OMNIFLORA

OMNIFLORA N hard capsules

Important notes (mandatory information)

Omniflora N hard capsules. Areas of application: mildly effective medicine for supporting bowel function, e.g. in cases of constipation and diarrhoea.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Omniflora N hard capsules for children aged 1 and over and adults
Active ingredients: Lyophilisate from Lactobacillus gasseri 25 mg Lyophilisate from Bifidobacterium longum 25 mg
Traditional gastrointestinal medicine

Read the entire package leaflet carefully because it contains important information for you. Always take this medicine exactly as described in this package leaflet or exactly as instructed 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 your symptoms worsen or if acute diarrhoea does not improve after 2 days or constipation does not improve after 7-10 days, you must see a doctor.

What this package leaflet contains

1. WHAT IS OMNIFLORA N AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING OMNIFLORA N?
3. HOW SHOULD OMNIFLORA N BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD OMNIFLORA N BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS OMNIFLORA N AND WHAT IS IT USED FOR?

Omniflora N is a traditional gastrointestinal medicine. It contains lactic acid bacteria that support the development of the intestinal flora and bowel function. Area of application: Traditionally used as a mildly effective medicine for supporting bowel function, e.g. in cases of constipation and diarrhoea.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING OMNIFLORA N?

Omniflora N must not be taken:

• if you are hypersensitive (allergic) to one of the active ingredients or any of the other ingredients listed in section 6 of this medicine;
• in cases of acute diarrhoea with high fever or blood in the stool;
• by children under 1 year of age;
• by patients with weakened immune systems (e.g. HIV infection, organ transplantation, leukaemia, malignant tumours, radiation, chemotherapy, long-term high-dose cortisone treatment) due to the previously unassessable risk of generalised colonisation with the active ingredients Lactobacillus gasseri and Bifidobacterium longum.

Warnings and precautions

Please talk to your doctor or pharmacist before using Omniflora N. If acute or persistent complaints or unclear complaints in the gastrointestinal tract occur, a doctor should be consulted. The use of this medicine is only supportive and should only be used in cases of illness as a supplement to other effective therapeutic measures. When supporting bowel function in cases of diarrhoea, particular attention must be paid to replacing fluids and electrolytes as the most important therapeutic measure, especially in children and the elderly. In principle, a doctor should be consulted in cases of diarrhoea that lasts longer than 2 days, contains blood or is accompanied by fever and circulatory problems. Patients with acute pancreatitis should consult a doctor before taking this medicine.

Children

For infants up to the age of 2, a doctor should be consulted before use.

Taking Omniflora N with other medicines

Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. The effectiveness of Omniflora N may be reduced if antibiotics are taken at the same time. Therefore, take Omniflora N at least 2 hours after taking the antibiotic dose.

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 using this medicine. There are no adequate studies on the use of this medicine during pregnancy and breast-feeding. No evidence of risks has emerged from the widespread use of Lactobacillus gasseri and Bifidobacterium longum as medicines or in food; nevertheless, due to the insufficient studies, taking Omniflora N during pregnancy and breast-feeding is not recommended.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Omniflora N

This medicine contains lactose and sucrose. Therefore, please only take Omniflora N after consulting your doctor if you know that you suffer from an intolerance to certain sugars. One Omniflora N hard capsule contains 0.042 g lactose (a source of 0.021 g glucose and 0.021 g galactose) and 0.020 g sucrose corresponding to approx. 0.005 bread units (BE). You should take this into account if you are on a diabetic diet.

3. HOW SHOULD OMNIFLORA N BE TAKEN?

Always take this medicine exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed, adults should take 1 hard capsule 3 times a day. In cases of acute intestinal problems, up to 2 hard capsules can be taken 3 times a day. After the symptoms have subsided, a maintenance dose of 1 hard capsule per day is recommended. For infants aged 1 - 2, a doctor should be consulted before use. Children aged 1 and over should take 1 hard capsule 1 - 2 times a day. If the child's condition does not improve or if it worsens, a doctor should be consulted immediately. Use in children under 1 year of age is not indicated.

Method of administration

The hard capsules should be swallowed whole with some liquid during meals. To administer to infants, the hard capsule should be opened and the contents mixed with a small amount of lukewarm liquid or porridge. The mixture should be taken immediately.

Duration of use

The duration of use of Omniflora N is not limited, but in general a treatment of 7 to 10 days is sufficient. If acute diarrhoea does not improve within 2 days or if your symptoms worsen, you should definitely see a doctor. Please also refer to the information under "Warnings and precautions". Please talk to your doctor or pharmacist if you have the impression that the effect of Omniflora N is too strong or too weak.

If you have taken more Omniflora N than you should

In the event of an intentional or accidental overdose, please inform your doctor or pharmacist.

If you forget to take Omniflora N

Do not take a double dose if you have forgotten to take the previous dose.

If you stop taking Omniflora N

If you interrupt the treatment or stop using it prematurely, the desired effect may not occur. Therefore, please consult your doctor or pharmacist if you want to end or interrupt the treatment.

If you have any further questions on 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.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

In rare cases, hypersensitivity reactions, usually in the form of a skin rash, may occur. Within each frequency group, the side effects are listed in decreasing order of severity.

System organ class (SOC), frequency	Side effect
Immune system disorders, Rare	Hypersensitivity
Skin and subcutaneous tissue disorders, Not known	Skin rash

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, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD OMNIFLORA N BE STORED?

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". Storage conditions: Do not store above 30°C. Note on shelf life after opening: Omniflora N should be used within 2 months after opening the container. During this time, Omniflora N can be stored at room temperature (e.g. when travelling) without any loss of effectiveness. The container must be closed tightly after each capsule is removed.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Omniflora N contains

The active ingredients are: 1 hard capsule contains: 25 mg lyophilisate from Lactobacillus gasseri corresponding to 8 x 108 to 8 x 109 CFU/g (corresponding to 2 x 107 to 2 x 108 CFU/capsule) with residual culture medium*, 25 mg lyophilisate Bifidobacterium longum corresponding to 8 x 108 to 8 x 109 CFU/g (corresponding to 2 x 107 to 2 x 108 CFU/capsule) with residual culture medium*.
* Starting materials of the residual culture media: H-whole milk, peptone, sodium hydroxide, sodium carbonate, calcium carbonate, ascorbic acid, lactose monohydrate, sucrose (sugar) gelatine.

The other ingredients are

Gelatine; lactose; precipitated silicon dioxide; sodium dodecyl sulphate.

What Omniflora N looks like and contents of the pack

Omniflora N is a colourless, transparent hard capsule and is available in packs of 20 hard capsules, 50 hard capsules or 100 hard capsules (2 x 50).

Pharmaceutical entrepreneur and manufacturer

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich
Barthstraße 4, 80339 Munich
Telephone (089)78 77-209
Fax (089)78 77-304
E-mail: medical.contactcenter@gsk.com

This package leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 04/2018
Areas of application: mildly effective medicine for supporting bowel function, e.g. in cases of constipation and diarrhoea.