Ulipristal 30mg Film-Coated Tablets - Summary of Product Characteristics

1. Name of the Medicinal Product

• Product Name: Ulipristal 30 mg film-coated tablet

2. Composition

• Active Ingredient: 30 mg ulipristal acetate
• Excipients: 240 mg lactose (as monohydrate), 1.35 mg sodium

3. Pharmaceutical Form

• Form: Film-coated tablet, white, round, biconvex, embossed with U30

4. Clinical Particulars

4.1 Therapeutic Indications

• Use: Emergency contraception within 120 hours (5 days) after unprotected sexual intercourse or contraceptive failure.

4.2 Posology and Method of Administration

• Dosage: One tablet orally as soon as possible, no later than 120 hours.
• Note: Repeat dose if vomiting occurs within 3 hours.
• Special Considerations:
  • No dose adjustment for renal impairment.
  • Not recommended for severe hepatic impairment.
  • Suitable for adolescents.
• Administration: Oral, with or without food.

4.3 Contraindications

• Do Not Use If: Hypersensitivity to ulipristal acetate or excipients.

4.4 Special Warnings and Precautions

• Occasional Use: Not a replacement for regular contraception.
• Pregnancy: Do not use if pregnant, does not interrupt pregnancy.
• Effectiveness:
  • Not guaranteed post-ovulation.
  • Reduced efficacy with higher BMI.
• Menstrual Changes: Possible early or delayed periods.

4.5 Interactions

• CYP3A4 Inducers: Reduce efficacy; avoid use.
• CYP3A4 Inhibitors: Increase concentration; clinically insignificant.
• Other Drugs: May impair hormonal contraceptives.

4.6 Fertility, Pregnancy, Lactation

• Pregnancy: Not intended for use during pregnancy.
• Breastfeeding: Not recommended for one week post-intake.

4.7 Effects on Ability to Drive

• Caution: Possible dizziness, somnolence, blurred vision.

4.8 Undesirable Effects

• Common Side Effects: Headache, nausea, abdominal pain, dysmenorrhea.

4.9 Overdose

• Information: Doses up to 200 mg reported without major safety concerns.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

• Mechanism: Selective progesterone receptor modulator, delays ovulation.
• Efficacy: Non-inferior to levonorgestrel, effective up to 120 hours.

5.2 Pharmacokinetic Properties

• Absorption: Rapid, peak at ~1 hour.
• Distribution: Highly bound to plasma proteins.

5.3 Preclinical Safety Data

• Non-Clinical Findings: No special hazards identified.

6. Pharmaceutical Particulars

6.1 List of Excipients

• Lactose monohydrate, pregelatinised starch, sodium starch glycolate, magnesium stearate, among others.

6.3 Shelf Life

• Duration: 24 months

6.4 Storage

• Conditions: Protect from light, no special temperature needed.

7. Marketing Authorisation Holder

• Company: Zentiva Pharma UK Limited

8. Authorisation Number

• Number: PL 17780/1150

9. Date of Authorisation

• Date: 24/07/2023

10. Date of Revision

• Date: 24/07/2023

Company Contact Details

• Address: First Floor, Andrews House, College Road, Guildford, Surrey, UK
• Customer Service: +44 (0)844 8793 188
• Medical Information: +44 (0)800 090 2408
• Email: [email protected], [email protected]