Sign Out
If any of the conditions/risk factors mentioned as follows is present, the benefits of Slinda should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using Slinda. 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 Slinda use should be discontinued.
Hyperkalemia: Drospirenone is an aldosterone antagonist with potassium sparing properties. In most cases, no increase of potassium levels is to be expected. However, it's recommended to check serum potassium levels during the first treatment cycle in women presenting with renal insufficiency and pre-treatment serum potassium in the upper reference range and during concomitant use of potassium sparing medicinal products (see Interactions).
Circulatory disorders: From epidemiological studies there is little evidence for an association between progestogen-only preparations and an increased risk of myocardial infarction or cerebral thromboembolism. Rather, the risk of cardiovascular and cerebral events is related to increasing age, hypertension, and smoking. In women with hypertension the risk of stroke may be slightly enhanced by progestogen-only preparations.
Although not statistically significant, some studies indicate that there may be a slightly increased risk of venous thromboembolism (deep venous thrombosis, pulmonary embolism) associated with the use of progestogen-only preparations. Generally recognized risk factors for venous thromboembolism (VTE) include a positive personal or family history (VTE in a sibling or a parent at a relatively early age), age, obesity, prolonged immobilization, major surgery or major trauma.
Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof and discontinuation of Slinda should be considered in case of prolonged immobilization due to surgery or illness.
Bone metabolism: Treatment with Slinda leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is currently unknown whether the decrease in estradiol serum levels may have a clinically relevant effect on bone mineral density. Loss of bone mineral density is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if bone mineral density decrease in this population will reduce peak bone mass and increase the risk for fracture in later life.
Breast Cancer: A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using oral contraceptives (OCs), mainly using estrogen-progestogen preparations. The excess risk gradually disappears during the course of the 10 years after cessation of combined OC (COC) use. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The breast cancers diagnosed in users of OCs tend to be less advanced clinically than the cancers diagnosed in those who have never used OCs.
The risk of having breast cancer diagnosed in users of progestogen-only preparations is possibly of similar magnitude to that associated with COC. However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs.
Other tumours: In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of combined hormonal contraceptives. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur.
Liver function: Discontinue Slinda if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may require the discontinuation of Slinda use until markers of liver function return to normal and Slinda causation has been excluded.
Diabetes: Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using POPs such as Slinda. However, diabetic patients should be carefully observed during the first months of use. Special attention should be paid to diabetic patients with vascular involvement.
Other conditions: If a sustained hypertension develops during the use of Slinda, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Slinda should be considered.
Like with any other hormonal contraceptive, chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Slinda.
Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see Adverse Reactions). Depression can be serious and is well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; (hereditary) angioedema.
Each white active tablet contains 17.50 mg of lactose anhydrous and each green placebo tablet contains 55.50 mg of lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Medical examination/consultation: Prior to the initiation or reinstitution of Slinda a complete medical history (including family history) should be taken and pregnancy must be ruled out. Blood pressure should be measured, and a physical examination should be performed, guided by the contra-indications (see Contraindications) and warnings (see Precautions). The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given. The frequency and nature of examinations should be based on established practice guidelines and be adapted to the individual woman.
Women should be advised that oral contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
Reduced efficacy: The efficacy of POPs may be reduced in the event of e.g. missed tablets (see Dosage & Administration), gastro-intestinal disturbances (see Dosage & Administration) or concomitant medication (see Interactions).
Laboratory tests: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
Effects on ability to drive and use machines: No studies on the influence on the ability to drive and use machines have been performed with Slinda. No effects on ability to drive and use machines have been observed in users of oral hormonal contraceptives.
Use in Pregnancy: Ectopic pregnancy: The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills. Despite the fact that Slinda consistently inhibits ovulation ectopic pregnancy should be taken into account in the differential diagnosis if the woman presents amenorrhoea or abdominal pain.
Changes in the menstrual bleeding pattern: Disruption of the menstrual bleeding pattern may occur during use of hormonal contraceptives that inhibit ovulation, including Slinda.
If the bleeding is very frequent and irregular, another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out. Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test.
The treatment should be stopped if a pregnancy occurs.
