Binosto - instructions for use, dose, side effects, contraindications

Excipients: sodium citrate anhydrous - 1900.00 mg, citric acid anhydrous - 839.63 mg, sodium hydrogen carbonate - 751.00 mg, sodium carbonate anhydrous - 430,00 mg, strawberry flavoring - 30,00 mg, acesulfame potassium - 4,00 mg , sucralose - 4,00 mg.

Description:Round flat tablets white or almost white with beveled edges with a strawberry smell.

Pharmacotherapeutic group:Bone resorption inhibitor-bisphosphonate

ATX: & nbsp

M.05.B.A.04 Alendronic acid

Pharmacodynamics:

The active substance of the preparation Binosto - sodium alendronate trihydrate is a bisphosphonate that inhibits bone resorption caused by osteoclasts without directly affecting the formation of new bone tissue.

Pre-clinical studies have shown that alendronate is predominantly localized in areas of active bone resorption. Alendronate suppresses the activity of osteoclasts, but does not affect their accumulation and attachment. During treatment with alendronate, normal bone tissue is formed.

At the heart of the toxic effect on the esophagus in the treatment of alendronate lies many factors, including the main is local irritation of the mucosa of the esophagus under the influence of crystals of the substance (tablet oesophagitis). As an accompanying factor, acid gastroesophageal reflux may act, and, therefore, a decrease in acid exposure is the main treatment for esophagitis caused by alendronate.

In the "Side effect" section you can find out the data of the post-marketing research of the drug in the USA.

Treatment of osteoporosis in postmenopausal women

Osteoporosis is defined as a decrease in bone mineral density (BMD) of the spine or hip by 2.5 standard deviations (SD) compared with the average in the population of young people or as a history of a pathological fracture regardless of BMD.

In a one-year multicentre study of postmenopausal women with osteoporosis, the therapeutic equivalence of alendronate at a dose of 70 mg once a week (n= 519) and alendronate at a dose of 10 mg once daily (n=370).

In the group taking alendronate at a dose of 70 mg once a week, the average increase in BMD in the lumbar spine during the year was 5.1% in relation to baseline values (95% CI: 4.8, 5.4%), and in the group taking 10 mg per day, the increase was 5.4% (95% CI: 5.0, 5.8%). The average increase in BMD in the femoral neck was 2.3% and 2.9%, and for the entire femur - 2.9% and 3.1% in patients taking 70 mg of alendronate once a week or 10 mg once daily respectively. Both treatment groups were also comparable with each other for BMD values in other parts of the skeleton.

The effect of alendronate on bone mass and the incidence of fractures in women after menopause was studied in two clinical studies of the initial efficacy of the same design (n= 994), as well as in the study of fracture therapy (FIT: n=6459).

In studies of initial efficacy, an increase in the mean MCTT with alendronate at a dose of 10 mg per day compared with placebo in three years was 8.8% for the spine, 5.9% for the femoral neck, and 7.8% for the trochanter. The total BMD of the body also increased significantly. In the group treated with alendronate, the proportion of patients who experienced one or more vertebral fractures decreased by 48% compared with the placebo group (3.2% in the alendronate group compared to 6.2% in the placebo group). During the two-year extension period of these studies, the BMD values of the spine and trochanter continued to increase, and the BMD of the femoral neck and the entire body remained unchanged.

Study of fracture therapy FIT consisted of two placebo-controlled clinical trials in which patients took alendronate daily (5 mg daily for two years, then for the next year or two years, 10 mg daily).

FIT 1: a three-year clinical trial in which 2,027 patients were included, with at least one initial vertebral fracture (compression). In this study, daily alendronate intake reduced the incidence of one or more vertebral fractures by 47% (in the alendronate group 7.9% compared with 15.0% in the placebo group). In addition, a statistically significant reduction in the incidence of hip fracture was found (1.1% compared with 2.2%, a decrease of 51%).

FIT 2: a four-year clinical trial in which 4432 patients with low bone mass were included, but without an initial vertebral fracture. In this study, when analyzing data from a subset of women with osteoporosis (37% of the total population with a condition, which correspond to the above definition of osteoporosis), there was a significant difference in the frequency of one or more fractures of the spine (2,9% compared with 5.8%, a decrease of 50%) and hip fractures (in the alendronate group 1.0% compared with 2.2% in the placebo group, a decrease of 56%).

