Myrtipeg®

It acts by an osmotic mechanism, retaining water in the intestines and thus softening stool. It is not absorbed, does not ferment and does not irritate the intestinal mucosa.
It is eliminated with feces in an unmodified form.

Myrtipeg has Macrogol 4000 as its functional ingredient, which is mixed with the following excipients:
– Blueberry flavor, with flavoring function;
– Sucralose, with sweetening function;
– Amorphous silica, with anti-caking powder function.

Package contents:
20 pouches of 11 g each

Composition
One envelope contains:

Macrogol 4000 g 10.795 Blueberry flavor g 0.150 Amorphous silica g 0.050
Sucralose g 0.005.

Description
Myrtipeg® is a medical device for oral use based on Macrogol 4000, with laxative action in the form of single-dose sachets containing 11 grams of powder. In order to exert the intended action, the contents of each sachet are intended to be dissolved in water and swallowed. One package of Myrtipeg® contains 20 single-dose sachets and a package insert.

Mechanism of action:
Myrtipeg® acts by an osmotic mechanism, retaining water in the intestine (preventing its absorption by the small intestine) and thus softening the stool. It is not absorbed, does not ferment and does not irritate the intestinal mucosa. It is eliminated with feces in an unmodified form. Therefore, the treatment of constipation is achieved through an increase of water in the fecal mass without changes in plasma volume and loss of electrolytes.

Directions:
Myrtipeg® is indicated in cases of constipation and can also be used for bowel cleansing before colonoscopy.

Method of use and duration of treatment:
Dissolve one sachet in a cup filled with water (at least 200/250 ml) and drink it as soon as it is prepared. It is recommended to take Myrtipeg® away from meals. The dose for adults is one/two sachets/day according to individual response while the daily dose for children aged 8 to 12 years weighing between 20 to 40 kg can be reduced to one sachet/day according to medical indication. The period of intake should not exceed one month, after which it should be discontinued for two weeks and then may be resumed on medical advice, The above doses, on medical advice, may also be taken every other day, preferably in the evening before bedtime.

In children, if the disorder continues despite a proper diet, discontinue treatment and consult the doctor to investigate for a possible underlying disease.
It is preferable to drink the entire amount fairly quickly, avoiding sipping it for a long time. A diet rich in fluids promotes the effect of Myrtipeg®.
For bowel cleansing before colonoscopy, one sachet should be dissolved in one liter of water, and then according to the doctor’s instructions, 1 to 2 liters of the solution thus prepared should be drunk.

Warnings:
In case of pregnancy or lactation seek medical advice.
Laxative abuse (frequent or prolonged use or overdose) can cause persistent diarrhea resulting in loss of water, minerals (especially potassium) and other essential nutrients.
Keep out of the reach and sight of children.

Precautions for use:
Treatment of chronic or recurrent constipation always requires a physician’s intervention for diagnosis and surveillance during the course of therapy. Consult your doctor when the need for laxative results from a sudden change in previous bowel habits (frequency and characteristics of evacuations) that has lasted for more than two weeks or when laxative use fails to produce an effect.
It is also advisable for the elderly or those in poor health to consult their doctor before using a laxative.

Contraindications:
Hypersensitivity to any of the components of the product. Avoid administration in cases of intestinal blockage.
Laxatives should not be used by individuals with acute abdominal pain or pain of unknown origin, nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding.
The presence of one or more of these symptoms or signs requires appropriate diagnostic investigation by the physician in order to rule out one of the pathological conditions that contraindicate the use of laxatives (e.g., intestinal obstruction, stenosis or perforation, paralytic ileus, severe inflammatory bowel disease).
Severe state of dehydration.

Drug interactions:
Not reported, but Myrtipeg® intake should be spaced at least two hours apart from oral medications.

Side effects:
Rarely, Myrtipeg® may cause abdominal distension, abdominal pain, nausea, vomiting. Very rare: hypersensitivity reactions. If allergic reactions occur, stop taking Myrtipeg® and consult a physician immediately.
The patient should report to the physician any side effects that persist for more than a week, or the appearance of any other side effects.
The user and/or patient must report any serious incidents occurring in relation to the device to the manufacturer and to the competent authority of the member state in which the user and/or patient is established.

It is a medical device CE 0373.
Read the warnings or instructions for use carefully.
Ministerial authorization of 06/20/2023.