MUTAFLOR gastro-resistant hard capsules

MUTAFLOR ^® is an agent for the treatment of intestinal diseases.

Active ingredient: Escherichia coli strain Nissle 1917

Areas of application: Chronic constipation, ulcerative colitis in the remission

phase Warning: Store at 2 ° C to 8 ° C (in the refrigerator)!

For information on risks and side effects, read the package insert and ask your doctor or pharmacist!

Status: March 2014
Ardeypharm GmbH, 58313 Herdecke
Mutaflor ^® gastric juice- resistant hard capsules

indication

• Substance group and mode of action:
  • The preparation is an agent for the treatment of intestinal diseases.
  • The bacterium Escherichia coli (E. coli) strain Nissle 1917 contained in the drug as an active ingredient is a natural intestinal colonizer. When it is released in the large intestine, it has an anti-inflammatory effect and acts against pathogenic microorganisms. In addition, it promotes the body's own defences. In addition, the bacterium E. coli strain Nissle 1917 supports digestion. It releases substances into the intestines that stimulate the activity of the intestinal muscles (peristalsis) and serve as energy suppliers for the mucous membrane of the large intestine and promote its blood circulation.
• The medicine is used for:
  • inflammation of the colon (ulcerative colitis) in the relapse-free period (remission phase)
  • long-lasting constipation (chronic constipation)

dosage

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Dosage:
  • Adults and young people aged 12 and over:
    • The recommended dose is:
      • The following dosing scheme is used to initiate long-term therapy with stronger preparations:
        • 1 capsule daily for the first 4 days, 2 capsules daily for the following 2 days, and 3 capsules daily for the following days.
        • Once 3 capsules are well tolerated, therapy should be continued with dosage forms of other concentrations.
  • Children:
    • In the case of inflammation of the large intestine (ulcerative colitis) in the relapse-free period (remission phase):
      • A dosage recommendation cannot be given due to a lack of clinical studies in children.
    • For constipation (constipation):
      • From the 1st - 4th day 1 capsule, from the 5th day 2 capsules.

• duration of use
  • Adults and young people aged 12 and over:
    • Once 3 capsules are well tolerated, therapy should be continued with the stronger capsules.
  • Children:
    • For constipation, this medicine can be used for up to 6 weeks.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of is too strong or too weak.

• If you take more than you should
  • No special measures are required even if excessive amounts are taken.

• If you forget to take a dose
  • Do not take a double dose to make up for a forgotten dose. The intake should be continued - regardless of the missed intake - while maintaining the previous dosage.

• If you stop taking it
  • No special precautionary measures are required here if used as intended.

• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.
  

way

• The entire daily dose should be taken whole with a meal, preferably breakfast, with sufficient liquid.

side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• The evaluation of side effects is based on the following frequency information:
  • Very common: affects more than 1 in 10 people
  • Common: affects 1 to 10 users in 100
  • Uncommon: affects 1 to 10 users in 1,000
  • Rare: affects 1 to 10 users in 10,000
  • Not known: frequency cannot be estimated from the available data
• Possible side effects:
  • Bloating often occurs at the beginning of the intake. In very rare cases, undesirable effects such as abdominal pain, intestinal noises, loose stool or diarrhea, nausea and vomiting can also occur in the gastrointestinal tract.
  • In very rare cases, skin reddening or rashes can also occur.
  • In very rare cases, headaches can also occur.
  • Please tell your doctor or pharmacist if any of the listed side effects gets serious, or if you notice any side effects that are not listed.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

• Taking with other medicines
  • Tell your doctor or pharmacist if you are taking/using any other medicines, have recently taken/used or might take/use any other medicines, including medicines obtained without a prescription.
  • Certain antibiotics and sulphonamides in particular can reduce the effectiveness of this medicine.

Contraindications

• The drug must not be taken
  • if you are allergic to E. coli strain Nissle 1917 or any of the other ingredients of this medicine.

pregnancy and breast feeding period

• The bacterium E. coli strain Nissle 1917 contained in this drug as an active ingredient is a natural intestinal colonizer. When used as intended, there are no known risks during pregnancy and breastfeeding.

patient notes

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking this medicine.

• Driving and using machines
  • There are no special precautions required.

For children with constipation

In Germany, not only do around 20% of adults suffer from chronic constipation, more and more children and young people are also having problems with regular bowel movements. The unpleasant symptoms severely affect the well-being of the affected children, while side effects such as a feeling of fullness, bad breath, headaches and tiredness often occur.

The probiotic drug Mutaflor ^® mite was specially developed for the treatment of chronic constipation. The highly concentrated living active ingredient is well tolerated and is therefore also suitable for children.

Gentle & natural
In constipation, the gut is out of balance and lacks beneficial gut bacteria that are necessary for the gut to function normally. The active ingredient in Mutaflor ^® mite is highly concentrated bacteria of the E. coli strain Nissle 1917, which are found in the healthy intestine and are therefore particularly well tolerated. The natural intestinal colonizers have an anti-inflammatory effect in the large intestine and fight pathogenic microorganisms. In addition, the bacteria support digestion and stimulate defecation in a gentle and natural way.

RECOMMENDATIONS FOR APPLICATION:
The daily dose of Mutaflor ^®mite should be taken whole with a meal, preferably breakfast, with plenty of liquid. Unless otherwise prescribed by a doctor, children with constipation take 1 capsule of Mutaflor ^® mite from the first to the fourth day, then 2 capsules a day.

Please always keep Mutaflor ^® mite at 2°C to 8°C in the refrigerator and out of the reach of children. IMBALANCED DIET Irregular meal times, too little exercise, and a diet low in fiber with too much fat, sweets, and white flour products can lead to constipation in children. Mutaflor ^® mite with natural bacteria can get the intestine going again and gently stimulate bowel movements.








TAKING ANTIBIOTICS

Taking antibiotics can upset the delicate balance in the gut and result in side effects such as constipation or diarrhea. By supplying natural intestinal germs such as E. coli bacteria strain Nissle 1917, the necessary balance in the intestine can be restored.



AS AN INTEGRATED THERAPY Mutaflor ^® mite with natural intestinal bacteria is not only suitable for regulating digestion in children, but can also be used in adults and adolescents from the age of 12 to initiate long-term therapy with stronger Mutaflor ^® capsules. 

FREQUENT QUESTIONS & ANSWERS: Why can the active ingredient in Mutaflor ^®





mite help with diarrhea and constipation?
In the case of diarrhea (diarrhea) as well as constipation (constipation), the intestinal flora is out of balance. This means that there are not enough beneficial intestinal bacteria in the intestine to maintain normal function. The natural probiotic living ingredient E. coli strain Nissle 1917 in Mutaflor ^® mite supports the restoration of the natural balance. It can help with both diarrhea and constipation in a natural and gentle way.

How long can Mutaflor ^® mite be taken?
In the case of constipation, Mutaflor ^®be used by children up to 6 weeks. Please discuss the age-appropriate dosage and duration of use of the drug with the treating pediatrician.

What side effects can occur when taking Mutaflor ^® mite?
Flatulence can occur at the beginning of the intake, in very rare cases there can be undesirable effects in the gastrointestinal tract such as abdominal pain, intestinal noises, loose stool, nausea or vomiting. In very rare cases, skin reddening and skin rashes or headaches can also occur.

Mutaflor Suspension has to be sent with refrigerated transport, we don't do that
if it has to be sent abroad.

An interruption of cooling for a few days (1-2 days) at
room temperature, e.g. for transport, usually has no
effect on the number of germs.