Details for: SLYND
Company: DUCHESNAY INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02522802 | SLYND | DROSPIRENONE | 4 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
SLYND is used to prevent pregnancy in girls and adult women aged 12 years and older who can become pregnant.
What it does
SLYND prevents the release of the egg from the ovary (ovulation).
SLYND is a progestin only pill. It only contains drospirenone. It does not contain any estrogen.
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
When it should not be used
- Are allergic to drospirenone or any of the other ingredients in this medicine or container.
- Have or have had kidney disease or kidney failure.
- Have or have had reduced adrenal gland function.
- Have or had cervical cancer or any cancer that is sensitive to progestin drugs.
- Have or have had liver problems, including liver tumors/cancer.
- Have or have had unexplained bleeding from your vagina.
What the medicinal ingredient is
Medicinal ingredient: drospirenone.
What the non-medicinal ingredients are
Non-medicinal ingredients of white active tablet (containing drospirenone): anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.
Non-medicinal ingredients of green inactive tablet (placebo): colloidal silicon dioxide, corn starch, FD&C blue 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow ferric oxide.
What dosage form it comes in
4 mg tablets
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SLYND. Talk about any health conditions or problems you may have, including if you:
- Have or have had cervical cancer (cervix).
- Have or have had breast cancer or a family history of it.
- Have or have had blood clots or a family history of it.
- Have or have had bone loss.
- Have diabetes or have high blood sugar levels.
- Have or have had unusual vaginal bleeding.
- Have high level of potassium in your blood (hyperkalemia).
- Have any other medical conditions and are taking other medicines for them.
- Are going to have surgery or will be on bed rest.
- Have or have had depression (feeling of sadness).
- Are or think you are pregnant.
- Have abdominal pain.
Other warnings you should know about:
Breast cancer
The risk of breast cancer in women increases as you get older. It also increases if there is family history of breast cancer, meaning if your mother or sister have or had breast cancer. Other factors that increase your risk for breast cancer are being obese, never having children, or having your first full-term pregnancy at a late age.
In a few women, using of birth control pills can speed up the growth of a breast cancer that has not yet been found. The risks for breast cancer related to using birth control pills seem to be small. You should, however, have a healthcare professional check your breasts at least once per year.
While you are taking SLYND, check your breasts often. See your healthcare professional if you notice any changes, such as:
- Dimpling or sinking of the skin,
- Changes in the nipple, or
- Any lumps you can see or feel.
Cervical cancer
Women who use birth control pills may have a higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners and exposure to the human papilloma virus (HPV).
Blood clots
Women who use birth control that contains hormones could develop blood clots in the lower leg, thigh or pelvis. There is more risk if you gave birth within 6 weeks or if you have a history of blood clots.
Diabetes
If you have diabetes, you might have a higher chance of high blood sugar while taking SLYND for the first few months. Your healthcare professional will monitor your health during this time.
Vaginal bleeding
Abnormal bleeding (breakthrough bleeding or spotting) sometimes happens in women using birth control pills including SLYND. This is blood coming from the vagina between periods. It is most likely to happen in the first 3 months of starting a birth control pill. The abnormal bleeding might go away over time or by changing to another birth control product. If the bleeding is heavy or does not stop, tell your healthcare professional.
Missing periods
You may miss periods when taking hormonal birth control, even if you are not pregnant. However, if you are having regular periods and then do not have one, it is possible that you may be pregnant. If you were not taking SLYND as directed by your healthcare professional, you should have a pregnancy test. This will rule out if the missed period is because you are pregnant.
High blood potassium levels
SLYND may increase the levels of potassium in your blood (hyperkalemia). Your healthcare professional may ask you to have blood tests to check your potassium levels.
Liver problems
SLYND can cause liver problems, including jaundice (yellowing of the skin or eyes). Your healthcare professional will do blood tests to check your liver health.
Use in pregnancy
Birth control pills should not be taken by pregnant women. Tell your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking SLYND if you get pregnant. You should check with your healthcare professional about risks to your unborn child from any medicines taken during pregnancy. If you want to get pregnant, talk to your healthcare professional before stopping SLYND.
Breast feeding
Very small amounts of drospirenone will pass into the breast milk. However, no effects on the baby are expected. Generally, pills that contain only a progestin used by nursing mothers did not change milk production, or the growth and development of the baby.
Check-ups and tests
Before starting SLYND, you will need to have examinations and tests. Your healthcare professional will conduct a physical exam. He or she will examine your breasts, liver, arms and legs. They will conduct a pelvic exam which includes a PAP smear. Your healthcare professional will also ask you some questions about your personal health history and that of your close relatives. He or she will also measure your blood pressure and do blood tests.
