Ibandronic acid-vista 150 mg

INSTRUCTION for medical use of the medicinal product IBANDRONIC ACID-VISTA 150 mg (IBANDRONIC ACID-VISTA 150 mg)

Composition:

Active substance: ibandronic acid;

One film-coated tablet contains 150 mg of ibandronic acid in the form of sodium ibandronate monohydrate 168.75 mg;

Excipients: lactose monohydrate; microcrystalline cellulose; crospovidone (type A); colloidal anhydrous silicon dioxide; sodium stearyl fumarate;

film coating (Opadry II white): polyvinyl alcohol; titanium dioxide (E 171); talc; macrogol 3350.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: elongated tablets, white to almost white in color, with engraving «I9ВЕ» on one side and «150» on the other side.

Pharmacotherapeutic group.

Drugs used in the treatment of bone disorders. Drugs affecting bone structure and mineralization. Bisphosphonates. Ibandronic acid.

ATC code M05B A06.

Pharmacological Properties

Pharmacodynamics

Mechanism of action

Ibandronic acid is a highly active nitrogen-containing bisphosphonate that selectively acts on bone tissue and specifically inhibits osteoclast activity without having a direct effect on bone formation. The drug does not affect the process of replenishing the osteoclast pool. In postmenopausal women, it reduces the elevated rate of bone turnover to premenopausal levels, resulting in progressive increases in bone mass and a reduction in fracture rate.

Pharmacodynamic effects

Ibandronic acid inhibits bone resorption. In vivo, ibandronic acid prevents bone destruction caused experimentally by gonadal function blockade, retinoids, tumors, and tumor extracts. In young (rapidly growing) rats, increased bone mass was observed compared to untreated animals, despite the occurrence of bone resorption. Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclast activity. In growing rats, no signs of impaired mineralization were observed even at doses exceeding more than 5000 times the dose required for osteoporosis treatment.

Long-term daily administration and intermittent administration (with long intervals) over prolonged periods in rats, dogs, and monkeys were associated with the formation of new bone of normal quality, with preserved or increased mechanical strength, even at doses within the toxic range.

The efficacy of daily and intermittent administration of ibandronic acid with dosing intervals of 9–10 weeks was confirmed in a clinical study (MF 4411) involving humans, in which ibandronic acid demonstrated effectiveness in preventing fractures.

In animal models, ibandronic acid causes biochemical changes indicating dose-dependent inhibition of bone tissue resorption, including reduced levels of biochemical markers of bone collagen degradation in urine (such as deoxypyridinoline and cross-linked N-telopeptide of type I collagen).

Pharmacokinetics

The primary pharmacological effect of ibandronic acid on bone is not directly related to actual plasma concentrations of ibandronic acid, as demonstrated in various studies in animals and humans.

Absorption

After oral administration, ibandronic acid is rapidly absorbed in the upper gastrointestinal tract. Plasma concentration increases proportionally with dose increases up to 50 mg orally, and increases significantly more with further dose escalation. Maximum plasma concentration is reached within 30 minutes to 2 hours (on average, 1 hour) when administered on an empty stomach. Absolute bioavailability is approximately 0.6%. Absorption is impaired when administered with food or beverages (other than plain water). Bioavailability decreases by approximately 90% when taken with a standard breakfast compared to administration on an empty stomach. No significant reduction in bioavailability occurs if ibandronic acid is taken 60 minutes before the first food intake. However, bioavailability and increases in bone mineral density are reduced if food or beverages are consumed less than 60 minutes after taking ibandronic acid.

Distribution

After initial systemic distribution, ibandronic acid rapidly binds to bone tissue or is excreted in urine. In humans, the apparent volume of distribution is at least 90 L, and approximately 40–50% of the drug circulating in blood penetrates and accumulates in bone tissue. Plasma protein binding is approximately 85–87% (determined in vitro at therapeutic concentrations of ibandronic acid), thus indicating a low potential for interaction with other drugs due to displacement.

Metabolism

There is no evidence that ibandronic acid is metabolized in animals or humans.

