Aquallibra

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT AQUALIBRA (Aqualibra®)

Composition:

Active substances:

One film-coated tablet contains:

80 mg of dry extract of licorice root (Ononidis radix) (5 – 8:1), extraction solvent – water;

90 mg of dry extract of Orthosiphon leaf (Orthosiphonis folium) (5 – 7:1), extraction solvent – water;

180 mg of dry extract of Solidago herb (Solidaginis herba) (4 – 7:1), extraction solvent – water;

Excipients: povidone K 30, crospovidone type A, colloidal anhydrous silicon dioxide, microcrystalline cellulose, magnesium stearate, talc, macrogol 3000, polyvinyl alcohol, lactose monohydrate, spray-dried liquid glucose, maltodextrin, titanium dioxide (E 171), copper chlorophyllin.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties. Dark green, round, convex film-coated tablets with a smooth surface.

Pharmacotherapeutic group. Agents used in urology. Other urological medicinal agents. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

Increased urine production promotes the treatment of bacterial and inflammatory diseases of the urinary tract and also prevents the formation of urinary stones. The extracts of Ononis root (Extr. Ononidis radix), Orthosiphon leaves (Extr. Orthosiphonis folium), and Solidago herb (Extr. Solidaginis herba) contained in the medicinal product Aqualibra complement each other in their effects.

Ononis root (Ononidis radix) contains isoflavonoids such as ononin, flavonoids, and a small amount of essential oil, exerting a diuretic effect.

Orthosiphon leaves (Orthosiphonis folium) contain lipophilic flavones (including sinensetin, tetramethyl ether of scutellarein, and eupatorin), essential oil, and a significant amount of potassium salts, exerting diuretic and mild spasmolytic effects.

Solidago herb (Solidaginis herba) contains saponins, flavonoids, and phenolic glycosides, exerting diuretic, mild spasmolytic, and anti-inflammatory effects.

In most cases, the active principles or components responsible for the efficacy of individual substances have not been clearly identified. In any case, efficacy is achieved only when a large amount of fluid is consumed.

Clinical trials. The efficacy and tolerability of Aqualibra were studied in a randomized, multicenter, placebo-controlled, double-blind clinical trial. The study included 200 patients aged 18–75 years with acute uncomplicated lower urinary tract infection (primary infection or recurrence) presenting with all typical symptoms of cystitis and bacterial counts of 10⁴–10⁶ colony-forming units per 1 mL of urine. The primary endpoint was a reduction in bacterial count by more than two-fold in 1 mL of urine or complete microbial elimination after 6 days of treatment with Aqualibra.

Due to contamination or failure to meet inclusion criteria, 78 patients were excluded from the per-protocol population. Urine culture analysis in the per-protocol population showed achievement of the primary endpoint in 64.4% of patients in the Aqualibra group compared to only 25.4% in the placebo group (p < 0.0001).

At baseline, pathogenic Escherichia coli was detected in 72.9% of urine cultures in the Aqualibra group and in 69.8% of cultures in the placebo group, with bacterial counts ≥ 10³ CFU/mL. At the end of the study, reduction of Escherichia coli counts to < 10³ CFU/mL was not achieved in only 27.1% of results in the Aqualibra group versus 47.6% in the placebo group.

Furthermore, effective symptom relief with Aqualibra administration was demonstrated. At the end of treatment, participants in the Aqualibra group no longer experienced pain or burning during urination, whereas mild dysuric symptoms still persisted in the placebo group.

Pharmacokinetics.

Pharmacokinetic data for the fixed combination of Ononis root, Orthosiphon leaves, and Solidago herb extracts are not available.

Clinical characteristics.

Indications.

Indicated for use in children aged 12 years and older and adults for bacterial and inflammatory diseases of the urinary tract, as well as for prevention and treatment of urolithiasis due to increased urine production.

If blood appears in the urine, body temperature rises, or symptoms persist for more than 5 days, medical advice must be sought.

Contraindications.

Hypersensitivity to the active substances or to any of the excipients. Do not use in edema caused by cardiac or renal insufficiency.

Special precautions.

Adequate studies on the use of Aqualibra in children have not been conducted; therefore, this medicinal product should not be used in children under 12 years of age. Patients with rare hereditary disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take Aqualibra.

Interaction with other medicinal products and other forms of interaction.

Studies to establish interactions have not been conducted.

Special precautions for use.

Aqualibre is indicated for adults and children aged 12 years and older.

Patients with rare hereditary disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication.

If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

Use during pregnancy or breastfeeding.

Aqualibre should not be used during pregnancy and lactation due to insufficient study data.

Ability to influence reaction rate while driving or operating machinery.

The medicinal product Aqualibre does not affect the ability to drive a vehicle or operate other machinery.

Dosage and Administration.

For adults and children aged 12 years and older, the recommended dose is 2 film-coated tablets of the medicinal product Aqualibra, taken 3 times daily.

The film-coated tablets should be swallowed whole, without chewing, with an adequate amount of liquid. During the entire treatment period, it is necessary to ensure sufficient fluid intake (at least 2 liters per day).

The duration of treatment with the medicinal product is determined by the physician and is not fundamentally limited; it depends on the type, severity, and course of the disease. Information provided in the sections "Indications" and "Adverse Reactions" should be taken into account.

Children. Appropriate studies on the use of Aqualibra in children have not been conducted; therefore, this medicinal product should not be administered to children under 12 years of age.

Overdose.

There have been no reported cases of overdose with the medicinal product Aqualibra to date. If an excessive amount of Aqualibra is taken, symptoms of adverse reactions (see section "Adverse Reactions") may intensify. If increased urge to urinate occurs, it should be balanced by adequate fluid intake. In case of ingestion of an excessive amount of Aqualibra, medical advice should be sought immediately.

Side effects

The frequency of side effects is defined according to the following categories:

Very common (≥ 1/10)

Common (from ≥ 1/100 to < 1/10)

Uncommon (from ≥ 1/1000 to < 1/100)

Rare (from ≥ 1/10000 to < 1/1000)

Very rare (< 1/10000)

Not known (frequency cannot be estimated from available data)

Gastrointestinal disorders

Very rare: gastrointestinal disturbances (nausea, vomiting, diarrhoea)

Skin and subcutaneous tissue disorders

Very rare: hypersensitivity reactions (skin rash, pruritus)

If side effects occur, administration of the medicinal product should be discontinued and medical advice should be sought. The physician can then assess the severity and determine any necessary further actions. If the first signs of hypersensitivity occur, the medicinal product Aqualibra must not be taken again.

Reporting of side effects after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, are encouraged to report all suspected side effects and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua

Shelf life

3 years

Storage conditions

Store at a temperature not exceeding 30°C. Keep out of the reach and sight of children.

Packaging

20 film-coated tablets per blister, 3 or 6 blisters per cardboard box.

Supply classification

Over-the-counter (without prescription)

Manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG

Manufacturer's address

Kuhloweg 37, 58638 Iserlohn, Germany

Marketing Authorisation Holder

MEDICE Arzneimittel Pütter GmbH & Co. KG

Address of the Marketing Authorisation Holder

Kuhloweg 37, 58638 Iserlohn, Germany