While you are taking SLYND, you will need to have regular check-ups with your healthcare professional. Your first check up should be about three months after starting SLYND. Afterward, you will see your healthcare professional about once per year. At these visits, your healthcare professional will conduct physical and internal exams. He or she will also measure your blood pressure and do blood tests.
If you are scheduled for any laboratory tests, be sure to tell your healthcare professional that you are taking SLYND. This is because birth control pills can affect some blood tests.
SLYND may not work as well as it should to prevent pregnancy if you:
- miss pills,
- don’t take your pills as directed by your healthcare professional,
- have gastrointestinal problems, or
- are taking certain medicines.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with SLYND:
- medicines used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole, griseofulvin;
- antibiotics such as rifabutin, rifampicin, rifampin, griseofulvin and clarithromycin;
- medicines used to treat nausea and vomiting such as aprepitant;
- medicines used to treat epilepsy (anticonvulsants) including felbamate, lamotrigine, oxcarbazepine, phenytoin, primidone, barbiturates, carbamazepine, topiramate, rufinamide, ethosuximide;
- immunosuppressors such as cyclosporines;
- medication used in the treatment of human immunodeficiency virus (HIV/AIDS) such as atazanavir, boceprevir, cobicistat, darunavir, darunavir-cobicistat, efavirenz, indinavir, nevirapine, ritonavir, atazanavir-cobicistat;
- drugs used to treat high blood pressure in the blood vessels between the heart and the lungs (pulmonary hypertension) including bosentan;
- St. John’s Wort, an herbal product used to treat depression and other conditions;
- non steroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems;
- potassium-sparing diuretics;
- potassium supplements;
- ACE inhibitors, Angiotensin-II receptor antagonists, aldosterone antagonists for the treatment of high blood pressure;
- heparin, used to treat blood clots.
This is not a complete list of possible drug interactions with SLYND. Talk to your healthcare professional for more information about drug interactions.
Proper use of this medication
How to take SLYND:
1. Be sure to read these directions: a. Before you start taking SLYND, and b. Anytime you are not sure what to do.
2. Have backup birth control, like condoms or spermicide, ready
3. Decide with your healthcare professional what is the best day and time for you to start taking your pill. Pick a time of day that will be easy to remember. It is important to take it at the same time every day and in the order as directed on your blister pack.
4. For Day 1 starters, pick the day label strip sticker that corresponds with the first day of your period (Day 1). For example, if your period begins on Monday, pick the day label strip with Monday as the first day.
5. Place the day label strip sticker on top of the pill blister pack over “Place day label here”. For example, if your period begins on Monday, place the day label strip with Monday as the first day on the top of your pill pack. Labelling the card with the days of the week will help remind you to take your pill everyday.
6. Look at your SLYND pill pack
- 24 white pills. These pills contain hormone to be taken for 24 days (days 1- 24).
- 4 green pills. These pills do not contain hormone and are considered placebo. These pills are to be taken for the last 4 days (days 25-28).
- Where to start taking pills; and
- The order to take the pills. Follow the arrows in the diagram. Take pills from left to right each week.
a. Each SLYND pill pack has:
b. Check the pill pack for:
7. Taking SLYND
- Take SLYND exactly as directed by your healthcare professional.
- Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack.
- Swallow pills whole.
- Take SLYND with or without food.
- Day 1 Start schedule: If you are not currently using a hormonal birth control method:
- Start SLYND on the first day (Day 1) of your period (Day 1 Start). Your healthcare professional should tell you when to start taking your birth control pill. You will use a Day 1 Start if your healthcare professional told you to take your first pill on the first day of your period.
- Take 1 white pill each day for 24 days in a row. You should finish all the white pills first.
- Then, take 1 green pill each day for 4 days in a row. Your period should start during this time.
- Take 1 pill every day in the order of the blister pack, at the same time each day, for 28 days.
- After taking the last pill on Day 28 from the blister pack, the next day start taking the first white pill (Day 1) from a new pack at your usual time. Follow the above schedule with each pack of SLYND. Take the first pill in the new pack whether or not you are having your period.
If you have trouble remembering to take SLYND, talk to your healthcare professional. They can advise on how to make pill-taking easier or about using another method of birth control.
You may miss your period while taking SLYND, even if you are not pregnant. However, tell your healthcare professional right away if you:
- miss a period and have not taken SLYND according to directions, or
- miss 2 periods in a row, or
- feel like you may be pregnant
These could mean you are pregnant. If you have a positive pregnancy test, you should stop taking SLYND.
Switching to SLYND from a different type of birth control:
- For any switch, always follow your healthcare professional’s instructions.
- If you are switching from another birth control pill to SLYND:
- Start your new SLYND blister pack on the same day that you would start the next pack of your previous birth control method.
- Do not continue taking the pills from your previous birth control pack.
- If you are switching from a vaginal ring or transdermal patch to SLYND:
- Start taking SLYND on the day you would have inserted the next ring or applied the next patch.
