Product Information:

SEM-O 14mg Tablets contain Semaglutide 14mg, the maximum approved dose of oral semaglutide, a once-daily GLP-1 receptor agonist used for the treatment of type 2 diabetes mellitus in adults. It is formulated with SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate), an absorption enhancer that enables gastric uptake of this peptide-based drug.

This is the final maintenance dose in the oral semaglutide regimen, used after successful titration from 3mg to 7mg.

✅ Note: This aligns with the globally approved Rybelsus® 14mg, the highest strength for oral semaglutide in diabetes management.

Uses of (SEM-O 14MG TABS):

1. Type 2 diabetes mellitus – for patients requiring maximal glycemic control
2. Adjunct to diet and exercise to improve blood glucose and HbA1c levels
3. May contribute to cardiovascular risk reduction (based on injectable semaglutide outcomes)

❌ Not approved for weight loss—oral semaglutide is indicated only for type 2 diabetes, unlike injectable semaglutide (Wegovy® 2.4mg) for obesity.

Key Benefits of (SEM-O 14MG TABS):

1. Most effective oral GLP-1 agonist for HbA1c reduction (up to 1.8–2.0%)
2. Promotes clinically meaningful weight loss (average 5–7 kg)
3. Once-daily tablet—no injections required
4. Low risk of hypoglycemia when used without insulin or sulfonylureas
5. Convenient for patients averse to injectables

How To Use (SEM-O 14MG TABS):

1. Take once daily in the morning, on a completely empty stomach.
2. Swallow whole with no more than 120 mL (4 oz) of plain water only.
3. Wait at least 30 minutes before eating, drinking (other than water), or taking other medications.
4. Do not split, crush, or chew the tablet.

Dosing Protocol:

1. Start: 3mg once daily for ≥30 days
2. Step up: 7mg once daily for ≥30 days
3. Maintenance: 14mg once daily (maximum dose)
4. Do not initiate directly at 14mg—titration is mandatory to improve tolerability.

When Not to Use (SEM-O 14MG TABS):

Do not use if you have:

1. Type 1 diabetes or diabetic ketoacidosis
2. Personal or family history of medullary thyroid carcinoma (MTC)
3. Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. Hypersensitivity to semaglutide or any excipients

⚠️ Black Box Warning:

Semaglutide causes thyroid C-cell tumors in rodents. It is contraindicated in patients with personal or family history of MTC or MEN 2.

Side Effects of (SEM-O 14MG TABS):

Common (more frequent at 14mg, but usually transient):

1. Nausea, vomiting, diarrhea, constipation
2. Abdominal pain, bloating, decreased appetite
3. Dyspepsia, gastroesophageal reflux

Less common:

1. Fatigue, dizziness
2. Elevated amylase/lipase

Serious (rare but require vigilance):

1. Acute pancreatitis (severe, persistent upper abdominal pain radiating to back)—discontinue immediately
2. Worsening diabetic retinopathy (in patients with pre-existing disease)
3. Acute kidney injury (from dehydration due to GI losses)
4. Gallbladder disease (gallstones, cholecystitis)
5. Seek emergency care if severe abdominal pain, vision changes, or persistent vomiting occurs.

Dosage: (SEM-O 14MG TABS):

1. Maximum maintenance dose: 14mg once daily
2. Only after completing ≥30 days on 7mg
3. Not for daily use beyond 14mg

Who It’s For (SEM-O 14MG TABS):

Adults with type 2 diabetes who have completed stepwise titration and require optimal glycemic and weight control, and who can adhere to strict dosing instructions.

Warnings & Precautions:

1. Maintain adequate hydration to prevent renal injury
2. Monitor kidney function periodically
3. Use caution in patients with diabetic retinopathy or history of pancreatitis/gallstones
4. Educate on proper administration—absorption fails if taken with food or other meds

Drug Interactions:

1. Other oral drugs: May have delayed or reduced absorption—administer ≥30 minutes apart
2. Insulin or sulfonylureas: ↑ Risk of hypoglycemia
3. Always inform your doctor about all medications.

Additional Information:

1. Store in original blister pack at room temperature (<30°C)
2. Keep out of reach of children
3. Available by prescription in Pakistan