WARNING TO WOMEN WHO SMOKE
Minastrin 24 Fe is a prescription birth control medicine used by women to prevent pregnancy.
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.
Some examples of serious blood clots are blood clots in the:
- Legs (deep vein thrombosis)
- Lungs (pulmonary embolus)
- Eyes (loss of eyesight)
- Heart (heart attack)
- Brain (stroke)
A few women who take birth control pills may get:
- High blood pressure
- Gallbladder problems
- Rare cancerous or noncancerous liver tumors
All of these events are uncommon in healthy women.
The most common side effects of birth control pills are:
- Spotting or bleeding between menstrual periods
- Nausea
- Breast tenderness
- Headache
These side effects are usually mild and usually disappear with time.
Less common side effects are:
- Acne
- Less sexual desire
- Bloating or fluid retention
- Blotchy darkening of the skin, especially on the face
- High blood sugar, especially in women who already have diabetes
- High fat (cholesterol, triglyceride) levels in the blood
- Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself
- Problems tolerating contact lenses
- Weight gain
This is not a complete list of Minastrin 24 Fe side effects. Ask your doctor or pharmacist for more information.
Tell your doctor about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:
- barbiturates
- bosentan
- carbamazepine
- felbamate
- griseofulvin
- oxcarbazepine
- phenytoin
- rifampin
- St. John’s wort
- topiramate
Consider using another birth control method when you take medicines that may make birth control pills less effective.
- Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your doctor may need to adjust the dose of lamotrigine.
- If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills. Certain blood tests may be affected by birth control pills.
Your doctor will not give you Minastrin 24 Fe if you have:
- Ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
- Ever had a stroke
- Ever had a heart attack
- Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
- An inherited problem with your blood that makes it clot more than normal
- High blood pressure that medicine can't control
- Diabetes with kidney, eye, nerve, or blood vessel damage
- Ever had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision
- Ever had breast cancer or any cancer that is sensitive to female hormones
- Liver disease, including liver tumors
Also, do not take birth control pills if you:
- Smoke and are over 35 years old
- Are or suspect you are pregnant
- Are allergic to anything in Minatrin 24 Fe
Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy, also called cholestasis of pregnancy. Tell your doctor if you have ever had any of the above conditions (your doctor may recommend another method of birth control).
Birth control pills do not protect you against any sexually transmitted infection, including HIV, the virus that causes AIDS.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Minastrin 24 Fe there are no specific foods that you must exclude from your diet when receiving Minastrin 24 Fe.
Tell your doctor if you are allergic to estrogen, progestin, or any other medications.
Tell your doctor about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:
- barbiturates
- bosentan
- carbamazepine
- felbamate
- griseofulvin
- oxcarbazepine
- phenytoin
- rifampin
- St. John’s wort
- topiramate
- lamotrigine
Tell your doctor if you have or have ever had:
- blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
- a stroke
- a heart attack
- certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
- an inherited problem with your blood that makes it clot more than normal
- high blood pressure that medicine can't control
- diabetes with kidney, eye, nerve, or blood vessel damage
- certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision
- breast cancer or any cancer that is sensitive to female hormones
- liver disease, including liver tumors
Also, tell your doctor if you:
- Smoke and are over 35 years old
- Are or suspect you are pregnant
- Are allergic to anything in Minatrin 24 Fe
Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.
Tell your doctor if you are breastfeeding or plan to breastfeed. If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Minastrin 24 Fe, may decrease the amount of milk you make. A small amount of the pill's hormones may pass into breast milk.
The right way to take the capsule is to take one capsule every day at the same time in the order directed on the package. Minastrin 24 Fe can be taken without regard to meals.
- Decide What Time of Day You Want to Take Your Capsule. It is important to take Minastrin 24 Fe in the order directed on the package at the same time every day. Minastrin 24 Fe can be taken without regard to meals.
- The Minastrin 24 Fe-pill pack has 24 "active" yellow capsules (with hormones) to be taken for 24 days, followed by 4 "reminder" maroon capsules (without hormones) to be taken for the next four days.
- Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins).
- Place this day label strip on the capsule dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic.
- Take the first yellow pill of the pack during the first 24 hours of your period.
- You will not need to use a back-up method of birth control, since you are starting the capsule at the beginning of your period. However, if you start Minastrin 24 Fe later than the first day of your period, you should use another method of birth control (such as a condom and spermicide) as a back-up method until you have taken 7 yellow capsules.
- Take the first yellow capsule of the pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
- Use another method of birth control (such as a condom and spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). This also applies if you start Minastrin 24 Fe after having been pregnant, and you have not had a period since your pregnancy.
When You Switch From a Different Birth Control Tablet
- When switching from another birth control pill, finish all the tablets, then Minastrin 24 Fe should be started on the same day that a new pack of the previous birth control tablet would have been started.
- When switching from a transdermal patch or vaginal ring, finish the 21 days of use, wait 7 days, then Minastrin 24 Fe should be started when the next application would have been due.
- When switching from an injection, Minastrin 24 Fe should be started when the next injection would have been due. When switching from an intrauterine device or an implant, Minastrin 24 Fe should be started on the day of removal.
- Take one capsule at the same time every day until the pack is empty.
- Do not skip capsules even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).
- Do not skip capsules even if you do not have sex very often.
- When you finish a pack of capsules, start the next pack on the day after your last maroon capsule. Do not wait any days between packs.
What to Do if You Miss Capsules
- Take the capsule as soon as you remember. Take the next capsule at your regular time. This means you may take two capsules in one day.
- You do not need to use a back-up birth control method if you have sex.
- Take two capsules on the day you remember and two capsules the next day.
- Then take one capsule a day until you finish the pack.
- You could become pregnant if you have sex in the 7 days after you restart your capsules. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days.
- Throw out the rest of the Minastrin 24 Fe pack and start a new pack that same day.
- Keep taking one capsule every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of capsules that same day.
- You could become pregnant if you have sex in the 7 days after you restart your capsules. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days.
- You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant.
- Throw out the rest of the capsule pack and start a new pack that same day.
- Keep taking 1 capsule every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of capsules that same day.
- You could become pregnant if you have sex on the days when you missed capsules or during the first 7 days after you restart your capsules. You must use another birth control method (such as a condom and spermicide) as a back-up the next time you have sex and
- for the first 7 days after you restart your capsules.
- You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant.
- Throw away the capsules you missed.
- Keep taking one capsule each day until the pack is empty.
- You do not need a back-up method.
- Start the next pack of Minastrin 24 Fe as scheduled.
- Use a back-up method (such as a condom and spermicide) anytime you have sex.
- Contact your healthcare provider and continue taking one active yellow capsule each day until otherwise directed.
To achieve maximum contraceptive effectiveness, Minastrin 24 Fe must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. Follow package insert instructions if you miss a dose. Minastrin 24 Fe tablets may be taken with or without food.
If you take too much Minastrin 24 Fe, call your doctor or local Poison Control Center right away. No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.
Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) is available in blister cards (dispensers) containing 28 soft gelatin capsules:
- 24 oval, transparent, pale yellow, (active) capsules imprinted with “WC” on one side and each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.
- 4 oval, opaque, maroon, (non-hormonal placebo) capsules imprinted with “WC” on one side and each containing 75 mg ferrous fumarate.
- The ferrous fumarate capsules do not serve any therapeutic purpose.