Risarteva (Tablets) Instructions for Use

Marketing Authorization Holder

Teva, LLC (Russia)

Manufactured By

Teva Pharmaceutical Works, Private Limited Company (Hungary)

ATC Code

M05BA07 (Risedronic acid)

Active Substance

Risedronic acid (Rec.INN WHO registered)

Dosage Form

Risarteva

Film-coated tablets, 35 mg: 4 or 12 pcs.

Dosage Form, Packaging, and Composition

4 pcs. – PVC/PVDC/aluminum foil blisters (1) – cardboard packs.
4 pcs. – PVC/PVDC/aluminum foil blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Bone resorption inhibitor for osteoporosis

Pharmacotherapeutic Group

Bone resorption inhibitor – bisphosphonate

Pharmacological Action

Bone resorption inhibitor. Risedronate binds to hydroxyapatite at the cellular level and suppresses osteoclast function, reducing bone resorption.

The time to reach the maximum therapeutic effect is 3 months, and the duration of the therapeutic action is 16 months.

Pharmacokinetics

Absorption from the gastrointestinal tract is rapid and dose-independent.

Taking the drug 30 minutes before breakfast or 2 hours after lunch reduces absorption by 55%, and taking it 1 hour before breakfast reduces absorption by 30% compared to taking it on an empty stomach (no food or fluid intake for 10 hours before or 4 hours after a meal).

Plasma protein binding is 24%. C_max is 1 hour. V_d is 6.3 L/kg. 60% of the administered dose accumulates in bone tissue. It is not metabolized. T_1/2 in the initial phase is 1.5 hours, and in the terminal phase is 220 hours.

It is excreted in feces unchanged or by the kidneys (within 24 hours – 50% of the absorbed dose, 28 days – 85% of the absorbed dose). Renal clearance is 105 ml/min, total clearance is 122 ml/min.

Renal clearance is independent of the drug concentration; there is a linear relationship between renal clearance and creatinine clearance.

Indications

Postmenopausal osteoporosis (prevention and treatment), glucocorticoid-induced osteoporosis (prevention and treatment in men and women).

ICD codes

Dosage Regimen

Take orally once daily. Swallow the tablet whole with a full glass (200 ml) of plain water. Do not chew or suck the tablet.

Take at least 30 minutes before the first food, beverage, or other medication of the day. Alternatively, take 2 hours or more after a meal.

For postmenopausal osteoporosis (treatment and prevention), the dose is 5 mg once daily.

For glucocorticoid-induced osteoporosis (treatment and prevention in men and women), the dose is 5 mg once daily.

For Paget’s disease of bone in adults, the dose is 30 mg once daily for 2 months. A repeat course may be considered after a 2-month treatment-free interval if indicated.

After taking the tablet, remain in an upright position (sitting or standing). Do not lie down for at least 30 minutes after ingestion and until after the first food of the day.

Do not take concurrently with medications or supplements containing calcium, magnesium, aluminum, or iron, as they significantly reduce absorption.

Ensure adequate intake of calcium and vitamin D through diet or supplements during therapy.

Adverse Reactions

From the digestive system: abdominal pain (including gastralgia), dysphagia, belching, glossitis, esophagitis, duodenitis, esophageal and gastric ulcers, colitis, diarrhea or constipation, nausea; sometimes – impaired liver function.

From the nervous system: headache, dizziness, asthenia, unusual fatigue, calf muscle cramps, myasthenia.

From the sensory organs: acute iritis (scleral hyperemia, eye pain), amblyopia, blurred vision, dry eye mucosa, tinnitus.

Allergic reactions: skin rash.

Other: bone pain, arthralgia, bronchitis (cough), sinusitis, chest pain, peripheral edema, minor transient hypocalcemia and hypophosphatemia.

Contraindications

Renal failure (creatinine clearance less than 30 ml/min), hypocalcemia, age under 18 years (efficacy and safety of use have not been established).

Use in Pregnancy and Lactation

Use during pregnancy is only possible if the intended benefit to the mother outweighs the potential risk to the fetus.

During breastfeeding, the use of the drug should be discontinued.

Use in Renal Impairment

Contraindicated in renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

Contraindicated under 18 years of age (efficacy and safety of use have not been established).

Special Precautions

Use with caution in erosive-ulcerative lesions of the gastrointestinal mucosa.

To monitor treatment effectiveness, it is recommended to determine alkaline phosphatase activity.

To increase the transit speed through the gastrointestinal tract and reduce unwanted effects on the gastrointestinal mucosa, patients are advised not to lie down for 30 minutes after taking risedronic acid.

During treatment, it is recommended to follow an adequate diet with sufficient calcium and vitamin D. If necessary, additional calcium and vitamin D supplements may be prescribed.

During treatment, minor asymptomatic decreases in plasma calcium and phosphorus concentrations may occur.

Foods, beverages, and medicines containing calcium, magnesium, aluminum, or iron should not be taken simultaneously with risedronic acid.

Cases of osteonecrosis of the jaw have been reported in patients with malignant neoplasms treated with bisphosphonates. Risk factors include malignant neoplasms, chemotherapy, glucocorticoid use, and poor oral hygiene.

Drug Interactions

Medicines containing calcium, magnesium, aluminum, or iron may reduce the absorption of the active substance.

It is compatible with hormone replacement therapy agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.