Elimination

Ibandronic acid is eliminated from the bloodstream via bone uptake (approximately 40–50% in postmenopausal women), with the remainder excreted unchanged by the kidneys. The portion of ibandronic acid not absorbed is excreted unchanged in feces.

The range of apparent elimination half-life is broad, varying between 10 and 72 hours. Since calculated values depend significantly on study duration, administered dose, and assay sensitivity, the terminal half-life is likely considerably longer, as is the case with other bisphosphonates. Initial plasma levels decline rapidly, reaching 10% of peak values within 3 hours and 8 hours after intravenous administration or oral administration, respectively. Total clearance of ibandronic acid is low, averaging 84–160 mL/min. Renal clearance (approximately 60 mL/min in healthy postmenopausal women) accounts for 50–60% of total clearance and depends on creatinine clearance. The difference between apparent total and renal clearance reflects drug uptake by bone tissue.

Excretion pathways likely do not involve known acidic or basic transport systems involved in the elimination of other active substances. Furthermore, ibandronic acid does not inhibit major human hepatic P450 isoenzymes and does not induce the cytochrome P450 system in rats.

Pharmacokinetics in special populations

Sex

Bioavailability and pharmacokinetic parameters of ibandronic acid are independent of sex.

Race

There are no data on clinically significant interethnic differences between Mongoloid and Caucasian patients regarding the distribution of ibandronic acid. Data on Negroid patients are insufficient.

Patients with renal impairment

Renal clearance of ibandronic acid in patients with varying degrees of renal impairment is linearly dependent on creatinine clearance. Dose adjustment is not required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min).

In individuals with severe renal impairment (creatinine clearance < 30 mL/min) who received oral ibandronic acid 10 mg for 21 days, plasma concentrations were 2–3 times higher than in individuals with normal renal function, and total clearance of ibandronic acid was 44 mL/min. After intravenous administration of 0.5 mg ibandronic acid, total, renal, and non-renal clearance decreased by 67%, 77%, and 50%, respectively, in individuals with severe renal impairment, but no reduction in drug tolerability due to increased exposure was observed. Due to limited clinical experience with the drug, it is not recommended for patients with severe renal impairment (see sections "Special precautions" and "Dosage and administration"). Pharmacokinetics of ibandronic acid in patients with end-stage renal disease has been evaluated in only a small number of patients undergoing hemodialysis; therefore, pharmacokinetics in non-dialyzed patients is unknown. Due to limited data, ibandronic acid should not be used in patients with end-stage renal disease.

Patients with hepatic impairment (see section "Dosage and administration")

There are no data on the pharmacokinetics of ibandronic acid in patients with hepatic impairment. The liver does not play a significant role in the clearance of ibandronic acid, which is not metabolized but is excreted by the kidneys and through uptake by bone tissue. Therefore, dose adjustment is not required in patients with hepatic impairment.

Elderly patients (see sections "Dosage and administration")

Multivariate analysis has shown that studied pharmacokinetic parameters are independent of age. Since renal function declines with age, this is the only factor that should be considered (see section "Patients with renal impairment").

Paediatric population (see section "Dosage and administration")

There are no data on the use of the drug in children.

Clinical characteristics.

Indications.

Treatment of osteoporosis in postmenopausal women with increased risk of fractures. Reduction in the risk of vertebral fractures has been demonstrated; efficacy in preventing hip fractures has not been established.

Contraindications.

Hypersensitivity to ibandronic acid or to any other component of the medicinal product (see section "Composition").

Hypocalcemia.

Esophageal disorders associated with delayed esophageal emptying, such as stricture or achalasia.

Inability to remain in an upright position (sitting or standing) for at least 60 minutes.

Interaction with other medicinal products and other forms of interaction.

Drug–food interaction.

The oral bioavailability of ibandronic acid is generally reduced when administered with food. In particular, food products containing calcium, including milk, and other polyvalent cations (aluminum, magnesium, iron) may interfere with drug absorption, consistent with findings from animal studies. Therefore, the drug should be taken after an overnight fast (at least 6 hours) and food should not be consumed for 1 hour after administration of the medicinal product (see section "Dosage and administration").

