SYMBIOFLOR

Symbioflor 1 drop, 100 ml solution

Symbioflor 1 drops, 100 ml solution

• contains live bacterial cultures
• to support the immune system
• solution for oral administration
• prescription drug
• Manufacturer: SymbioPharm GmbH, Germany
• PZN: 8636223

Important notes (mandatory information):

Symbioflor 1 drops, suspension. Active ingredient: Enterococcus faecalis bacteria. Areas of application: to reduce the relapse rate in recurrent infections of the upper and lower respiratory tract, especially in inflammations of the paranasal sinuses (sinusitis) and the bronchi (bronchitis).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Symbioflor 1, drops for oral administration, suspension
Active ingredient: Enterococcus faecalis 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 this package leaflet contains

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

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

Enterococcus faecalis bacteria are live bacteria that have a beneficial effect on the immune system. Symbioflor 1 is used to reduce the relapse rate in recurrent infections of the upper and lower respiratory tract, especially in inflammations of the paranasal sinuses (sinusitis) and the bronchi (bronchitis).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SYMBIOFLOR 1?

Symbioflor 1 must not be taken if you are hypersensitive (allergic) to the bacterial culture with Enterococcus faecalis bacteria or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions:
If you experience any adverse reactions or if you become pregnant, please inform your doctor. Symbioflor 1 is not suitable for the treatment of disease symptoms that occur in acute respiratory diseases. No controlled studies have been conducted on patients under 18 years of age and over 65 years of age.

Taking Symbioflor 1 with other medicines:
Please inform your doctor or pharmacist if you are taking/using or have recently taken/used or intend to take/use any other medicines. Antibiotics can inhibit Enterococcus faecalis bacteria and thus reduce the effectiveness of this medicine. Therefore, the doctor should be consulted before taking Symbioflor 1 together with antibiotics.

Taking Symbioflor 1 with food and drink:
There are no restrictions to be observed.

Pregnancy and breast-feeding:
Although no harmful effects on the foetus (teratogenic effects) of Symbioflor 1 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 1 has no influence on the ability to drive and use machines.

Symbioflor 1 contains lactose and glucose:
Therefore, please only take Symbioflor 1 after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE SYMBIOFLOR 1?

Always take Symbioflor 1 exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose for adults aged 18 and over is: Take 30 drops 3 times a day. Take Symbioflor 1 in the morning after getting up, at noon before eating and in the evening before going to bed. Keep Symbioflor 1 in your mouth for a minute and gargle with it before swallowing. Shake well before use. This will cause a slight clouding. The clearly noticeable, sometimes unpleasant odour of the solution is characteristic of the product and can vary in intensity. Symbioflor 1 does not contain any preservatives and is therefore susceptible to contamination if used improperly. This can be 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 1, problems with the dripping 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 nature of the present illness and can be up to 6 months in chronic infections.

If you have taken more Symbioflor 1 than you should:
No countermeasures are necessary.

If you forget to take Symbioflor 1:
Do not take double the dose, but continue taking the medicine in the originally prescribed dosage.

If you stop taking Symbioflor 1:
No special measures are indicated. If necessary, consult your doctor.

If you have any further questions about the use of 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.

Very rare (may affect up to 1 in 10,000 patients):
Headache, vomiting, rash, dry mouth, diarrhoea, skin reactions, stomach pain, hives, nausea, itching, 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 1?

Store Symbioflor 1 unopened at no more than +30°C. Do not freeze. Close the bottle tightly 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 1 contains:
The active ingredient is: Bacterial culture (1.0 ml) with Enterococcus faecalis bacteria (DSM 16440, cells and autolysate) corresponding to 1.5 - 4.5 x 107 live cells. 1 ml = 12 drops. The other ingredients are: Lactose monohydrate, cystine, sodium carbonate decahydrate, sodium chloride, magnesium sulfate heptahydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, purified water, standard I nutrient broth (peptone [from casein], dry yeast extract, sodium chloride, glucose monohydrate, purified water).

What Symbioflor 1 looks like and contents of the pack:
Symbioflor 1 is a golden-yellow, particle-free suspension for oral administration. Symbioflor 1 is packaged in 50 ml brown 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), 3 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

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