Active ingredients: Laxatives
Movicol 13.8 g, powder for oral solution
Movicol package leaflets are available for packs:- Movicol 13.8 g, powder for oral solution
- Movicol 13.7 g, powder for oral solution, Unflavoured
- Movicol 13.9 g / 25 ml concentrate for oral solution Orange flavor
Indications Why is Movicol used? What is it for?
The name of this medicine is MOVICOL, 13.8g sachet, powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents and the elderly. It is not recommended for children under 12 years of age.
MOVICOL helps you to have an "adequate bowel evacuation even if the constipation has been going on for a long time. MOVICOL also works in the treatment of severe constipation, called fecaloma.
Contraindications When Movicol should not be used
Do not take MOVICOL if your doctor has told you that you have:
- a blockage of the intestine (intestinal obstruction, ileus)
- a perforation of the intestinal wall
- a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease or toxic megacolon
- an "allergy to the active substances or to any of the ingredients of MOVICOL
Precautions for use What you need to know before taking Movicol
Heart conditions
If you are taking MOVICOL for fecal impaction, please follow the special instructions under "Dose, method and time of administration"
Interactions Which drugs or foods can change the effect of Movicol
Some medicines, eg. antiepileptics, may not be as effective while taking MOVICOL. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Warnings It is important to know that:
Pregnancy and breastfeeding
MOVICOL can be taken during pregnancy and while breastfeeding.
If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking MOVICOL.
Driving and using machines
MOVICOL does not affect your ability to drive or use machines.
Dosage and method of use How to use Movicol: Dosage
This medicine can be taken at any time with or without food or drink.
Constipation
A dose of MOVICOL is 1 sachet.
Take one sachet 1-3 times a day, depending on the severity of your constipation.
Fecaloma
For the treatment of faecal impaction, a dose of 8 sachets of MOVICOL per day is required. The 8 sachets should be taken over a 6 hour period if needed for up to 3 days. If you have a heart condition, do not take more than 2 sachets per hour.
How to mix:
Open the sachet and pour the contents into a glass. Add about 125 ml of water to the glass (1/2 glass). Mix well until all the powder has dissolved and the MOVICOL solution is clear or slightly opaque, then drink the solution. If you are taking MOVICOL for fecal impaction it may be easier to dissolve 8 sachets in 1 liter of water.
Duration of treatment:
Constipation
Treatment with MOVICOL usually lasts about 2 weeks. If you need to take MOVICOL for longer, contact your doctor. If your constipation is caused by a disease such as Parkinson's disease or multiple sclerosis, or if you are taking medicines that cause constipation, your doctor may advise you to take MOVICOL for longer than 2 weeks. Generally in long-term treatment, the dose can be reduced to 1 or 2 sachets per day.
Fecaloma
MOVICOL treatment can last up to 3 days.
Overdose What to do if you have taken too much Movicol
If you take more MOVICOL than you should
He may have excessive diarrhea, which can lead to dehydration. In this case, stop taking MOVICOL and drink plenty of fluids. If you are concerned, ask your doctor or pharmacist.
If you forget to take MOVICOL
Take the missed dose as soon as you remember
Side Effects What are the side effects of Movicol
Like all medicines, MOVICOL can cause side effects. Contact your doctor immediately and stop taking MOVICOL if:
- have a severe allergic reaction which causes you to have difficulty breathing, or swelling of your face, lips, tongue or throat.
Other side effects include:
allergic reactions which can cause skin rashes, itching, red skin or hives, swelling of the hands, feet or ankles, headache and high or low levels of potassium in the blood.
Sometimes he can have indigestion, stomach pain or grumbling. You may also feel bloated, suffer from flatulence, feel nauseous or vomit, and when you start taking MOVICOL, you may experience anal irritation and mild diarrhea. These side effects usually improve by reducing the dose of MOVICOL you take.
If any of the side effects gets serious or lasts more than a few days, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Keep medicines out of the reach and sight of children.
Do not use MOVICOL after the expiry date which is stated on the sachet.
Do not store above 25 ° C. Once you have prepared the MOVICOL solution in water, if you cannot drink it all at once, keep it in the refrigerator (2oC-8oC) and keep it covered. Throw away any unused solution within 6 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
OTHER INFORMATION
Each 13.8g sachet of MOVICOL contains:
Macrogol 3350 13, 125 g
Sodium chloride 0.3507 g
Sodium hydrogen carbonate (bicarbonate) 0.1785 g
Potassium chloride 0.0466 g
MOVICOL also contains lime and lemon flavoring, and acesulfame potassium as a sweetener. The lime and lemon flavor consists of the following ingredients: acacia gum, maltodextrin, lime oil, lemon oil, citral, citric acid and water.