Interaction with other medicinal products.

Metabolic interactions are unlikely, as ibandronic acid does not inhibit major human hepatic CYP450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats (see section "Pharmacokinetics"). Ibandronic acid is excreted via the kidneys and is not subject to biotransformation processes.

Calcium preparations (supplements), antacids, and certain other medicinal products containing polyvalent cations.

Calcium preparations (supplements), antacids, and certain other oral medicinal products containing polyvalent cations (aluminum, magnesium, iron) may interfere with drug absorption. Therefore, patients should not take other oral medicinal products at least 6 hours before and 1 hour after taking the drug.

Acetylsalicylic acid and NSAIDs.

Since acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (NSAIDs), and bisphosphonates may cause gastrointestinal irritation, concomitant use of NSAIDs with this drug should be done with caution (see section "Special precautions for use").

H2-blockers and proton pump inhibitors.

In study BM16549 involving 1500 patients, dosing regimens of ibandronic acid (daily and once-monthly) were compared, with 14% and 18% of patients also receiving H2-receptor blockers or proton pump inhibitors at 1 and 2 years, respectively. The incidence of upper gastrointestinal events in patients receiving 150 mg of ibandronic acid once monthly was similar to that in patients receiving 2.5 mg daily.

In a study involving healthy volunteers (men) and postmenopausal women, intravenous ranitidine increased the bioavailability of ibandronic acid by approximately 20%, possibly due to reduced gastric acidity. However, since this increase falls within the normal range of bioavailability for ibandronic acid, dosage adjustment of the drug is not required when co-administered with H2-receptor blockers or other agents that increase gastric pH.

Special precautions for use.

Hypocalcemia.

Hypocalcemia should be corrected prior to initiating treatment with the medicinal product. All other disorders of bone metabolism and mineral metabolism should also be effectively treated. Adequate intake of calcium and vitamin D is required, as this is important for all patients.

Gastrointestinal irritation.

Oral bisphosphonates may cause local irritation of the mucosa of the upper gastrointestinal tract.

Due to these potential effects and the possibility of worsening of underlying conditions, caution is required when administering the medicinal product to patients with active upper gastrointestinal disorders (Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or peptic ulcers). Adverse reactions such as esophagitis, esophageal ulcers, and esophageal erosions have been reported with oral bisphosphonates, which in some cases were severe and required hospitalization, rarely with hemorrhage or subsequent development of esophageal stricture or perforation. The risk of developing severe esophageal adverse reactions is higher in patients who do not follow dosing instructions and/or in individuals who continue taking oral bisphosphonates after developing symptoms indicative of esophageal irritation. Therefore, patients must pay particular attention to following dosing recommendations (see section "Dosage and administration"). Physicians should be vigilant for symptoms suggestive of possible esophageal reactions and should inform patients to discontinue the medicinal product and seek medical advice if they experience dysphagia, pain on swallowing, retrosternal pain, new or worsening heartburn. Although an increased risk was not observed in controlled clinical trials, cases of gastric and duodenal ulcers have been reported during post-marketing use of oral bisphosphonates. Some of these were severe and associated with complications. Since NSAIDs and bisphosphonates may both cause gastrointestinal irritation, concomitant use of NSAIDs with this product should be done with caution.

Osteonecrosis of the jaw.

Osteonecrosis of the jaw has been reported very rarely during post-marketing use in patients treated with ibandronic acid for osteoporosis (see section "Undesirable effects").

Initiation or re-initiation of treatment should be delayed in patients with open, non-healing soft tissue lesions in the oral cavity. Prior to starting treatment with ibandronic acid, patients with concomitant risk factors are recommended to undergo a dental examination with appropriate preventive interventions and individual benefit-risk assessment.

