Foroza, 70 mg 8 pcs.

Bone resorption inhibitor.

Aminobisphosphonate is an analogue of pyrophosphate.

The mechanism of action is associated with inhibition of osteoclast activity.

Indications

Active ingredient

Composition

1 film-coated tablet contains:

the 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;

coating composition:

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

How to take, the dosage

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

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

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

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

3. Do not lie down until the first meal, which should not be more than 30 minutes after taking the pills.

4. The drug should not be taken before going to bed or before getting out of bed in the morning.

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

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

In patients with significant renal impairment (creatinine Cl less than 35 mL/min), use of the drug is not recommended because there is no experience with this population.

Interaction

Simultaneous use of calcium preparations (including food supplements) and antacids impairs absorption of alendronate. In this regard, it is recommended to take other medicinal products not earlier than 30 minutes after taking Foroza.

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

While no specific studies on drug interactions have been conducted, the use of alendronate in clinical trials with a large number of commonly used drugs has not been accompanied by the development of clinically significant interactions.

Special Instructions

Drink Foroz tablets only with plain water, because other drinks (including mineral water, tea, coffee, fruit juices) impair absorption of the drug. Taking alendronate before bedtime or while lying in a horizontal position increases the risk of esophagitis.

If symptoms of esophageal irritation, such as dysphagia, sore throat pain, or the onset/worsening of existing heartburn occur, patients should see their physician to evaluate the possibility of continuing therapy. The risk of severe esophageal side effects is higher in patients who take alendronic acid in violation of these instructions and/or continue taking it after the onset of symptoms indicative of esophageal irritation. It is important to explain the rules of taking the drug in detail to the patient and make sure they understand them. Patients should be aware of the increased risk of esophageal adverse events if they do not follow the instructions.

Hypocalcemia and other metabolic disorders (such as vitamin D deficiency) should be corrected prior to initiating therapy with Forosa. Due to increased bone mineral density with alendronate therapy a slight clinically asymptomatic decrease of serum calcium and phosphate levels is possible especially in GCS-treated patients whose calcium absorption may be decreased. Therefore, ensuring adequate intake of calcium and vitamin D in the body is especially important in patients receiving GCS.

Patients should be cautioned that if they accidentally miss the once weekly dosage, they should take 1 tablet on the morning of the next day (it is not acceptable to take 2 tablets on the same day). Thereafter, they should continue to take 1 tablet on the day of the week that was chosen at the start of therapy.

There are also reports of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates. Patients with underlying risk factors (e.g., cancer, chemotherapy, radiation therapy, use of GCS, poor oral hygiene, anemia, coagulopathy, infection, gum disease) should undergo a dental examination with appropriate prophylactic dental treatment before bisphosphonate therapy is indicated. During treatment, these patients should avoid invasive dental interventions whenever possible. For patients who developed osteonecrosis of the jaw during bisphosphonate treatment, surgical dental intervention may exacerbate the condition.

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

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

Low-energy fractures of the proximal femoral diaphysis have often been bilateral, so patients with a long-standing femoral diaphysis fracture who are taking bisphosphonates should have the opposite femur evaluated. Discontinuation of bisphosphonates in patients with stress fractures is appropriate after an assessment of their condition based on an individual risk/benefit assessment.

The decision to treat must be made for each patient individually after a thorough risk/benefit assessment, especially for patients with Barrett’s esophagus.

Impact on the ability to drive vehicles and engage in other activities requiring increased concentration and rapid psychomotor reactions. Alendronic acid has no effect on the ability to drive vehicles and engage in other activities requiring increased concentration and rapid psychomotor reactions.

Special precautions for disposal of unused drug. No special precautions are necessary when disposing of unused product.

Contraindications

Hypersensitivity to alendronate or other Foroza components; oesophageal strictures or achalasia and other conditions resulting in delayed esophageal movement; inability of patient to stand or sit for 30 minutes; hypocalcemia; severe renal insufficiency (creatinine Cl less than 35 ml/min); severe mineral metabolism disorders; pregnancy; lactation period; childhood (efficacy and safety of use are not established).

With caution: patients with gastrointestinal diseases, such as dysphagia, gastritis, duodenitis, acute peptic ulcer, active gastrointestinal bleeding or upper GI surgery in the past, and hypovitaminosis D.

Side effects

Gastrointestinal disorders: often – abdominal pain, dyspeptic disorders (constipation or diarrhea, flatulence), dysphagia, heartburn; infrequently – nausea, vomiting, esophagitis, gastritis; rarely – stricture of the esophagus, ulceration of mucosa of the mouth, pharynx, esophagus, stomach and duodenum, upper GI bleeding, melena; very rarely – esophageal perforation.

Nervous system disorders: frequency is unknown – dizziness, perversion of taste, headaches, irritability.

An organ of vision: rare – scleritis, uveitis (inflammation of the choroid of the eye) and inflammation of the episcleral connective tissue.

Skin and subcutaneous tissue disorders: very rare – hypersensitivity reactions (including cutaneous hyperemia, urticaria, angioedema, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis); frequency unknown – alopecia, photosensitivity.

Skeletal, muscular and connective tissue: often – muscle pain, bone pain; rarely – marked pain in the muscles of the bones and joints; frequency unknown – osteonecrosis of the jaw, low-energy fractures of the proximal diaphysis of the femur, swollen joints.

Laboratory findings: very rare – asymptomatic transient hypocalcemia and hypophosphatemia.

Overdose

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

Treatment: symptomatic. The use of milk and antacid drugs for binding alendronate is indicated. Due to the risk of esophageal damage, vomiting should not be induced, the patient should be in an upright position.

Pregnancy use

There are no data on the use of alendronic acid in pregnant women. In animal studies it was revealed disturbance of fetal bone formation when using high doses of alendronic acid, dysfunction of labor associated with hypokalemia. The drug should not be used during pregnancy.

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

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