PEROCUR

PEROCUR 250 mg hard capsules

Important notes (mandatory information)

Perocur 250 mg hard capsules. Active ingredient: Saccharomyces cerevisiae HANSEN CBS 5926 - dry yeast. Areas of application: for the treatment of symptoms in acute diarrhoea, including traveller's diarrhoea and diarrhoea during tube feeding, and for the prevention of traveller's diarrhoea.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Perocur 250 mg hard capsules for use in diarrhoea in adults, adolescents and children from 6 months of age and for the prevention of traveller's diarrhoea in adults and adolescents from 12 years of age
Active ingredient: Saccharomyces cerevisiae HANSEN CBS 5926 - dry yeast

Read the entire package leaflet carefully before you start taking this medicine, as 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 experience any side effects, talk to 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, talk to your doctor.

What this package leaflet contains

1. WHAT IS PEROCUR 250 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PEROCUR 250 MG?
3. HOW TO TAKE PEROCUR 250 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE PEROCUR 250 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS PEROCUR 250 MG AND WHAT IS IT USED FOR?

Perocur 250 mg contains dry yeast from cultures of the defined strain Saccharomyces cerevisiae HANSEN CBS 5926 (also known as Saccharomyces boulardii in medical terminology) in viable form and belongs to the group of antidiarrhoeals. For the treatment of symptoms in acute diarrhoea, including traveller's diarrhoea and diarrhoea during tube feeding, and for the prevention of traveller's diarrhoea.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PEROCUR 250 MG?

Perocur 250 mg must not be taken:

• if you are allergic to yeast or any of the other ingredients of this medicine listed in section 6.
• by immunosuppressed or hospitalised patients (due to serious illness or impaired/weakened immune system).
• by patients with a central venous catheter.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Perocur 250 mg. In the case of diarrhoea that lasts longer than 2 days or is accompanied by blood or fever, a doctor should be consulted. In the case of diarrhoeal diseases, especially in children, attention must be paid to the replacement of fluids and salts (electrolytes) as the most important treatment measure. If microbiological stool tests are carried out during or shortly after treatment with this medicine, the intake should be communicated to the testing laboratory, as otherwise false-positive results may be obtained.

Children and adolescents

This medicine should not be taken by infants under 6 months of age for the treatment of diarrhoea due to insufficient studies on dosage and safety. The treatment of diarrhoea in infants and toddlers requires consultation with a doctor. This medicine should not be taken by children under 12 years of age for the prevention of traveller's diarrhoea due to insufficient studies.

Taking Perocur 250 mg with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. The simultaneous administration of this medicine and medicines against fungal infections (antimycotics) may impair the effect of Perocur 250 mg. If monoamine oxidase inhibitors are taken at the same time, blood pressure may increase.

Pregnancy and breast-feeding

The safety during pregnancy and breast-feeding has not been sufficiently studied. Perocur 250 mg is not recommended for pregnant and breast-feeding women.

Driving and using machines

No restrictions.

Perocur 250 mg contains lactose

Therefore, please only take Perocur 250 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE PEROCUR 250 MG?

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

In acute diarrhoea:

• Children between 6 months and 2 years 1– to 2–times daily 1 hard capsule. In children of this age group, treatment should only be carried out under medical supervision.
• Children from 2 years of age, adolescents and adults: 1– to 2–times daily 1 hard capsule.
• Infants under 6 months: Use is not intended.

For the prevention of traveller's diarrhoea:

• Adolescents from 12 years of age and adults: 1– to 2–times daily 1 hard capsule starting 5 days before departure.
• Children under 12 years of age: Use is not intended.

Method of administration

For oral use. Please take the hard capsules unchewed with sufficient liquid (e.g. a glass of water) before meals. For administration to children under 6 years of age, open the hard capsule by pulling apart the capsule halves and stir the contents into food or liquid (room temperature). In the case of diarrhoea caused by tube feeding, only the contents of the capsules should be added to the nutrient solution.

Duration of use

In the treatment of symptoms in acute diarrhoeal diseases, taking Perocur 250 mg for 4 - 7 days is usually sufficient. For the prevention of traveller's diarrhoea, treatment should be continued consistently throughout the entire duration of the trip. However, please always observe the information in section 2 "Warnings and precautions" and section 4 "What side effects are possible?".

If you have taken more Perocur 250 mg than you should

Poisoning with preparations made from dry yeast has not been reported to date. If you have taken more Perocur 250 mg than you should, please inform a doctor. He/she can decide on any necessary measures. The side effects listed below may occur more frequently.

If you forget to take Perocur 250 mg

If you have taken too little Perocur 250 mg or have forgotten to take it, do not take double the amount next time, but continue taking it as prescribed by your doctor or as described in the dosage instructions.

If you stop taking Perocur 250 mg

The intake can be interrupted or stopped at any time, as discontinuation is generally harmless.

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.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Ingestion may cause flatulence. Incompatibility reactions may also occur, namely 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), shortness of breath and allergic shock. The frequency of these possible side effects cannot be specified.

Very rare side effects

Invasion of yeasts into the bloodstream (fungaemia).

Side effects with unknown frequency

Severe blood poisoning (sepsis).

Countermeasures in the event of side effects

If you experience any of the above side effects, especially swelling of the mucous membranes in the facial area (Quincke's oedema), shortness of breath or signs of allergic shock, discontinue this medicine and inform a doctor (immediately) so that he/she can decide on the severity and any necessary measures. Perocur 250 mg must not be taken again at the first signs of a hypersensitivity reaction. Please inform your doctor or pharmacist if any of the listed side effects affect you severely or if you notice any side effects not listed in this package leaflet.

Reporting of side effects

If you experience 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 to provide more information about the safety of this medicine.

5. HOW TO STORE PEROCUR 250 MG?

Keep this medicine out of the reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the blister pack and the carton after "use by". The expiry date refers to the last day of the month indicated.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Perocur 250 mg contains

The active ingredient is Saccharomyces cerevisiae HANSEN CBS 5926 - 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 2 x 10hoch10 viable cells/g; lyophilised. The other ingredients are: lactose, magnesium stearate (Ph.Eur.) [vegetable], hypromellose, purified water, titanium dioxide (E 171).

For diabetics, the intake of one hard capsule of Perocur 250 mg should be counted as 0.01 BE.

What Perocur 250 mg looks like and contents of the pack

Appearance: White hard capsules. Perocur 250 mg is available in packs of 10, 20, 50 or 100 hard capsules.

Pharmaceutical entrepreneur (distributor)

Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Telefax: (08024) 908-1290
E-mail: service@hexal.com

Pharmaceutical entrepreneur (marketing authorisation holder) and manufacturer

Pharma-Zentrale GmbH
Loerfeldstraße 20
58313 Herdecke
Telephone: 02330/977676
Telefax: 02330/977697
E-mail: office@pharma-zentrale.de

This package leaflet was last revised in January 2021.

Source: Information from the package leaflet
Status: 09/2021
Active ingredient: Saccharomyces cerevisiae HANSEN CBS 5926 - dry yeast. Areas of application: for the treatment of symptoms in acute diarrhoea, including traveller's diarrhoea and diarrhoea during tube feeding, and for the prevention of traveller's diarrhoea.