NOTICE
ANSM - Updated on : 20/09/2013
Product name
ACTICARBINE, coated tablet
Activated charcoal / papaverine (chlorhydrate)
Sidebar
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions or doubts, please ask your doctor or pharmacist for more information.
- 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
In this leaflet :
1. WHAT IS ACTICARBINE, coated tablet AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ACTICARBINE, coated tablet?
3. HOW DO I TAKE ACTICARBINE, Coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW CAN I USE ACTICARBINE, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS ACTICARBINE, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
INTESTINAL ADSORBENT
ANTISPASMODIC
(A: digestive system and metabolism)
Therapeutic indications
Indicated in adults for the treatment of difficult digestion, particularly with intestinal bloating.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ACTICARBINE, coated tablet?
List of information required before taking the medicine
Not applicable.
Contraindications
Never take ACTICARBINE, coated tablet in the following cases:
- known allergy to any of the ingredients.
Unless otherwise advised by your doctor, this drug MUST NOT be used during pregnancy.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take special care with ACTICARBINE, coated tablet:
Precautions for use
- In case of bloating or flatulence, avoid pulses (lentils, flageolet, peas, etc.) and certain green vegetables (cabbage, Brussels sprouts, chard, etc.).
- In the event of associated diarrhea, it is necessary to :
o rehydrate with plenty of salty or sweet drinks, to compensate for fluid losses due to diarrhea (the average daily water intake for adults is 2 liters)
o eat during diarrhea,
§ by excluding certain foods, particularly raw vegetables, fruit, green vegetables, spicy dishes and iced foods or drinks.
§ with a preference for grilled meats and rice.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking or using other drugs:
As this drug may reduce the absorption of other drugs, they should be administered at a distance from it (more than 2 hours, if possible).
TO AVOID POSSIBLE HARMFUL INTERACTIONS BETWEEN SEVERAL DRUGS, INFORM YOUR DOCTOR OR PHARMACIST OF ANY TREATMENT IN PROGRESS.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breast-feeding
Pregnancy
Unless otherwise advised by your doctor, this product should not be used during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor immediately: only he/she will be able to adapt the treatment to your condition.
Breast-feeding
This drug should not be taken during breast-feeding.
As a general rule, always seek the advice of your doctor or pharmacist before taking any medication during pregnancy or while breast-feeding.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Driving vehicles and using machines:
Particular attention is drawn to the risk of drowsiness due to the presence of papaverine, especially for drivers and users of machines.
List of excipients
Not applicable.
3. HOW DO I TAKE ACTICARBINE, coated tablet?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
For adults only
1 to 2 tablets before 3 meals, to be swallowed whole with a glass of water.
Method and route of administration
Take by mouth.
Symptoms and instructions in case of overdose
If you have taken more ACTICARBINE, coated tablet than you should have :
No cases of overdose have been reported with this drug.
Papaverine, one of the active ingredients in this medicine, may cause nausea, vomiting, weakness, central nervous system depression, double vision, profuse sweating, facial flushing, dry mouth, dizziness and sinus tachycardia in very large doses.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ACTICARBINE, coated tablet may have undesirable effects, although not everyone is subject to them:
- dark stools may appear.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW CAN I USE ACTICARBINE, coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use ACTICARBINE, coated tablet after the expiration date stated on the outer packaging.
Storage conditions
No special storage conditions.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of in the mains 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 ingredients and excipients
What does ACTICARBINE, coated tablet contain?
The active ingredients are:
Activated charcoal ............................................................................................................................. 70,000 mg
Papaverine hydrochloride ........................................................................................................... 14,000 mg
For one coated tablet
The other components are:
Alginic acid, sucrose, corn starch, liquid glucose, polyethylene glycol 6000, magnesium stearate, bleached shellac, talc, gum arabic, titanium dioxide, carnauba wax.
Pharmaceutical form and contents
What is ACTICARBINE, coated tablet and what does it contain?
This medicine comes in coated tablet form.
Boxes of 40, 42, 80 or 84 coated tablets.
Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different
Holder
Laboratoire des Réalisations Thérapeutiques ELERTE
181 - 183, rue André Karman
BP 101
93303 Aubervilliers Cedex
Operator
Laboratoire des Réalisations Thérapeutiques ELERTE
181 - 183, rue André Karman
BP 101
93303 Aubervilliers Cedex
Manufacturer
Laboratoire des Réalisations Thérapeutiques ELERTE
181 - 183, rue André Karman
BP 101
93303 Aubervilliers Cedex
Product names in member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
This leaflet was last approved on {date}.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this product is available on the INSM (France) website.
Information reserved for healthcare professionals
Not applicable.
Other
Not applicable.