Selfemra

Selfemra is a prescription medicine used to treat Premenstrual Dysphoric Disorder (PMDD).

Selfemra belongs to a group of drugs called selective serotonin reuptake inhibitor (SSRI). It works by increasing the amount of serotonin, a natural substance in the brain that helps with many body functions.

Selfemra is a prescription medicine used to treat Premenstrual Dysphoric Disorder (PMDD) including mood swings, irritability, bloating, and breast tenderness.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• TEVA Pharmaceuticals USA Inc.

Selfemra may cause serious side effects. See "Drug Precautions" section.

Common possible side effects in people who take Selfemra include: 

• headache
• pain
• diarrhea
• sexual problems (decrease in desire)
• diarrhea
• weakness
• feeling tired or fatigued 
• change in sleep habits, including insomnia
• sinus infection or sore throat 
• dizziness
• anxiety and/or nervousness

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Triptans used to treat migraine headache 
• Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, MAOI’s (including linezolid, an antibiotic), or antipsychotics 
• Tramadol 
• Over-the-counter supplements such as tryptophan or St. John’s Wort 

If you take Selfemra, you should not take any other medicines that contain fluoxetine including: 

• Symbyax 
• Prozac Weekly
• Prozac

This is not a complete list of Selfemra drug interactions. Ask your doctor or pharmacist for more information

Selfemra and some medicines may interact with each other, may not work as well, or may cause serious side effects. Your healthcare provider or pharmacist can tell you if it is safe to take Selfemra with your other medicines. Do not start or stop any medicine while taking Selfemra without talking to your healthcare provider first.

Selfemra and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

• Selfemra and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice:
  • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when Selfemra is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Selfemra may be associated with these serious side effects:

2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:

• agitation, hallucinations, coma or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• racing heartbeat
• high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle rigidity

3. Severe allergic reactions and Rash:

• trouble breathing
• swelling of the face, tongue, eyes or mouth
• rash, itchy welts (hives) or blisters, alone or with fever or joint pain

4. Abnormal bleeding: Selfemra and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Seizures or convulsions

6. Manic episodes/Hypomania. Tell your doctor if you notice any of the following:

• greatly increased energy
• severe trouble sleeping
• racing thoughts
• reckless behavior
• unusually grand ideas
• excessive happiness or irritability
• talking more or faster than usual

7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking or memory problems

Do not stop Selfemra without first talking to your healthcare provider. Stopping Selfemra too quickly may cause serious symptoms including:

• anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
• headache, sweating, nausea, dizziness
• electric shock-like sensations, shaking, confusion

Do not take Selfemra if you: 

• are allergic to Selfemra. Ask your pharmacist for a complete list of ingredients.
• take a Monoamine Oxidase Inhibitor (MAOI). 
• take Mellaril (thioridazine). Do not take Mellaril within 5 weeks of stopping Selfemra because this can cause serious heart rhythm problems or sudden death. 
• take the antipsychotic medicine pimozide (Orap) because this can cause serious heart problems.

Other precautions:

• Do not take an MAOI within 5 weeks of stopping Selfemra. 
• Do not start Selfemra if you stopped taking an MAOI in the last 2 weeks. People who take Selfemra close in time to an MAOI may have serious or even life threatening side effects. Get medical help right away if you have any of these symptoms:
  • high fever 
  • uncontrolled muscle spasms 
  • stiff muscles 
  • rapid changes in heart rate or blood pressure
  • confusion 
  • loss of consciousness (pass out) 

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 Selfemra there are no specific foods that you must exclude from your diet when receiving Selfemra.

Before starting Selfemra, tell your healthcare provider if you: 

• Are taking certain drugs or treatments such as:
  • Triptans used to treat migraine headache 
  • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, MAOI’s (including linezolid, an antibiotic), or antipsychotics 
  • Tramadol 
  • Over-the-counter supplements such as tryptophan or St. John’s Wort 
  • Electroconvulsive therapy (ECT) 
• have liver problems 
• have kidney problems 
• have heart problems 
• have or had seizures or convulsions 
• have bipolar disorder or mania 
• have low sodium levels in your blood 
• have a history of a stroke 
• have high blood pressure 
• have or had bleeding problems 
• are pregnant or breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Selfemra falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

Selfemra has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Selfemra, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Take Selfemra exactly as prescribed.
• If you miss a dose of Selfemra, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Selfemra at the same time.
• To prevent serious side effects, do not stop taking Selfemra suddenly. If you need to stop taking Selfemra, your doctor can tell you how to safely stop taking it.
• Selfemra is available in capsule form. It is usually taken once a day, either every day of the menstrual cycle or on certain days of the month. Taking it on certain days is defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle.
• Take Selfemra at around the same time of the day.
• Selfemra can be taken with or without food.
• If you do not think you are getting better or have any concerns about your condition while taking Selfemra, call your doctor.

Take Selfemra exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Selfemra is 20 mg a day, either every day of the menstrual cycle or on certain days of the month. Taking it on certain days is defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle.

If you take too much Selfemra call your local Poison Control Center or seek emergency medical attention right away.

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Selfemra or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Selfemra is not approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD).