Medicinal Products

DIOSMECTITIS MYLAN 3 g

Generic drug of Smecta
Therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Diosmectite
laboratory: OY Simcere Europe Ltd

Powder for oral suspension
Sachets Box of 30
All forms

Indication

· Symptomatic treatment of acute diarrhea in children and infants in addition to oral rehydration and in adults.

· Symptomatic treatment of chronic diarrhea.

· Symptomatic treatment of pain related to oesogastroduodenal and colic affections.

Dosage DIOSMECTITIS MYLAN 3 g Powder for oral suspension Sachets Box of 30

Treatment of acute diarrhea:

In infants and children:

· Before 1 year: 2 sachets a day for 3 days then 1 sachet a day.

· After 1 year: 4 sachets a day for 3 days then 2 sachets a day.

In adults:

On average 3 sachets a day.

In practice, the daily dosage can be doubled at the beginning of treatment.

Other indications:

In infants and children:

· Before 1 year: 1 sachet per day.

· Between 1 and 2 years old: 1 to 2 sachets a day.

· After 2 years: 2 to 3 sachets a day.

In adults:

On average 3 sachets a day.

Administration mode :

The contents of the sachet should be suspended just before use.

To administer preferably:

· After meals in esophagitis,

· Away from meals in other indications.

In children and infants:

The contents of the sachet can be diluted in a bottle of 50 ml of water to be distributed during the day, or mixed with a semi-liquid food: porridge, compote, mashed potatoes, "petit-pot".

In adults:

The contents of the sachet can be diluted in half a glass of water.

Against indications

· Hypersensitivity to diosmectite or any of the excipients.

· Due to the presence of aspartame, this medicine is contraindicated in cases of phenylketonuria.

Diosmectite Mylan side effects

The following side effects have been reported in clinical studies in children and adults. These side effects were generally of minor and transient intensity and mainly concerned the digestive tract.

The frequencies of adverse reactions were classified as follows: frequent (≥1 / 100, <1/10), infrequent (≥1 / 1000, ≤1 / 100)

Gastrointestinal disorders:

Frequent: constipation usually giving way to reduction in dosage but may in rare cases lead to discontinuation of treatment.

Uncommon: flatulence, vomiting.

During marketing, cases of hypersensitivity reactions (frequency unknown) including urticaria, rash, pruritus and angioedema have been reported.

Cases of aggravation of constipation have also been reported.

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