What is Active?
Activelle is a combined hormone substitute preparation in tablet form containing estradiol (a natural estrogen) and norethisterone acetate (a gestagen). It is used for the treatment of inter-annual complaints in women whose last rule bleeding is at least 12 months.
The continuous combination of both hormones means that no menstrual bleeding occurs – unlike in sequential preparations. Activelle alleviates typical annual symptoms such as heat flashes, sleep disorders and vaginal dryness.
The gestagen norethisteron protects the cervical mucosa from the growth-promoting effect of the estrogen.
Active Ingredients & Mechanism of Action
Active ingredient: Estradiol 1 mg, Norethisteronacetat 0,5 mg
Activelle equals the hormone deficiency after the change years:
Estradiol (estrogen):
- Replaces the missing body's estrogen
- Relieves vasomotor symptoms (heatwalls, night sweat)
- Improves vaginal moisture
- Protects against bone wound
Norethisterone acetate (days):
- Protects the cervical mucosa (endometrium)
- Prevents endometrium hyperplasia
- Continuous administration = no bleeding
Continuous combination therapy: Both hormones are taken every day (no cycle), therefore usually no bleeding occurs.
Who is it suitable for?
Activelle is suitable for:
- Postmenopausal women (last bleeding > 12 months)
- Medium weight to heavy annual weights
- Women with intact uterus (stag protection required)
Advantages:
- bleeding-free (continuous therapy)
- One day a tablet
- Proven combination of active substances
Not suitable:
- Perimenopausal women (yet regular bleeding)
- Women after hysterectomy (no stags necessary)
- In contraindications against HRT
Available Dosages
Active film tablets:
- 1 mg of estradiol + 0.5 mg of norethisterone acetate
- 1 tablet daily, without a break
Therapy start:
- Early 12 months after the last control bleeding
- When converting sequential HRT: after completion of the cycle
Therapy duration:
- As short as possible, regular review (at least annually)
How to Take
Intake:
- 1 tablet daily with some water
- Always at the same time
- Independent meals
- Throughout without a break
For forgotten use:
- Pick up within 12 hours
- Then continue as usual
- No double dose
Important:
- regular inspections
- Breast examination and mammography according to recommendation
Contraindications
Do not apply at:
- Breast cancer (known or suspected)
- estrogen-dependent tumors
- Unexplained vaginal bleeding
- Active or earlier thrombosis/pulmonary embolism
- Active liver disease
- Porphyry
Preview at:
- Risk factors for thromboses
- uterus myomas
- Endometriosis
- Gallensteinleiden
- Migraine
- Diabetes mellitus
- High blood pressure
Pregnant period: Contraindicated.
Possible Side Effects
Acid (1-10%):
- Breast tensions
- Headaches
- stomach pain
- Lubrication (in the beginning)
Occasionally:
- Weight gain
- Mood changes
- nausea
- Blowing
- leg pain
Selten, but seriously:
- Venous thromboemboly
- Increased breast cancer risk in long-term therapy
- stroke
- bile stone diseases
** Most side effects are mild and better in the first few months.
Interactions
Reactions:
- CYP3A4 inductors (Carbamazepine, Phenytoin, Rifampicin, Johanniskraut) – reduced estrogen action
- CYP3A4 inhibitors – increased estrogen levels
- thyroid hormones – dose adjustment possible
Important: Johanniskraut can significantly reduce the effectiveness of HRT!
Frequently Asked Questions
Similar Medications
Is Active right for you?
A licensed doctor will review your information and issue a prescription if suitable. Discreet and secure.
Important Notice
This information does not replace medical advice. If you have questions about your health or the suitability of this medication, please consult a doctor. Read the package leaflet before use.