PERENTEROL

PERENTEROL forte 250 mg capsules

Important notes (mandatory information)

Perenterol forte 250 mg capsules. Active ingredient: Saccharomyces-cerevisiae dry yeast. Areas of application: for the treatment of symptoms in acute diarrhoea, prevention and treatment of symptoms of travel diarrhoea as well as diarrhoea during tube feeding and for accompanying treatment in longer-lasting forms of acne.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Perenterol forte 250 mg capsules for children from 2 years of age and adults
Active ingredient: Saccharomyces-cerevisiae dry yeast

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 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 you do not feel better or if you feel worse after two days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS PERENTEROL FORTE AND WHAT IS IT USED FOR?

Perenterol forte is a medicine with 250 mg dry yeast for oral administration in case of diarrhoea and acne. Perenterol forte is used for the treatment of symptoms in acute diarrhoea, prevention and treatment of symptoms of travel diarrhoea as well as diarrhoea during tube feeding and for accompanying treatment in longer-lasting forms of acne.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PERENTEROL FORTE?

Perenterol forte must not be taken:

• if you are allergic to yeast or any of the other ingredients of this medicine listed in section 6.
• if you suffer from a life-threatening illness (e.g. complicated intensive medical conditions) or a weakened immune system (e.g. due to HIV infections, organ transplantation, leukaemia, malignant tumours, radiation, chemotherapy, long-term high-dose cortisone treatment) and/or if you have a central venous catheter. In these cases, the risk of colonisation of the entire body (generalised colonisation) with Saccharomyces boulardii cannot be assessed at present.

Infants and toddlers under 2 years of age must be excluded from self-medication in any case, as diarrhoea in infants and toddlers under 2 years of age requires consultation with a doctor.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Perenterol forte if you suffer from serious underlying diseases, especially in the gastrointestinal tract. Saccharomyces boulardii is a living microorganism which, under unfavourable conditions such as those occurring in immunocompromised patients, can cause generalised fungal infections by migrating from the gastrointestinal tract into the bloodstream or by external contamination of central venous catheters. Isolated cases of such fungal infections are known in hospital patients who had a central venous catheter, suffered from life-threatening illnesses or serious underlying diseases (mostly in the gastrointestinal tract) or had a severely weakened immune system. You should consult a doctor in case of diarrhoea that lasts longer than 2 days or is accompanied by blood or fever. In case of diarrhoeal diseases, you must pay attention to the replacement of fluids and salts (electrolytes) as the most important treatment measure, especially in children. If acne worsens or does not improve, you should consult a doctor. If microbiological stool examinations are carried out during or shortly after treatment with Perenterol forte, you or your doctor should inform the testing laboratory about the intake, as otherwise false-positive results could be obtained.

Taking Perenterol forte together with other medicines

Do not take medicines against fungal diseases (antimycotics) that work in the gastrointestinal tract at the same time. This can impair the treatment result of Perenterol forte. Please note that this information may also apply to medicines that have been used recently. Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Taking Perenterol forte together with food, drinks and alcohol

You must not take Perenterol forte together with alcohol.

Pregnancy and breast-feeding

So far, no evidence of risks during pregnancy and breast-feeding has emerged from the widespread use of yeast as a food. Results of experimental studies for Saccharomyces boulardii are not available. Therefore, the medicine should not be used during pregnancy and breast-feeding.

Driving and using machines

No precautions are required.

Perenterol forte contains lactose

Therefore, please only take Perenterol forte after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE PERENTEROL FORTE?

