Active ingredients: Macrogol
MOVIPREP® powder for oral solution
Moviprep package inserts are available for packs:- MOVIPREP® powder for oral solution
- MOVIPREP Orange flavor, powder for oral solution
Indications Why is Moviprep used? What is it for?
Moviprep is a lemon flavored laxative contained in four sachets. There are two large sachets ("Sachet A") and two small sachets ("Sachet B"). For a single treatment they are all necessary.
Moviprep is used in adults to cleanse the bowel, to prepare it for examination.
Moviprep works by emptying the contents of the intestine, so you should expect to feel movement of fluid inside the abdomen.
Contraindications When Moviprep should not be used
Do not take Moviprep:
- if you are allergic (hypersensitive) to the active substances or to any of the other ingredients of Moviprep (listed in section 6).
- if you have an "intestinal obstruction.
- if you have a perforation of the intestinal wall.
- if you have problems related to stomach emptying.
- if you have intestinal paralysis (usually occurs after surgery on the abdomen).
- if you suffer from phenylketonuria. It is a hereditary inability of the body to use a particular amino acid. Moviprep contains a source of phenylalanine.
- if your body is unable to produce enough glucose-6-phosphate dehydrogenase.
- if you have toxic megacolon (severe complication of acute colitis).
Precautions for use What you need to know before taking Moviprep
If you are in poor health or have a serious medical condition, you should be particularly aware of the possible side effects listed in section 4. If you are unsure, ask your doctor or pharmacist.
Talk to your doctor or pharmacist before taking Moviprep if any of the following apply to you:
- needs to thicken liquids to be able to swallow them without problems
- it tends to regurgitate swallowed drinks and foods or stomach acids
- have kidney disease
- have heart failure or heart disease including high blood pressure, irregular heartbeat or palpitations
- thyroid disease
- has dehydration
- have flare-ups of inflammatory diseases of the intestinal tract (Crohn's disease or ulcerative colitis)
Do not administer Moviprep without medical supervision to patients with impaired consciousness
Interactions Which drugs or foods can change the effect of Moviprep
Other medicines and Moviprep
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking other medicines, take them at least one "hour before taking Moviprep or at least one" hour after as they can be eliminated through the digestive system and not work as they should.
Moviprep with food and drink
Do not take solid food from when you start taking Moviprep and until after the exam.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
There is no data on the use of Moviprep during pregnancy or breastfeeding and it should only be used if considered essential by your doctor. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Moviprep.
Driving and using machines
Moviprep does not affect the ability to drive or use machines.
Important information about some of the components of Moviprep
This medicinal product contains 56.2 mmol per liter of absorbable sodium. Patients on a sodium-controlled diet should keep this in mind.
This medicinal product contains 14.2 mmol per liter of potassium. Patients with impaired renal function or patients on a potassium-controlled diet should be aware of this.
Contains a source of phenylalanine. It can be harmful to people with phenylketonuria.
Dose, Method and Time of Administration How to use Moviprep: Posology
Always take Moviprep exactly as your doctor has told you. If in doubt, you should consult your doctor or pharmacist. The usual dose is 2 liters of solution, which is obtained as follows: this pack contains two transparent bags, each containing two sachets: Sachet A and Sachet B. Each pair of sachets (A and B) must be dissolved in one liter of water. The package is therefore sufficient to prepare two liters of Moviprep solution.
Before taking Moviprep, please read the following instructions carefully. You need to know:
- When to take Moviprep
- How to prepare Moviprep
- How to drink Moviprep
- What should you expect to happen
When to take Moviprep
Always take this medicine exactly as described in this leaflet or as directed by your doctor. If in doubt, consult your doctor.Your treatment with Moviprep must be completed prior to the clinical examination and can be taken:
is
divided into one liter of Moviprep the previous evening and one liter early in the morning on the day of the examination,
or
two liters the night before the exam.
Important: Do not take solid food from when you start taking Moviprep and until after the exam.
How to prepare Moviprep
- Open a transparent bag and take out sachets A and B.
- Pour the contents of BOTH sachets A and B into a one-liter graduated container.
- Add water to the container up to the 1 liter mark and mix until all the powder is completely dissolved and the Moviprep solution is transparent or slightly opaque. This can take up to 5 minutes.
How to drink Moviprep
Drink the first liter of Moviprep solution over an hour or two. Try to drink a full glass every 10 - 15 minutes.
When ready, prepare and drink the second liter of Moviprep solution obtained with the contents of sachets A and B of the second bag.
