Overview: Miudella is an intrauterine device (IUD), a form of birth control, that is inserted into the uterus to prevent pregnancy for up to three years. Common side effects include changes in menstrual bleeding, pelvic or back pain, painful periods, and pain during sex. Serious side effects are rare but can include infections or uterus problems.
Uses
What is Miudella used for?
Miudella is a copper-containing intrauterine device (IUD) that is inserted into the uterus and is commonly used to prevent pregnancy for up to three years.
Learn more about Birth Control With Miudella
Miudella may also be used for other conditions as determined by your healthcare provider.
How does Miudella work (mechanism of action)?
Miudella works by slowly releasing copper into the uterus. It prevents pregnancy by affecting how sperm move and stopping them from fertilizing an egg.
How is Miudella supplied (dosage forms)?
Brands and other names
- Miudella
Dosage forms and strengths
Miudella is available as an intrauterine device (IUD) that is inserted by a healthcare provider.
How should I store Miudella?
Miudella is usually inserted by a healthcare provider during an office visit. You will not store it at home.
Side Effects
What are the most common side effects of Miudella?
The most common side effects of Miudella are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Changes in menstrual bleeding (see below)
- Painful periods
- Pelvic or back pain or discomfort
- Pain or bleeding during or after placement of Miudella
- Pain during sex
- Pain or cramping
- Low red cell blood levels (anemia)
- Vaginal irritation or discharge
There may be other side effects of Miudella that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Miudella?
While less common, the most serious side effects of Miudella are described below, along with what to do if they happen.
Severe Allergic Reactions. Miudella may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Severe Infection. Miudella can increase your risk of a severe infection or sepsis within the first few days after the device is inserted. Call your healthcare provider right away if you have severe pain or fever.
Uterus Problems. Miudella may go into the wall of the uterus (become embedded) or go through the wall of the uterus (perforation). This increases your risk of pregnancy. It also increases the risk of infection and damage to other organs. The risk of perforation is higher if you are breastfeeding while using Miudella. Tell your healthcare provider right away if you cannot feel the threads of the device inside your vagina or if you have pain or bleeding that gets worse after Miudella is inserted.
Expulsion. Miudella may come out of the uterus by itself, which is called expulsion. The risk of expulsion may be higher if Miudella is placed within four weeks of you delivering a baby. If Miudella comes out, you will be at higher risk of pregnancy. Tell your healthcare provider right away if you cannot feel the threads of Miudella inside your vagina or if you have pain or bleeding that gets worse after Miudella is inserted.
Changes in Menstrual Bleeding. Miudella can cause your period to become longer and heavier. It can also cause frequent spotting or light bleeding between periods. Call your healthcare provider right away if bleeding remains heavier or longer than usual or if you continue to have spotting.
Pelvic Inflammatory Disease. Miudella can increase the risk of pelvic infections, including pelvic inflammatory disease (PID), which is an infection that can affect the uterus, ovaries, or fallopian tubes. Bacteria that cause pelvic inflammatory disease can get into your body when Miudella is inserted. Call your healthcare provider right away if you have any of the following symptoms of PID.
- Pain in your lower belly or pelvis
- Heavy vaginal discharge that is discolored and has a bad smell
- Heavy bleeding during your period or bleeding between periods
- Pain or bleeding during sex
- Chills or fever
- Pain when your pee or problems peeing
- Sores on your genitals
Pregnancy Problems. If you become pregnant while using Miudella, you may be at higher risk of miscarriage, infection, and early labor or delivery. You may also be at higher risk of that pregnancy being outside the uterus (ectopic pregnancy). With ectopic pregnancy, as the fertilized egg grows, it can burst (rupture) and cause life-threatening bleeding and death. Call your healthcare provider right away if you think you might be pregnant or have any of the following symptoms.
- Pain in your lower stomach or vomiting
- Sharp belly cramps
- Unusual vaginal bleeding or discharge
- Pain on one side of your body
- Dizziness or weakness
- Pain in your shoulder, neck, or rectum
- Fever, chills, or flu-like symptoms
Warnings & Precautions
Who should not use Miudella?
Allergies to Ingredients. People who are allergic to any of the following should not use Miudella.
- Miudella
- Copper
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Miudella.
