Recordati Pharma GmbH
Hylak N solution to support bowel function, 100 ml
Hylak N solution to support bowel function, 100 ml
- contains live bacterial cultures
- for the treatment of complaints in the stomach and intestines
- Oral solution
- over-the-counter medicinal product
- Manufacturer: Recordati Pharma GmbH, Germany (original product from Germany)
Hylak N, liquid. Active ingredient: substrate of the metabolites of Lactobacillus helveticus. Indications: traditionally used as a mild drug to support bowel function, e.g. in constipation and diarrhoea.
For risks and side effects, read the package leaflet and ask your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Hylak N, oral liquid for use in children and adults.
Active ingredient: substrate of the metabolites of Lactobacillus helveticus
Read all of this leaflet carefully, as it contains important information for you. This medicine can be obtained without a prescription. However, in order to achieve the best possible treatment success, Hylak N must be used as directed.
Keep this leaflet. You may want to read them again later. Ask your pharmacist if you need more information or advice. If your symptoms worsen or don't improve, you definitely need to see a doctor. If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.This
leaflet contains:
WHAT HYLAK N IS AND WHAT IT IS USED FOR WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYLAK N HOW TO TAKE HYLAK N WHAT SIDE EFFECTS ARE POSSIBLE? HOW TO STORE HYLAK N FURTHER INFORMATION
1. WHAT HYLAK N IS AND WHAT IT IS USED FOR
Hylak N is a traditional medicine. Hylak N is traditionally used as a mild-acting medicine to support bowel function, e.g. in constipation and diarrhoea. If signs of illness appear, such as fever and convulsions, a doctor should be consulted.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYLAK N
Do not take Hylak N:
in case of known hypersensitivity to the active substance or to any of the excipients.in children under 2 years of age, as well as in case of acute diarrhoea with high fever or blood admixture.
Special care should be taken when taking Hylak N:
in diarrhoea, especially in children and the elderly, care must be taken to replace fluid and electrolytes as the main therapeutic measure. In principle, diarrhoea that lasts longer than 2 days, has blood admixtures or is accompanied by fever and circulatory disorders, a doctor should be consulted.
This medicine contains lactose:
If you have been told by your doctor that you have an intolerance to sugars, contact your doctor before taking this medicine.
When taking Hylak N with other medicines:
Concomitant use with stomach acid binding drugs (antacids) should be avoided. Note: Hylak N should not be taken in milk, as flocculation of the milk occurs. A BeeintHowever, avenging the efficacy or tolerability of Hylak N is not associated with this. Patients taking Hylak N can continue to consume milk and dairy products.
Pregnancy and lactation:
Studies with Hylak N in pregnant women showed no evidence of pregnancy-specific risks. In general, the benefits and risks of using medicines during pregnancy should be weighed up particularly carefully. Note the special dosage for pregnant and lactating women.
3. HOW TO TAKE HYLAK N
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 of age: In the first few days, measure 2.0 ml 3 times a day before or during the meal with the help of the measuring cup and take in plenty of liquid (e.g. water, teas, orange juice, but preferably not in milk [see \"Note\" for interactions]), after improvement of the symptoms the dose can be reduced to half. The dosage of Hylak N in pregnant and lactating women is 0.5 ml 3 times a day in plenty of liquid (e.g. water, teas, orange juice, but preferably not in milk [see note interactions]). Children from 2 years: The dosage of Hylak N in children from the age of 2 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 preferably not in milk [see note on interactions]).
Duration of application:In principle,
the duration of application is not limited. However, please note the information under application areas. 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 cause side effects, although not everybody gets them. The following frequencies are used for the assessment of adverse reactions:The frequency of adverse reactions is based on the following categories:Very common:more than 1 person in 10Common:1 to 10 users in 100Uncommon:1 to 10 users in 1 000 Rare:1 to 10 users per 10 000Very rare:less than 1 person in 10 000Not known:
Frequency cannot be estimated on the basis of the available data.
In rare cases, hypersensitivity reactions such as itching and redness of the skin, as well as nausea and flatulence, may occur. In people with heartburn, it is recommended to divide the daily dose of 6 ml over more than 3 individual doses.
Reporting side effects:
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects, you can: They contribute to the provision of more information on the safety of this medicine.
5. HOW TO STORE HYLAK N
Keep medicines out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiration date refers to the last day of the month. After opening, Hylak N has a shelf life of 6 months. Do not store above 25°C. Note: A possible slight turbidity has no influence 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 metabolites 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 crude whey.