Rybelsus 3 mg (Semaglutide) 10 Tablets

Rybelsus 3 mg is manufactured in oral tablet form:

• Dosage Form and Packaging: 1 blister contains 10 tablets. Original factory packaging contains 1 blister card (10 tablets) or 3 blister cards (30 tablets).
• Active Substance: Semaglutide — 3 mg per single tablet.
• Excipients: Salcaprozate sodium (SNAC) — absorption enhancer, microcrystalline cellulose, povidone K90, magnesium stearate.

Pharmacodynamics: Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. It acts as a GLP-1 receptor agonist, selectively binding to and activating GLP-1 receptors. The drug stimulates glucose-dependent insulin secretion from pancreatic beta cells, decreases glucagon hypersecretion, and slows gastric motility, protecting against postprandial glucose spikes.

Pharmacokinetics: Salcaprozate sodium (SNAC) causes a local increase in pH and facilitates the absorption of semaglutide in the stomach. Peak plasma concentration is achieved 1 to 2 hours post-dose. The elimination half-life is approximately 1 week, maintaining steady-state plasma levels with daily administration. Excreted as metabolites via urine and feces.

Rybelsus 3 mg is prescribed by a physician for the following conditions:

• 🔹 Type 2 Diabetes Mellitus (Monotherapy): In adult patients when diet and exercise alone do not provide adequate glycemic control and metformin is considered inappropriate due to intolerance or contraindications.
• 🔹 Combination Therapy: In combination with other glucose-lowering medicinal products (metformin, thiazolidinediones, SGLT2 inhibitors, insulin) when glycemic control is insufficient.
• 🔹 Initiation Phase: The 3 mg dose is used exclusively as an initial adaptation dose for the first 30 days of therapy.

Rybelsus 3 mg is intended strictly for oral administration:

• 💊 Initial Adaptation Dose: The starting dose is 3 mg (1 tablet) once daily for 30 days. This dose is intended for gastrointestinal adaptation and is not therapeutically effective for glycemic control.
• ⏱️ Dose Escalation: After 30 days, the dose must be increased to a maintenance dose of 7 mg once daily (if needed, further escalated to 14 mg once daily under medical supervision).
• ⚠️ Strict Administration Rules: Take the tablet on an empty stomach upon waking, swallowed whole with a small sip of plain water (no more than 120 ml). Wait at least 30 minutes before eating, drinking, or taking other oral medications.

The use of Rybelsus 3 mg is contraindicated in the following conditions:

• ❌ Hypersensitivity to semaglutide or to any of the excipients.
• ❌ Personal or family history of medullary thyroid carcinoma (MTC).
• ❌ Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• ❌ Type 1 diabetes mellitus and treatment of diabetic ketoacidosis.
• ❌ Severe gastrointestinal disorders (e.g., severe gastroparesis).
• ❌ Pregnancy and breastfeeding period.

When using Rybelsus 3 mg concurrently with other medicinal products, consider the following factors:

• ⚠️ Oral Medications: Delayed gastric emptying may affect the rate and extent of absorption of other co-administered oral drugs.
• ⚠️ Insulin and Sulfonylureas: Increased risk of hypoglycemia; a reduction in the dose of insulin or sulfonylurea may be required.
• ⚠️ Levothyroxine Sodium: Total exposure of thyroxin may increase by 33% when co-administered (monitoring of thyroid parameters is recommended).

The use of Rybelsus 3 mg during pregnancy and lactation is strictly contraindicated. When planning a pregnancy, discontinuation of the medication at least 2 months in advance is required due to the long half-life of semaglutide. Breastfeeding must be discontinued if therapy becomes necessary.

Side effects of Rybelsus 3 mg occur most frequently in the gastrointestinal system during the initial adaptation period:

• 🤢 Gastrointestinal System (Very Common): Nausea, diarrhea, vomiting, decreased appetite, dyspepsia, abdominal pain, constipation, flatulence.
• 📉 Metabolic Disorders: Hypoglycemia (when used in combination with insulin or sulfonylureas).
• 🧠 Nervous System (Common): Dizziness, fatigue, dysgeusia (taste alteration).
• 🔬 Laboratory Parameters: Increased lipase and amylase activity, slight increase in heart rate.

Symptoms of Overdose: Severe nausea, persistent vomiting, severe diarrhea, risk of hypoglycemia (especially in combination therapy).

Overdose Treatment: There is no specific antidote. Symptomatic and supportive treatment should be initiated based on clinical manifestations. Prolonged observation is necessary due to the long half-life of semaglutide.

Rules for storing Rybelsus 3 mg:

• 🌡️ Temperature Regime: Store at temperatures between 15 °C and 30 °C in the original package.
• 💧 Moisture Protection: Store in the original blister to protect from moisture and light. Do not transfer tablets to other containers.
• 👶 Safety: Keep safely out of reach of children. Do not use past the expiration date.

To confirm the authenticity of Rybelsus 3 mg, pay attention to the following features:

• 🛡️ Packaging and Logo: The official logo of Novo Nordisk (Apis bull in a circle) is printed on the front of the box. White-and-green design featuring a yellow-green graphic block with a clear "3 mg" indication.
• 🔍 Marking: The batch number (Batch No.), date of manufacture (Mfg Date), and expiration date (Exp Date) are embossed or printed on the side of the box and blister.
• 📦 Tablet and Blister Form: Tablets are packaged in a specialized moisture-barrier blister. Each tablet has a distinct shape and embossing indicating the dosage (3 on one side).