Symbioflor E. coli - Oral drops, suspension

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Symbioflor E. coli is a bacterial preparation for use in irritable bowel syndrome (colon irritabile).

Application

WHAT ARE Symbioflor E. coli - DROPS AND WHAT ARE THEY USED FOR?

Symbioflor E. coli ­ drops are a bacterial preparation that improves the immune system in the intestinal tract.

Symbioflor E. coli - drops are used for functional disorders of the gastrointestinal tract and irritable bowel syndrome (colon irritabile).

How is it used?

What is Symbioflor E. coli and what is it used for?

Symbioflor E. coli is a bacterial preparation for use in irritable bowel syndrome (colon irritabile).

In case of longer lasting or stronger pain as well as in case of unsatisfactory course of therapy,
contact your doctor (see section 2).

What should you consider before taking it?

What should you consider before taking Symbioflor E. coli?

Symbioflor E. coli must not be taken
- if you are allergic to Escherichia coli bacteria or any of the other ingredients of this medicine listed in section 6.
- if you have more severe organic diseases of the gastrointestinal tract such as acute
inflammation of the gallbladder, the pancreas or in case of intestinal obstruction.
- if you have a very strong abnormal weight loss or an extreme weight loss due to malnutrition (cachexia, marasmus).

Warnings and precautions
Please talk to your doctor or pharmacist before taking Symbioflor E. coli.

Before making the diagnosis "irritable bowel", your doctor should have ruled out organic causes of the gastrointestinal disorders.

Do not take Symbioflor E. coli during acute febrile illnesses. Please interrupt the treatment temporarily.

Do not take Symbioflor E. coli during antibiotic treatment or within 5 days after its completion (see also section Taking Symbioflor E. coli together with other medicines).

Consult your doctor and stop treatment if the symptoms are more severe, e.g. acute diarrhoea with high fever or blood impurities, or if the diarrhoea lasts for more than 2 days, as well as if other, longer lasting or unclear symptoms occur in the gastrointestinal area.

Taking Symbioflor E. coli together with other medicines
Tell your doctor or pharmacist if you are taking / using, have recently taken / used or intend to take / use any other medicines.

Antibiotics can inhibit the Escherichia coli bacteria and thus weaken the effectiveness of this medicine.

Taking Symbioflor E. coli together with food and drinks
Take the drops during meals (see section 3).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Although no harmful effects of Symbioflor E. coli on the unborn child are known, the drops should only be used during pregnancy and breast-feeding after careful consideration of the benefits and risks by the doctor.

Driving and using machines
Symbioflor E. coli has no or negligible influence on the ability to drive and use machines.

Symbioflor E. coli contains sodium.
Symbioflor E. coli contains less than 1 mmol sodium (23 mg) per dose of 20 drops, i.e. it is almost "sodium-free".

How should the medicine be taken?

How should Symbioflor E. coli be taken?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:
Adults take 10 drops three times a day during meals at the beginning of treatment. Increase the dose to 20 drops three times a day after one week.


If gastrointestinal symptoms such as flatulence, diarrhoea, abdominal pain or discomfort worsen or occur more frequently at the beginning of treatment, Symbioflor E. coli should be taken diluted in water or in a smaller amount, or the number of drops should be increased more slowly.

A period of use of 8 weeks is recommended.
If the symptoms worsen during treatment or persist after 8 weeks of treatment, consult a doctor.

Use in children and adolescents
No dosage can be recommended as the safety and efficacy of Symbioflor E. coli in children and adolescents has not been proven.

Instructions for the proper use of the medicine
Shake Symbioflor E. coli well before use! This will create a slight cloudiness.

Symbioflor E. coli does not contain any preservatives and is therefore susceptible to contamination if used improperly. This is avoided by opening the bottle only briefly for use and allowing the contents to drip out carefully. Do not touch the dropper! Due to the high surface tension of Symbioflor E. coli, problems with the dripping on or off of the solution cannot be completely avoided. After shaking and before opening, tap the bottom of the bottle on the table (this will free the air tube from liquid). Dripping is facilitated by tilting (approx. 45° angle) and gently tapping the bottom of the bottle. The speed of dripping can be influenced by varying the angle of inclination.

If you have taken more Symbioflor E. coli than you should
no countermeasures are necessary.

If you forget to take Symbioflor E. coli
Do not take double the amount, but continue taking the originally prescribed dosage

If you stop taking Symbioflor E. coli
no special measures are indicated. If necessary, consult your doctor.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

What side effects are possible?

How should Symbioflor E. coli be stored?

Do not store Symbioflor E. coli above 30°C before opening. Do not freeze.
Close the bottle tightly immediately after use and store in the refrigerator (2°C to 8°C).

After first opening the bottle, the contents can be kept for 4 weeks.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after 'use by:'. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice the following:
strong flocculation of the solution.

Ask your pharmacist how to dispose of the medicine when you are no longer using it. You will help to protect the environment.

Special storage instructions

HOW SHOULD SYMBIOFLOR E. COLI - DROPS BE STORED?

Do not store Symbioflor E. coli - drops above 30°C before opening. Do not freeze.
Close the bottle tightly immediately after use and store in the refrigerator (2°C ­ 8°C).

After first opening the bottle, the contents can be kept for 4 weeks.

Keep this medicine out of the reach of children.

Do not use the medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice the following:
strong flocculation of the solution.

Special information on the content

Contents of the pack and further information

What Symbioflor E. coli contains

- The active ingredient is: bacterial concentrate with Escherichia coli bacteria (DSM 17252, cells and autolysate) corresponding to 1.5 to 4.5 x 107 living cells
- 1 ml = 14 drops
- The other ingredients are: sodium chloride, magnesium sulfate heptahydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and purified water

What Symbioflor E. coli looks like and contents of the pack
Symbioflor E. coli is a colourless, particle-free suspension for oral use.
Symbioflor E. coli is packaged in 50 ml brown glass bottles with a plastic cap and dropper.