NOTICE
ANSM - Updated on: 20/09/2013
Name of the medicinal product
PARAFFINE GIFRER OIL, oral solution
Liquid Paraffin
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, 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 PARAFFINE GIFRER OIL, ORAL SOLUTION AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE PARAFFINE GIFRER OIL, drinkable solution?
3. HOW TO TAKE PARAFFINE OIL GIFRER, oral solution?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PARAFFINE OIL GIFRER, oral solution?
6. ADDITIONAL INFORMATION
1. WHAT IS PARAFFINE GIFRER OIL, ORAL SOLUTION AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
LAX (A: digestive system and metabolism)
Therapeutic indications
This medication is a laxative used orally. It is recommended in occasional constipations.
It usually works 6 to 8 hours after taking.
2. BEFORE YOU TAKE PARAFFINE GIFRER OIL, drinkable solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take PARAFFINE GIFRER OIL, oral solution in the following cases:
· If you have an allergy to paraffin oil
· If you have obstructive colopathy, given the laxative effect of the drug
· If you have indeterminate and inflammatory bowel syndrome (ulcerative colitis, Crohn's disease ...
· Do not use in people who have difficulty swallowing because of the risk of inhalation of the liquid paraffin that leads to lipoid pneumonia.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with PARAFFINE GIFRER OIL, oral solution:
Special warnings
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
· The administration of paraffin oil in young children, patients bedridden or having difficulty swallowing should be cautious as it may cause bronchial passages and respiratory disorders.
Generally speaking, do not take this medication before going to bed.
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 can be linked to two causes:
· a disease of the intestine that requires treatment by the physician,
· or an imbalance of intestinal function due to eating 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 ...)
· rehabilitation of defecation reflex
· sometimes, the addition of sound to food
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 amount of water with infant milk powders, a diet rich in vegetable products, addition of Juice.
Regular intake of laxatives in young age may interfere with the normal functioning of the defecation reflex).
Precautions for use
· This oil should not be heated.
· Prolonged use of paraffin oil is likely to decrease the absorption of certain vitamins.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
NEVER LEAVE TO CHILDREN.
Interaction with other medicines
Taking other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medicine, under normal conditions of use, may be used occasionally during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
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 PARAFFINE OIL GIFRER, oral solution?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Adult: the usual dosage is 1 to 3 tablespoons per day
Children over 6 years: 1 to 3 teaspoons per day
Child under 6 years of age: according to medical opinion
The dose may be taken 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, avoid sleeping within 2 hours ( see Caution with PARAFFINE OIL GIFRER, oral solution ) and take into account that the laxative effect may occur during the night.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Symptoms and Instructions for Overdose
If you used more PARAFFINE GIFRER OIL, you should have:
The use of high doses of liquid paraffin exposes to a risk of:
· diahrrée
· anal seeping,
· and perianal irritation
If you take or administer more PARAFFINE GIFRER OIL, you should not contact your doctor.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, PARAFFIN OIL GIFRER, oral solution is likely to have side effects, although not everyone is subject to it.
· in exceptional conditions or because of misuse, possibilities of respiratory disorders ( see Paraffine Oil Gifrer, oral solution ).
· in high doses, risk of oily flow or irritation in the anus.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE PARAFFINE OIL GIFRER, oral solution?
Keep out of the reach and sight of children.
Expiration date
Do not use PARAFFINE GIFRER OIL, oral solution after the expiry date which is stated on the outer packaging.
Storage conditions
This medication should be stored in a dark place.
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 PARAFFINE GIFRER OIL contain, oral solution?
The active substance is:
Liquid paraffin oil .............................................. .......................... qsp the capacity of the sales model
Pharmaceutical form and content
What is PARAFFINE GIFRER OIL, oral solution and contents of the pack?
This medication is in the form of a drinkable solution. Box of 1 bottle of 250 ml, 500 ml or 1000 ml.
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
GIFRER BARBEZAT
8 to 10 rue Paul Bert
69150 DECINES-CHARPIEU
exploiting
GIFRER BARBEZAT
8-10, rue Paul Bert
69153 DECINES CEDEX
Maker
GIFRER BARBEZAT
8-10, rue Paul Bert
69153 DECINES CEDEX
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.