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Demulen (Generic Estrogen and Progestin Oral Contraceptives)

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WARNING

The risk of severe side effects from oral contraceptives, such as heart attacks, blood clots, and strokes, is increased by smoking. Women over 35 who smoke heavily are at an increased risk (15 or more cigarettes per day). If you take oral contraceptives, you should not smoke.

Why is this medication prescribed?

Pregnancy can be avoided by using oral contraceptives, sometimes known as birth control tablets. Two female sex hormones are oestrogen and progestin. In order to prevent ovulation, oestrogen and progestin combinations are effective (the release of eggs from the ovaries). Also, they alter the uterine lining (womb) to stop pregnancy from occurring as well as the mucus at the cervix (uterine opening) to stop sperm (male reproductive cells) from entering. Although they are a fairly efficient means of birth control, oral contraceptives are unable to stop the transmission of the HIV virus, which is the cause of AIDS, and other sexually transmitted diseases.

Certain people also utilise specific brands of oral contraceptives to treat acne. Oral contraceptives treat acne by reducing the levels of specific naturally occurring chemicals that can contribute to acne.

Some oral contraceptives (Beyaz, Yaz) are also used to treat premenstrual dysphoric disorder symptoms in women who have chosen to use an oral contraceptive to prevent pregnancy (premenstrual dysphoric disorder symptoms are physical and emotional symptoms that happen each month before the menstrual period).

How should this medicine be used?

Oral contraceptives are available in packages of 21, 28, or 91 tablets that need to be swallowed once day, daily, or nearly daily during a regular cycle. Use oral contraceptives with meals or milk to prevent nausea. Every day, take your oral contraceptive at the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the directions on your oral contraceptive exactly. Never take it in larger or less amounts, more frequently, or for a longer period of time than your doctor has instructed.

Oral contraceptives are available under numerous brand names. Oral contraceptives come in a variety of brands, each of which has slightly different ingredients or dosages, slightly different instructions for use, and slightly different dangers and advantages. Make sure you are aware of the brand and precise instructions for the oral contraceptive you are using. Get a copy of the manufacturer’s information for the patient from your doctor or pharmacist and carefully study it.

If you have a packet of 21 tablets, take 1 tablet every day for 21 days before stopping for 7 days. then launch a fresh packet.

If your package contains 28, take 1 pill each day for 28 days straight in the order listed on your packet. The day after you take your 28th tablet, begin a new package. The following is the list of the upcoming events. Some 28-tablet packs have a mix of color-coded tablets with varying concentrations of oestrogen and progesterone, as well as additional color-coded tablets that may be inactive or contain a folate supplement.

Take 1 pill each day for 91 days if the package contains 91 tablets. There are three trays of pills in your packet. Once you have taken all of the tablets on all of the trays, begin with the first tablet on the first tray and continue taking 1 tablet per day in the sequence listed on the packet. Tablets from the previous batch are a different colour. Either an inert component or a very little amount of oestrogen could be present in these tablets. The day following the 91st tablet, begin your new packet.

When you should begin using your oral contraceptive, your doctor will instruct you. Often, oral contraceptives are started on the first or fifth day of your period, the first Sunday following it starts, or the day when bleeding starts. For the first 7 to 9 days that you take your oral contraceptive, your doctor will also advise you on whether you need to use another method of birth control and will assist you in making a decision. Pay close attention to these guidelines.

While taking the inactive pills, the low dose oestrogen pills, or the week that you don’t take your oral contraceptive, you may likely have withdrawal bleeding resembling a menstrual period. There won’t be any planned bleeding if you are taking a packet that solely contains active tablets, but there could be spotting and unexpected bleeding, especially early on in your therapy. Even if you are still bleeding, start taking your new package as directed.

If you vomit or have diarrhoea while taking an oral contraceptive, you might need to use a backup birth control method. Before starting your oral contraceptive, discuss this with your doctor so that you can get ready with a backup birth control option just in case. If you vomit or have diarrhoea while you are using an oral contraceptive, call your doctor to find out how long you should use the backup method.

Wait 4 weeks after delivery before starting oral contraceptives if you just gave birth. Ask your doctor when you should start using oral contraceptives if you’ve had an abortion or miscarriage.

Only when oral contraceptives are taken consistently will they be effective. Even if you are bleeding, experiencing stomach aches, or don’t believe you are likely to become pregnant, keep taking your oral contraceptives every day. Without consulting your doctor, do not stop using oral contraceptives.

