Captogastril – Oral Powder to Help Relieve Gastric Acidity, Bloating, Indigestion and Gastroesophageal Reflux

Captogastril – Oral Powder to Help Relieve Gastric Acidity, Bloating, Indigestion and Gastroesophageal Reflux

Captogastril is an oral medical device supplied as a powder that dissolves directly in the mouth (orosoluble powder). It helps relieve gastric acidity, bloating, indigestion, and the burning sensation and discomfort associated with reflux.

1. Device Characteristics and Intended Use:

Various factors, including an unbalanced diet, stress, prolonged medication use, and consumption of foods and drinks that increase gastric acidity, may contribute to symptoms associated with excess stomach acid or digestive disturbances, such as nausea, bloating, post-meal fullness, acid reflux and heartburn.

2. Mechanism of Action:

Captogastril contains simethicone, a surface-active antifoaming agent that reduces the surface tension of gas bubbles in the mucus and digestive fluids present in the stomach and intestines. This helps break down the bubbles and prevents the formation of new ones, allowing excess gas to be expelled more easily from the gastrointestinal tract.

Sodium bicarbonate, magnesium carbonate and magnesium hydroxide help neutralise stomach acid.

The combination of sodium bicarbonate and citric acid produces a mild effervescent effect, helping to disperse the active ingredients evenly and providing a pleasant sensation during use.

3. Ingredients:

Active ingredients: simethicone (80 mg), magnesium hydroxide (150 mg), magnesium carbonate (100 mg), sodium bicarbonate (135 mg).

Excipients: xylitol, citric acid, sorbitol, lemon flavouring, silicon dioxide, ginger essential oil (flavouring), sucralose, acesulfame K, sodium saccharin.

4. Dosage and Directions for Use:

• To support digestion and relieve bloating and abdominal distension: Take 1 sachet after a main meal, up to a maximum of 2 sachets daily.
• To help neutralise stomach acid and relieve reflux and heartburn: Take 2 sachets after a main meal, up to a maximum of 4 sachets daily.

Pour the powder directly from the sachet into the mouth and allow it to dissolve gradually.

Note: Children aged 6–18 years should use this product only under a doctor’s guidance. Pregnant or breastfeeding women should consult a doctor before use.

5. Possible Adverse Effects:

Adverse effects are unlikely at the doses required to achieve the intended therapeutic effect. The product may have a mild laxative effect due to its xylitol content.

6. Interactions with Medicines and Food Supplements:

Due to the presence of adsorbent substances, Captogastril may delay or reduce the absorption of medicines taken at the same time. These may include antacids, antiepileptic medicines, antibiotics, medicines for diabetes, and thyroid medicines such as levothyroxine.

Allow an interval of at least 2 hours between taking Captogastril and oral contraceptives. If you are taking other prescribed medicines, consult a doctor before using Captogastril.

No interactions with food supplements have been reported to date. However, as a general precaution, food supplements—including vitamins, nutrients and herbal products—as well as homeopathic remedies should be taken at least 2 hours apart from Captogastril.

7. Storage:

• Store in a cool, dry place.
• Store at room temperature, not exceeding 25°C.
• Do not use if the sachet is damaged.
• Keep out of reach of children.

8. Warnings and Contraindications:

• Children aged 6–18 years should use the product only under a doctor’s guidance. Pregnant or breastfeeding women should consult a doctor before use.
• The product contains sodium and magnesium salts. Consult a doctor if you are taking medicines or following a special diet.
• The time required to achieve the desired effect depends on the cause of excess gas.
• The product is not suitable for patients with hypernatraemia or hypermagnesaemia.
• Patients with hypertension should use the product only after consulting a doctor.
• Do not use for more than 30 consecutive days. If symptoms persist, consult a doctor.
• Do not use if you have a history of allergy or intolerance to any of the ingredients.
• Each stick pack is for single use only and should be opened immediately before use.

9. Expiry Information:

Do not use after the expiry date stated on the packaging. The expiry date applies to the product in intact packaging when stored correctly.

10. Disposal:

Expired devices or devices requiring disposal must be disposed of in accordance with local medical waste management regulations. Do not discard the product or its packaging into the environment.

MEDICAL DEVICE — CE 0426

11. Manufacturer, Country of Origin, and Distributor:

• Manufacturer: S.I.I.T S.r.l.
  Address: Via Ludovico Ariosto, 50/60 – 20090 Trezzano Sul Naviglio (MI), Italy.
• 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