Smecta 60 sachets

BEAUFOUR IPSEN INDUSTRIE

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Smecta 60 sachets

Smecta sachet is a powder for oral suspension intended for use in acute or chronic diarrhea. It has a slight taste of vanilla and orange.

It is a naturally purified and standardized glue.

Smectite covers the mucosa and protects it, increasing the resistance of mucus and binding pathogens, bacteria, viruses and toxins.

Smecta Composition:

Diosmectite 3,000 g.

Excipients: Glucose monohydrate, saccharin sodium, vanilla flavor, orange flavor:

Smecta Therapeutic indications: Symptomatic treatment of pain symptoms associated with diseases of the esophagus, stomach, duodenum and colon. Treatment of acute and chronic diarrhea in children. (including infants) and adults.

Smecta Dosage:

Treatment of acute diarrhea:

In infants and children:

Under 1 year: 2 sachets daily for 3 days and then 1 sachet daily.

Over 1 year: 4 sachets per day for 3 days and then 2 sachets per day.

In adults: The recommended daily dose is 6 sachets per day.

Treatment for other indications:

For children:

- under 1 year: 1 sachet daily

- between 1 and 2 years: 1 to 2 sachets per day

- over 2 years: 2 to 3 sachets per day

In adults: An average of three sachets per day.

Method of administration: The contents of the sachet should be suspended immediately before use. It is recommended that diosmectite be taken after meals in patients with esophagitis and between meals in other indications.

In infants and children: The contents of the sachet can be dissolved in a pacifier or bottle with 50 ml of water and given during the day or mixed well with semi-liquid food: porridge, stewed fruit, vegetable puree and baby food.

In adults: On average, 3 sachets a day are dissolved in half a glass of water.

Contraindications: Hypersensitivity to diosmectite or to any of the substances in the medicinal product.

It is recommended to apply:

- after meals for esophagitis

- between meals for other indications

Precautions for use: Smecta should not be taken by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose insufficiency.

Interaction with other medicinal products and other forms of interaction: As the absorbent properties of this product may affect the rate and / or level of absorption of other substances, it is recommended that other medicinal products not be administered concomitantly with Smecta.

Pregnancy and lactation: Smecta can be taken during pregnancy and lactation, as it remains chemically unchanged and is not absorbed.

Effects on ability to drive and use machines: No effect on ability to drive and use machines.

Side effects: Very rare cases of development or worsening of constipation have been reported. Treatment was continued after dose reduction.

Adverse reactions observed in clinical trials have always been minor and short-lived in the gastrointestinal tract. The established frequency is as follows: Rare (> 1 / 1,000 to <1/100): periods of constipation relieved after individual changes in treatment regimen

Additional information from the post-marketing study shows: Very rare (frequency not known): hypersensitivity, including urticaria, pruritus or angioedema.

Overdose: Overdose can lead to severe constipation.

Pharmacokinetic properties: As a consequence of its chemical structure, diosmecite is not absorbed or metabolised.

Incompatibilities: None known.