Tolerability
Slynd® has demonstrated an acceptable tolerability profile.1
Slynd® was generally well-tolerated by participants during clinical trials. The most commonly reported adverse events (AEs) in long-term clinical trials of >9 cycles of treatment with Slynd® (2,700 women) were acne (3.8%), metrorrhagia (2.9%), headache (2.7%), and breast pain (2.2%).
Possible side effects of Slynd®
Common: 1 in 10
- Headache
- Nausea or abdominal pain
- Changes in sexual desire, altered mood
- Acne
- Breast discomfort, painful periods, bleeding and
irregular menstrual periods - Weight gain
Uncommon: 1 in 100
- Anaemia (decreased number of the red blood cells), fatigue (tiredness), fluid retention
- Dizziness
- Vomiting, diarrhoea, constipation
- Vaginal infections
- Increased amount of the following, shown in blood tests: potassium, liver enzymes (ALT, AST, GGT), bilirubin, creatine phosphokinase, triglycerides
- Appetite changes
- Uterine leiomyoma (benign tumour of the uterus)
- Depressed mood, depression, anxiety
- Absence of menstrual periods, altered menstrual bleeding, pelvic pain, ovarian cysts, vaginal discharge and dryness
- Hair loss, increased sweating, itching, rash, seborrhoea (greasy skin), dermatitis (inflammation of the skin)
- Elevated blood pressure, hot flushes
- Hypersensitivity
Rare: 1 in 1000
- Contact lens intolerance
- Weight loss
- Excessive amount of urine
- Breast cyst, breast secretion, abnormal cervical smear, genital itching
Contraindications & Special Warnings 1
Contraindications1
POPs like Slynd® 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 Slynd® 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
Special warnings and precautions for use.1
If any of the conditions/risk factors mentioned is present, the benefits of Slynd® should be weighed against the possible risks for each individual and discussed before starting Slynd®. In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide whether Slynd® use should be discontinued.
- Hyperkalaemia
- Circulatory disorders
- Loss of bone mineral density
- Breast cancer
- Other tumours
- Disturbances in liver function
- Hypertension
- Chloasma gravidarum
- Depressed mood
- Depression
- Suspected ectopic pregnancy (presenting with amenorrhoea or abdominal pain)
- Diabetic patients (particularly with vascular involvement)
Reporting Side Effects
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to Exeltis UK Limited by email to pharmacovigilance.uk@exeltis.com
References: 1. Slynd® Summary of Product Characteristics.
