REMENCLIST

I N S T R U C T I O N for medical use of the medicinal product Remencysto (Remencysto)

Composition:

Active substances: 1 film-coated tablet contains dry extract of bearberry leaves (2.5–4.5 : 1) (extraction solvent: water) – 864 mg, corresponding to 180–210 mg of hydroquinone derivatives calculated as anhydrous arbutin;

Excipients: colloidal anhydrous silicon dioxide, microcrystalline cellulose, sodium croscarmellose, magnesium stearate;

Film coating: Biogrund Aquapolish® P White 014.36 MS: titanium dioxide (E 171), talc (E 553b), medium-chain triglycerides, hydroxypropylcellulose (E 463), hydroxypropylmethylcellulose (E 464).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: white, elongated tablets, film-coated, with a break line. The break line is intended solely for facilitating tablet splitting to ease swallowing and is not intended for dividing the tablet into equal doses.

Pharmacotherapeutic group. Agents used in urology. ATC code G04B.

Pharmacological Properties

Pharmacodynamics. Many of the chemical compounds of plant origin are excreted by the kidneys, therefore they are used as urinary antiseptics. Bearberry leaf (Arctostaphylos uva-ursi folium) is commonly used as a herbal remedy for the treatment of lower urinary tract infections. The main component of dried bearberry leaves and of preparations derived from them is the glycoside β-arbutin (β-D-glucopyranoside of hydroquinone), which constitutes 4% to 12% of the dry weight of bearberry leaves.

The extract of bearberry leaves possesses antiseptic properties due to hydroquinone (HQ) derivatives, particularly arbutin. Arbutin is absorbed from the gastrointestinal tract almost unchanged and is hydrolyzed into the active component hydroquinone in the form of hydroquinone-glucuronide and sulfate conjugates, exerting antiseptic and astringent effects on the mucous membranes of the urinary tract.

Pharmacokinetics. Hydroquinone-glucuronide and sulfate conjugates are mainly excreted in urine, while the original arbutin is not present in urine. In the urinary bladder, hydroquinone may be released from type II conjugates either by direct hydrolysis in the presence of alkaline urine, or by uptake and intracellular breakdown within pathogenic bacteria.

Clinical characteristics

Indications. Remensisto is a herbal medicinal product which, after exclusion of serious diseases by a physician, is used for mild recurrent urinary tract inflammations accompanied by a burning sensation during urination and/or frequent urination in women.

Remensisto is a traditional herbal medicinal product used according to indications supported by long-standing use.

Contraindications. Hypersensitivity to the active substance or to any of the excipients of the medicinal product. Kidney disease.

Interaction with other medicinal products and other forms of interaction. The medicinal product containing extract of bearberry leaf should not be used concomitantly with agents that increase urine acidity, since a reduction in the antibacterial effect of bearberry leaf cannot be excluded.

Special precautions for use

If symptoms of the disease worsen or such symptoms as elevated temperature, dysuria, spasms, or blood in the urine occur during the use of the medicinal product, consult a physician.

Birch leaves may cause a greenish-brown discoloration of urine.

Use in men is not recommended because the above-mentioned symptoms in this patient group require medical consultation.

Use of the medicinal product in children (under 18 years of age) is not recommended, as treatment of lower urinary tract symptoms in this age group should be conducted under medical supervision.

This medicinal product contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

Pregnancy. Currently, experience with the use of birch leaves in pregnant women is lacking or very limited. There are insufficient animal studies on reproductive toxicity.

The use of Remencysto during pregnancy is not recommended.

Breastfeeding. It is unknown whether the active substance or its metabolites pass into breast milk. Risk to newborns/infants cannot be excluded. Remencysto should not be used by women during breastfeeding.

Fertility. There is no data available on the effect on fertility.

Ability to influence the reaction rate when driving a vehicle or operating machinery. The medicinal product may cause dizziness (see section "Adverse reactions") and thus may affect the ability to drive a vehicle or operate machinery.

Method of Administration and Dosage

For oral use. The film-coated tablet should be swallowed whole without chewing, with a small amount of liquid.

Adult women (aged 18 years and older)

Take 1 film-coated tablet twice daily.

Patients with hepatic impairment

There are insufficient data to provide dosage recommendations for patients with impaired liver function.

The medicinal product should not be used for longer than one week or for more than 5 courses per year. If symptoms persist for more than 4 days during treatment, medical advice must be sought.

Adult men

Use of the medicinal product in men is not recommended (see section "Special precautions").

Children. Use in children (under 18 years of age) is not recommended.

Overdose

If doses higher than recommended are used, gastrointestinal disturbances may occur, such as vomiting, nausea, hematuria, and liver damage. In such cases, the medicinal product should be discontinued immediately and medical advice should be sought. Treatment is symptomatic.

Side effects

Very rarely (< 1/10,000), patients with sensitive stomach may experience gastrointestinal symptoms (nausea, vomiting, abdominal pain, diarrhea). Nervous system side effects: dizziness.

Allergic reactions such as rash and itching may occur in rare cases.

If side effects occur, treatment should be discontinued and medical advice should be sought. The doctor will assess the severity of the side effects.

Reporting suspected side effects

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions 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 temperatures not exceeding 25 °C.

Packaging. 14 film-coated tablets in a blister; 1 or 2 blisters with the instruction for medical use in a cardboard box.

Availability. Over-the-counter.

Manufacturer. Richard Bittner AG / Richard Bittner AG.

Manufacturer's address and location of business activity. Ossiacherstrasse 7, A-9560 Feldkirchen, Austria / Ossiacherstrasse 7, A-9560 Feldkirchen, Austria.