Binosto, 70 mg 4 pcs.

Osteoporosis, bone fragility, menopause – Treatment of osteoporosis in postmenopausal women to prevent the development of fractures, including hip fractures and compression fractures of the spine;

– Treatment of osteoporosis in men to prevent fractures.

Active ingredient

Composition

Composition per 1 tablet:

The active ingredient:

Alendronate sodium trihydrate (micronized) (in terms of alendronic acid) -91.37 (70.0) mg.

Auxiliary substances:

Sodium citrate anhydrous – 1900.00 mg,

Citric acid anhydrous – 839.63 mg,

sodium bicarbonate – 751.00 mg,

Anhydrous sodium carbonate – 430.00 mg,

Strawberry flavoring -30.00 mg,

acesulfame potassium – 4.00 mg,

sucralose – 4.00 mg.

Description

The round, flat tablets are white or nearly white with beveled edges and a strawberry scent.

How to take, the dosage

Doses

The recommended dose is one effervescent tablet, 70 mg, once a week.

Patients should be warned that if they miss taking one tablet of Binosto 70 mg, they should take one effervescent tablet the morning of the next day. They should not take two pills on the same day, but should continue to take one pill on the day of the week that they have chosen to take it since the beginning of treatment.

The optimal duration of bisphosphonate therapy for osteoporosis has not been established. The need for continued bisphosphonate therapy should be evaluated on a regular basis based on the benefit/risk of Binosto for each patient, especially after 5 or more years of use.

Pediatric use:

Alendronate sodium is not recommended for use in children younger than 18 years of age due to insufficient data on the safety and efficacy of the drug in the treatment of osteoporosis in children.

The use in elderly patients;

The clinical studies did not show differences in efficacy or safety profiles of alendronate depending on age. Therefore, no dose adjustment is required for use in elderly patients.

The use in patients with renal insufficiency:

Dose adjustment for patients with a glomerular filtration rate (GFR) greater than 35 mL/min is not necessary. Alendronate is not recommended for use in patients with renal impairment with a GFR of less than 35 mL/min due to insufficient data on use.

How to use

In order to ensure adequate bioavailability of alendronate, Binosto should be taken at least 30 minutes before the first meal of food, drink or other daily medication, with only plain water, since other drinks (including mineral water), foods and some medications may decrease absorption of alendronate (see See section “Interaction with other medicinal products and other forms of interaction”).

In order to improve gastric absorption and thereby reduce the likelihood of local and esophageal irritation/disadvantage (see section “Special Indications”):

– Binosto is recommended to be taken dissolved in half a glass of plain water (at least 120 ml or 4.2 fluid ounces). Dissolving the tablet in water creates a buffered solution with a pH of 4.8-5.4. The resulting solution can be drunk only after the effervescence stops and the tablet completely dissolves to form a clear or slightly cloudy colorless or nearly colorless liquid, after which at least another 30 ml of water (1/6 of a glass) is added to the solution. Additional amounts of water may be required.

– Do not swallow fizzy tablets that have not dissolved or chew or crush fizzy tablets because of the risk of irritation of the oropharyngeal mucosa (see “Special Precautions” and “Side Effects”).

– If the tablet does not dissolve completely, the solution should be stirred until it is clear or slightly cloudy, colorless or nearly colorless.

– Patients should remain upright after the first meal, which should not be earlier than 30 minutes after consuming the drug solution.

Patients should remain upright for at least 30 minutes after drinking the drug solution.

– Binosto should not be taken before going to bed or before getting out of bed in the morning.

– Binosto may be indicated for patients who are unable or unwilling to swallow pills.

Patients should take additional calcium and vitamin D supplements if dietary intake is insufficient (see Special Precautions).

Interaction

Special Instructions

Pregnancy use

Alendronate should not be used during pregnancy. There are insufficient data on the use of alendronate in pregnant women. Animal studies have shown no direct adverse effects during pregnancy, embryonic and fetal development or postnatal development.

There are no data on the effects of alendronic acid on the fetus when the drug is used during pregnancy. However, there is a theoretical risk of negative effect on the fetus (especially on the bone tissue) if the pregnancy occurs after a course of bisphosphonate therapy. Once ingested, bisphosphonates are incorporated into the bone matrix, from where they are gradually released over several years.

The amount of bisphosphonates embedded in the bone matrix and able to get back into the systemic bloodstream directly depends on the dose and duration of use of the drug. Animal studies have shown abnormalities of fetal bone formation when using high doses of alendronic acid and maternal dysfunction associated with hypocalcemia.

Pre-breastfeeding use

There are no data on excretion of alendronate with the breast milk. Alendronate should not be used during breastfeeding.

Children

Binosto should not be used in children younger than 18 years of age because of insufficient data on safety and effectiveness in diseases associated with childhood osteoporosis.

