NOTICE
ANSM - Updated: 16/11/2011
Name of the drug
PARAFFIN OIL COOPER, oral solution in bottle
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary record
In this notice :
1. WHAT PARAFFIN OIL COOPER, oral solution in vial AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE PARAFFIN OIL COOPER, oral solution in vial?
3. HOW TO TAKE PARAFFIN OIL COOPER, oral solution in vial?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PARAFFIN OIL COOPER, oral solution in vial?
6. ADDITIONAL INFORMATION
1. WHAT PARAFFIN OIL COOPER, oral solution in vial AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
LAXATIVE (A: digestive tract and metabolism)
Therapeutic indications
This medicine is a laxative used orally. It is recommended in occasional constipations.
2. BEFORE YOU TAKE PARAFFIN OIL COOPER, oral solution in vial?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take PARAFFIN OIL COOPER, oral solution in vial in the following cases:
· If you are allergic to paraffin oil,
· If you have obstructive colopathy (bowel disease), given the laxative effect of the drug,
· If you have painful abdominal syndrome of undetermined and inflammatory cause (ulcerative colitis, Crohn's disease, ...),
· Do not use in people who have difficulty swallowing because of the risk of inhalation of liquid paraffin that causes lipoid pneumonitis.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take care with PARAFFIN OIL COOPER, oral solution in bottle:
Special warnings
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
· The use of paraffin oil in young children, patients who are bedridden or who have difficulty swallowing should be careful because it can cause bronchial passage and respiratory problems.
In general, do not take this medicine before going to bed.
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 with pains, fever, swelling of the belly must seek the advice of the doctor.
Chronic constipation (long-term constipation):
It can be related to two causes:
· a bowel disease that requires management by the doctor,
· an imbalance in bowel function due to dietary habits and lifestyle.
The treatment includes among others:
· an increase in food intake of plant products (green vegetables, raw vegetables, wholemeal bread, fruits ...)
· an increase in the consumption of water and fruit juice
· an increase in physical activity (sport, walking ...)
· Rehabilitation of the defecation reflex
· sometimes, the addition of sound to the diet.
It is helpful to consult your doctor or pharmacist.
Special case of the child:
In children the treatment of constipation is based on lifestyle and dietetic measures: including the use of the right amount of water with infant milk powders, diet rich in plant products, addition of Juice.
In children, the laxative prescription must be exceptional.
Regular laxatives at a young age may hinder the normal functioning of the defecation reflex).
Precautions for use
· This oil should not be heated.
· Prolonged use of paraffin oil may decrease the absorption of certain vitamins (A, D, E and K).
IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Interactions with other drugs
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medicine, under normal conditions of use, can be used punctually during pregnancy and lactation.
In general, you should seek the advice of your doctor or pharmacist before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE PARAFFIN OIL COOPER, oral solution in vial?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Adult: The usual dosage is 1 to 3 tablespoons daily
Child over 6 years old: 1 to 3 teaspoons daily
The taking can take place in one or more times preferably in the morning on an empty stomach, 2 hours before or after meals. If you take it in the evening, you should avoid getting into bed within 2 hours ( see Warning ) and take into account that the laxative effect may occur during the night.
Action time: 6 to 8 hours after taking.
Method and route of administration
Oral way.
Duration of treatment
No prolonged use without medical advice.
Symptoms and instructions in case of overdose
If you take more PARAFFIN OIL COOPER, oral solution in bottle than you should:
The use of high doses of liquid paraffin poses a risk of:
· diarrhea,
· anal oozing,
· and perianal irritation (around the anus).
If you take more COOPER PARAFFIN OIL, oral solution in vial than you should, contact your doctor.
Instructions for omitting one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, PARAFFIN OIL COOPER oral solution in bottle is likely to have side effects, although not everyone is subject:
· at high dose, risk of oily discharge or irritation at the anus.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PARAFFIN OIL COOPER, oral solution in vial?
Keep out of the reach and sight of children.
Expiration date
Do not use PARAFFIN OIL COOPER, oral solution in bottle after the expiry date stated on the outer carton.
Storage conditions
This medicine should be stored away from light.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away at the sewer or with the garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What PARAFFIN OIL COOPER contains, oral solution in bottle?
The active substance is:
Liquid paraffin ................................................ ............................................... qsp the capacity of the bottle
The other components are:
Not applicable.
Pharmaceutical form and content
What PARAFFIN OIL COOPER, oral solution in bottle and contents of the pack?
This medicine is in the form of oral solution in bottles of 250 ml or 500 ml.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
exploiting
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Maker
FARMACLAIR
440, AVENUE OF THE GENERAL DE GAULLE
14200 HEROUVILLE SAINT CLAIR
Names of the medicine in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for health professionals
Not applicable.
Other
Not applicable.