CATIDRAL PLUS – Powder for Oral Suspension for Use in Diarrhoea

CATIDRAL PLUS – Powder for Oral Suspension for Use in Diarrhoea

1. Ingredients:

Each sachet contains:

• Diosmectite: 3.00 g.
• Sodium chloride: 0.263 g.
• Potassium chloride: 0.0373 g.
• Anhydrous tripotassium citrate: 0.162 g.
• Anhydrous trisodium citrate: 0.147 g.
• Glucose (anhydrous dextrose): 1.982 g.

Excipients: partially hydrolysed guar gum (PHGG), vanillin, silicon dioxide, vanilla flavouring, colouring agent (beta-carotene).

The product is gluten-free.

2. Product Description and Directions for Use:

Catidral® plus is a single-use medical device supplied as a powder in sachets for preparation of an oral suspension immediately before use. Each sachet is for single use only once opened.

Mix the entire contents of one sachet with 100 mL of water. To obtain a homogeneous suspension, pour the powder into a glass, add water and stir slowly until the powder is evenly dispersed.

Taking Catidral® plus between meals is recommended.

3. Indications:

• Acute and chronic diarrhoea, and painful symptoms associated with gastrointestinal diseases.
• Prevention of chemotherapy-induced diarrhoea.

4. Recommended Dosage:

During the first 3 days:

• Children over 2 years of age: Up to 4 sachets daily.
• Adults: Up to 6 sachets daily.

Thereafter, gradually reduce the dose until the diarrhoea resolves.

5. Duration of Treatment:

Do not use Catidral® plus for more than 5 consecutive days. If symptoms persist, consult a doctor.

6. How Catidral® plus Works:

Each sachet contains diosmectite and electrolytes.

Diosmectite is a natural clay with a crystalline structure consisting of multiple thin, stacked layers, giving it a high adsorption capacity. This structure enables diosmectite to retain excess fluid within the intestinal lumen, making stools firmer and slowing their elimination.

Through this mechanism, Catidral® plus may help reduce the risk of dehydration associated with diarrhoea. Its balanced electrolyte content also helps restore normal fluid and electrolyte balance.

Diosmectite also interacts with glycoproteins in the mucus layer covering the gastric and duodenal mucosa. This interaction modifies the physical properties of the mucus, forming a protective gel layer that helps protect the mucosa against increased acid secretion and substances harmful to the stomach.

7. Safety Precautions Before Use:

• Consult a doctor if using Catidral® plus alongside other treatments.
• Keep out of reach of children.
• Do not use if the original packaging is damaged or no longer intact.
• Do not use after the expiry date stated on the packaging.

8. Warnings:

• Due to its high adsorption capacity, diosmectite may affect the gastrointestinal absorption of certain oral medicines. Other oral medicines or treatments should therefore be taken separately from Catidral® plus, allowing an interval between administrations.
• Do not use in people with constipation.
• People with diabetes or those following a special diet should be aware that the product contains sugar.
• If taking medicines, consult a doctor or healthcare professional before use.
• Pregnant or breastfeeding women should consult a doctor or healthcare professional before use.

9. Expiry Information and Storage:

• Do not use after the expiry date stated on the packaging.
• Store at room temperature, away from direct sunlight, heat sources and moisture. Avoid contact with water.
• The expiry date applies only to the product in intact packaging when stored correctly.

10. Manufacturer, Trademark, Country of Origin, and Distributor:

• Manufacturer: Pharma Line S.r.l.
  Address: Via Bertani, 2 – 20154 Milano (MI), Italy.
• Trademark: Catidral® is a registered trademark of Pharma Line S.r.l.
• Country of Origin: Italy.
• Distributor in Vietnam:
  VITAONE INTERNATIONAL JOINT STOCK COMPANY
  Registered business address: 42 Street 12, Quarter 37, Hiep Binh Ward, Ho Chi Minh City, Vietnam.
  Head office: 42 Street 12, Quarter 37, Hiep Binh Ward, Ho Chi Minh City, Vietnam.
  Telephone: 077 397 2868.