BELANGRIJK: HOE DEZE INFORMATIE TE GEBRUIKEN: Dit is een samenvatting en bevat NIET alle mogelijke informatie over dit product. Deze informatie garandeert niet dat dit product veilig, effectief of geschikt voor u is. Deze informatie is geen individueel medisch advies en vervangt het advies van uw zorgverlener niet. Vraag uw zorgverlener altijd om volledige informatie over dit product en uw specifieke gezondheidsbehoeften.
PROGESTIN/ESTROGEN CONTRACEPTIVE – ORAL (proe-JES-tin/ES-troe-jen)
WAARSCHUWING: Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. These hormones prevent pregnancy in 3 ways. One way is by preventing the release of an egg (ovulation). A second way is by changing the cervical mucus, making it more difficult for an egg to meet sperm (fertilization). A third way is by changing the womb lining, making it difficult for a fertilized egg to attach to the lining of the womb (implantation). A fertilized egg (embryo/unborn baby) needs to attach to the womb to receive blood and nutrients and continue to grow. If an embryo/unborn baby does not attach, it cannot survive.
Besides preventing pregnancy, birth control pills have been shown to help make your periods more regular, decrease blood loss and painful periods (dysmenorrhea), and decrease your risk of ovarian cysts.
Use of this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea, chlamydia).
HOE TE GEBRUIKEN?:
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Benodigde tijd: 00 dagen 00 uur 05 minuten
Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your pills and what to do if you miss a dose. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth once daily or as directed by your doctor. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.
It is very important to continue taking this medication exactly as prescribed by your doctor. With certain brands of birth control pills, the amount of estrogen and progestin in each active tablet will vary at different times in the cycle. Therefore, it is very important that you follow the package instructions to find the first tablet, start with the first tablet in the pack, and take them in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.
- Inname van dit medicijn
Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.
- Pill pack contains
Your pill pack contains 21 pills with active medication. It may also contain 7 reminder pills with no medication. Take one active pill (with hormones) once daily for 21 days in a row. If you are using a product with 28 tablets, take an inactive pill once daily for 7 days in a row after you have taken the last active pill unless otherwise directed by your doctor. If you are using a product with 21 tablets, do not take any tablets for 7 days unless otherwise directed by your doctor. You should have your period during the fourth week of the cycle. After you have taken the last inactive tablet in the pack or gone 7 days without taking an active tablet, start a new pack the next day whether or not you have your period. If you do not get your period, consult your doctor.
- First time
If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (e.g., patch, other birth control pills), take the first tablet in the pack on the first Sunday following the beginning of your menstrual period or on the first day of your period. If your period begins on a Sunday, begin taking this medication on that day. For the first cycle of use only, use an additional form of non-hormonal birth control (e.g., condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you start on the first day of your period, you do not need to use back-up birth control the first week.
Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (e.g., patch, other birth control pills) to this product. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.
- stomach cramping/bloating
- vaginal discomfort/irritation
- increased vaginal fluids
- or breast tenderness/enlargement may occur
- Acne may improve or get worse.
- Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.
If any of these effects persist or worsen, notify your doctor promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.
Denk eraan dat uw arts dit medicijn heeft voorgeschreven omdat hij of zij heeft geoordeeld dat het voordeel voor u groter is dan het risico op bijwerkingen. Veel mensen die dit medicijn gebruiken, hebben geen ernstige bijwerkingen.
Tell your doctor immediately if any of these serious side effects occur:
- changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods)
- problem wearing contact lenses
- dark patches on the skin (melasma)
- unwanted facial/body hair
- swelling of the ankles/feet
- weight changes (gain or loss)
This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience:
- sudden shortness of breath
- chest/jaw/left arm pain
- coughing up blood
- sudden dizziness/fainting
- pain/swelling/warmth in the groin/calf
- tingling/weakness/numbness in the arms/legs
- headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches)
- onduidelijke spraak
- weakness on one side of the body
- vision problems/changes
Tell your doctor immediately if any of these rare but very serious side effects occur:
- lumps in the breast
- severe stomach/abdominal/pelvic pain
- mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping)
- unusual tiredness
- donkere urine
- vergelende ogen/huid
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:
- jeuk/zwelling (vooral van het gezicht/tong/keel)
- ernstige duizeligheid
- moeite met ademhalen
Dit is geen volledige lijst van mogelijke bijwerkingen. Als u andere effecten bemerkt die hierboven niet zijn vermeld, neem dan contact op met uw arts of apotheker.
