• 1023.15 mg Lactobacillus helveticus DSM 4183, metabolic products from aqueous substrate

• disodium hydrogen phosphate
• potassium monohydrogen phosphate
• Phosphoric acid for pH adjustment
• lactic acid
• potassium sorbate
• Citric acid monohydrate
• lactose
• water, purified
• Residual fermentation medium (Lactobacillus helveticus DSM 4183)

1. What Hylak® N is and what it is used for
Hylak® N is a traditional medicine.
Hylak® N is applied

• Traditionally used as a mild drug to support the intestinal function, eg in constipation and diarrhea. If signs of illness, such as fever and cramps, appear, a doctor should be consulted.

2. What you need to know before taking Hylak® N?
Hylak® N must not be taken

• if you have a known hypersensitivity to the active substance or any of the other ingredients.
• in children under 2 years of age and in acute diarrhea with high fever or blood.

Particular caution is required when taking Hylak® N.
In the case of diarrhea, especially in children and the elderly, replacement of fluids and electrolytes is the most important therapeutic measure. In principle, a doctor should be consulted in the case of diarrhea that lasts longer than 2 days, shows blood admixtures or is associated with fever and circulatory disorders.
This medicine contains lactose. Therefore, please only take Hylak® N after consulting your doctor if you know that you suffer from a sugar intolerance.

Taking Hylak® N with other medicines
Simultaneously taking medicines that bind gastric acid (antacids) should be avoided.

a notice
Hylak® N should not be taken with milk as the milk will flocculate. However, this does not impair the effectiveness or tolerability of Hylak® N. Patients taking Hylak® N can continue to consume milk and milk products.

Pregnancy and lactation
Studies with Hylak® N in pregnant women did not provide any indication of pregnancy-specific risks. In general, when using drugs during pregnancy, the benefit and risk should be weighed very carefully. Note the special dosage for pregnant and lactating women.

3 How should HYLAK® N be taken?
Always take Hylak® N exactly as directed in this leaflet. Please check with your doctor or pharmacist if you are not sure.

Adults and adolescents over 12 years:
In the first few days, measure 2.0 ml 3 times a day before or during meals using the measuring cup and add plenty of liquid (e.g. water, tea, orange juice, but if possible not milk [see “Note” in case of interactions]); after the symptoms have improved, the dose can be reduced by half.
The dosage of Hylak® N in pregnant and breastfeeding women is 0.5 ml 3 times a day in plenty of liquid (e.g. water, tea, orange juice, but if possible not in milk [see note on interactions]).

Children from 2 years:
The dosage of Hylak® N for children from the age of 2 up to the age of 12 is 0.5 ml 3 times a day in plenty of liquid (e.g. children’s teas, apple juice, but if possible not in milk [see note in Interactions]).

Duration of use
In principle, the duration of use is not limited. However, please note the information under Areas of application.
Please talk to your doctor or pharmacist if you have the impression that the effect of Hylak® N is too strong or too weak. If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. What side effects are possible?
Like all medicines, Hylak® N can have side effects, although not everyone gets them.
The following frequencies are used as a basis for evaluating side effects:
very common: more than 1 in 10 people treated
common: less than 1 in 10 but more than 1 in 100 people treated
uncommon: less than 1 in 100 but more than 1 in 1000 people treated
rare: less than 1 in 1000, but more than 1 in 10,000 people
very rare: less than 1 in 10,000 people, including isolated cases
In rare cases, hypersensitivity reactions such as itching and skin redness, nausea and flatulence can occur.
For people with heartburn, it is advisable to divide the daily dose of 6 ml into more than 3 individual doses.

Please tell your doctor or pharmacist if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet.

5. How should HYLAK® N be stored?
Store drug out of reach of children.
Do not use the medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
After opening, Hylak® N has a shelf life of 6 months.
Do not store above 25°C.

Note
Any slight turbidity that may occur has no effect on the effectiveness.
Shake bottle before use!

6. Further information
What Hylak® N contains
1 ml Hylak® N contains: Active
ingredients
1023.15 mg aqueous concentrate of the metabolic products of Lactobacillus helveticus, DSM 4183.
The other ingredients are:
sodium monohydrogen phosphate, potassium monohydrogen phosphate, phosphoric acid, lactic acid, potassium sorbate, citric acid monohydrate, lactose, water, residual fermentation medium consisting of raw whey.