Alendronate may cause local irritation of the upper gastrointestinal mucosa. In this regard, caution should be exercised when prescribing Binosto for patients with upper GI diseases, such as dysphagia, esophageal disease, gastritis, duodenitis, ulcer, serious GI disease suffered in the previous 12 months, such as peptic ulcer, and active gastrointestinal bleeding, surgery on the upper GI, except for pyloroplasty. For patients diagnosed with Barrett’s esophagus, the prescription of alendronate should be decided individually based on an assessment of the ratio of expected benefit to possible risk.

In treatment with alendronate, adverse esophageal reactions (esophagitis, esophageal erosion or ulceration) are known, sometimes severe, requiring hospital treatment and rarely complicated by stricture formation.

As a result, physicians should be alert to any signs or symptoms suggestive of possible esophageal dysfunction, and patients should be advised to discontinue alendronate and seek medical attention if they experience symptoms of esophageal irritation, such as dysphagia, pain on swallowing or in the chest, and onset or increase in heartburn.

The risk of severe esophageal adverse events is higher in those patients who violate the recommendations for taking the drug and/or continue to take it when symptoms of esophageal irritation appear. It is especially important to give the patient recommendations for taking the drug so that he or she understands that the risk of developing esophageal damage increases if these recommendations are not followed (see section on Dosage and administration).

Although no increased risk was noted in expanded clinical trials of alendronate, post-registration reports have reported rare cases of gastric and duodenal ulcers, sometimes severe and complicated.

In patients with cancer treated with intravenous bisphosphonates, cases of local osteonecrosis of the jaw have been reported, mostly associated with prior tooth extraction and/or local infection (including osteomyelitis). Many of the patients also received chemotherapy and glucocorticosteroids. There are also known cases of osteonecrosis of the jaw in patients with osteoporosis who have taken oral bisphosphonates. The following risk factors should be considered when assessing the individual risk of jaw necrosis:

The activity of the bisphosphonate (zolendronic acid is highest), the route of administration (see A history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures, and poorly fitting dentures. Prior to initiating therapy with oral bisphosphonates, a dental exam and preventive treatment measures are recommended for patients with poor dental status.

While taking bisphosphonates, these patients are advised to avoid invasive dental procedures if possible. If a patient develops osteonecrosis of the jaw during bisphosphonate therapy, surgical dental treatment may worsen the patient’s condition. It is not known whether stopping bisphosphonates reduces the risk of osteonecrosis of the jaw in patients who require dental procedures. In each case, the decision must be made by the treating physician based on an assessment of the ratio of expected benefit to possible risk for the individual patient.

While on bisphosphonate therapy, patients should be educated about the importance of good oral hygiene, preventive exams, and patients should be reminded to report any oral symptoms such as tooth movement, pain, or swelling.

Bone, joint, and/or muscle pain has been known to occur while taking bisphosphonates.

Post-registration experience with bisphosphonates shows that in rare cases these symptoms have been severe and/or resulted in disability (see section “Side effects”). The time of symptom onset varied from one day to several months after the start of treatment. In most patients, symptoms disappeared after discontinuation of treatment. In some of them, symptoms reappeared when the same drug or another bisphosphonate drug was resumed. Atypical subjacent or diaphyseal fractures of the hip are known to occur while taking bisphosphonates, mainly in patients receiving long-term therapy for osteoporosis. These transverse or oblique fractures can occur along the entire length of the femur from the fibula to the epicondyle. These fractures occur after minor or no trauma, with some patients experiencing severe pain in the hip or groin area, often combined with radiological symptoms of stress fractures, weeks or months before a full hip fracture pattern appears.

Fractures are often bilateral, so patients with a hip fracture who are taking bisphosphonates should have the second (contralateral) hip evaluated. These fractures do not heal well. If an atypical hip fracture is suspected, discontinuation of bisphosphonate therapy should be considered until an individual assessment of the ratio of expected benefit to possible risk is made. Patients should be encouraged to report any hip or groin pain during bisphosphonate therapy. All patients presenting with these complaints should be evaluated for incomplete femoral fracture.

The adverse event of osteonecrosis of the external auditory canal has been reported and has been predominantly associated with long-term use of alendronate. Possible risk factors for osteonecrosis of the external auditory canal include steroid use, chemotherapy, infections, and trauma.

A rare reports of severe skin reactions, including Stevens-Johnson syndrome and Lyell syndrome (toxic epidermal necrolysis), have been reported during post-registration use.

Patients should be warned that if they accidentally miss taking Binosto once a week, they should take 1 tablet the morning of the next day after they remember. They should not take two pills on the same day, but they should return to taking the medication once a week on the day of the week that was chosen at the beginning of treatment thereafter.

Binosto is not recommended in patients with renal impairment with a glomerular filtration rate less than 35 mL/min (see section “Dosage and administration”).

Osteoporosis causes other than estrogen deficiency and age should be taken into consideration.

