Pharmaceutical form and contents
Film-coated tablet. Box of 8, 20 or 40 tablets.
Name and address of marketing authorization holder and manufacturing authorization holder responsible for batch release, if different
Holder
LABORATOIRES IPHYM
2053 AVENUE HENRI SCHNEIDER
69330 JONAGE
Operator
LABORATOIRES IPHYM
2053 AVENUE HENRI SCHNEIDER
69330 JONAGE
Manufacturer
Laboratoires Richard
ZI des Reys de Saulce
26270 Saulce sur Rhone
Drug names in member states of the European Economic Area
This drug is authorized in the member states of the European Economic Area under the following names:
In accordance with current regulations.
Date of approval of the package leaflet
The last date on which this notice was approved was {date}.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this drug is available on the Afssaps (France) website.
Information for healthcare professionals only
Not applicable.
Other
Not applicable.