- If you are switching from a progestin-only method such as an implant or injection to SLYND:
- Start taking SLYND on the day of removal of your implant or on the day when you would have had your next injection.
- If you are switching from an intrauterine device or system (IUD or IUS) to SLYND:
- Start taking SLYND on the day of removal of your IUD or IUS.
Usual Dose:
Take one tablet per day.
Overdose:
Missed Dose
If you miss pills (including starting the blister pack late) you could get pregnant. If you miss more than 1 white pill, you will need to use a non-hormonal birth control method for 7 days. The more pills you miss, the more likely you are to get pregnant.
Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
| If you miss 1 white pill (active pills) | |
| If you miss 2 or more white pill (active pills) in a row | |
| If you miss 1 or more green pills (inactive pills) |
If you forget one pill or more pills two months in a row, talk to your healthcare professional. They will suggest ways to make pill-taking easier or about using another method of birth control.
If you vomit or have diarrhea within 3 to 4 hours of taking your pill:
- Take a new pill (the pill scheduled for the next day) as soon as possible within 12 hours of the usual time you take your pill.
- Continue taking all your remaining pills in order. Start the first pill of your next blister pack the day after finishing your current blister pack. This will be 1 day earlier than originally scheduled. Continue on your new schedule.
- If it has been more than 12 hours since the last pill was taken, see “Missed Dose” below for more directions.
If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. If you have sex within 7 days after 1 or more days of vomiting or diarrhea, use an extra type of birth control, like condoms or spermicide, as back-up.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking SLYND. If you experience any side effects not listed here, contact your healthcare professional.
- Acne
- Headache
- Mood swings
- Painful period cramps
- Rash, red and itchy skin
- Oily skin
- Pain: breast, back, body pain
- Muscle spasms
- Swelling
- Headaches, migraines
- Nose bleeds
- Hair loss
- Heavy sweating
- Hot flushes
- High blood pressure
- Dizziness, sense of spinning
- Eyes sensitive to contact lenses
- Breast tenderness, or increase in size
- Vomiting
- Diarrhea or constipation
- Feeling gassy
- Weight gain, obesity
- Decreased or increased appetite
- Feeling bloated
- Weakness, tiredness
- Dry vagina
- Mouth pain or burning feeling in the mouth
- Metallic taste
Many women may feel sick to their stomach (nauseous), especially during the first few months of taking SLYND. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare professional.
SLYND can cause abnormal blood test results. Your healthcare professional may do blood tests during your treatment.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| COMMON | |||
| Vaginal bleeding changes: increased or decreased menstrual bleeding, spotting, infrequent periods, delayed or absence of bleeding | ✔ | ||
| UNCOMMON | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | ✔ | ||
| Behavior and mood changes: agitation including aggressive behavior or hostility, anxiety, nervousness, changes in sexual desire or sexual activity, increased eating, stress | ✔ | ||
| Depression: Persistent feeling of sadness, difficulty sleeping or sleeping too much, weakness, lack of energy, fatigue | ✔ | ||
| Ectopic pregnancy or Miscarriage: breast tenderness; nausea; persistent lower abdominal pain or cramping; spotting and/or vaginal bleeding | ✔ | ||
| Hypersensitivity (allergic reaction): fever, skin rash, hives, itching, swelling, shortness of breath, wheezing, runny nose, itchy, watery eyes | ✔ | ||
| Hyperkalemia (high potassium levels in your blood): weakness or numbness in an arm or leg, palpitations or irregular heartbeats, nausea, vomiting, shortness of breath, severe pain in your chest | ✔ | ||
| Leg pain that will not go away, sudden unusually severe headache, sudden severe shortness of breath, chest pain as these could be a sign of blood clot forming in blood vessels | ✔ | ||
| Sudden change in vision or blindness as it could be a sign of blood clot forming in blood vessels | ✔ | ||
| Weakness or numbness in your arm or leg, trouble speaking as these could be a sign of blood clot forming in blood vessels | ✔ | ||
| Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness | ✔ | ||
| Reproductive system disorders, including ovarian cysts: Pelvic pain or spasms, painful intercourse, abdominal bloating or swelling, pain during bowel movements; cysts usually disappear on their own within a few months and may not show symptoms; serious cysts are uncommon | ✔ | ||
| Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): Pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine | ✔ | ||
| Uterine Fibroids (noncancerous growths in the wall of the uterus): abdominal pain, constipation, feeling the need to urinate more frequently, and vaginal bleeding | ✔ | ||
| Vaginal infections (inflammation of the vagina or surrounding area): itching, burning or unusual or increased vaginal discharge | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store in original package at room temperature (15 to 30°C).
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about SLYND:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website (https://www.duchesnay.com/en/), or by calling 1-888-666-0611.
This leaflet was prepared by Duchesnay Inc.
Last Revised November 30, 2021