MOVICOL Generic drug of the Therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Macrogol 3350 , Sodium bicarbonate , Potassium chloride (E508) , Sodium chloride.
what is MOVICOL ?
This medication is indicated for:
- symptomatic treatment of constipation in adults.
- treatment of faecal impaction in adults. Fecal impaction is defined as an accumulation of feces in the rectum with no evacuation for several days.
PRESENTATION (S) AVAILABLE FOR MOVICOL
20 polyethylene aluminum foil bag (s) of 13.8108 g
| FEATURE | DESCRIPTION |
| Pharmaceutical class | laxatives |
| Active substance (s) | for a sachet of 13.8108 g: potassium chloride (0.0466 g), sodium bicarbonate (0.1785 g), sodium chloride (0.3507 g), macrogol 3350 (13.1250 g) |
| General medicine | no |
| Pharmaceutical form | powder for oral solution |
| Route (s) of administration | oral |
| Selling price | € 4.83 |
| Social security reimbursement rate | 30 % |
| Laboratory (s) | NORGINE PHARMA |
| Conditions of issue | restricted prescription drug |
what is MOVICOL medication used for and indication?
Symptomatic treatment of constipation in adults.
Treatment of faecal impaction in adults. Fecal impaction is defined as an accumulation of feces in the rectum with no evacuation for several days.
MOVICOL Dosage
movicol for adults
The dosage is 1 to 2 sachets per day, preferably taken as a single dose, in the morning. It is usually unnecessary to exceed 1 sachet per day in the elderly. The effect of MOVICOL is manifested within 24 to 48 hours after administration.
In the event of faecal impaction, the recommended dose is 8 sachets per day, divided into 2 daily intakes at a rate of 4 sachets in 500 ml of water morning and evening for a period ranging from 1 to 3 days. The administration will be stopped as soon as a satisfactory evacuation of the accumulated faeces is obtained. Special measures will be put in place to minimize the risk of recurrence.
Each sachet should be dissolved in a glass of water.
MOVICOL Contraindications
Never take MOVICOL, powder for oral solution in sachet in the following cases:
- certain diseases of the intestine and colon,
- in case of abdominal pain (stomach pain).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
HOW TO TAKE MOVICOL?
How many sachets should you take?
- If you are taking MOVICOL WITHOUT AROMA to treat constipation: the usual dose is 1 to 2 sachets per day, preferably taken as a single dose in the morning.
- Seniors usually do not need more than 1 sachet per day.
- If you are taking MOVICOL WITHOUT AROMA to treat faecal impaction: the usual dose is 8 sachets per day (4 sachets morning and evening, in 2 divided doses).
Administration mode
This medication is for oral use.
To use this medicine, please observe the following instructions:
- Open the bag.
- Pour the contents of the sachet into a glass of water.
- Stir the powder with a clean spoon until the mixture becomes clear.
- Swallow the mixture.
- The mixture can be stored for 6 hours in the refrigerator in a closed container.
Duration of treatment
- In the event of constipation, the effect of MOVICOL WITHOUT AROMA appears 24 to 48 hours after its administration.
- If faecal impaction occurs, you should take this medicine until the accumulated faeces are evacuated satisfactorily. The duration of treatment is on average 1 to 3 days.
To avoid the risk of these problems recurring, refer to the section How to reduce the risk of recurrence ?.
If you have taken more MOVICOL WITHOUT AROMA, powder for oral solution in sachet than you should
- Diarrhea can occur. This usually disappears 24 to 48 hours after stopping treatment or after reducing the dose. In case of strong loss of fluid through vomiting and / or diarrhea, stomach pain, consult your doctor.
If you forget to take MOVICOL WITHOUT AROMA, powder for oral solution in sachet
- Do not take a double dose to make up for the dose you forgot to take.
If you stop taking MOVICOL WITHOUT AROMA, powder for oral solution in sachet
- The faecal impaction may return after stopping treatment. This risk must nevertheless be evaluated by your doctor.
how does MOVICOL work?
- The electrolyte content of the reconstituted solution is such that the intestine-plasma electrolytic exchanges can be considered as zero.
- On the other hand, the pharmacokinetic data confirm the absence of digestive absorption and biotransformation of macrogol 3350 after oral ingestion.
HOW TO STORE MOVICOL?
- Keep this medication out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiration date refers to the last day of that month.
- No special storage conditions.
- After reconstitution in water, the resulting solution can be stored for a maximum of 6 hours at a temperature between + 2 ° C and + 8 ° C (in the refrigerator) in a closed container. After this time, you must discard the solution that has not been used.
- Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.
MOVICOL Side Effects
Summary of the safety profile
The undesirable effects below are presented in order of frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1 / 1,000, <1/100); rare (≥ 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known (frequency cannot be estimated from the available data).