When assessing the risk of developing osteonecrosis of the jaw, the following risk factors should be considered:

• Potency of the bone resorption-inhibiting medicinal product (risk is higher with highly potent compounds), route of administration (risk is higher with parenteral administration), and cumulative dose of bone resorption therapy.
• Malignant neoplasms, concomitant pathological conditions (e.g., anemia, coagulopathy, infection), tobacco smoking.
• Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to the head and neck region.
• Poor oral hygiene, periodontal disease, ill-fitting dentures, history of dental disease, invasive dental procedures such as tooth extraction.

During treatment with ibandronic acid, all patients should maintain good oral hygiene, undergo regular dental examinations, and promptly report any oral symptoms such as tooth mobility, pain, swelling, non-healing ulcers, or discharge. Invasive dental procedures should only be performed after careful consideration during treatment and should be avoided during and shortly after administration of ibandronic acid. Management of patients who develop osteonecrosis of the jaw should be coordinated closely between the physician and a dentist or oral and maxillofacial surgeon experienced in managing osteonecrosis of the jaw. Consideration should be given to temporarily interrupting treatment with ibandronic acid until improvement occurs and concomitant risk factors are reduced.

Osteonecrosis of the external auditory canal.

Osteonecrosis of the external auditory canal has been reported with bisphosphonate use, primarily during long-term therapy. Potential risk factors for osteonecrosis of the external auditory canal include steroid hormone use, chemotherapy, and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients taking bisphosphonates who present with ear symptoms, including chronic ear infections.

Atypical femoral fractures.

Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, particularly in patients receiving long-term osteoporosis treatment. These transverse or short oblique fractures may occur anywhere along the femur, from slightly below the lesser trochanter to slightly above the supracondylar flare. These fractures occur with minimal or no trauma, and some patients experience thigh or groin pain, often associated with characteristic features of stress fractures, for several weeks to months before the fracture manifests as a complete femoral fracture. Fractures are often bilateral; therefore, the contralateral femur should also be evaluated in patients receiving bisphosphonate therapy who have developed a femoral shaft fracture. Poor healing of these fractures has also been reported. Pending full evaluation of the patient, including individual benefit-risk assessment, consideration should be given to discontinuing bisphosphonate therapy in patients with suspected atypical femoral fractures.

During bisphosphonate treatment, patients should be advised to report new thigh, hip, or groin pain; all patients with such symptoms should be evaluated for incomplete femoral fracture.

Atypical fractures of other long bones.

Atypical fractures of other long bones, such as the ulna and tibia, have been reported in patients receiving long-term bisphosphonate therapy. As with atypical femoral fractures, these fractures may occur following minimal trauma or without trauma, and some patients experience prodromal pain prior to the manifestation of a complete fracture. In cases of ulnar fracture, this may be associated with repetitive stress due to prolonged use of walking aids (see section "Undesirable effects").

Renal impairment.

Due to limited clinical experience, the medicinal product is not recommended for use in patients with creatinine clearance below 30 ml/min (see section "Pharmacokinetics").

Important information about excipients.

Galactose intolerance.

The medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

Disposal of unused medicine and expired products.

Environmental contamination with the medicinal product should be minimized. The medicinal product must not be disposed of via wastewater or household waste. Disposal should be carried out via a designated waste collection system, if available.

Use during pregnancy or breastfeeding.

Pregnancy.

The medicinal product is intended for use only in postmenopausal women. The medicinal product should not be used in women of reproductive age. There are no adequate data on the use of ibandronic acid in pregnant women. Reproductive toxicity was observed in rat studies. The potential risk in humans is unknown. The medicinal product must not be used during pregnancy.

Breastfeeding.

It is unknown whether ibandronic acid passes into breast milk. Studies in lactating rats have shown low levels of ibandronic acid in milk after intravenous administration. The medicinal product should not be used during breastfeeding.

Fertility.

There are no data on the effect of ibandronic acid in humans. In reproductive studies in rats, oral administration of ibandronic acid reduced fertility.

Effect on ability to drive and use machines.

Given the pharmacodynamic characteristics, pharmacokinetic profile, and reported adverse reactions, ibandronic acid is expected to have no effect or a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage.

