Europe — EMA
Cystinol Akut Dragees
Cystinol Akut Dragees – oral dragees with bearberry leaf dry extract for urinary tract health support and infection prevention.
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What is Dry Extract From Bearberry Leaf (3,5-5,5:1), Extraction Solvent: Ethanol 60% (V/V)?
Cystinol Akut Dragees are oral dragees that contain a dry extract from bearberry leaf (Uvae ursi) standardized at a 3.5‑5.5:1 ratio, extracted with 60 % ethanol. The product is marketed in the EU as an over‑the‑counter herbal supplement, presented as a coated tablet, with strength not disclosed on the label. It is intended for oral administration and is classified as a urinary tract antiseptic.
What is Dry Extract From Bearberry Leaf (3,5-5,5:1), Extraction Solvent: Ethanol 60% (V/V) used for?
Cystinol Akut Dragees are commonly used to support urinary tract health and to help reduce the risk of urinary tract infections.
- Support of normal urinary tract function. - Prevention of recurrent urinary tract infections in adults. - Adjunctive care during periods of increased urinary stress (e.g., travel). - Maintenance of urinary tract hygiene in individuals with a history of uropathogen colonisation.
What are the side effects of Dry Extract From Bearberry Leaf (3,5-5,5:1), Extraction Solvent: Ethanol 60% (V/V)?
The safety profile of bearberry leaf extract reflects the pharmacology of its main constituent, arbutin, which is converted to hydroquinone in the urinary tract.
Common: - Mild gastrointestinal discomfort such as nausea or abdominal cramps. - Transient darkening of urine due to hydroquinone metabolites. - Mild skin irritation or rash at the site of contact. - Headache or dizziness in susceptible individuals.
Serious: - Allergic reactions including swelling of the face, lips, or throat. - Hepatotoxicity manifested by elevated liver enzymes. - Hemolytic anemia in persons with glucose‑6‑phosphate dehydrogenase (G6PD) deficiency. - Severe hypotension or syncope after high‑dose exposure.
What precautions apply to Dry Extract From Bearberry Leaf (3,5-5,5:1), Extraction Solvent: Ethanol 60% (V/V)?
When considering Cystinol Akut Dragees, certain precautionary measures should be observed to minimise risk.
- Not recommended for pregnant or breastfeeding women unless advised by a healthcare professional. - Avoid use in children under 12 years of age. - Persons with known G6PD deficiency should refrain from use. - Individuals with chronic kidney disease should consult a physician before taking the product. - Patients taking anticoagulant therapy should be monitored for potential interactions. - Discontinue use and seek medical advice if any allergic symptoms develop.
What does Dry Extract From Bearberry Leaf (3,5-5,5:1), Extraction Solvent: Ethanol 60% (V/V) interact with?
Bearberry leaf extract may interact with several medicines, and the nature of the interaction determines whether the combination should be avoided or used with caution.
Avoid: - Warfarin or other vitamin K antagonists, because hydroquinone may enhance anticoagulant effects. - Antidiabetic agents, as the extract may potentiate hypoglycaemia. - Lithium therapy, due to possible increased lithium levels. - Other urinary antiseptics or antibiotics targeting the same pathogens, which could lead to additive effects.
Use with caution: - Diuretics, because increased urinary output may alter the concentration of active metabolites. - Non‑steroidal anti‑inflammatory drugs (NSAIDs), which may increase the risk of renal irritation. - Herbal supplements containing high levels of phenolic compounds, which could compound hepatic metabolism.
Frequently asked questions
What is the active ingredient in Cystinol Akut Dragees?+
How does bearberry leaf extract help the urinary tract?+
Can Cystinol Akut Dragees be used to prevent urinary tract infections?+
Is Cystinol Akut Dragees safe for pregnant women?+
What are the most common side effects of bearberry leaf extract?+
Are there any serious adverse reactions associated with Cystinol Akut Dragees?+
Should people with G6PD deficiency avoid Cystinol Akut Dragees?+
Can Cystinol Akut Dragees interact with blood thinners?+
Is it necessary to take Cystinol Akut Dragees with food?+
How long may someone use Cystinol Akut Dragees for urinary health support?+
Can children use Cystinol Akut Dragees?+
What should I do if I experience an allergic reaction while taking Cystinol Akut Dragees?+
Product details
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