Tabulated summary of side effects
| System organ class | Frequency | Side effects |
| Immune system disorders | Very rare | Hypersensitivity reactions such as anaphylactic reactions, dyspnea and skin reactions (see below) |
| Skin and subcutaneous tissue disorders | Frequency not known | Allergic-type events including angioedema, urticaria, pruritus, rash and erythema |
| Metabolism and nutrition disorders | Frequency not known | Electrolyte disturbances, especially hyperkalaemia and hypokalaemia |
| Nervous system disorders | Frequency not known | Headache |
| Gastrointestinal disorders | Frequency not known | Abdominal pain *, nausea, vomiting, bloating, diarrhea ** |
| General disorders and administration site conditions | Frequency not known | Peripheral edema |
Description of selected adverse reactions
* In particular in subjects suffering from functional intestinal manifestations
** In the event of too large a dose, the onset of diarrhea which ceases within 24 to 48 hours after stopping treatment. Treatment can then be resumed at a lower dose.
MOVICOL Interactions
The data available to date do not suggest the existence of clinically significant interactions.
Drive and use machines
Warnings and Precautions
Special warnings
- The liquid contained in MOVICOL after reconstitution with water does not replace regular fluid intake. Adequate fluid intake should be maintained.
- If the patient presents with symptoms suggestive of fluid and electrolyte disturbances (especially in the event of dehydration or flare-ups of heart failure), MOVICOL treatment should be immediately discontinued, an electrolyte check-up should be performed and any abnormalities detected should be treated. appropriately.
- The absorption of other medicinal products may be temporarily reduced by the reduction in the duration of intestinal transit induced by MOVICOL (see section Interactions with other medicinal products and other forms of interactions). Usual oral treatments should not be taken within 1 hour of ingestion of MOVICOL.
- The drug treatment of constipation is only an adjunct to the hygieno-dietetic treatment:
-
- Enriching the supply of vegetable fiber and drink,
- Advice on physical activity and rehabilitation of the exemption.
Precautions for use
- This medicine contains polyethylene glycol.
- Very rare allergic type manifestations (rash, urticaria, edema) have been described with specialties based on polyethylene glycol. Exceptional cases of anaphylactic shock have been reported. It is therefore not recommended to prescribe this medication to a patient with known sensitivity to polyethylene glycol.
- MOVICOL does not contain any sugar or polyols, it can be prescribed to diabetic patients or subjects on a galactose-free diet.
- This medicinal product contains 8.125 mmol (186.87 mg) sodium per sachet. This is equivalent to 9.3% of the WHO recommended maximum daily dietary intake of sodium.
- This medicine contains 26.38 mg of potassium per sachet. To be taken into account in patients with renal failure or in patients controlling their dietary potassium intake, take it into account in the daily ration.
- The efficacy and safety of MOVICOL in the treatment of faecal impaction have not been studied.
PREGNANCY & BREAST-FEEDING & FERTILITY
Pregnancy
- No effects during pregnancy are expected since systemic exposure to macrogol is negligible. Movicol can therefore be used during pregnancy.
Feeding with milk
- No effects are expected in the nursing infant / child since maternal systemic exposure to macrogol is negligible. Movicol can therefore be used during breast-feeding.
Fertility
- There are no data on the effects of Movicol on fertility in humans. There was no effect on fertility in studies in male and female rats ( see Preclinical Safety ).
What happens if I overdose from MOVICOL?
What is Forms and Composition ?
SHAPES and PRESENTATIONS |
Movicol without flavoring:
- Powder for oral solution (white): Sachets, box of 20. Movicol chocolate: Powder for oral solution (white to light brown): Sachets, box of 20. Movicol: Powder for oral solution (lemon flavoring): Sachets , box of 20.
COMPOSITION |
Movicol without flavoring:
| p bag | |
| Macrogol 3350 | 13.125 g |
| Sodium bicarbonate | 178.6 mg |
| Potassium chloride | 50.2 mg |
| Sodium chloride | 350.8 mg |
- Excipients with known effect: sodium (186.87 mg / sachet) and potassium (26.33 mg / sachet).
Movicol chocolate:
| p bag | |
| Macrogol 3350 | 13.125 g |
| Sodium bicarbonate | 178.5 mg |
| Potassium chloride | 31.7 mg |
| Sodium chloride | 350.7 mg |
- Excipients: acesulfame potassium (E950), chocolate flavor (maltodextrin (potato), arabic gum, vegetable oils and fats (coconut), propylene glycol, benzyl alcohol)).
- Excipients with known effect: sodium (186.87 mg / sachet), potassium (26.33 mg / sachet) and benzyl alcohol (14.1 mg / sachet).
Movicol:
| p bag | |
| Macrogol 3350 | 13.125 g |
| Sodium bicarbonate | 178.5 mg |
| Potassium chloride | 46.6 mg |
| Sodium chloride | 350.7 mg |
- Excipients: lemon flavor (vegetable gum (E414), maltodextrin, essential oils of lemon and lime, citral, citric acid (E330)), acesulfame potassium (E950).
- Excipients with known effect:sodium (186.87 mg / sachet) and potassium (26.38 mg / sachet).
NOT’s
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general information:
- Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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