Other uses for this medicine

In addition to treating endometriosis and heavy or irregular menstruation, oral contraceptives are sometimes used (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Discuss the dangers of using this drug for your illness with your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking oral contraceptives,

  • Inform your doctor and pharmacist as soon as possible if you have an allergy to oestrogen, progestin, or any other medications.
  • Inform your doctor and pharmacist about all prescription and non-prescription drugs, vitamins, and dietary supplements you are using. Make sure you bring up any of the following: Acetaminophen (APAP, Tylenol); antibiotics such as ampicillin (Principen), clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Erythrocin), isoniazid (INH, Nydrazid), metronidazole (Flagyl), minocycline (Dynacin, Minocin), rifabutin (Mycobutin), ‘Blood thinners’ or anticoagulants like warfarin (Coumadin); antifungal medications including itraconazole (Sporanox), ketoconazole (Nizoral), and griseofulvin (Fulvicin, Grifulvin, Grisactin); clofibrate (Atromid-S); atorvastatin (Lipitor); fluoxetine (Prozac, Sarafem, in Symbyax), cyclosporine (Neoral, Sandimmune), bosentan (Tracleer), cimetidine (Tagamet), danazol (Danocrine), delavirdine (Rescriptor), diltiazem (Cardizem, Dilacor, Tiazac), and HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); modafinil (Provigil); medications for seizures such as carbamazepine (Tegretol), felbamate (Felbatol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), primidone (Mysoline), and topiramate (Topamax); nefazodone; rifampin (Rimactane, in Rifadin, in Rifater); oral steroids including dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone); morphine (Kadian, MS Contin, MSIR, among others); Levothyroxine (Levothroid, Levoxyl, Synthroid), theophylline (Theobid, Theo-Dur), verapamil (Calan, Covera, Isoptin, Verelan), vitamin C, and zafirlukast are all thyroid medications (Accolate). Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • If you use any of the drosperinone-containing oral contraceptives (Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah), let your doctor and pharmacist know if you also use any of the following: Benazepril (Lotensin), enalapril (Vasotec), and lisinopril (Prinivil, Zestril) are examples of angiotensin-converting enzyme (ACE) inhibitors. Angiotensin II antagonists include irbesartan (Avapro), losartan (Cozaar), and valsartan (Diovan); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such ibuprofen (Advil, Motrin, Naprosyn), triamterene (Dyrenium), and spironolactone (Aldactone), as well as diuretics (‘water pills’) like amiloride (Midamor), eplerenone (Inspra), heparin, and potassium supplements. Tell your doctor or pharmacist if you’re taking cholestyramine (Locholest, Prevalite, Questran), a folate supplement, methotrexate (Trexall), pyrimethamine (Daraprim), sulfasalazine (Azulfidine), or valproic acid before taking Beyaz or Safyral as well (Depakene, Stavzor).
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you have thrombophilia (a condition in which the blood clots readily) or if you have ever had blood clots in your legs, lungs, or eyes; coronary artery disease, which causes blockages in the blood vessels that supply the heart, cerebrovascular disease, which causes occlusions or weakening of the blood vessels in or leading to the brain; stroke or mini-stroke, irregular heartbeat, cardiovascular disease, a heart attack, chest discomfort, circulatory problems brought on by diabetes, migraines accompanied by additional symptoms such vision changes, weakness, and dizziness; high blood pressure, liver cancer, liver tumours, or other forms of liver disease; breast cancer; cancer of the uterus, cervix, or vagina; during a pregnancy or when using hormonal contraceptives (birth control pills, patches, rings, implants, or injections), yellowing of the skin or eyes;unexplained abnormal vaginal bleeding, kidney illness, or adrenal insufficiency, a condition where the body lacks certain natural components needed for critical processes including blood pressure. If you have just undergone surgery or have been unable to move around for any reason, let your doctor know as well. If you currently have or have ever had any of these illnesses, your doctor may advise you not to use any oral contraceptives or to stop using specific types altogether.
  • Moreover, let your doctor know if you are overweight, if anybody in your family has ever had breast cancer, or if you have ever experienced lumps, an abnormal mammogram (breast x-ray), or fibrocystic breast disease (swollen, painful breasts and/or breast lumps that are not cancer); diabetes, asthma, toxaemia (high blood pressure during pregnancy), high blood cholesterol or fats, heart attack, chest pain, seizures, and migraine headaches; in addition to jaundice (yellowing of the skin or eyes), depression, gallbladder illness, and abnormal weight gain (bloating) during the menstrual cycle are other conditions to be aware of.
  • If you are breastfeeding a baby or intend to become pregnant, avoid using oral contraceptives. Call your doctor right away if you get pregnant while using oral contraceptives.
  • You may be pregnant if you stop having periods while using oral contraception. Call your doctor if you are taking a 91-tablet packet and you miss one period. If you follow the instructions for another type of packet and skip one period, you can still take your tablets. But, call your doctor and use another method of birth control until you have a pregnancy test if you have taken your pills as prescribed and you miss one period or if you have taken them as prescribed and you miss two. You won’t anticipate having periods frequently if you are taking a 28-tablet packet that solely contains active tablets, so it can be challenging to determine whether you are pregnant. If you develop pregnancy symptoms like nausea, vomiting, or sore breasts while using this type of oral contraceptive, call your doctor and get a pregnancy test, or if you have any reason to believe you might be pregnant.
  • Inform the surgeon or dentist that you are using oral contraceptives if you are having surgery, including dental surgery.
  • It’s important for you to be aware that oral contraceptives may result in a patchy darkening of the skin, particularly on the face. Avoid exposure to natural or artificial sunlight while using oral contraceptives if you have previously experienced changes in your skin tone while pregnant or while using oral contraceptives. Use protective clothing, sunglasses, and sunscreen.
  • In case you wear contact lenses, let your doctor and pharmacist know. See an eye doctor if you experience changes in your eyesight or your ability to wear contact lenses while using an oral contraceptive.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you miss doses of your oral contraceptive, you may not be protected from pregnancy. You may need to use a backup method of birth control for 7 to 9 days or until the end of the cycle. Every brand of oral contraceptives comes with specific directions to follow if you miss one or more doses. Carefully read the directions in the manufacturer’s information for the patient that came with your oral contraceptive. If you have any questions, call your doctor or pharmacist. Continue to take your tablets as scheduled and use a backup method of birth control until your questions are answered.

