Pro-Symbioflor (Drops) Instructions for Use

Marketing Authorization Holder

Symbiopharm GmbH (Germany)

ATC Code

A07FA (Antidiarrheal microorganisms)

Dosage Form

Pro-Symbioflor

Oral drops: 50 ml dropper bottle

Dosage Form, Packaging, and Composition

Oral drops from light yellow to yellow-brown in color with a characteristic odor; a slight suspension is possible.

Excipients : lactose monohydrate 4.9 mg, sodium carbonate decahydrate 0.96 mg, sodium chloride 3.8 mg, magnesium sulfate heptahydrate 0.779 mg, potassium chloride 0.133 mg, calcium chloride dihydrate 0.076 mg, magnesium chloride hexahydrate 0.608 mg, purified water 0.98 ml.

50 ml – dark glass dropper bottle (1) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora (probiotic)

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

A drug of bacterial origin that regulates the balance of the intestinal microflora.

The therapeutic effect is due to the immunomodulatory and adjuvant activity of the bacterial lipopolysaccharide (autolysate of the E.coli strain DSM 17252), which affects the production of specific and nonspecific, including local, defense factors. The autolysate of the Enterococcus faecalis strain DSM 16440 contributes to the normalization of microbiocenosis.

Indications

• Irritable bowel syndrome.

ICD codes

Dosage Regimen

Orally. It is prescribed for children from 4 years of age and adults.

The bottle should be shaken vigorously before use.

For persons over 12 years of age and adults, it is recommended to start treatment with Pro-Symbioflor by taking 5 drops 3 times a day. Over two weeks, the dose should be increased to 20 drops 3 times a day.

The drug can be used by children from 4 years of age; start taking it with a dosage of 5 drops 3 times a day, over 2 weeks the dose is increased to 10 drops 3 times a day and maintained for 4-6 weeks of therapy. The course of treatment with the drug is up to 8 weeks (depending on the pathological condition). Increasing the duration of the treatment course is possible as prescribed by a doctor. The use of the drug in children should be carried out under medical supervision.

Adverse Reactions

In rare cases, flatulence, bloating and pain in the epigastric region, as well as urticaria and allergic reactions are possible.

Contraindications

• Acute cholecystitis;
• Acute pancreatitis;
• Intestinal volvulus;
• Cachexia;
• Exhaustion;
• Galactose intolerance;
• Lactase deficiency;
• Glucose-galactose malabsorption;
• Hypersensitivity to any of the components of the drug.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, the drug can be used only after prior consultation with a doctor.

Pediatric Use

Contraindicated in children under 4 years of age.

Special Precautions

Information for people on a sodium diet 10 drops of the drug contain 0.05 mol (1.12 mg) of sodium.

Do not freeze! Shake well before use! Close the bottle tightly each time after use!

Effect on the ability to drive vehicles and operate machinery

No effect.

Overdose

No cases of overdose have been observed with the use of the drug.

Drug Interactions

Prescribing the drug does not exclude the use of other drugs used for this disease.

Storage Conditions

Before first opening, store protected from light, at a temperature from 2°C (35.6°F) to 27°C (80.6°F). After opening the bottle, store for 3 weeks at a temperature from 2 to 8°C (46.4°F)! Keep out of reach of children!

Shelf Life

The shelf life is 2 years, after opening the bottle – 3 weeks.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.