Leaflet QSIVA 11.25mg / 69mg modified-release capsules

Indicated for: weight management

Route of administration: oral

Substance: phentermine + topiramate (anti-obesity agent + antiepileptic)

ATC: A08AA51 (Alimentary tract and metabolism | Antiobesity preparations, excl. diet products | Centrally acting antiobesity products)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Glaucoma warning
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Suicidal ideation / mental changes
Suicidal ideation / mental changes

Seek medical help if suicidal thoughts or major behavior changes occur.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Vision disturbances
Vision disturbances

This medicine may cause vision disturbances.

The combination of phentermine and topiramate is used for the management of obesity in patients who have not succeeded in losing weight through diet and exercise. Phentermine is an appetite suppressant, while topiramate helps reduce cravings and increase feelings of fullness.

The medication is taken orally, usually once daily, and should be used as directed by your doctor. It is important to combine the treatment with a healthy lifestyle to achieve the best results.

Side effects may include insomnia, dizziness, dry mouth, constipation, or, in rare cases, psychiatric or cardiovascular disorders.

Patients should inform their doctor about any other medications being used or pre-existing conditions, such as hypertension or kidney diseases, to ensure the safe use of this combination.

General data about QSIVA 11.25mg / 69mg

  • Substance: phentermine + topiramate
  • Date of latest medicines list: 01-02-2025
  • Product code: W70854001
  • Concentration: 11.25mg / 69mg
  • Pharmaceutical form: modified-release capsules
  • Quantity: 14
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: CATALENT GERMANY SCHORNDORF GMBH - GERMANIA
  • Holder: VIVUS BV - TARILE DE JOS
  • Number: 15768/2025/01
  • Shelf life: 3 years

Concentrations available for phentermine + topiramate

  • 11.25mg/69mg
  • 15mg/92mg
  • 3.75mg/23mg
  • 7.5mg/46mg