What side effects can this medication cause?

Side effects from oral contraceptives are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Abdominal pain or bloating
  • Diarrhoea
  • Constipation
  • Gingivitis (swelling of the gum tissue)
  • Greater or lesser appetite
  • Gaining or losing weight
  • Tan or black spots on the skin
  • Acne
  • Hair growth in unexpected locations
  • Between menstrual cycles, there may be bleeding or spotting
  • Modifications to menstrual flow
  • Unpleasant or skipped periods
  • Discomfort, enlargement, or discharge in the breast
  • Vaginal edoema, redness, irritability, burning, or itchiness
  • White vaginal spotting

Some adverse effects may be severe. Although the following signs are unusual, if you notice any of them, consult your doctor right away:

  • Terrible headache
  • Violent vomiting
  • Speech issues
  • Faintness or dizziness
  • An arm or leg that is weak or numb
  • Chest heaviness or severe chest pain
  • Spitting blood
  • Breathing difficulty
  • Leg discomfort
  • Partial or total blindness
  • Having two distinct visions
  • Eyes that are enlarged
  • Stomach discomfort that is quite bad
  • Skin or eye yellowing
  • Excessive fatigue, weakness, or lack of energy
  • Fever
  • Urine with a dark colour
  • Stool with a light colour
  • Edoema of the lower legs, ankles, feet, or hands
  • Depression, particularly if you also experience difficulty sleeping, exhaustion, a decline in energy, or other mood changes
  • Uncommon bleeding
  • Rash
  • Unusually heavy or prolonged menstrual bleeding that lasts more than seven days straight

Using oral contraceptives may raise your risk of developing liver tumours. Although these tumours are not cancerous, they have the potential to rupture and result in significant internal bleeding. Moreover, using oral contraceptives may make you more likely to get liver or breast cancer, a heart attack, a stroke, or a major blood clot. Discuss the dangers of using oral contraceptives with your doctor.

Studies suggest that women who use the drosperinone-containing oral contraceptives Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah may be more susceptible to developing deep vein thrombosis, a serious or life-threatening condition in which blood clots form in the veins, typically in the legs and may spread throughout the body to the lungs. Other research, meanwhile, does not support this elevated risk. The danger of blood clots and the best oral contraceptive or alternative form of birth control for you should be discussed with your doctor before you start taking oral contraceptives.

Other adverse reactions to oral contraceptives are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication out of the reach of children and tightly wrapped in the packet it came in. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

  • Nausea
  • Uterine bleeding

What other information should I know?

Keep all of your appointments with your physician and the lab. Every year, you should receive a thorough physical exam that includes a Pap test, breast and pelvic checks, and blood pressure readings. When checking your breasts, according to your doctor’s instructions and report any lumps right away.

Inform the lab staff that you use oral contraceptives before you undergo any testing.

Your doctor might advise you to use a different method of birth control until you start menstruating regularly once more if you decide to stop taking oral contraceptives and get pregnant. If you have never given birth or had irregular, infrequent, or no menstrual periods prior to taking oral contraceptives, it could take a while for you to get pregnant after stopping the medication. Nonetheless, after ceasing some oral contraceptives, it is possible to become pregnant within a few days. You should start utilising a different method of birth control as soon as you stop using oral contraceptives if you wish to stop using them but avoid getting pregnant. With your doctor, go over any concerns you might have.

The amount of folate in your body may decrease as a result of oral contraceptives. If you wish to get pregnant quickly after stopping oral contraceptives, talk to your doctor because folate is crucial for the growth of a healthy baby. Your physician might advise that you use an oral contraceptive that also contains a folate supplement or a folate supplement (Beyaz, Safyral).

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

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