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SLYND is a brand name for Drospirenone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Contraception
Verbatim from this product's MHRA label. Tap a section to expand.
Posology How to take Slynd 4 mg film-coated tablets 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. Tablets must be taken every day at about the same time of the day so that the interval between two tablets is always 24 hours.
Tablets should be taken in the order shown on the blister. Stickers marked with the 7 days of the week are provided. The woman should choose the sticker that starts with the day she begins taking the tablets and stick it on the blister.
The first tablet of the treatment should be taken on the first day of menstrual bleeding. Thereafter tablet taking is continuous. A subsequent pack is started immediately after finishing the previous pack, without a break in daily tablet intake.
How to start Slynd 4 mg film-coated tablets No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman’s natural cycle (first day of her menstrual bleeding). When doing so, no additional contraceptive measures are necessary.
Following first-trimester abortion After first-trimester abortion it is recommended to start Slynd 4 mg film-coated tablets immediately after abortion took place. In that case there is no need to use an additional contraceptive method.
Following delivery or second-trimester abortion Contraceptive treatment with Slynd 4 mg film-coated tablets is recommended to start between 21 and 28 days after delivery or second trimester abortion. If contraceptive treatment with Slynd 4 mg film-coated tablets is initiated later but before the menstruations have returned, pregnancy must be ruled out and an additional method of contraception should be used for the first week.
6. Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch) The woman should start Slynd 4 mg film-coated tablets preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch.
In these cases, the use of an additional contraceptive is not necessary. The woman may also start Slynd 4 mg film-coated tablets at the latest on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet taking an additional barrier method is recommended.
Changing from a progestogen-only-method (progestogen-only pill (POP), injection, implant) or from a progestogen-releasing intrauterine system (IUS) The woman may switch any day from another POP and should start Slynd 4 mg film- coated tablets the day after, within 24 hours of discontinuing the previous POP.
1). 2%). Tabulated list of adverse reactions Adverse reactions that have been reported in short- and long- term clinical trials with Slynd 4 mg film-coated tablets are listed in the table below. All adverse reactions are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
1) Common Uncommon Rare Infections and infestations Vaginal infection Neoplasms benign. malignant and unspecified Uterine leiomyoma Blood and lymphatic system disorders Anaemia Immune system disorders Hypersensitivity Metabolism and nutrition disorders Appetite disorder Hyperkalaemia Psychiatric disorders Libido disorder Mood disturbances Anxiety symptoms Depression Depressed mood Nervous system disorders Headache Dizziness Eye disorders Contact lens intolerance Vascular disorders Hot flush Hypertension Gastrointestinal disorders Nausea Abdominal pain Vomiting Diarrhoea Constipation Skin and subcutaneous tissue disorders Acne Alopecia Hyperhidrosis Rash Seborrhoea Pruritus Dermatitis Renal and urinary disorders Polyuria Reproductive system and breast disorders Breast discomfort Metrorrhagia Vaginal haemorrhage Dysmenorrhea Menstruation irregular Amenorrhoea Menstrual disorders Pelvic pain Ovarian cyst Vulvovaginal dryness Vaginal discharge Breast cyst Cervical dysplasia Galactorrohoea Vulvovaginal pruritus General disorders and administration site conditions Fatigue Oedema peripheral Investigations Weight increased Transaminases increased Blood bilirubin increased Blood creatine phosphokinase increased Gamma- Glutamyltransferase Weight decreased increased Blood triglycerides increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
If any of the conditions/risk factors mentioned below is present, the benefits of Slynd 4 mg film-coated tablets should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using Slynd 4 mg film-coated tablets.
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 4 mg film-coated tablets 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. 5). 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 Slynd 4 mg film-coated tablets should be considered in case of prolonged immobilization due to surgery or illness.
Bone metabolism Treatment with Slynd 4 mg film-coated tablets 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.
Progestogen-only contraceptives (POCs) like Slynd 4 mg film-coated tablets 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 4 mg film- coated tablets 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. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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A woman may switch from an implant or following IUS removal on the same day that the implant or IUS is removed. A woman may switch from using an injectable contraceptive and should start Slynd 4 mg film-coated tablets on the day the next injection was due to occur.
In all of these cases, the use of an additional contraceptive is not necessary. Management of missed tablets Tablets should be taken every 24 hours. If the woman is less than 24 hours late in taking any single tablet, contraceptive protection is not reduced.
The woman should take the tablet as soon as she remembers and should take further tablets at the usual time. If the user is more than 24 hours late in taking any white, active tablet, contraceptive protection may be reduced and use of a barrier method such as a condom should be considered for the next 7 days.
The missed tablet should be taken as soon as it is remembered, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. If tablets were missed in the first week after initiation of Slynd 4 mg film-coated tablets and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.
If tablets were missed in the third week of pill taking, the risk of reduced reliability is imminent because of the forthcoming 4-day hormone-free interval. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented.
The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take the active tablets at her usual time. The user is advised not to take the placebo pills and continue straight on to the next active blister pack.
Missed (green) placebo tablets can be disregarded. However, they should be discarded to avoid unintentionally prolonging the interval between active tablet taking. , vomiting or diarrhea), absorption may not be complete and additional contraceptive measures should be taken.
If vomiting or diarrhea occurs within 3-4 hours after tablet taking, a new (replacement) tablet should be taken as soon as possible. The new tablet should be taken within 24 hours of the usual time of tablet-taking if possible. 2 “Management of missed tablets”, is applicable.
If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) from another blister pack. Paediatric population Safety and efficacy of Slynd 4 mg film-coated tablets have been established in women of reproductive age.
Safety and efficacy are expected to be the same for post pubertal adolescents under the age of 18 and users 18 years and older. Use of this product before menarche is not indicated. Method of administration Oral use.
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.
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 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 Slynd 4 mg film-coated tablets consistently inhibits ovulation ectopic pregnancy should be taken into account in the differential diagnosis if the woman presents amenorrhoea or abdominal pain. Liver function Discontinue Slynd 4 mg film-coated tablets 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 Slynd 4 mg film-coated tablets use until markers of liver function return to normal and Slynd 4 mg film-coated tablets 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 Slynd 4 mg film-coated tablets.
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 Slynd 4 mg film-coated tablets, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Slynd 4 mg film-coated tablets should be considered.
Like with any other hormonal contraceptive, chloasma may occasionally occur, especially in […]