When dissolved in 125 milliliters of water, each sachet provides the equivalent of:
Sodium 65 millimoles / liter
Chloride 53 millimoles / liter
Potassium 5.4 millimoles / liter
Bicarbonate 17 millimoles / liter
Description of what MOVICOL looks like and contents of the pack
MOVICOL is available in packs of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MOVICOL 13.8 G, POWDER FOR ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MOVICOL contains the following active ingredients:
Macrogol 3350 13.125 g
Sodium chloride 350.7 mg
Sodium hydrogen carbonate 178.5 mg
Potassium chloride 46.6 mg
The electrolyte ion content per sachet in the reconstituted solution of 125 ml is as follows:
Sodium 65 mmol / l
Chloride 53 mmol / l
Bicarbonate 17 mmol / l
Potassium 5.4 mmol / l
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder for oral solution.
Free flowing white powder.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
For the treatment of chronic constipation. MOVICOL is also capable of resolving fecal impaction defined as refractory constipation with fecal load in the rectum and / or colon.
04.2 Posology and method of administration
Chronic constipation
A course of treatment with MOVICOL for constipation does not normally exceed two weeks, although treatment can be repeated if necessary.
As with all laxatives, prolonged use is generally not recommended. Prolonged treatment may be necessary for patients suffering from severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's disease, or induced by regular intake of constipating medications, in particular opioids and antimuscarinics.
Adults, adolescents and the elderly: 1-3 sachets per day divided into doses, depending on the individual response to treatment.
For prolonged use, the dose can be reduced to 1 or 2 sachets per day.
Children under 12: not recommended. Other MOVICOL medicinal products are available for treatment in children.
Fecaloma
A course of treatment with MOVICOL for fecal impaction does not normally exceed 3 days.
Adults, adolescents and the elderly: 8 sachets per day, all to be consumed within 6 hours.
Children under 12: not recommended. Other MOVICOL products are available for treatment in children.
Patients with impaired cardiovascular function: for the treatment of faecal impaction, the total dose should be divided so that no more than two sachets are taken every hour.
Patients with renal insufficiency: no dosage adjustment is necessary for the treatment of both constipation and faecal impaction.
Administration
Each sachet must be dissolved in 125ml of water. For use in fecal impaction, the 8 sachets can be dissolved in 1 liter of water.
04.3 Contraindications
Intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon.
Hypersensitivity to the active substances or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
The diagnosis of fecal impaction / fecal load in the rectum should be confirmed by a physical or radiological examination of the abdomen and rectum.
Mild adverse reactions are possible as indicated in section 4.8.
If patients develop symptoms indicating fluid / electrolyte exchanges (e.g. edema, shortness of breath, fatigue, dehydration, heart failure) the administration of MOVICOL should be stopped immediately, electrolytes measured and any abnormalities treated appropriately.
The absorption of other medicinal products may be temporarily reduced due to the increase in the gastrointestinal transit rate induced by MOVICOL (see section 4.5).
04.5 Interactions with other medicinal products and other forms of interaction
Macrogol increases the solubility of alcohol-soluble and relatively water-insoluble medicines. There is a possibility that the absorption of other medicinal products may be temporarily reduced while using MOVICOL (see section 4.4). There have been isolated reports of decreased efficacy of some concomitantly administered medicinal products, eg antiepileptics.
04.6 Pregnancy and lactation
Pregnancy
There are limited data from the use of MOVICOL in pregnant women.
Animal studies have shown indirect reproductive toxicity (see section 5.3).
Clinically, macrogol 3350 is not expected to cause effects during pregnancy, since systemic exposure to macrogol 3350 is negligible.
MOVICOL can be used during pregnancy.
Feeding time
Macrogol 3350 is not expected to cause effects on newborns / infants, since systemic exposure of lactating women to Macrogol 3350 is negligible.
MOVICOL can be used during breastfeeding.
Fertility
There are no data on the effects of MOVICOL on human fertility. In studies in male and female rats (see section 5.3) no effects on fertility were observed.
04.7 Effects on ability to drive and use machines
MOVICOL does not affect the ability to drive and use machines.