Results of laboratory tests

In clinical studies, there was an asymptomatic, small and temporary decrease in the concentration of calcium and phosphate in the blood serum (by 18% and 10%, respectively)taking alendronate at 10 mg per day (compared with approximately 12% and 3% in the placebo group).

However, the frequency of reduction in serum calcium concentration to <8.0 mg / dL (2.0 mmol / L) and serum phosphate up to ≤ 2.0 mg / dL (0.65 mmol / L) was similar in both treatment groups.

Research applications in men

Although osteoporosis in men is not as common as in postmenopausal women, a significant proportion of fractures associated with osteoporosis are men. The prevalence of deformity of the spine associated with osteoporosis is the same in men and women. The use of alendronate in a dose of 10 mg per day in men for 2 years reduced the excretion in the urine of cross-linked Nof the collagen type I of the type I by approximately 60% and of the bone-specific alkaline phosphatase by approximately 40%.

Pharmacokinetics:

Suction

The bioavailability of alendronate with oral fasting in the morning two hours before a standard breakfast at a dose of 5-70 mg was 0.64% in women and 0.60% in men. When taking alendronate on an empty stomach for an hour or half an hour before a standard breakfast, bioavailability decreased to 0.46% and 0.39%, respectively.

Bioavailability Binosto is comparable to that of commonly used tablets alendronate,However, for effervescent tablets, intra-individual differences in excretion (and, consequently, in absorption) are less (the coefficient of variation in total excretion during the first 48 hours is 32.0 compared to 42.1%, the coefficient of variation of the maximum excretion rate is 37.5 compared to 45 , 6%).

In studies of osteoporosis, alendronate was effective when taken at least 30 minutes before the first meal or drink during the day. Alendronate bioavailability was insignificant when taken during a standard breakfast and within two hours after it. With the simultaneous administration of alendronate with coffee or orange juice, bioavailability was reduced by approximately 60%.

Distribution

Studies in rats have shown that after intravenous administration at a dose of 1 mg / kg, alendronate is temporarily distributed into soft tissues, after which it quickly passes into bone tissue or is excreted in urine. The average equilibrium volume of distribution of alendronate, excluding bone, in man is at least 28 liters. The concentration of alendronate in plasma after oral administration of therapeutic doses is too low for analytical detection (less than 5 ng / ml).The binding to plasma proteins in humans is approximately 78%.

Metabolism

There is no confirmed evidence that alendronate is metabolized in humans or animals.

Excretion

After a single intravenous injection [¹⁴C] alendronate approximately 50% of the radioactivity was excreted in the urine within 72 hours and had little or no excretion with feces. After a single intravenous injection of the drug at a dose of 10 mg, the renal clearance of alendronate was 71 ml / min, and the systemic clearance did not exceed 200 ml / min.

The plasma concentration was reduced by more than 95% within 6 hours after intravenous administration. The half-life in the final phase in the human body exceeds ten years, which reflects the release of alendronate from bone tissue. In studies on rats, it has been shown that alendronate is not excreted through the acid and basic transport systems of the kidneys. Therefore, it can be expected that it does not violate the excretion of other drugs through these systems in humans.

Features of use in patients with impaired renal function

Preclinical studies have shown that a drug that does not accumulate in bone tissue is rapidly excreted in the urine.It was not possible to establish the maximum saturating capacity of bone tissue in animals with intravenous administration of a cumulative dose of 35 mg / kg. Despite the lack of clinical data, there is likely a reduction in alendronate excretion in patients with kidney disease (as obtained in animal studies).

Thus, in patients with impaired renal function, a somewhat greater accumulation of alendronate in the bone tissue can be expected (see section "Dosing and Administration").

Indications:

- Treatment of osteoporosis in postmenopausal women in order to prevent the development of fractures, including hip fractures and compression fractures of the spine;

- treatment of osteoporosis in men to prevent the occurrence of fractures.

Contraindications:

Hypersensitivity to alendronate or any of the components of the drug.
Dysfunction of the esophagus and other factors that slow its emptying (for example, stricture, achalasia).
The patient's inability to stand or sit upright for 30 minutes.
Hypocalcemia.
Vitamin deficiency D.
Severe disorders of mineral metabolism.
Severe renal insufficiency - creatinine clearance (CK) <35 ml / min.
Childhood.

