THERAPEUTIC INDICATIONS:

Contraception.

CONTRAINDICATIONS:

Progestogen-only contraceptives (POCs) like Slinda should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during Slinda use, the medicinal product should be discontinued immediately

 Active venous thromboembolic disorder

·         Presence or history of severe hepatic disease as long as liver function values have not returned to normal

·         Severe renal insufficiency or acute renal failure

·         Known or suspected sex-steroid sensitive malignancies.

·         Undiagnosed vaginal bleeding.

·         Hypersensitivity to the active substance or to any of the excipients

Undesirable effects:

Changes in the bleeding pattern was an adverse reaction frequently reported in the clinical trials.

The most commonly reported adverse reactions in long-term clinical trials of more than 9 cycles of treatment with (2,700 women) were acne (3.8%), metrorrhagia (2.9%), headache (2.7%) and breast pain (2.2%).

Common side effect ≥ 1/100 to < 1/10:

Libido disorder Mood disturbances, Headache, Nausea Abdominal pain, Acne, Breast discomfort Metrorrhagia Vaginal haemorrhage Dysmenorrhea Menstruation irregular, Weight increased.

Uncommon (≥ 1/1,000 to < 1/100):

Vaginal infection, Uterine leiomyoma, Anaemia, Hypersensitivity, Appetite disorder Hyperkalaemia, Anxiety symptoms Depression Depressed mood, Dizziness, Hot flush Hypertension, Vomiting Diarrhoea Constipation, Alopecia Hyperhidrosis Rash Seborrhoea Pruritus Dermatitis, Amenorrhoea Menstrual disorders Pelvic pain Ovarian cyst Vulvovaginal dryness Vaginal discharge, Fatigue Oedema peripheral, Transaminases increased Blood bilirubin increased Blood creatine phosphokinase increased GammaGlutamyltransferase increased Blood triglycerides increased

Rare (≥ 1/10,000 to < 1/1,000):

Polyuria, Breast cyst Cervical dysplasia Galactorrohoea Vulvovaginal pruritus, Weight decreased

Dosage and administration:

One tablet is to be taken daily for 28 consecutive days, one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days.