If hypocalcemia is present, calcium concentration in blood should be normalized before starting treatment with alendronate (see section “Contraindications”). Other disorders of mineral metabolism (e.g., vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting therapy with alendronate. In patients with these disorders during therapy with Binosto it is necessary to monitor serum calcium concentration and symptoms of hypocalcemia.

Because alendronate increases bone mineral content, decreased serum calcium and phosphate concentrations may be observed, especially in patients receiving glucocorticosteroids in whom calcium absorption may be decreased.

In general, this decrease is small and asymptomatic. However, rare cases of symptomatic hypocalcemia are known, which sometimes reached a severe degree and developed in patients with an appropriate predisposition (e.g., hypoparathyroidism, vitamin D deficiency, calcium malabsorption).

The provision of adequate calcium and vitamin D intake is particularly important for patients taking glucocorticosteroids.

Binosto contains 26.2 mmol (or 602.54 mg) of sodium in one tablet. This should be considered when treating patients on a sodium-controlled diet.

Peculiarities of use in children

Alendronate sodium is not recommended for use in children younger than 18 years of age due to insufficient data on safety and effectiveness of the drug in the treatment of osteoporosis in children (see section “Dosage and administration”).

Impact on the ability to drive vehicles and operate machinery

There have been no studies on the effect on the ability to drive vehicles and operate mechanisms. However, some adverse reactions observed while taking Binosto may affect the ability of some patients to drive vehicles or operate other mechanisms. Individual reactions to Binosto may vary (see section “Adverse effects”).

Contraindications

With caution

In case of exacerbation of upper gastrointestinal (GI) diseases such as dysphagia, esophageal disease, gastritis, duodenitis or peptic ulcer.

In cases of serious gastrointestinal disease in the previous 12 months, such as peptic ulcer, gastrointestinal bleeding, or upper GI surgery (except pyloroplasty).

Predisposition to hypocalcemia (hypothyroidism, calcium malabsorption).

Side effects

In a one-year clinical trial in postmenopausal women with osteoporosis, the overall safety profiles of alendronate at a dose of 70 mg once weekly (n=519) and alendronate at a dose of 10 mg daily (n=370) were broadly similar.

In two three-year clinical trials with virtually identical designs in menopausal women (alendronate at 10 mg dose: n=196, placebo: n=397), the safety profiles of alendronate at 10 mg/day and placebo were generally similar.

The adverse events described in these studies as possibly, probably, or definitely related to alendronate administration are shown in the table below. Adverse events occurred in > 1% of patients in each admission group in the one-year study. In > 1% of patients taking alendronate at a dose of 10 mg/day, adverse events were observed at a higher frequency than in the placebo group in the 3-year study:

The frequency of adverse events was established as follows: Very infrequent (> 1/10), Frequent (> 1/100, < 1/10), Infrequent (> 1/1000, < 1/100), Rare (> 1/10000, < 1/1000), Very rare (< 1/10000, including individual cases).

Immune system disorders

Rare: Hypersensitivity reactions, including urticaria and Quincke’s edema

Metabolic and nutritional disorders

Rare: Symptomatic hypocalcemia, often in the background of predisposition factors

Nervous system disorders

Often: headache, dizziness Infrequent: taste disturbance2 Often unknown: irritability

An organ of vision side

Infrequent: Visual inflammation (uveitis, scleritis, episcleritis)

Hearing organ and labyrinth disorders

Often: Systemic dizziness2

Very rare: Osteonecrosis of the external auditory canal

Disorders on the side of

gastrointestinal

gastrointestinal tract

Often: abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer , dysphagia , bloating, acidic belching

Infrequent: nausea, vomiting, gastritis, esophagitis , esophageal erosion, melena2

Rarely: esophageal stricture , esophageal ulceration3 , upper GI disorders (perforation, ulcers, bleeding)1

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Gauge and subcutaneous tissue disorders

Often: alopecia2, itching2

Infrequent: skin rash, erythema

Rarely: Skin rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis4

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Musculoskeletal and connective tissue disorders

Very common: Musculoskeletal pain (in bones, muscles or joints), sometimes severe pain

Often: Joint swelling

Rarely: local osteonecrosis of the jaw, associated primarily with prior tooth extraction and/or local infection (including osteomelitis), often with slow recovery, atypical vertebral and diaphyseal fractures of the femur (unwanted bisphosphonate class response).

General disorders and disorders at the site of administration

Often: Asthenia, peripheral edema

Infrequent: Transient symptoms as an acute phase reaction (myalgia, malaise, and rarely fever), usually in association with initiation of treatment

Intermittent: symptoms as an acute phase reaction (myalgia, malaise, and rarely fever), usually in association with initiation of treatment

1 See. Special Indications.

2 The incidence rates determined from clinical studies were comparable for the drug group and the placebo group.

3 See “Dosage and administration” and “Special Precautions” sections.

4 This adverse reaction has been identified during post-registration monitoring.

5 These adverse reactions have been identified for the drug in tablet form, and not all of them can be attributed to Binosto, which is used as an oral buffered solution.

Overdose

Similarities