Carefully:

With exacerbation of diseases of the upper gastrointestinal tract (GI tract) such as dysphagia, esophageal diseases, gastritis, duodenitis or stomach ulcers.
In case of serious gastrointestinal diseases that have been transferred in the previous 12 months, for example, peptic ulcer, gastrointestinal bleeding, surgical intervention on the upper gastrointestinal tract (except pyloroplasty).
Predisposition to hypocalcemia (hypothyroidism, calcium malabsorption).

Pregnancy and lactation:

Application in pregnancy

Alendronate should not be used during pregnancy. Data on the use of alendronate in pregnant women is not enough. Animal studies did not show immediate adverse effects during pregnancy, embryonic and fetal development, or postnatal development. Data on the effect of alendronic acid on the fetus when using the drug during pregnancy are absent. However, there is a theoretical risk of adverse effects on the fetus (especially bone tissue) if pregnancy occurs after taking bisphosphonate therapy.After entering the body, bisphosphonates are inserted into the bone matrix, from which they are gradually released over several years. The number of bisphosphonates embedded in the bone matrix and able to get back into the systemic blood flow, directly depends on the dose and duration of application of the drug. In studies on animals, violations of fetal bone formation were detected with high doses of alendronic acid and dysfunction of labor related to hypocalcemia.

Application in the period of breastfeeding

Data on the allocation of alendronate with breast milk are absent. Alendronate should not be used during breastfeeding.

Children

The drug Binosto should not be used in children under the age of 18 due to insufficient data on safety and efficacy in diseases associated with childhood osteoporosis.

Dosing and Administration:

Doses

The recommended dose is one effervescent tablet, 70 mg once a week. Patients should be warned that if they miss a single 70 mg binostoxide pill, they should take one effervescent tablet in the morning of the next day.Do not take two tablets in one day, but in the future you need to continue taking one tablet on the day of the week that was chosen for admission from the very beginning of treatment. The optimal duration of osteoporosis therapy with bisphosphonates has not been established. The need for continuing bisphosphonate therapy should be evaluated on a regular basis on the basis of the benefit / risk of using the Binosto drug for each patient, especially after 5 or more years of use.

Application in children:

It is not recommended to use alendronate sodium in children under 18 years of age in connection with insufficient data on the safety and efficacy of the drug in the treatment of osteoporosis in children.

Application in elderly patients:

In clinical studies, there was no difference in the efficacy or safety profiles of alendronate, depending on age. Therefore, dose adjustment when used in elderly patients is not required. Use in patients with renal insufficiency:

Correction of the dose for patients with a glomerular filtration rate (GFR) of more than 35 ml / min is not required. Alendronate is not recommended for patients with renal insufficiency, in which the GFR is less than 35 ml / min, due to insufficient application data.

Mode of application

In order to ensure the necessary bioavailability of alendronate, it is necessary to take Binosto at least 30 minutes before the first meal, drinks or other daily medications, drink only with normal water, as other drinks (including mineral water), food and some medicinal drugs can reduce the absorption of alendronate (see section "Interaction with other drugs and other forms of interaction").

In order to improve the flow into the stomach and thereby reduce the likelihood of local and esophageal irritation / undesirable phenomena (see section "Special instructions"):

- Binosto is recommended to take in dissolved form in half a glass of ordinary water (not less than 120 ml or 4.2 liquid ounces). When the tablet is dissolved in water, a buffer solution with a pH of 4.8-5.4 is formed. The resulting solution can be drunk only after the hissing has ceased and the tablet is completely dissolved to form a clear or slightly cloudy, colorless or almost colorless liquid, after which at least 30 ml of water (1/6 of a glass) is added to the solution.Additional water may be required.

Do not swallow insoluble effervescent tablets, chew or dissolve effervescent tablets due to the danger of irritation of the mucous membrane of the oropharynx (see sections "Special instructions" and "Side effect").

If the tablet is not completely dissolved, the solution should be stirred until it becomes clear or slightly cloudy, colorless or almost colorless.

Patients should remain in the vertical position after the first meal, which should occur no earlier than 30 minutes after the use of the drug solution.

Patients should remain in an upright position for at least 30 minutes after ingestion of the drug solution.

Binosto should not be taken at bedtime or before morning ascension from bed.

Binosto can be prescribed to patients who can not or do not want to swallow tablets.

Patients should additionally take calcium and vitamin preparations D, if their intake with food in the body is insufficient (see section "Special instructions").

Side effects:

In a one-year clinical trial in women with osteoporosis during the postmenopause, general safety profiles of alendronate at a dose of 70 mg once a week (n= 519) and alendronate at a dose of 10 mg per day (n= 370) were generally similar.