Pregnancy. Do not use Miudella if you are pregnant or think you might be pregnant. If you become pregnant, contact your healthcare provider right away. See the Pregnancy section for more details.
Uterus Problems. Miudella should not be used if you have bleeding from the uterus for an unknown reason, or if you have problems that change the shape of your uterus, such as fibroids. Miudella may not work as well if you have these conditions.
Pelvic or Genital Infections. Miudella should not be used if you have or are at high risk of pelvic inflammatory disease (PID), which is an infection that can affect the uterus, ovaries, or fallopian tubes. It should also not be used if you have recently had an infection of the uterus after a pregnancy or abortion, or if you currently have an infection of the uterus, ovaries, fallopian tubes, cervix, or vagina. The infection should be treated before using Miudella.
Cancer. Miudella should not be used if you have or think you may have uterine or cervical cancer.
Wilson’s Disease. Miudella should not be used if you have a genetic disorder where copper builds up in the body, called Wilson’s disease. Miudella can make this condition worse.
Another Intrauterine Device (IUD). Miudella should not be used if you already have an intrauterine device (IUD) inside your uterus. The other device must be removed before Miudella can be placed.
What should I know about Miudella before using it?
Miudella is an intrauterine device (IUD) that is inserted into the uterus by your healthcare provider at a medical facility. Miudella is only available from healthcare providers who have gone through special training to learn how to insert it. It will be removed or replaced after three years, but it can be removed at any time.
Miudella does not protect you from HIV, AIDS, or other sexually transmitted diseases (STDs).
Tell your healthcare provider right away if you have intense pain, cramping, bleeding, or dizziness after Miudella is inserted. It may need to be removed or replaced.
Check that Miudella is in place by feeling the threads inside the vagina once a month. Talk with your healthcare provider if you have questions about how to do this.
If you think Miudella has fallen out of your uterus (expulsion) or is out of place, call your healthcare provider right away and use backup birth control (such as condoms or spermicide).
Do not use menstrual cups or discs with Miudella. Miudella may come out of place or fall out.
You can use tampons with Miudella. Be extra careful when changing tampons so that you do not accidentally pull the Miudella threads. Call your healthcare provider right away if you think you have pulled Miudella out of place.
Make sure to keep all follow-up appointments with your healthcare provider. They will use these appointments to check that Miudella is in the right position.
You may need X-rays or other imaging to check whether Miudella is in place, or to help find the device when it is time to take it out. Depending on the exact position of the device, removal may be difficult and may require surgery. Talk to your healthcare provider if you have questions.
Tell all your healthcare providers that you have Miudella in place. In some cases, it may not be safe to get an MRI (magnetic resonance imaging) or to have certain procedures that use high levels of radiofrequency (RF) energy (diathermy).
What should I tell my healthcare provider before using Miudella?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Miudella is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have or have had any of the following.
- Dizziness or fainting (syncope)
- Slow heart rate (bradycardia)
- Seizures
- Recently had a baby
- HIV, AIDS, or another sexually transmitted disease (STD)
- Anemia
- Unexplained vaginal bleeding
- Conditions that affect the shape of your uterus, such as fibroids
Pregnancy. Do not use Miudella during pregnancy. Using Miudella while you are pregnant may cause complications during pregnancy. If you become pregnant or think you might be pregnant while using Miudella, contact your healthcare provider right away.
Breastfeeding. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Miudella while breastfeeding.
How can I get more information about Miudella?
For more information about Miudella, you can visit the manufacturer’s website at www.miudella.com or call them at 866-246-2133.
Interactions
Does Miudella interact with foods or drinks?
There are no known interactions between Miudella and foods or drinks.
It is unknown if drinking alcohol will affect Miudella.
Does Miudella interact with other medicines (drug interactions)?
There are no known interactions between Miudella and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Overdose/Missed Dose
What should I do if I accidentally use too much Miudella?
If you or someone else has used too much Miudella, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Miudella?
Miudella is inserted by a healthcare provider and left in place for up to three years. If it has been in place for too long or has come out of place, avoid sexual intercourse or use backup birth control (such as condoms or spermicide) and contact your healthcare provider right away.
Are you currently using Miudella (copper)?
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