Instructions for use FOROSA
Forosis can cause local irritation of the mucous membrane of the upper gastrointestinal tract. Because there is a risk of worsening concomitant diseases, caution should be exercised when prescribing Forosa to patients with upper gastrointestinal diseases such as dysphagia, esophageal disease, gastritis, duodenitis or ulcers, as well as to patients who have recently (within the last year) had a serious gastrointestinal disease ( for example, gastric ulcer, acute gastrointestinal bleeding) or surgery of the upper gastrointestinal tract, excluding pyloroplasty. In patients with Barrett's esophagus, the benefits and risks of treatment with alendronate should be individually assessed.
Esophageal side effects (in some cases severe and requiring hospitalization) such as esophagitis, ulcers or erosions of the esophagus, in rare cases complicated by stricture or perforation of the esophagus, have been described in patients treated with alendronate. Therefore, the physician should be alert for any sign or symptom of a possible esophageal reaction. Patients should be instructed to stop taking Forosa and seek medical attention if symptoms of esophageal irritation develop, such as dysphagia, pain when swallowing, chest pain, or new/worsening heartburn.
The risk of severe esophageal side effects increases in patients who misuse Forosa and/or continue to take the drug after developing symptoms indicating esophageal irritation. It is very important to give detailed instructions when prescribing and explain them to the patient. Patients should be advised that the risk of esophageal injury may increase if they do not follow these instructions.
There are post-marketing reports of rare cases of gastric and duodenal ulcers, some of them with severe course and complications. A causal relationship with the drug cannot be excluded.
Forosa is not recommended for use in patients with impaired renal function and GFR below 35 ml/min.
Before starting treatment with Forosa, hypocalcemia must be corrected. Before you start taking Forosa, it is also necessary to effectively compensate for other disorders of mineral metabolism (for example, vitamin D deficiency and hypoparathyroidism). In such patients, serum calcium levels and symptoms of hypocalcemia should be monitored during treatment with Forosa.
Due to the positive effects of Forosa on bone mineralization, a decrease in serum calcium and phosphorus levels may be observed. It is usually mild and asymptomatic. However, in rare cases, symptomatic hypocalcemia has been described, which is sometimes severe and occurs in patients with predisposing conditions (eg, hypoparathyroidism, vitamin D deficiency and cases of intestinal calcium malabsorption).
Therefore, it is especially important to ensure that a patient taking glucocorticoids gets enough calcium and vitamin D.
Osteonecrosis of the mandible, mainly associated with tooth extraction and/or local infection (including osteomyelitis), has been described in patients with cancer receiving IV bisphosphonates along with other treatment regimens. Many of these patients also received chemotherapy and corticosteroids. Osteonecrosis of the mandible has also been described in patients taking oral bisphosphonates.
In patients with underlying risk factors (eg, cancer, chemotherapy, radiation therapy, corticosteroids, poor oral hygiene, periodontitis), dental examination and appropriate prophylactic treatment should be performed prior to initiating bisphosphonate treatment.
These patients should avoid invasive dental procedures if possible during treatment. In patients with osteonecrosis of the mandible that develops during bisphosphonate treatment, surgery may aggravate the disease. There are no data suggesting a reduction in the risk of osteonecrosis of the mandible after discontinuation of bisphosphonate treatment in patients requiring dental procedures.
When developing a patient management plan, the physician must individually assess the benefits and risks of treatment.
Bone, joint and/or muscle pain has been reported in patients taking bisphosphonates. These symptoms were rare and/or rarely disabling. The time for symptoms to develop varied from one day to several months after the start of treatment. Most patients experienced improvement in symptoms after stopping treatment. Some have experienced a return of symptoms when they take the same drug or a different bisphosphonate again.
Stress fractures (also known as osteoporotic fractures) in the proximal femoral shaft have been reported with long-term use of alendronic acid (time to fracture ranged from 18 months to 10 years in most cases). These fractures occurred with minimal trauma or spontaneously. Some patients have complained of hip pain, often accompanied by radiographic evidence of a stress fracture, several weeks or months before a complete femur fracture. Such fractures were often bilateral, so when the femoral shaft is fractured during treatment with bisphosphonates, it is important to examine the contralateral limb. These fractures are characterized by poor healing. In such cases, discontinuation of bisphosphonates is recommended, depending on an individual assessment of the benefits and risks of such a decision.
If you miss a dose, take the pill the next morning after you remember to do so. You should not take two tablets on the same day. You must return to taking the pill on the originally chosen day of the week.
Forosa does not affect the ability to drive vehicles or operate machinery.
Forosa, 8 pcs., 70 mg, film-coated tablets
Take Forosa® tablets only with plain water, because other drinks (including mineral water, tea, coffee, fruit juices) impair the absorption of the drug. Taking alendronate before bed or in a horizontal position increases the risk of developing esophagitis.
If symptoms of esophageal irritation occur, such as dysphagia, chest pain, or new/worsening of existing heartburn, patients should consult a physician to evaluate the possibility of continuing therapy. The risk of severe esophageal side effects is greater in patients who take alendronic acid not in accordance with these instructions and/or who continue to take it after symptoms suggestive of esophageal irritation have occurred. It is important to explain in detail to the patient the rules for taking the drug and make sure that he understands them. Patients should be aware of the increased risk of adverse events from the esophagus if they deviate from the instructions.