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

The adverse events described in these studies as possible, probably or specifically related to the use of alendronate, are presented in the table below. Adverse events were observed the ≥ 1% of patients in each admission group in a one-year study. Have ≥ 1% of patients who took alendronate at a dose of 10 mg / day, adverse events were observed with a greater frequency than in the placebo group in the triennium study:

	Annual study		Three-year research
	alendronate, 70 mg (1 time / week, n=519), %	alendronate 10 mg (1 time / day, (n=370), %	alendronate, 10 mg (1 time / day, n=196),%	placebo (n-397),%
Disorders from the digestive tract
abdominal pain	3,7	3,0	6,6	4,8
dyspepsia	2,7	2,2	3,6	3,5
sour belch	1,9	2,4	2,0	4,3
nausea	1,9	2,4	3,6	4,0
bloating	1,0	1,4	1,0	0,8
constipation	0,8	1,6	3,1	1,8
diarrhea	0,6	0,5	3,1	1,8
disfagia	0,4	0,5	1,0	0,0
flatulence	0,4	1,6	2,6	0,5
gastritis	0,2	1,1	0,5	1,3
gastric ulcer	0,0	1,1	0,0	0,0
oesophageal ulcer	0,0	0,0	1,5	0,0
Violations from hand skeletal- muscular connective fabrics
musculoskeletal pain (in bones, muscles or joints)	2,9	3,2	4,1	2,5
muscular spasm	0,2	1,1	0,0	1,0
Disturbances from the nervous system
headache	0,4	0,3	2,6	1,5

The following adverse events were reported during clinical trials and / or post-marketing use.

The frequency of adverse events is established as follows: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10000, <1/1000), very rarely (<1/10000, including individual cases).

Immune system disorders	Rarely: hypersensitivity reactions, including urticaria and angioedema
Disorders from the metabolism and nutrition	Rarely: symptomatic hypocalcemia, often against the background of predisposing factors¹
Disturbances from the nervous system	Often: headache, dizziness² Infrequently: violation of taste sensations²Frequency unknown: irritability
From the side of the organ of vision	Infrequently: inflammation of the organs of vision (uveitis, scleritis, episcleritis)
From the side of the hearing organ and labyrinthine disorders	Often: systemic dizziness² Rarely: osteonecrosis of external auditory aisle
Infringements from gastrointestinal tract⁵	Often: abdominal pain, indigestion, constipation, diarrhea, flatulence, oesophageal ulcer³, dysphagia³, bloating, acidic eructation Infrequently: nausea, vomiting, gastritis, esophagitis³, erosion of the esophagus, melena² Rarely: esophageal stricture³, ulceration of the esophagus³, disorders of the upper gastrointestinal tract (perforation, ulcers, bleeding)¹
Disturbances from the skin and subcutaneous tissues	Often: alopecia², itching² Infrequently: skin rash, erythema Rarely: skin rash with photosensitivity, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis⁴
Disturbances from musculoskeletal and connective tissue	Often: musculoskeletal pain (in the bones, muscles or joints), sometimes severe pain^1,2 Often: swelling of the joints² Rarely: local osteonecrosis of the jaw associated mainly with previous tooth extraction and / or local infection (including osteomelitis), often with slow recovery^1,4, atypical susceptible and diaphyseal fractures of the femur (unwanted reaction of the bisphosphonate class).
General disorders and disorders at the site of administration	Often: asthenia², peripheral edema² Infrequently: transient symptoms as an acute phase reaction (myalgia, malaise and rarely fever), usually in connection with the onset of treatment²
Laboratory indicators	hypophosphataemia

¹ See section "Special instructions".

² The frequency of occurrence, determined by the results of clinical studies, was comparable for the drug group and the placebo group.

³See the section "Dosage and administration" and "Special instructions".

⁴This unwanted reaction was established during post-registration surveillance.

⁵These undesirable reactions have been identified for the drug in the form of tablets, and not all of them can be attributed to the preparation of Binosto, which is used as a buffer solution for oral administration.

Overdose:

In case of overdose, hypocalcemia, hypophosphatemia, undesirable side effects of the upper gastrointestinal tract, including upset stomach, heartburn, esophagitis, gastritis, stomach and esophagus ulcers are possible. There is no specific treatment for alendronate overdose. The patient should take milk or antacids to bind alendronate. To prevent irritation of the esophagus, do not induce vomiting. Patients should maintain their vertical position.

