Forosa, pills 70mg, 8pcs

Composition

1 film-coated tablet contains:

Active ingredient:

alendronate sodium trihydrate 91.350 mg, which corresponds to the content of alendronic acid 70 mg;

excipients:

microcrystalline cellulose,

colloidal anhydrous silicon dioxide,

croscarmellose sodium,

magnesium stearate;

shell composition:

Lustre Clear LC 103 (microcrystalline cellulose, carrageenan, macrogol 8000).

Pharmacological action

Inhibitor of bone resorption.

Aminobisphosphonate, is an analog of pyrophosphate.

The mechanism of action is associated with the suppression of osteoclast activity.

Indications

• treatment of osteoporosis in men to prevent fractures;
• treatment of osteoporosis in postmenopausal women, including to reduce the risk of compression fractures of the spine and hip fractures;
• treatment of osteoporosis caused by prolonged use of corticosteroids.

Use during pregnancy and lactation

There are no data on the use of alendronic acid in pregnant women. Animal studies revealed a violation of fetal bone formation when using high doses of alendronic acid, labor dysfunction associated with hypokalemia. Do not use the drug during pregnancy.

It is not known whether alendronic acid penetrates into human breast milk, so if it is necessary to use alendronic acid during lactation, the question of stopping breastfeeding should be decided.

Contraindications

• hypersensitivity to alendronate or other components of the drug Foroz;
• stricture or achalasia of the esophagus and other conditions, leading to the slower movement of food through the esophagus;
• the inability of the patient to stand or sit for 30 minutes;
• hypocalcemia;
• severe renal insufficiency (Cl creatinine less than 35 ml/min);
• severe disorders of mineral metabolism;
• pregnancy;
• lactation;
• children’s age (efficacy and safety not established).

With caution: patients with gastrointestinal diseases such as dysphagia, gastritis, duodenitis, acute peptic ulcer disease, active gastrointestinal bleeding or surgery on the upper gastrointestinal tract in the anamnesis, hypovitaminosis D.

Side effects

From the gastrointestinal tract: often-abdominal pain, dyspeptic disorders (constipation or diarrhea, flatulence), dysphagia, heartburn; infrequently-nausea, vomiting, esophagitis, gastritis; rarely-esophageal strictures, ulceration of the mucous membrane of the mouth, pharynx, esophagus, stomach and duodenum, bleeding from the upper gastrointestinal tract, melena; very rarely-esophageal perforation.

Nervous system disorders: frequency unknown — dizziness, taste distortion, headaches, irritability.

From the side of the organ of vision: rarely-scleritis, uveitis (inflammation of the choroid of the eye) and inflammation of the episcleral connective tissue.

From the skin and subcutaneous tissues: very rarely-hypersensitivity reactions (including skin hyperemia, urticaria, angioedema, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis); frequency unknown — alopecia, photosensitivity.

Musculoskeletal and connective tissue disorders: often-muscle pain, bone pain; rarely-severe pain in muscles, bones and joints; frequency unknown-osteonecrosis of the jaw, low-energy fractures of the proximal femoral diaphysis, joint swelling.

Laboratory parameters: very rarely — asymptomatic transient hypocalcemia and hypophosphatemia.

Interaction

Concomitant use of calcium supplements (including dietary supplements) and antacids impairs the absorption of alendronate. In this regard, it is recommended to take other medications no earlier than 30 minutes after taking the drug Forosa.

NSAIDs (including acetylsalicylic acid) may increase the gastrointestinal side effects of alendronic acid.

Despite the fact that no specific drug interaction studies have been conducted, the use of alendronate in clinical trials with a large number of widely used drugs was not accompanied by the development of a clinically significant interaction.

How to take, course of use and dosage

To ensure proper absorption of the drug, Forosa tablets should be taken on an empty stomach in the morning, washed down with a glass of ordinary water (at least 200 ml), at least 30 minutes before the first meal, drinks or other medications. Other beverages (including mineral water) may reduce the absorption of the drug.

