NOTICE
ANSM - Last updated: 05/07/2017
Name of the medicinal product
NORMACOL LAVEMENT ADULTS, rectal solution, single dose container
Sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or 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 talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is NORMACOL LAVEL ADULTS, rectal solution, single dose container and in which cases is it used?
2. What should I know before using NORMACOL LAVEMENT ADULES, rectal solution, single dose container?
3. How to use NORMACOL LAVEMENT ADULTS, rectal solution, single dose container?
4. What are the possible side effects?
5. How to store NORMACOL LAVEMENT ADULES, rectal solution, single dose container?
6. Package contents and other information.
1. WHAT IS NORMACOL LAVEL ADULTS, rectal solution, single-dose container AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group - ATC code: A06AG20.
NORMACOL LAVEMENT ADULTS is a laxative presented in single dose container of 130 ml of rectal solution and is used from the age of 15 years for:
· Preparation for radiological and endoscopic examination of the rectosigmoid.
· Symptomatic treatment of low constipation.
2. BEFORE YOU USE NORMACOL LAVENT ADULTS, rectal solution, single dose container?
Never use NORMACOL LAVEL ADULTS, rectal solution, single dose container:
· If you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6,
· Children under 15 years of age,
· Hydro-electrolyte disorders with sodium retention,
· Patients with intestinal occlusion,
· Severe renal impairment,
· Megacolon (congenital or acquired).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before using NORMACOL LAVEMENT ADULES.
This medicine contains sodium parahydroxybenzoate (E219) and may cause allergic reactions.
This medicine contains sorbic acid or a salt thereof and may cause local skin reactions (eg, eczema).
Prolonged or repeated use is discouraged.
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 should not be treated with an enema.
It can be linked to two causes:
· a disease of the intestine that requires treatment by the physician,
· or an imbalance in intestinal function due to dietary 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 ...),
· a rehabilitation of the defecation reflex,
· sometimes, adding sound to the diet.
It is helpful to seek advice from your doctor or pharmacist.
It is preferable not to use this medication in cases of hemorrhoids, anal fissures, ulcerative colitis.
The product should be used with caution in elderly or frail patients with mild to moderate chronic renal insufficiency or heart failure or under strictly deodorised diet since there is a risk of electrolyte disturbances.
The product should be used with caution according to the instructions described in section 3 "How to use NORMACOL LAVEMENT ADULES, rectal solution, single dose container? ". Personnel administering the enema should be advised to discontinue administration immediately in the event of resistance, as force to introduce may result in local lesions and rarely rectal perforations.
Patients should be encouraged to maintain adequate hydration during treatment.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
children
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, of fruit juice.
Treatment by an enema without medical advice is contraindicated (regular intake of laxatives in young age may interfere with the normal functioning of the defecation reflex).
Other medicines and NORMACOL LAVEMENT ADULTS, rectal solution, single dose container
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
The product should be used with caution in patients receiving other hypokalemic drugs, digitalis or medicines that may cause torsades de pointes or other drugs that may affect electrolyte levels because hyperphosphatemia, hypocalcemia, hypernatremic dehydration and an acidosis might appear.
NORMACOL LAVEMENT ADULTS, rectal solution, single dose container with food and beverages
Not applicable.
Pregnancy and breast feeding
Treatment of constipation of pregnancy should only involve rectal laxatives on a very ad hoc basis. It is preferable, as a precautionary measure, not to use phosphate enemas.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
NORMACOL LAVEMENT ADULES, rectal solution, single dose container contains sodium methyl parahydroxybenzoate (E219) and sorbic acid.
3. HOW TO USE NORMACOL LAVEMENT ADULTS, rectal solution, single dose container?
Dosage
Preparation for endoscopic or radiological examinations :
1 enema the night before and 1 on the day of the examination.
Constipation :
1 enema five to twenty minutes before the time chosen for the exemption.
Use in children
NORMACOL LAVEMENT ADULTS should not be used in children less than 15 years of age.
There is another pharmaceutical form of NORMACOL LAVALLY adapted to the child.
Administration mode
Rectal route. DO NOT SWALLOW.
The solution is presented in a flexible plastic container serving as a pear and equipped with a lubricated rectal cannula.
1. When administering the enema, the subject should be in the lying position on the left side, knees folded in front of him, arms resting.
2. Remove by simple traction the tinted protective cap covering the lubricated cannula,
3. Gently insert the cannula into the anal orifice and inject the liquid into the rectal bulb by gradually compressing the body of the container. Discontinue administration immediately if resistance occurs due to the presence of localized lesions.
4. After removal of the cannula, the patient will remain in the same position until a need to evacuate occurs, ie for 2 to 5 minutes.
If you have used more NORMACOL LAVEL ADULTS, rectal solution, single dose container you should not have
Not applicable.
If you forget to use NORMACOL LAVEMENT ADULTS, rectal solution, single dose container
Not applicable.
If you stop using NORMACOL LAVEMENT ADULTS, rectal solution, single dose container
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Prolonged or repeated use may cause anal burning.
Very rarely have been reported:
· Cases of hydro-electrolyte disorders with hyperphosphatemia, hypocalcaemia, acidosis and hypernatremic dehydration and manifesting by convulsions. These were almost always cases of overdose in young children with anorectal malformation or Hirschsprung disease or in patients with renal insufficiency,
· The possibility of local irritation, or even of necrosis secondary to a perforation following a traumatic administration.
There have also been reports of allergic-type reactions including anaphylactic reactions: dyspnea, edema, urticaria, rash and erythema.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE NORMACOL LAVEMENT ADULTS, rectal solution, single dose container?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What NORMACOL LAVEMENT ADULES contains, rectal solution, single dose container
· The active substances are:
Sodium dihydrogen phosphate dihydrate .............................................. 23.66 g
Sodium hydrogen phosphate dodecahydrate .............................................. 10.40 g
For a single-dose container of 130 ml.
· The other ingredients are hydrolyzed sterilized gum, sorbic acid, sodium methyl parahydroxybenzoate (E219), purified water.
What is NORMACOL LAVEMENT ADULES, rectal solution, single dose container and contents of the pack
This medication is in the form of a rectal solution in a single-dose container. Box of 1.
Marketing Authorization Holder
NORGINE SAS
2 RUE JACQUES DAGUERRE
92500 RUEIL-MALMAISON
Marketing Authorization Operator
NORGINE SAS
2 RUE JACQUES DAGUERRE
92500 RUEIL-MALMAISON
Maker
NORGINE PHARMA
29 ETHE VIRTON STREET
28100 DREUX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).