In het VK – Bel uw arts voor medisch advies over bijwerkingen.
In het Verenigd Koninkrijk – Bel uw arts voor medisch advies over bijwerkingen.
Before using this medication, tell your doctor or pharmacist if you are allergic to any estrogens (e.g., ethinyl estradiol, mestranol) or any progestins (e.g., norethindrone, desogestrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
- This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, liver problems (e.g., liver tumor, active liver disease), current or suspected pregnancy, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (e.g., pills, patch), unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over).
- Before using this product, tell your doctor your medical history, especially of: high blood pressure, high cholesterol or triglyceride (blood fat) levels, depression, diabetes, swelling (edema), gallbladder problems, kidney disease, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems.
- Do not smoke cigarettes or use tobacco. Hormonal birth control (e.g., pills, injections, devices) combined with smoking significantly increases your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist, or consult the Patient Information Leaflet that comes with this product.
- If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.
- Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions.
- This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.
- If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.
- It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.
- This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.
This medication passes into breast milk. This may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
De effecten van sommige medicijnen kunnen veranderen als u tegelijkertijd andere medicijnen of kruidenproducten gebruikt. Dit kan uw risico op ernstige bijwerkingen vergroten of ervoor zorgen dat uw medicijnen niet correct werken. Deze geneesmiddelinteracties zijn mogelijk, maar komen niet altijd voor. Uw arts of apotheker kan vaak interacties voorkomen of beheersen door de manier waarop u uw medicijnen gebruikt te veranderen of door nauwlettend toezicht te houden.
Om uw arts en apotheker te helpen u de beste zorg te geven, moet u uw arts en apotheker op de hoogte stellen van alle producten die u gebruikt (inclusief geneesmiddelen op recept, geneesmiddelen zonder recept en kruidenproducten) voordat u met de behandeling met dit product begint. Als u dit product gebruikt, mag u de dosering van andere geneesmiddelen die u gebruikt niet starten, stoppen of wijzigen zonder toestemming van uw arts.
Sommige producten die kunnen interageren met dit medicijn zijn onder meer:
- aromatase inhibitors (e.g., anastrazole, exemestane)
- sodium tetradecyl sulfate
- medication for underactive thyroid (hypothyroidism)
- drugs that may increase blood levels of this drug (e.g., acetaminophen, ascorbic acid/vitamin C, atorvastatin, azole antifungals such as itraconazole/ketoconazole/vaginal miconazole)
Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.
Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include:
- certain beta blockers (e.g., metoprolol)
- corticosteroids such as prednisolone
- certain benzodiazepines such as lorazepam/temazepam
- and theophylline, among others.
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.
This medication can affect the results of certain lab tests (e.g., blood tests for clotting factors, thyroid). Make sure laboratory personnel and all your doctors know you use this medication.
Dit document bevat niet alle mogelijke interacties tussen geneesmiddelen. Houd een lijst bij van alle producten die u gebruikt. Deel deze lijst met uw arts en apotheker om uw risico op ernstige medicatieproblemen te verminderen.
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe nausea and vomiting. Females may experience sudden/unusual vaginal bleeding.
OPMERKINGEN: Deel dit medicijn niet met anderen.
Keep all appointments with your doctor and the laboratory. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (pap smear). Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.
Missed dose advice is different depending on the brand used and the number of doses missed. Refer to the product package information for advice on missed doses. You may need to use back-up birth control (e.g., condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.
If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control.
- Store at room temperature between 59-86 degrees F (between 15-30 degrees C) away from light and moisture.
- Bewaar niet in de badkamer.
- Houd alle medicijnen uit de buurt van kinderen en huisdieren.
- Spoel medicijnen niet door het toilet of giet ze niet in een afvoer, tenzij u hierom wordt gevraagd.
- Gooi dit product op de juiste manier weg wanneer het is verlopen of niet langer nodig is.
Raadpleeg uw apotheker of plaatselijk afvalverwerkingsbedrijf voor meer informatie over het veilig weggooien van uw product.