During this treatment, we recommend that you drink another liter of clear liquid to avoid feeling very thirsty and dehydrated. Water, broth, fruit juice (without pulp), soft drinks, tea or coffee (without milk) are all suitable drinks. These drinks can be taken at any time you wish.
What should you expect to happen
When you start drinking the Moviprep solution, it is important to be near a bathroom. At some point, you will begin to feel fluid movements in your intestines. This is completely normal and indicates that the Moviprep solution is working. Bowel movements will stop once you have finished drinking.
If you follow these instructions, your bowels will be clean and this will help you perform and succeed in the exam.
Overdose What to do if you have taken too much Moviprep
If you take more Moviprep than you should
If you take more Moviprep than you should, you may have excess diarrhea which can cause you to become dehydrated. Take large quantities of fluids, especially fruit juices. If you are worried, contact your doctor or pharmacist. If you forget to take Moviprep If you forget to take Moviprep, take the dose as soon as you realize you have not taken it. If it has been several hours since you should have taken it, ask your doctor or pharmacist for advice. It is important that you complete your preparation at least one hour before the exam.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Children
Moviprep should not be taken by children under the age of 18.
Side Effects What are the side effects of Moviprep
Like all medicines, Moviprep can cause side effects, although not everybody gets them.
It is normal to have diarrhea when taking Moviprep.
Stop taking it and contact your doctor immediately if you have any of the following side effects:
Very common side effects (may affect more than 1 in 10 people) are: abdominal pain, abdominal distension, tiredness, feeling sick, anal pain and nausea.
Common side effects (may affect up to 1 in 10 people): feeling hungry, sleep problems, dizziness, headache, vomiting, indigestion, thirst and chills.
Uncommon side effects (may affect up to 1 in 100 people): discomfort, difficulty swallowing and changes in liver function tests.
The following side effects have sometimes been reported but the frequency with which they occur is not known because it cannot be estimated from the available data: flatulence (wheezing), temporary increase in blood pressure, irregular heart rhythm or palpitations, dehydration, retching (straining), very low plasma sodium levels which can cause convulsions (fits) and changes in blood salt levels such as decreased bicarbonate, increased or decreased calcium, increased or decreased chloride and decreased phosphate . Plasma levels of potassium and sodium may also be reduced particularly in patients taking medicines that affect the kidneys such as ACE inhibitors and diuretics used to treat heart disease.
These reactions usually occur for the duration of the treatment alone. If they persist, consult your doctor.
Allergic reactions can occur.
If any of the following occur, stop taking Moviprep and contact your doctor immediately. You should not take any more Moviprep until you have told your doctor.
- skin rash or itching
- swelling of the face, ankles or other parts of the body
- palpitations
- excessive fatigue
- shortness of breath
If you do not have any bowel movements within 6 hours of taking Moviprep, stop taking it and contact your doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https: // www. aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated after "expiry" on the carton. Please note that the expiration dates may be different for the different sachets. The expiry date refers to the last day of the month.
Keep the Moviprep sachets at room temperature (not above 25 ° C).
Once Moviprep has dissolved in water, the solution can be stored (covered) at room temperature (not above 25 ° C). It can also be stored in the refrigerator (2 ° C - 8 ° C). Do not keep it for more than 24 hours.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Moviprep contains
Sachet A contains the following active ingredients:
Macrogol (also known as polyethylene glycol) 3350 100 g
Sodium sulphate anhydrous 7,500 g
Sodium chloride 2.691 g
Potassium chloride 1.015 g
Sachet B contains the following active ingredients:
Ascorbic acid 4,700 g
Sodium ascorbate 5,900 g
When the components of the two sachets are mixed to obtain one liter of solution, the concentration of electrolyte ions is as follows:
Sodium 181.6 mmol / L (of which no more than 56.2 mmol are absorbable)
Sulphate 52.8 mmol / L
Chloride 59.8 mmol / L
Potassium 14.2 mmol / L
Ascorbate 29.8 mmol / L
The other ingredients are:
Lemon flavor (containing maltodextrin, citral, lemon oil, lime oil, xanthan gum, vitamin E), aspartame (E 951) and acesulfame potassium (E 950) as sweeteners. For more information, see paragraph 2.
Description of what Moviprep looks like and contents of the pack
This pack contains two clear bags, each containing two sachets: Sachet A and Sachet B. Each pair of sachets (A and B) must be dissolved in one liter of water.
Moviprep powder for oral solution is available in packs of 1, 10, 40, 80, 160 and 320 single treatment packs and hospital packs of 40 single treatments. 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
MOVIPREP POWDER FOR ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
The components of MOVIPREP are contained in two separate sachets.
