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Normacol Enema rectal solution single-dose adult 130ml
Over-the-counter medication

Normacol Enema rectal solution single-dose adult 130ml

€2.51 EXCL. VAT €2.76 INCL. VAT
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Reference : 3400931307372
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Order NORMACOL LAVEMENT rectal solution in unidose container adult 130ml without prescription and give your opinion. This medicine is recommended for the treatment of constipation.

Find the composition and dosage of NORMACOL LAVEMENT rectal solution in unidose container adult 130ml in our online pharmacy: disodium phosphate dodecahydrate.

For warnings, precautions for use and contraindications, please refer to the NORMACOL LAVEMENT rectal solution in single-dose container adult 130ml without prescription leaflet.

Description of NORMACOL LAVEMENT rectal solution in single-dose container adult 130ml

Indication :

  • Low-grade constipation (INDICATION)
  • Rectosigmoid preparation for endoscopic or radiological examinations (INDICATION)
  • Constipation (INDICATION_GROUP)
  • Preparation for digestive endoscopy (INDICATION_GROUP)
  • Palliative care (INDICATION_GROUP)

Whether occasional or persistent, constipation affects 1 in 4 people, 80% of whom are women.

Terminal or distal constipation: evacuation problems

It's our rectum, the last part of the intestine before the anus, which sends the brain the signal that it's time to go to the toilet. In fact, our rectum distends as fecal matter arrives, and this distension is signalled to the central nervous system. Then, when we're on the toilet, the brain will instruct the anal canal to relax to allow the stool to pass. But this mechanism isn't always fully operational, and when it fails, we speak of terminal constipation (because it occurs at the end of the digestive process). Most often, terminal constipation is caused by :

  • A lack of sensitivity in the rectum, often due to chronic constipation over too long a period - in these cases, terminal constipation and transit constipation coexist.
  • Anismus, a distorted reflex of the anal area which causes the sphincter of the anus to close when we want it to open, preventing the evacuation of stools.
  • Finally, organ prolapse, i.e. when one or more organs of the pelvis (bladder, uterus, vagina, etc.) descend due to insufficient support from the muscles and tendons of the perineal area, can also lead to constipation.

Composition of this medicine

Molecules :

  • 10329 : NORMACOL LAVEMENT rectal solution in single-dose container adult (ITEM - )
  • sodium methyl p-hydroxybenzoate (MOLECULE - Notable excipient)
  • sterculia gum (MOLECULE - Excipient)
  • purified water (MOLECULE - Excipient)
  • disodium phosphate dodecahydrate (MOLECULE - Active substance)
  • monosodium phosphate dihydrate (MOLECULE - Active substance)
  • sorbic acid (MOLECULE - Notable effect excipient)

Directions for use and dosage of NORMACOL LAVEMENT rectal solution in single-dose container for adults 130ml

  • 1 enema 5 to 20 minutes before bowel movements in case of constipation
  • or 1 enema the evening before and 1 enema the day of the examination in preparation for a rectal examination.

There are four main causes of constipation:

  • Obstruction, leading to reduced stool passage.
  • Impaired colonic progression due to reduced dietary fiber intake.
  • Low colonic muscle tone(hypotonia) reduces the strength and frequency of contractions responsible for stool progression. Conversely, a highly toned colon(hypertonia) is accompanied by an increase in contractions, but these are not motorized and do not cause stools to progress: this is what happens in constipation, which is associated with abdominal pain in the so-called " irritable bowel syndrome".
  • Evacuation disorders linked to factors that hinder thenatural evacuation of stools: an over-toned anal canal, poor perception of rectal sensations, an over-toned anal sphincter during defecation.

NORMACOL LAVEMENT adult single-dose rectal solution 130ml

Normacol comes in a 130ml bottle.

Warnings on medicines for digestive problems

Warning: NORMACOL LAVEMENT solution rectale en récipient unidose adulte 130ml sans ordonnance is not a product like any other. Read the package insert carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.

  • Please inform your online pharmacist of your current treatments to identify any incompatibilities. The order validation form contains a personalized message field for this purpose.
  • Click here to find the package leaflet for this drug on the Agence Nationale de Sécurité du Médicament et des Produits de Santé website.
  • Pharmacovigilance: Report an adverse drug reaction(s)

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

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).

VIDAL OF THE FAMILY

NORMACOL LAVEMENT

Rectal Laxative

dihydrogen phosphate and sodium hydrogenphosphate

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

NORMACOL LAVEMENT Adult: rectal solution; 130 ml single dose container with cannula.
Refunded at 65%. - price: 1.44 euro (s).

NORMACOL LAVEMENT Child: rectal solution; 60 ml single canister container with cannula.
Refunded at 65%. - price: 1,21 euro (s).

Laboratory

COMPOSITION (summary)
p unidose Ad p childhood
Sodium dihydrogen phosphate 23.66 g 10.92 g
Sodium hydrogen phosphate 10.4 g 4.8 g
Methyl parahydroxybenzoate + +
Sodium sorbic acid + +

INDICATIONS (summary)
It is a laxative administered by way rectally. It softens the stool and triggers a contraction of the rectum which allows their evacuation.
It is used to prepare the rectum before certain endoscopic or radiological examinations.
It is also used in the treatment of constipation, especially when stools accumulate in the rectum and the repeated pushes do not allow to evacuate them.
CONTRAINDICATIONS (summary)
This treatment should not be used in the following cases:
  • disease causing bowel obstruction,
  • megacolon ,
  • severe renal failure ,
  • child under 15 years of age (adult rectal solution),
  • child under 3 years of age (child rectal solution).
WARNING (Contents)
It is necessary to drink plenty of water, especially in the elderly
This medication should not be used prolonged or repeated without medical advice.
Precautions are necessary in the weakened person or with heart failure , hemorrhoids , anal fissure or ulcerative colitis .
PREGNANCY AND BREAST-FEEDING (summary)
Rectal laxatives may be used on an ad hoc basis to treat constipation of pregnant or nursing women. Nevertheless, do not use this enema during pregnancy or lactation without medical advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
Insert the cannula into the rectum and gently empty the bottle.
The contents of the vial should not be swallowed.
The laxative effect is evident within 5 minutes of enema administration.

Usual dosage:

1 enema 5 to 20 minutes before the time chosen for the saddle in case of constipation or 1 enema the evening before and 1 enema on the day of the examination in case of preparation for an examination of the rectum.
TIPS (summary)
The treatment of constipation is essentially based on hygiene measures: high-fiber food, abundant drinks, regular physical activity and time to get to the saddle.
POSSIBLE ADVERSE EFFECTS (summary)
Allergic reaction .
Loss of mineral salts in case of overdose.
Local irritation and exceptionally necroses of the rectum.


GLOSSARY (summary)


anal fissure
Small crevice around the anus, often little or not visible, causing sharp pains during and after the saddle.


hemorrhoids
Abnormal dilation of a vein of the anus or rectum developing either externally or internally. It may cause bleeding.


heart failure
Inability of the heart to fulfill its function as a pump. The main symptoms of heart failure are fatigue and shortness of breath during an effort.


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


megacolon
Dilatation of part of the large intestine where gas and faeces accumulate. It is often accompanied by constipation.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


ulcerative colitis
Inflammatory disease of the rectum and colon, which evolves by flare-ups. Each flare is accompanied by fever, bloody stools.


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

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