04.8 Undesirable effects
Reactions related to the gastrointestinal tract occur more commonly.
These reactions may appear as a consequence of the expansion of the contents of the gastrointestinal tract and the increase in motility due to the pharmacological effects of MOVICOL. Mild diarrhea usually improves by reducing the dose.
The frequency of adverse events is unknown as it cannot be estimated from the available data.
04.9 Overdose
Severe abdominal pain or distension can be treated by nasogastric aspiration. Large fluid losses with diarrhea or vomiting may require correction of electrolyte changes.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: laxative with osmotic action.
ATC code: A06A D65.
Macrogol 3350 exerts its effects by virtue of its osmotic action in the intestine, inducing a laxative effect. Macrogol 3350 increases fecal volume and this causes intestinal motility through the neuromuscular system. The physiological consequence is a better propulsive advancement in the colon of softened stools and a facilitation of defecation.
The electrolytes associated with macrogol 3350 are exchanged through the intestinal wall (mucosa) with the electrolytes in the serum and excreted with the fecal water without net gain or loss of sodium, potassium and water.
No controlled comparative studies with other treatments (eg enemas) have been conducted for the indication of fecal impaction. In a non-comparative study of 27 adult patients, MOVICOL resolved fecal impaction in 12/27 (44%) after one day of treatment, 23/27 (85%) after 2 days of treatment and 24/27 (89%) after 3 days.
Clinical studies on the use of MOVICOL in chronic constipation have shown that the dose required to produce stool of normal consistency tends to decrease over time. Many patients respond to doses between 1 and 2 sachets per day, but this dose should be adjusted according to the individual response.
05.2 Pharmacokinetic properties
Macrogol 3350 transits unchanged along the intestinal tract. It is practically not absorbed in the gastrointestinal tract. Any macrogol 3350 that is absorbed is excreted in the urine.
05.3 Preclinical safety data
Preclinical studies demonstrate that macrogol 3350 has no significant systemic toxicity potential, based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity.
No direct embryotoxic or teratogenic effects were found in rats, even at maternal toxic levels, ie 66 times the maximum recommended human dose for chronic constipation and 25 times that for fecal impaction. Indirect embryo-fetal effects, such as reduction. fetal and placental weight, reduced fetal motility, increased hyperflexion of the limbs and paw, and miscarriages, were observed in rabbits at maternally toxic doses, 3.3 times the maximum recommended human dose for the treatment of chronic constipation and 1.3 times that for fecal impaction. Among laboratory animals, rabbits are a species sensitive to the effects of substances that act on the gastrointestinal level and the studies were conducted in extreme conditions, administering high volumes of dose, clinically not relevant. The findings may have been a consequence of an indirect effect of MOVICOL related to poor maternal condition, such as the result of an exaggerated pharmacodynamic response in the rabbit. There was no indication of a teratogenic effect.
There are long-term toxicity and carcinogenicity studies in animals with macrogol 3350. The results of these and other toxicity studies in which high doses of high molecular weight macrogol were administered orally demonstrate its safety at therapeutic doses. recommended.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Acesulfame potassium (E950)
Lime and lemon flavor *
(* The lime and lemon flavor consists of the following ingredients: acacia gum, maltodextrin, lime oil, lemon oil, citral, citric acid and water).
06.2 Incompatibility
None known.
06.3 Period of validity
3 years.
Reconstituted solution: 6 hours.
06.4 Special precautions for storage
Sachet: Do not store above 25 ° C.
Reconstituted solution: Store in a refrigerator (2 ° C - 8 ° C), covered.
06.5 Nature of the immediate packaging and contents of the package
Sachet: laminate consisting of 4 layers: low density polyethylene, aluminum, low density polyethylene and paper.
Packaging: boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Unused solution should be discarded within 6 hours.
07.0 MARKETING AUTHORIZATION HOLDER
Norgine Italia S.r.l.
Via Fabio Filzi 25
20124 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
MOVICOL 13.8 g, powder for oral solution - 10 sachets AIC n. 029851019
MOVICOL 13.8 g, powder for oral solution - 20 sachets AIC n. 029851021
MOVICOL 13.8 g, powder for oral solution - 8 sachets AIC n. 029851033
MOVICOL 13.8 g, powder for oral solution - 50 sachets AIC n. 029851045
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
January 1997 / December 18, 2005
10.0 DATE OF REVISION OF THE TEXT
09/2014