Interaction:

Absorption of alendronate may be impaired if Binosto is taken concomitantly with food, beverages (including mineral water), calcium preparations, antacids and other medications for oral use.In this regard, the interval between taking Binosto and other medications taken orally should be at least 30 minutes (see sections "Method of administration and dose" and "Pharmacological properties").

In a study involving healthy volunteers, the oral use of prednisone (20 mg three times daily for 5 days) did not lead to a clinically significant change in the bioavailability of alendronate (mean increase varied from 20% to 44%).

Other clinically significant interactions with drugs are not expected. In clinical studies, some patients received estrogen (intravaginally, transdermally or orally), taking alendronate. There were no undesirable phenomena associated with their simultaneous application.

Since the use of non-steroidal anti-inflammatory drugs (NGTG) is associated with the development of erosive-ulcerative gastrointestinal lesions, caution should be exercised while using NSAIDs and alendronate.

Although no specific studies of interactions have been conducted, alendronate has been used concurrently with a wide range of frequently prescribed medications in clinical trials without signs of clinical adverse interactions.

Special instructions:

Alendronate can cause local irritation of the mucous membrane of the upper gastrointestinal tract. Therefore, caution should be exercised in appointing Binosto to patients with upper gastrointestinal diseases, for example, in dysphagia, esophageal disease, gastritis, duodenitis, ulcer, a serious GI disease transferred in the previous 12 months, for example in peptic ulcers, active gastrointestinal hemorrhage, surgical operation on the upper gastrointestinal tract, with the exception of pyloroplasty. For patients with a diagnosed Barrett's esophagus, the question of the appointment of alendronate should be decided on an individual basis by assessing the relationship between the expected benefit and the potential risk.

In the treatment of alendronate, there are cases of undesired reactions from the side of the esophagus (esophagitis, erosion or ulcer of the esophagus), sometimes occurring in severe form and requiring inpatient treatment and in rare cases complicated by the formation of stricture.

In connection with this, doctors need to pay special attention to any signs or symptoms that indicate possible abnormalities on the part of the esophagus,and patients should be warned about the need to stop taking alendronate and seek medical help if symptoms of esophageal irritation, such as dysphagia, pain in swallowing or behind the sternum, or the appearance or intensification of heartburn.

The risk of severe adverse events on the side of the esophagus 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 understands that the risk of developing an esophageal lesion increases if these recommendations are not followed (see section "Method of administration and dose").

Although there was no increased risk in the extended clinical trials of alendronate, post-marketing reports reported rare cases of stomach and duodenum ulcers, sometimes severe and complicated.

Patients with oncology treated with intravenous bisphosphonates had cases of local osteonecrosis of the jaw associated mainly with previous tooth extraction and / or local infection (including osteomyelitis). Many of the patients also received chemotherapy and glucocorticosteroids.There are also cases of osteonecrosis of the jaw in patients with osteoporosis who took bisphosphonates orally.

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

bisphosphonate activity (highest in zoledronic acid), route of administration (see above) and total dose;
oncological disease, chemotherapy, radiotherapy, glucocorticosteroids, smoking;
dental disease in history, poor oral hygiene, periodontal disease, invasive dental procedures and poorly selected dentures.

Before starting oral bisphosphonate therapy, patients with unsatisfactory dental status are recommended to have a dental examination and preventive medical measures.

During the course of taking bisphosphonates, it is recommended that such patients avoid invasive dental procedures whenever possible. If a patient develops an osteonecrosis of the jaw during therapy with bisphosphonates, surgical dental treatment may worsen his condition. It is not known whether the discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw in patients who require dental procedures.In each case, the decision should be made by the attending physician on the basis of an estimate of the relationship between the expected benefit and the possible risk for the particular patient.

During therapy, bisphosphonates should explain to patients the importance of proper oral hygiene, preventive examinations, and also warn them about the need to report any symptoms from the oral cavity, such as mobility of the teeth, pain or swelling.

It is known about the occurrence of pain in the bones, joints and / or muscles during the course of taking bisphosphonates.

Post-registration experience of bisphosphonate application shows that in rare cases these symptoms were expressed and / or led to disability (see section "Side effect"). The time of onset of symptoms varied from one day to several months after the start of treatment. In most patients, the symptoms disappeared after discontinuation treatment. In some of them, the symptoms appeared again when the same drug or other bisphosphonate drug was resumed.