Sachet A contains the following active ingredients:
Macrogol 3350 100 g
Sodium sulphate anhydrous 7,500 g
Sodium chloride 2.691 g
Potassium chloride 1.015 g
Sachet B contains the following active ingredients:
Ascorbic acid 4,700 g
Sodium ascorbate 5,900 g
When the components of the two sachets are mixed to obtain one liter of solution, the
electrolyte ion concentration is as follows:
Sodium 181.6 mmol / l (of which no more than 56.2 mmol are absorbable)
Sulphate 52.8 mmol / l
Chloride 59.8 mmol / l
Potassium 14.2 mmol / l
Ascorbate 29.8 mmol / l
This product contains 0.233 g of aspartame in Sachet A.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder for oral solution
Sachet A: free flowing white to yellow powder.
Sachet B: free flowing white to light brown powder.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
For intestinal cleansing in preparation for clinical examinations that require a clean intestine, for example in intestinal endoscopy or radiology.
04.2 Posology and method of administration
Adults and the elderly:
One course of treatment involves the intake of two liters of MOVIPREP. During the course of treatment, it is strongly recommended that you also take one liter of clear liquid, including water, broth, pulp-free fruit juice, soft drinks, tea and / or coffee without milk.
A liter of MOVIPREP consists of a "Sachet A" and a "Sachet B" dissolved together in a liter of water. The reconstituted solution should be drunk over an hour or two. The intake should be repeated with a second liter of MOVIPREP.
The course of treatment can be taken:
- is divided into two times, taking one liter of MOVIPREP the previous evening and one liter of MOVIPREP early in the morning of the day of the clinical examination;
- or once in the evening before the clinical examination.
Leave at least one hour between the intake of liquid (MOVIPREP or clear liquid) and the start of the colonoscopy.
No solid food should be taken from the start of the treatment cycle until the end of the clinical examination.
Children: MOVIPREP is not recommended in children below 18 years, as no studies have been performed in the pediatric population.
04.3 Contraindications
Do not administer to patients who are known or suspected:
- gastrointestinal obstruction or perforation
- disorders related to gastric emptying (for example gastroparesis)
- ileus
- phenylketonuria (due to the presence of aspartame)
- glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbate)
- hypersensitivity to the active substances or to any of the excipients
- toxic megacolon which complicates severe inflammatory conditions of the intestinal tract such as Crohn's disease and ulcerative colitis.
Do not administer to unconscious patients.
04.4 Special warnings and appropriate precautions for use
Diarrhea is an expected effect as a consequence of the use of MOVIPREP. MOVIPREP should be administered with caution to weak patients in poor health or to patients with severe clinical changes such as:
- altered pharyngeal reflex, or with a tendency to aspiration or regurgitation
- alteration of the state of consciousness
- severe renal insufficiency (creatinine clearance
- heart failure (NYHA class III or IV)
• dehydration
• acute inflammatory disease of severe degree
The presence of dehydration must be corrected before using MOVIPREP.
Patients in a semi-conscious state or with a tendency to aspiration or regurgitation should be closely monitored during administration, particularly if it occurs via the nasogastric route.
If patients develop symptoms indicating fluid / electrolyte exchanges (e.g. edema, shortness of breath, increased fatigue, heart failure), plasma electrolytes should be measured and any abnormalities should be treated appropriately.
In debilitated and weak patients, in patients with poor health, in individuals with clinically significant renal impairment, and in individuals at risk for electrolyte imbalances, the physician should consider the need for basic and post-treatment electrolyte testing, and a kidney function test.
If symptoms such as excessive swelling, abdominal distension, abdominal pain, or any other reaction that make it difficult to continue with the preparation, patients may slow down or temporarily stop taking MOVIPREP and should consult their doctor.
04.5 Interactions with other medicinal products and other forms of interaction
Do not administer other medicines by mouth until one hour after taking MOVIPREP as they can be eliminated from the gastro-intestinal tract without being absorbed. In particular, the therapeutic effect of drugs with a reduced therapeutic index and a short half-life may be compromised.
04.6 Pregnancy and lactation
There are no data on the use of MOVIPREP during pregnancy or breastfeeding and it should only be used if considered essential by your doctor.
04.7 Effects on ability to drive and use machines
There are no known effects on the ability to drive and use machines.
04.8 Undesirable effects
An expected effect of bowel prep is diarrhea. Due to the nature of the surgery, side effects occur in most patients during the bowel prep process. Although they vary depending on the preparations, symptoms such as nausea, vomiting, bloating, abdominal pain, anal irritation and sleep disturbances are common in patients undergoing bowel preparation.
