Ozempic®

Ozempic is a medicine with the active substance semaglutide, developed by Novo Nordisk. It belongs to the group of GLP-1 receptor agonists — medicines that help lower blood glucose by mimicking a natural hormone released after meals.

Ozempic is used in adults with type 2 diabetes when diet and physical activity alone are not sufficient to control blood glucose levels. It can be used as monotherapy (on its own) or in combination with other glucose-lowering medicines such as metformin, sulfonylureas or insulin.

During treatment, body weight may also decrease, but Ozempic is not approved for weight loss. For weight management with semaglutide there is a separate product: Wegovy, which is specifically authorised for weight loss and weight maintenance in people with obesity or overweight.

Source: SmPC Ozempic (EMA, latest version).

Below you’ll find brief pen-use information. Always read the package leaflet or ask your doctor/pharmacist for advice.

Important information about the pen

• Injection: once weekly, on a fixed day.
• Each pen contains multiple doses; use a new needle for each injection.
• After first use, the pen can be used for up to 6 weeks at ≤ 30 °C (see leaflet).

Checks before each injection

1. Attach a new needle and check flow (a drop should appear).
2. Set the prescribed dose and inject according to the instructions.
3. Rotate injection sites (abdomen, thigh, upper arm).

Storage

• Unopened: in a refrigerator (2–8 °C), do not freeze; protect from light.
• After first use: up to 6 weeks at room temperature (max. 30 °C).

Source: Leaflet/SmPC Ozempic.

Semaglutide is a GLP-1 receptor agonist. It mimics the action of the natural hormone GLP-1, which is released after a meal. This causes the pancreas to release more insulin when blood glucose is high, the liver to reduce glucose output, and gastric emptying to slow. Together this helps lower blood glucose in type 2 diabetes.

Source: SmPC §5.1.

Ozempic is not approved for weight loss. In clinical studies in adults with type 2 diabetes, an average reduction in body weight was observed; this relates to effects on gastric emptying and appetite. For weight management with semaglutide there is a separate product:
Wegovy, which is specifically approved for weight loss and weight maintenance.

Source: SmPC §5.1.

Ozempic can be prescribed for adults with type 2 diabetes when diet and exercise alone are insufficient. It can be combined with other antidiabetic medicines (e.g. metformin, SU derivatives or insulin) as directed by your doctor.

Not intended for: type 1 diabetes or diabetic ketoacidosis; children/adolescents < 18 years (safety not established).

Source: SmPC §4.1.

Ozempic is available by prescription only. A licensed physician will assess whether you meet the medical criteria and can then issue a prescription.

Source: SmPC §4.1.

Pricing is set by the pharmacy and depends on strength and pack size. The SmPC does not contain pricing information. Ask your pharmacy for current costs.

Indication

Ozempic: type 2 diabetes. Wegovy: weight loss/weight maintenance. Saxenda: weight loss/weight maintenance. Mounjaro: weight loss/weight maintenance and type 2 diabetes.

Active substance and class

Ozempic/Wegovy: semaglutide (GLP-1). Saxenda: liraglutide (GLP-1). Mounjaro: tirzepatide (GIP + GLP-1).

Dosage/frequency

Ozempic/Wegovy/Mounjaro: once weekly (titration per SmPC). Saxenda: once daily (titration per SmPC).

Regulatory status/availability

Ozempic: authorised for type 2 diabetes. Wegovy: authorised for weight management. Saxenda: authorised for weight management. Mounjaro: authorised for weight management and type 2 diabetes.

Sources: SmPCs via EMA and internal pages: Wegovy, Saxenda, Mounjaro.

Possible side effects

• nausea
• diarrhoea
• vomiting
• constipation
• abdominal pain
• indigestion (heartburn)
• decreased appetite
• injection-site reactions (redness, itching, pain)

Other reported side effects

• dizziness
• tachycardia (fast heartbeat)
• pancreatitis (inflammation of the pancreas)
• gallbladder disorders (such as gallstones)
• changes in kidney function in case of dehydration
• hypersensitivity reactions (rash, angioedema)
• worsening of diabetic retinopathy with rapid glycaemic improvement

Serious side effects — contact your doctor immediately

• persistent severe abdominal pain (possible pancreatitis)
• severe or prolonged nausea/diarrhoea (dehydration or kidney injury)
• swelling of face, lips, tongue or throat (possible allergic reaction)
• pain in the upper right abdomen or jaundice (gallbladder/liver problems)
• sudden worsening of vision (diabetic retinopathy)

Sources: SmPC §4.8.

Do not use Ozempic if:

• you are hypersensitive to semaglutide or any excipients;
• you have type 1 diabetes or diabetic ketoacidosis;
• you are a child or adolescent under 18 years (safety and efficacy not established).

Use caution when combining with insulin or sulfonylureas (risk of hypoglycaemia); dose adjustment may be required.

Source: SmPC §4.3 / §4.4.

Use during pregnancy and breastfeeding is not recommended. There are insufficient data in humans; women planning pregnancy should discuss timely discontinuation with their doctor.

Source: SmPC §4.6.

Ozempic is given as a subcutaneous (under the skin) injection. Below you can read where to inject and what to consider before first use.

• Do not inject into a vein or muscle.
• Suitable injection sites:
  • front of the thigh
  • abdomen (front of the waist)
  • upper arm
• Before first use, have your doctor or nurse show you how to use the pen.

Source: Leaflet/SmPC Ozempic.

• • EMA – SmPC/Leaflet Ozempic (semaglutide)
  • SmPCs of comparator products via ema.europa.eu and internal pages: Wegovy, Saxenda, Mounjaro