Dosage.

For the treatment of osteoporosis, the recommended dose of the medicinal product is 1 tablet of 150 mg once a month orally. Tablets should be taken on the same day each month. The medicinal product should be taken after an overnight fast (at least 6 hours) and 60 minutes before the first intake of food or liquids (other than water) during the day (see section "Interaction with other medicinal products and other types of interactions") or other oral medicinal products or supplements (including calcium).

Patients should be informed that if they miss a monthly dose of the medicinal product, they should take the next tablet of 150 mg the following morning as soon as they remember, provided that the day of the next scheduled dose is not within the next 7 days. Subsequent doses of the medicinal product should be taken on the previously established day of the month. If the day of the next scheduled dose falls within the next 7 days, the missed dose should be skipped, and the next dose should be taken on the scheduled day of the month, continuing with 1 tablet per month on the previously established day of the month. Two tablets should not be taken within one week. Patients should take calcium and/or vitamin D supplements if dietary intake is inadequate (see sections "Special Warnings and Precautions for Use" and "Interaction with other medicinal products and other types of interactions"). The optimal duration of treatment of osteoporosis with bisphosphonates has not been established. The need for continued treatment should be periodically reviewed for each individual patient, considering the benefit and potential risk of using the medicinal product, particularly after 5 or more years of treatment.

Special Patient Groups.

Patients with renal impairment.

Due to limited clinical experience, the medicinal product is not recommended for patients with creatinine clearance below 30 ml/min (see sections "Pharmacokinetics" and "Special Warnings and Precautions for Use").

Dose adjustment is not required in patients with mild to moderate renal impairment if creatinine clearance is equal to or exceeds 30 ml/min.

Patients with hepatic impairment.

Dose adjustment is not required (see section "Pharmacokinetics").

Elderly patients (>65 years).

Dose adjustment is not required (see section "Pharmacokinetics").

Method of Administration.

• Tablets should be swallowed whole with one glass of plain water (180–240 ml), while sitting or standing in an upright position. Water with high calcium concentration should not be used. If there is concern about potentially high calcium levels in drinking water (hard water), it is recommended to use bottled water with low mineral content.
• Patients should remain upright for 60 minutes after taking the medicinal product.
• The medicinal product should be taken only with plain water.
• Patients should not chew or suck the tablet due to the risk of developing ulcers in the mucosa of the oropharynx.

Children.

There is no relevant experience with the use of the medicinal product in children under 18 years of age. The use of the medicinal product has not been studied in children under 18 years of age (see sections "Pharmacodynamics" and "Pharmacokinetics").

Overdose.

There is no specific information on the treatment of overdose with ibandronic acid. Symptoms. However, based on current knowledge of bisphosphonates, adverse reactions in the upper gastrointestinal tract may occur, such as gastrointestinal disturbances, dyspepsia, esophagitis, gastritis, ulceration, or hypocalcemia.

Treatment. To bind ibandronic acid, milk or antacids should be administered; any adverse reactions should be treated symptomatically. Due to the risk of esophageal irritation, vomiting should not be induced. Patients should remain in an upright position.

Side effects.

Summary of safety profile.

The most serious adverse reactions reported are anaphylactic reaction/shock, atypical femoral fractures, osteonecrosis of the jaw, gastrointestinal irritation, and eye inflammation (see "Description of individual adverse reactions" and section "Special warnings and precautions for use").

The most commonly reported adverse reactions were arthralgia and flu-like symptoms. These symptoms were usually associated with the first dose, were generally transient and mild to moderate in severity, resolved spontaneously in most cases upon continuation of treatment, and did not require medical intervention (see "Description of individual adverse reactions").

Below is a complete list of known adverse reactions.

The safety of ibandronic acid 2.5 mg once daily orally was evaluated in 1251 patients who participated in four placebo-controlled clinical trials, with the majority of patients enrolled in the pivotal three-year fracture study (MF 4411).

