Endosis 2

✔️ Dosage & Administration

• Treatment may begin on any day of the menstrual cycle.
• Recommended dose: 2 mg once daily, taken continuously without any break.
• Tablets should be taken at approximately the same time each day, with liquid if needed.
• Treatment should continue regardless of vaginal bleeding.
• A new pack should be started immediately after finishing the previous one

Children: Not indicated before menarche; safety in adolescents is not established.

Elderly: No relevant indication for geriatric use..

✔️ Missed Dose

If a tablet is missed, take one 2 mg tablet as soon as remembered, then continue the next dose at the usual time.

If vomiting or diarrhea prevents absorption, an additional 2 mg tablet should be taken.

✔️ Side Effect

Adverse effects are more common during the initial months of therapy and generally decrease with continued use.

Commonly Reported

1. Headache (9%)
2. Breast discomfort (5.4%)
3. Depressed mood (5.1%)
4. Acne (5.1%)

Other Reported Effects

1. Nervous system: Migraine
2. Cardiac: Palpitations (uncommon)
3. Vascular: Hypotension (uncommon)
4. Gastrointestinal: Nausea, abdominal pain, flatulence
5. Metabolic: Weight gain (3.6%)
6. Psychiatric: Irritability, nervousness, mood changes

✔️ Drug Interaction

Dienogest is primarily metabolized by the CYP3A4 enzyme system. Concomitant use with CYP3A4 inhibitors may increase plasma levels and the risk of adverse effects.

Notable interacting drugs include:

1. Azole antifungals (ketoconazole, itraconazole, fluconazole)
2. Macrolide antibiotics (erythromycin, clarithromycin)
3. Calcium channel blockers (verapamil, diltiazem)
4. Protease inhibitors (ritonavir, saquinavir)
5. Certain antidepressants (fluoxetine, fluvoxamine, and nefazodone)

✔️ Endosis should not be used in patients with:

• Hypersensitivity to dienogest or any excipient
• Active or past venous thromboembolism
• Cardiovascular or cerebrovascular disease
• Diabetes mellitus with vascular complications
• Severe hepatic disease or liver tumors
• Known or suspected hormone-dependent malignancy
• Undiagnosed vaginal bleeding

✔️ Overdose Effects

Clinical studies indicate no significant risk of acute toxicity following overdose. Doses of 20–30 mg/day over 24 weeks were well tolerated. No specific antidote is required; supportive care is sufficient.

✔️ Pregnancy & Lactation

Pregnancy: Endosis should not be used during pregnancy, as treatment of endometriosis is not required during this period.

Lactation: Use is not recommended during breastfeeding due to potential excretion in breast milk. A risk-benefit decision should be made regarding the continuation of breastfeeding or therapy.

✔️ Precautions & Warnings

• Pregnancy must be excluded before initiating therapy.
• Non-hormonal contraception (e.g., barrier methods) should be used if pregnancy prevention is required.
• Changes in menstrual bleeding patterns are common.
• Contraindicated in patients with severe hepatic impairment.
• Ovulation may be suppressed, but Endosis is not a contraceptive.

✔️ Storage:

Store below 30°C, protected from light and moisture.
Keep out of the reach of children.