It is known about cases of atypical susceptible or diaphyseal fractures of the femur with the use of bisphosphonates, mainly in patients receiving long-term therapy in the treatment of osteoporosis.These transverse or oblique fractures can occur along the entire length of the thigh from the small trochanter of the femur to the supracondylar expansion. These fractures occur after or without minor trauma, some patients experience severe pain in the thigh or inguinal area, which is often combined with the radiologic symptoms of stress fractures, several weeks or months before the full picture of the hip fracture appears. Fractures are often bilateral, so in patients with a hip fracture, taking bisphosphonates, the second (contralateral) thigh should be examined. These fractures are poorly fused. If an atypical hip fracture is suspected, consideration should be given to stopping bisphosphonate therapy before an individual assessment of the relationship between expected benefit and possible risk occurs.

During therapy with bisphosphonates, patients should be advised to report any pain in the thigh or in the groin. All patients who have received such complaints should be examined for incomplete fracture of the femur.

An undesirable phenomenon has been reported, such as osteonecrosis of the external auditory canal, which was predominantly associated with prolonged use of alendronate.Possible risk factors for the development of osteonecrosis of the external auditory canal include the use of steroids, chemotherapy, infections, trauma.

During post-marketing use, rare reports of severe skin reactions have been reported, including Stevens-Johnson syndrome and Lyell's syndrome (toxic epidermal necrolysis).

Patients should be warned that if they miss a dose of Binosto once a week, they should take 1 tablet the morning of the day after they remember. Do not take two tablets on the same day, but in the subsequent it is necessary to return to taking the drug once a week on the day of the week that was chosen at the beginning of treatment.

The drug Binosto is not recommended for patients with renal failure at a glomerular filtration rate of less than 35 ml / min (see section "Method of administration and dose").

Other causes of osteoporosis should be taken into account, in addition to estrogen deficiency and age.

In the presence of hypocalcemia, the concentration of calcium in the blood should be normalized before the treatment with alendronate (see section

"Contraindications"). Other disorders of mineral metabolism (eg, vitamin deficiency D and hypoparathyroidism) should also be effectively treated before alendronate therapy begins. In patients with these disorders during therapy with the drug Binosto, it is necessary to monitor the concentration of calcium in the blood serum and the symptoms of hypocalcemia.

Since alendronate increases the mineral content in the bones, a decrease in the concentration of calcium and phosphate in the blood serum can be observed, especially in patients taking glucocorticosteroids, in which calcium absorption can be reduced. Usually, this decrease is small and asymptomatic. Nevertheless, there are rare cases of symptomatic hypocalcemia, which sometimes reached a severe degree and developed in patients with a corresponding predisposition (eg, hypoparathyroidism, vitamin deficiency D, malabsorption of calcium).

Ensuring sufficient intake of calcium and vitamin D is especially important for patients taking glucocorticosteroids.

Binosto contains 26.2 mmol (or 602.54 mg) of sodium in one tablet. This should be taken into account when treating patients on a diet with a controlled sodium content.

Features of use in children

It is not recommended to use alendronate sodium in children under 18 years due to insufficient data on the safety and efficacy of the drug in the treatment of osteoporosis in children (see section "Method of administration and dose").

Effect on the ability to drive transp. cf. and fur:

There have been no studies to study the effect on the ability to drive a vehicle and work with machinery. However, some of the undesirable reactions observed with the taking of the Binosto drug may affect the ability of some patients to drive vehicles or other mechanisms. Individual reaction to the drug Binosto may differ (see section "Side effect").

Form release / dosage:Tablets effervescent, 70 mg.

Packaging:

2 tablets per strip of combined material (paper / LDPE / Al/ Zn-resin).

On 2 strips together with instructions for use in a pack of cardboard.

Storage conditions:

AT protected from light at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Special precautions when destroying an unused preparation

There is no need for special precautions when destroying an unused preparation.

Shelf life:

4 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003886

Date of registration:06.10.2016

Expiration Date:06.10.2021

The owner of the registration certificate:Polypharm, LLCPolypharm, LLC Russia

Manufacturer: & nbsp

SwissCo Servises, AG Switzerland

Representation: & nbspPOLIFARM, LLCPOLIFARM, LLC

Information update date: & nbsp11.02.2017

Illustrated instructions

Instructions

Binosto (Binosto)