In a two-year study involving postmenopausal women with osteoporosis (VM 16549), the overall safety profile was similar for ibandronic acid 150 mg once monthly and ibandronic acid 2.5 mg once daily orally. The total number of patients experiencing adverse reactions was 22.7% and 25% with ibandronic acid 150 mg once monthly after 1 and 2 years of treatment, respectively.

Most adverse reactions did not lead to discontinuation of treatment.

Adverse reactions listed below are categorized according to the Medical Dictionary for Regulatory Activities (MedDRA) organ system classes and frequency categories. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are listed in order of decreasing severity.

Adverse reactions observed during Phase III studies VM16549 and MF4411 in postmenopausal women receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg once daily orally, and during post-marketing use of ibandronic acid:

Immune system disorders:
Uncommon – exacerbation of bronchial asthma;
Rare – hypersensitivity reactions;
Very rare – anaphylactic reaction/shock*†.

Metabolism and nutrition disorders:
Uncommon – hypocalcaemia†.

Nervous system disorders:
Common – headache;
Uncommon – dizziness.

Eye disorders:
Rare – eye inflammation*†.

Gastrointestinal disorders:
Common – oesophagitis, gastritis, gastro-oesophageal reflux disease, dyspepsia, diarrhoea, abdominal pain, nausea;
Uncommon – oesophagitis, including oesophageal ulceration or strictures and dysphagia, vomiting, flatulence;
Rare – duodenitis.

Skin and subcutaneous tissue disorders:
Common – rash;
Rare – angioedema, facial swelling, urticaria;
Very rare – Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis.

Musculoskeletal and connective tissue disorders:
Common – arthralgia, myalgia, musculoskeletal pain, muscle cramps, musculoskeletal stiffness;
Uncommon – back pain;
Rare – atypical subtrochanteric and diaphyseal femoral fractures;
Very rare – osteonecrosis of the jaw; osteonecrosis of the external auditory canal (an adverse reaction characteristic of bisphosphonates as a class)†;
Not known – atypical fractures of long bones other than the femur.

General disorders and administration site conditions:
Common – flu-like illness*;
Uncommon – asthenia.

*See below.
†Identified during post-marketing use.

Description of individual adverse reactions.

Gastrointestinal adverse reactions.

Patients with a history of gastrointestinal disorders, including those with peptic ulcer disease without recent bleeding or hospitalization, and patients with dyspepsia or reflux controlled with medication, were included in the once-monthly treatment studies. In these patients, there was no difference in the frequency of upper gastrointestinal adverse events when treated with 150 mg once monthly compared to 2.5 mg daily.

Flu-like illness.

Flu-like illness included symptoms such as acute phase reactions or symptoms such as myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, and bone pain.

Osteonecrosis of the jaw.

Cases of osteonecrosis of the jaw have been reported, primarily in patients with malignancies receiving bone resorption inhibitors, including ibandronic acid (see section "Special warnings and precautions for use"). Cases of osteonecrosis of the jaw have also been reported during post-marketing use of ibandronic acid.

Atypical subtrochanteric and diaphyseal femoral fractures.

Epidemiological data suggest an increased risk of atypical subtrochanteric and diaphyseal femoral fractures with long-term bisphosphonate therapy for postmenopausal osteoporosis, particularly after three to five years of treatment; however, the pathophysiology is not fully understood. The absolute risk of atypical subtrochanteric and diaphyseal fractures of long bones (a class effect of bisphosphonates) remains very low.

Eye inflammation.

Inflammatory eye disorders such as uveitis, episcleritis, and scleritis have been reported with ibandronic acid use. In some cases, these inflammatory conditions resolved only after discontinuation of ibandronic acid.

Anaphylactic reaction/shock.

Cases of anaphylactic reaction/shock, including fatal cases, have been observed in patients receiving intravenous ibandronic acid.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions via the national reporting system.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children.

Packaging.

3 tablets in a blister pack. 1 blister pack in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Sintón Hispania, S.L.

Manufacturer's address and place of business.

Calle C/ Castello, no 1, Sant Boi de Llobregat, Barcelona, 08830, Spain.