Before starting therapy with Forosa®, correction of hypocalcemia and other metabolic disorders (such as vitamin D deficiency) is necessary. Due to the increase in bone mineral density during alendronate therapy, a slight clinically asymptomatic decrease in serum calcium and phosphate levels is possible, especially in patients receiving corticosteroids, in whom calcium absorption may be reduced. Therefore, ensuring that sufficient amounts of calcium and vitamin D enter the body is especially important in patients receiving corticosteroids.
Patients should be warned that if they accidentally miss a dose of the drug once a week, they should take 1 tablet. in the morning of the next day (it is unacceptable to take 2 tablets in one day). Subsequently, you should continue to take 1 tablet. on the day of the week that was chosen at the beginning of therapy.
There is also evidence of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates. Before prescribing bisphosphonate therapy, patients with associated risk factors (eg, cancer, chemotherapy, radiation therapy, corticosteroids, poor oral hygiene, anemia, coagulopathy, infection, gum disease) should undergo a dental examination with appropriate preventive dental treatment. During treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw during bisphosphonate treatment, dental surgery may worsen the condition.
There are no data regarding the possible reduction in the risk of osteonecrosis of the jaw after discontinuation of bisphosphonates in patients requiring dental intervention.
Low-energy fractures (also known as stress fractures) of the proximal femoral shaft may occur in patients taking alendronic acid long-term. Fractures can occur after minimal or no trauma, and some patients may experience hip pain, often with outward signs of stress fractures weeks/months before a complete femur fracture occurs.
Low-energy proximal femoral shaft fractures were often bilateral, so patients with a long-standing femoral shaft fracture taking bisphosphonates should have the contralateral hip evaluated. It is advisable to discontinue bisphosphonates in patients with stress fractures after assessing their condition based on an individual assessment of the risk/benefit ratio.
The decision to proceed with treatment must be made individually for each patient after a careful risk/benefit assessment, especially for patients with Barrett's esophagus.
Impact on the ability to drive vehicles and engage in other activities that require increased concentration and speed of psychomotor reactions.
Alendronic acid does not affect the ability to drive vehicles and engage in other activities that require increased concentration and speed of psychomotor reactions.
Special precautions when disposing of unused drug.
There is no need for special precautions when disposing of unused drug.
Forosa®
Take Forosa® tablets only with plain water, as other drinks (including mineral water, tea, coffee, fruit juices) impair the absorption of the drug. Taking alendronic acid before bed or in a horizontal position increases the risk of developing esophagitis.
If symptoms of esophageal irritation occur, such as dysphagia, chest pain, or new/worsening of existing heartburn, patients should consult a physician to evaluate the possibility of continuing therapy.
The risk of severe esophageal side effects is greater in patients who take alendronic acid not in accordance with these instructions and/or who continue to take it after symptoms suggestive of esophageal irritation have occurred. It is important to explain in detail to the patient the rules for taking the drug and make sure that he understands them. Patients should be aware of the increased risk of adverse events from the esophagus if they deviate from the instructions.
Before starting therapy with Forosa®, correction of hypocalcemia and other metabolic disorders (such as vitamin D deficiency) is necessary. Due to the increase in bone mineral density during alendronic acid therapy, a slight clinically asymptomatic decrease in serum calcium and phosphate levels is possible, especially in patients receiving
glucocorticosteroids, which may reduce calcium absorption. Therefore, it is important to ensure that sufficient amounts of calcium and vitamin D enter the body, which is especially important in patients receiving glucocorticosteroids.
Patients should be warned that if they accidentally miss a dose of the drug once a week, they should take 1 tablet in the morning of the next day (it is unacceptable to take 2 tablets in one day). In the future, you should continue to take 1 tablet on the day of the week that was chosen at the beginning of therapy.
There is also evidence of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates. Before initiating bisphosphonate therapy, patients with underlying risk factors (eg, cancer, chemotherapy, radiation therapy, corticosteroids, poor oral hygiene, anemia, coagulopathy, infection, gum disease) should undergo a dental examination with appropriate preventative dental treatment.
During treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw during bisphosphonate treatment, dental surgery may worsen the condition.
There are no data regarding the possible reduction in the risk of osteonecrosis of the jaw after discontinuation of bisphosphonates in patients requiring dental intervention.
Low-energy fractures (also known as stress fractures) of the proximal femoral shaft may occur in patients taking alendronic acid long-term. Fractures can occur after minimal or no trauma, and some patients may experience hip pain, often with outward signs of stress fractures weeks/months before a complete femur fracture occurs. Low-energy proximal femoral shaft fractures were often bilateral, so patients with a long-standing femoral shaft fracture taking bisphosphonates should have the contralateral hip evaluated. It is advisable to discontinue bisphosphonates in patients with stress fractures after assessing their condition based on an individual assessment of the risk/benefit ratio.
The decision to proceed with treatment must be made individually for each patient after a careful risk/benefit assessment, especially for patients with Barrett's esophagus.
