Rybelsus Tablets Semaglutide 7 mg (30 Tablets)

Rybelsus

Prescription Medicine

Antidiabetic / GLP-1 Receptor Agonist

Authorised as a prescription Only medicine by major regulatory agencies such as MHRA (UK), EMA (EU) and FDA (US).
Manufactured in accordance with Good Manufacturing Practice (GMP) standards.
Complies with relevant pharmacovigilance and risk management requirements for GLP 1 receptor agonists.

Authorised as a prescription Only medicine by major regulatory agencies such as MHRA (UK), EMA (EU) and FDA (US).
Manufactured in accordance with Good Manufacturing Practice (GMP) standards.
Complies with relevant pharmacovigilance and risk management requirements for GLP 1 receptor agonists.

Antidiabetic / GLP-1 Receptor Agonist

Description

Rybelsus 7 mg is a prescription oral tablet containing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for adults with type 2 diabetes mellitus whose blood sugar is insufficiently controlled with diet and exercise alone or in combination with other antidiabetic medicines. Taken once daily, it helps improve glycaemic control by stimulating insulin release when blood glucose is high, reducing glucagon secretion, and slowing gastric emptying. The 7 mg strength is usually used after a 3 mg starter dose and may be either the maintenance dose or an intermediate step before titration to 14 mg, depending on individual treatment goals and tolerability.

Bnefits

Once-daily oral GLP-1 receptor agonist for adults with type 2 diabetes.
Helps lower blood sugar levels as an adjunct to diet and exercise.
Improves glycaemic control by increasing glucose-dependent insulin secretion and reducing inappropriate glucagon release.
Slows gastric emptying, helping to reduce postprandial glucose spikes.
May support modest weight reduction in many patients as part of an overall treatment plan.
Oral formulation provides an alternative for patients who prefer tablets to injectable GLP-1 analogues.
Used after a 3 mg starter dose to help patients transition to an effective maintenance dose while minimising gastrointestinal side effects.
Can be used as monotherapy when metformin is inappropriate, or in combination with other antidiabetic medicines when indicated.

Indications

Adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications.
Adults with type 2 diabetes in combination with other medicinal products for the treatment of diabetes (e.g. metformin, SGLT2 inhibitors, sulfonylureas, insulin) where use of a GLP-1 receptor agonist is clinically appropriate.
Patients who have completed at least one month of 3 mg once-daily Rybelsus and require titration to 7 mg for improved glycaemic control.

Composition

Active ingredient: semaglutide 7 mg per tablet.
Inactive ingredients (excipients may vary slightly by market): salcaprozate sodium (SNAC), povidone (K90), microcrystalline cellulose, magnesium stearate.
Each tablet also contains sodium (approximately 23 mg per tablet, about 1% of the recommended maximum daily sodium intake for an adult).

Formulation

Film-coated oral tablets containing 7 mg semaglutide.
Available strengths in the range: 3 mg, 7 mg and 14 mg semaglutide tablets.
GLP-1 receptor agonist, analogue of human GLP-1, with once-daily oral dosing.
Pack of 30 tablets, providing a one-month supply at 7 mg once daily.

Packaging

Blister packs containing 30 film-coated tablets of Rybelsus 7 mg.
Outer carton printed with product name, strength, active ingredient, batch number and expiry date.
Includes a patient information leaflet with detailed instructions, safety information and guidance on use and storage.

Usage

Rybelsus must be prescribed and supervised by a healthcare professional experienced in the management of type 2 diabetes.
Usual dose titration: start with 3 mg once daily for 1 month, then increase to 7 mg once daily. After at least 1 month at 7 mg, the dose may be increased to 14 mg once daily if additional glycaemic control is needed and tolerated.
Take Rybelsus once daily on an empty stomach in the morning, with no more than 120 mL (about 4 ounces) of plain water.
After taking the tablet, wait at least 30 minutes before eating, drinking anything other than water, or taking any other oral medicines.
Swallow tablets whole; do not split, crush or chew.
If a dose is missed, skip the missed dose and take the next dose the following day at the usual time; do not take an extra tablet to make up for a missed dose.
Continue diet and exercise measures as recommended by the healthcare professional.
Do not use Rybelsus for type 1 diabetes or diabetic ketoacidosis, and do not use as a substitute for insulin.
Regularly monitor blood glucose and, where appropriate, HbA1c; adjust other antidiabetic medicines (especially insulin or sulfonylureas) to reduce the risk of hypoglycaemia as advised by the prescriber.

Contraindications

Hypersensitivity to semaglutide or any of the excipients.
Patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) in some markets, in line with local product information and regulatory guidance.
Severe gastrointestinal disease such as gastroparesis may warrant avoidance or very cautious use.
Use is not recommended in pregnancy or during breastfeeding; women planning pregnancy should discontinue semaglutide in advance according to local prescribing information.
Not indicated for use in children and adolescents under 18 years of age.

Adverse Effects

Very common gastrointestinal side effects: nausea, diarrhoea, vomiting, abdominal pain, decreased appetite and constipation, especially during dose escalation; these are usually mild to moderate and often diminish over time.
Possible hypoglycaemia, particularly when used in combination with insulin or sulfonylureas; dose adjustment of those agents may be required.
Other potential side effects: dyspepsia, gastritis, reflux, fatigue, dizziness and headache.
Risk of pancreatitis has been reported with GLP-1 receptor agonists; patients should be counselled about symptoms such as persistent severe abdominal pain and advised to seek urgent medical attention if they occur.
Possible risk of gallbladder-related events (e.g., cholelithiasis, cholecystitis).
Small increases in heart rate have been observed in some patients.
Hypersensitivity reactions including rash and, rarely, anaphylaxis may occur.
In animal studies, semaglutide caused thyroid C-cell tumours; relevance to humans is uncertain but underlies precautions for patients at risk of medullary thyroid carcinoma.

Storage Conditions

Store at room temperature in a dry place, typically below 25–30°C depending on local product label.
Keep tablets in the original blister pack to protect from moisture and light.
Do not use after the expiry date shown on the carton and blister.
Keep out of the sight and reach of children.
Do not store in the bathroom or other high-humidity environments.

Duration

Long-term treatment for chronic management of type 2 diabetes, as determined by the prescribing clinician based on individual response, tolerability and treatment goals. Therapy may be continued as long as clinical benefit outweighs potential risks and no contraindications develop.

Onset

Blood glucose improvements typically begin within the first weeks of therapy as the dose is titrated from 3 mg to 7 mg, with full effects on glycaemic control generally assessed over several weeks to months of stable dosing.