SYMBIOFLOR

SYMBIOFLOR 2 Suspension

Important notes (mandatory information)

Symbioflor 2 drops, suspension. Active ingredient: Escherichia coli bacteria. Areas of application: for regulating the body's own immune system and for disorders of the gastrointestinal tract, especially irritable bowel syndrome (colon irritabile).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Symbioflor 2, drops for oral administration, suspension
Active ingredient: Escherichia coli bacteria

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What is in this package leaflet

1. WHAT IS SYMBIOFLOR 2 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SYMBIOFLOR 2?
3. HOW TO TAKE SYMBIOFLOR 2?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SYMBIOFLOR 2?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SYMBIOFLOR 2 AND WHAT IS IT USED FOR?

Symbioflor 2 is a bacterial preparation that improves the immune system in the intestinal tract. Symbioflor 2 is used to regulate the body's own immune system and for disorders of the gastrointestinal tract, especially irritable bowel syndrome (colon irritabile). If the pain persists or becomes more severe or if the therapy is not satisfactory, you should consult your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SYMBIOFLOR 2?

Symbioflor 2 must not be taken:

• if you are allergic to the bacterial concentrate with Escherichia coli bacteria or any of the other ingredients of this medicine listed in section 6,
• in acute inflammation of the gallbladder, pancreas and intestinal obstruction,
• during acute febrile illnesses. In this case, Symbioflor 2 should be discontinued temporarily.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Symbioflor 2.

Taking Symbioflor 2 with other medicines

No interactions with other medicines are known.

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 2 on the foetus are known, it 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 2 has no or negligible influence on the ability to drive or operate machines.

3. HOW TO TAKE SYMBIOFLOR 2?

Always take this medicine exactly as described in this package 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 3 times a day at the beginning of treatment. After one week, the dose is increased to 20 drops 3 times a day. If signs of flatulence and upper abdominal discomfort occur at the beginning of treatment, Symbioflor 2 should be diluted more or taken in smaller quantities, or the increase in the number of drops should be slower. Shake Symbioflor 2 well before use! This will cause a slight clouding. Take Symbioflor 2 dissolved in a little water with meals. Symbioflor" 2 contains no 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 2, problems with the dripping on or off of the solution cannot be completely avoided. Dripping is facilitated by tilting the bottle and tapping it lightly on the bottom. The speed of dripping can be influenced by varying the angle of inclination. The duration of use depends on the condition of the present illness and can be up to 6 months in chronic cases.

Use in children and adolescents

Children receive 10 drops once a day, infants 5 drops once a day. Give children and infants Symbioflor 2 dissolved in a little water with the midday meal.

If you have taken more Symbioflor 2 than you should

No countermeasures are necessary.

If you forget to take Symbioflor 2

Do not take double the dose, but continue taking the medicine in the originally prescribed dosage.

If you stop taking Symbioflor 2

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.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Symbioflor 2 is generally well tolerated. However, the following side effects may occur

Occasionally (may affect up to 1 in 1,000 patients)

Flatulence, upper abdominal discomfort, nausea, diarrhoea.

Very rarely (may affect up to 1 in 10,000 patients)

Hives, rash, painful, persistent swelling of the skin and mucous membranes (angioedema).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE SYMBIOFLOR 2?

Do not store Symbioflor 2 above +30°C before opening. Do not freeze. Close the bottle immediately after use and store it in the refrigerator (2°C - 8°C). After first opening the bottle, the contents can be kept for at least 3 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: severe flocculation of the solution.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Symbioflor 2 contains

The active ingredient is: Bacterial concentrate with Escherichia coli bacteria (DSM 17252, cells and autolysate) corresponding to 1.5 - 4.5 x 107 live 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 2 looks like and contents of the pack

Symbioflor 2 is a colourless, particle-free suspension for oral administration. Symbioflor 2 is packaged in 50 ml amber glass bottles with a plastic cap and dropper.

This medicine is available in the following pack sizes

50 ml suspension (N2), 2 x 50 ml suspension (N3).

Pharmaceutical entrepreneur and manufacturer

SymbioPharm GmbH
Auf den Lüppen 10
35745 Herborn
Germany
Tel.: 02772981-300
Fax: 02772 981-301
E-mail: info@symbiopharm.de

This package leaflet was last revised in April 2013.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Escherichia coli bacteria. Areas of application: for regulating the body's own immune system and for disorders of the gastrointestinal tract, especially irritable bowel syndrome (colon irritabile).