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. Unless otherwise prescribed by your doctor, the usual dose for children from 2 years of age and adults is:

• for the treatment of acute diarrhoea 1 to 2 times a day 1 capsule Perenterol forte (corresponding to 250 to 500 mg dry yeast from Saccharomyces boulardii daily).
• for the prevention of travel diarrhoea, starting 5 days before departure, 1 to 2 times a day 1 capsule Perenterol forte (corresponding to 250 to 500 mg dry yeast from Saccharomyces boulardii daily).
• in case of diarrhoea caused by tube feeding, the contents of 3 capsules Perenterol forte in 0.5 litres of nutrient solution daily (corresponding to 750 mg dry yeast from Saccharomyces boulardii daily).
• in case of acne, 3 times a day 1 capsule Perenterol forte (corresponding to 750 mg dry yeast from Saccharomyces boulardii daily).

Please take the capsules unchewed before meals with sufficient liquid (preferably a glass of water). To make it easier to take, e.g. for children, the capsule can be opened by pulling it apart. The capsule contents can be stirred into food or drinks. The drinks or food must not be too hot or ice-cold (room temperature).

Duration of use

In principle, there are no restrictions on the duration of use of yeast preparations. However, please observe the "Warnings and precautions" in section 2. and section 4. "What side effects are possible?". In case of diarrhoea, you should continue the treatment for a few days after the symptoms have subsided. For accompanying treatment in chronic forms of acne, it is recommended to take the medicine for several weeks.

Please talk to your doctor or pharmacist if you have the impression that the effect of Perenterol forte is too strong or too weak.

If you have taken more Perenterol forte than you should

If you have accidentally taken one or two capsules more than intended, this will usually have no adverse effects. If you have significantly overdosed on this medicine, the side effects may occur more frequently (see section 4. "What side effects are possible?"). In this case, you should consult a doctor.

If you forget to take Perenterol forte

Do not take twice the amount if you have forgotten to take the previous dose.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Taking it can cause flatulence. Hypersensitivity reactions in the form of itching, hives (urticaria), rash, either localised or on the whole body (so-called local or generalised exanthema) as well as skin and mucous membrane swellings, mostly in the facial area (Quincke's oedema) can also occur. Furthermore, shortness of breath and allergic shock have been observed. If you notice any of the mentioned hypersensitivity reactions, especially swelling of the mucous membranes in the facial area (Quincke's oedema), shortness of breath or signs of allergic shock, stop taking this medicine and inform a doctor (immediately) so that he/she can decide on the severity and any necessary measures. There are reports that Saccharomyces boulardii can colonise the bloodstream in patients with a central venous catheter, with a life-threatening illness, with a serious underlying disease or with a reduced immune system. No information can be given on the frequency of these possible side effects.

Reporting of side effects

If you notice any side effects, contact 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 to provide more information about the safety of this medicine.

5. HOW TO STORE PERENTEROL FORTE?

Keep the medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label or carton after "Use by". The expiry date refers to the last day of the month indicated. Keep the glass bottle tightly closed to protect the contents from moisture. If you open the container and the capsules come into contact with air humidity, the capsule contents may rarely turn brown and become hard. The capsules should then no longer be taken.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Perenterol forte contains

The active ingredient is: Saccharomyces-cerevisiae dry yeast. 1 hard capsule contains 250 mg dry yeast from Saccharomyces cerevisiae HANSEN CBS 5926 (also known as Saccharomyces boulardii in medical terminology) corresponding to at least 1.8 x 10/10 viable cells/g lyophilisate. The other ingredients are: lactose monohydrate, magnesium stearate (Ph.Eur.), gelatine, sodium dodecyl sulphate, colouring agent: titanium dioxide (E171).

What Perenterol forte looks like and contents of the pack

Perenterol forte 250 mg capsules are white, opaque hard capsules. Perenterol forte is available in packs of 10, 20, 30, 50, 60 and 100 hard capsules. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
D-58638 Iserlohn
Tel.: 02371 937-0
Fax: 02371 937-106
E-mail: info@medice.de

This package leaflet was last revised in March 2014.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Saccharomyces-cerevisiae dry yeast. Areas of application: for the treatment of symptoms in acute diarrhoea, prevention and treatment of symptoms of travel diarrhoea as well as diarrhoea during tube feeding and for accompanying treatment in longer-lasting forms of acne.