As with other macrogol-containing products, allergic reactions such as rash, hives, pruritus, angioedema and anaphylactic reactions are possible.
Clinical trial data are available in a population of 825 patients treated with MOVIPREP in which undesirable effects data were actively requested. Adverse events reported in the post-marketing period are also included.
The frequency of adverse reactions to MOVIPREP is defined using the following convention:
Very common ≥ 1/10 (≥ 10%)
Common ≥ 1/100,
Uncommon ≥ 1 / 1,000,
Rare ≥ 1 / 10,000,
Very rare
Not known (frequency cannot be estimated from the available data)
04.9 Overdose
In case of accidental excessive overdose, where severe diarrhea occurs, conservative measures are usually sufficient; Large amounts of fluids, especially fruit juices, should be given. In the rare event that overdose causes severe metabolic damage, intravenous rehydration may be used.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: laxative with osmotic action
ATC code: A06A D
Oral administration of macrogol electrolyte solutions causes moderate diarrhea and leads to rapid emptying of the colon.
Macrogol 3350, sodium sulphate and high doses of ascorbic acid exert an osmotic action in the intestine, inducing a laxative effect.
Macrogol 3350 increases fecal volume by stimulating intestinal motility through the neuromuscular system.
The physiological consequence is a propulsive advancement of softened stools into the colon.
The electrolytes present in the formulation and the supplemental intake of clear fluids are provided to prevent clinically significant changes in sodium, potassium or water levels, and consequently to reduce the risk of dehydration.
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.
Ascorbic acid is mainly absorbed in the small intestine by an active, sodium-dependent and saturable transport mechanism. There is an inverse relationship between the ingested dose and the percentage of absorbed dose. For oral doses between 30 and 180 mg, approximately 70-85% of the dose is absorbed. After oral administration of ascorbic acid up to 12 g, only 2 g is known to be absorbed.
Following high oral doses of ascorbic acid and when plasma concentrations exceed 14 mg / liter, the absorbed ascorbic acid is eliminated mainly unchanged in the urine.
05.3 Preclinical safety data
Preclinical studies show that macrogol 3350, ascorbic acid and sodium sulfate do not have significant systemic toxicity potential.
No genotoxicity, carcinogenicity or reproductive toxicity studies have been conducted with this medicinal product.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Aspartame (E951)
Acesulfame potassium (E950)
Lemon flavor containing maltodextrin, citral, lemon oil, lime oil, xanthan gum, vitamin E.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
Sachets 3 years
Solution reconstituted 24 hours
06.4 Special precautions for storage
Sachets: Store below 25 ° C.
Reconstituted solution: Store below 25 ° C. The solution can be refrigerated.
Keep the solution covered.
06.5 Nature of the immediate packaging and contents of the package
One paper / low density polyethylene / aluminum / low density polyethylene sachet containing 112 g of powder ("sachet A") and one paper / low density polyethylene / aluminum / low density polyethylene sachet containing 11 g of powder ( "bag B"). Both sachets are contained in a transparent bag. A MOVIPREP pack contains a single treatment equal to two bags.
Packs of 1, 10, 40, 80, 160 and 320 single treatment packs. Hospital pack of 40 single treatments. Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Reconstitution of MOVIPREP with water can take up to 5 minutes and it is advisable to do it by first pouring the powder into the mixing container and then the water. The patient should wait until all the powder has dissolved before drinking the solution.
After reconstitution with water, MOVIPREP can be consumed immediately or, if preferred, it can be allowed to cool before use.
07.0 MARKETING AUTHORIZATION HOLDER
NORGINE BV
Hogehilweg 7, 1101 CA
Amsterdam ZO
Netherlands
08.0 MARKETING AUTHORIZATION NUMBER
MOVIPREP powder for oral solution - 1 treatment AIC n. 037711013
MOVIPREP powder for oral solution - 10 treatments AIC n. 037711025
MOVIPREP powder for oral solution - 40 treatments AIC n. 037711037
MOVIPREP powder for oral solution - 80 treatments AIC n. 037711049
MOVIPREP powder for oral solution - 160 treatments AIC n. 037711052
MOVIPREP powder for oral solution - 320 treatments AIC n. 037711064
MOVIPREP powder for oral solution - 40 treatments OSP AIC n. 037711126
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
18 December 2007/12 April 2013
10.0 DATE OF REVISION OF THE TEXT
04/2013