To reduce the risk of esophageal irritation, Forosa tablets should be taken:

1. Only after fully waking up and getting out of bed.

2. Swallow whole (do not chew, dissolve or dissolve them in the mouth due to the possible formation of ulcers in the mouth and pharynx.

3. Do not take a horizontal position before the first meal, which should be made no earlier than 30 minutes after taking the tablets.

4. Do not take the drug before going to bed or before getting out of bed in the morning.

The recommended dose is 70 mg (1 tablet) once a week.

For elderly patients and patients with hepatic impairment, moderate renal impairment (creatinine clearance >35 ml / min), no dose adjustment is required.

In patients with severe renal impairment (creatinine clearance less than 35 ml / min), the drug is not recommended, since there is no experience of using it in this population.

Overdose

Symptoms: abdominal pain, dyspeptic disorders, dysphagia, heartburn, esophagitis, gastritis; hypocalcemia and hypophosphatemia may develop.

Treatment: symptomatic. Milk and antacids have been shown to bind alendronate. Due to the risk of damage to the esophagus, do not induce vomiting, the patient should be in an upright position.

Special instructions

Forosa tablets should only be washed down with plain water, as other beverages (including mineral water, tea, coffee, fruit juices) impair the absorption of the drug. Taking alendronate at bedtime or in a horizontal position increases the risk of esophagitis.

If symptoms of esophageal irritation occur, such as dysphagia, pain behind the sternum, or the occurrence/worsening of existing heartburn, patients should consult a doctor to evaluate the possibility of continuing therapy. The risk of severe side effects from the esophagus is higher in patients taking alendronic acid in violation of these instructions and / or continuing to take it after the onset of symptoms indicating irritation of the esophagus. It is important to explain in detail to the patient the rules for taking the drug and make sure that they understand them. Patients should be aware of the increased risk of esophageal adverse events if they deviate from the requirements of the instructions.

Hypocalcemia and other metabolic disorders (such as vitamin D deficiency) should be corrected before starting therapy with Forosa. Due to an increase in bone mineral density during alendronate therapy, there may be a slight clinically asymptomatic decrease in serum calcium and phosphate levels, especially in patients receiving corticosteroids, in which calcium absorption may be reduced. Therefore, ensuring that sufficient amounts of calcium and vitamin D are available in the body is particularly important in patients receiving corticosteroids.

Patients should be warned that if they accidentally miss taking the drug at a dosage of 1 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 are also reports of osteonecrosis of the jaw in patients with ostorosis treated with oral bisphosphonates. Prior to bisphosphonate therapy, patients with concomitant risk factors (e. g. 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 as much as possible. For patients who have developed osteonecrosis of the jaw during treatment with bisphosphonates, surgical dental intervention may worsen the condition.

There are no data on a possible reduction in the risk of developing osteonecrosis of the jaw after discontinuation of bisphosphonates in patients who require dental intervention.

Low-energy fractures (also known as fatigue fractures) of the proximal femoral diaphysis may occur in patients taking alendronic acid for a long time. Fractures may occur after minimal or no trauma, and some patients may experience hip pain, often with external signs of stress fractures several weeks/months before a complete femoral fracture occurs.

Low-energy fractures of the proximal femoral diaphysis were often bilateral, so patients with a long-term fracture of the femoral diaphysis taking bisphosphonates should be examined in the opposite thigh. Discontinuation of bisphosphonates in patients with stress fractures is advisable after assessing their condition based on an individual assessment of the risk / benefit ratio.

Treatment decisions should be made individually for each patient after careful assessment of the risk/benefit ratio, especially for patients with Barrett’s esophagus.

Influence on the ability to drive vehicles and engage in other activities that require increased concentration of attention and speed of psychomotor reactions. Alendronic acid does not affect the ability to drive vehicles and engage in other activities that require increased concentration of attention and speed of psychomotor reactions.

Special precautions when disposing of an unused product. There is no need for special precautions when disposing of an unused drug.

Form of production

Film-coated tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Alendronic Acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, For women in the menopausal period, For postmenopausal women

Indications

Menopause, Osteoporosis