What is the most important information I should know about Remeron?

• While you are taking Remeron you may need to be monitored for worsening symptoms of depression and/ or suicidal thoughts at the start of therapy or when doses are changed. This concern about the increased risk of suicidal thoughts or behaviors may be greater if you are 18 years of age or younger and are taking Remeron. In patients younger than 18 years, the period of risk may extend beyond start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms: anxiety, panic attacks, difficulty sleeping, irritability, hostility, impulsivity, severe restlessness, and mania (mental and/ or physical hyperactivity). These symptoms may be associated with the development of worsening symptoms of depression and/ or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with Remeron. Do not stop taking Remeron.
• It may be several weeks before you start to feel better. Even when you start to feel better, do not stop taking Remeron without first talking to your doctor.
• Contact your doctor if you experience fever, chills, a sore throat, flu-like symptoms, or sores in the mouth or nose.
• Use caution when driving, operating machinery, or performing other hazardous activities. Remeron may cause drowsiness and dizziness. If you experience drowsiness or dizziness, avoid these activities.
• Dizziness is likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
• Avoid the use of alcohol while taking Remeron. Alcohol may increase drowsiness and dizziness.
• Remeron is available in a regular tablet formulation (Remeron) that should be swallowed with water. Remeron is also available in a rapidly-disintegrating formulation (Remeron SolTab) that will disintegrate rapidly when placed on the tongue and can be swallowed with or without water.

What is Remeron?

• Remeron is in a class of drugs called antidepressants. Remeron affects chemicals in your brain that may become unbalanced and cause depression.
• Remeron is used to relieve symptoms of depression such as feelings of sadness, worthlessness, or guilt; loss of interest in daily activities; changes in appetite; tiredness; sleeping too much; insomnia; and thoughts of death or suicide.
• Remeron may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Remeron?

• While you are taking Remeron you may need to be monitored for worsening symptoms of depression and/ or suicidal thoughts at the start of therapy or when doses are changed. This concern about the increased risk of suicidal thoughts or behaviors may be greater if you are 18 years of age or younger and are taking Remeron. In patients younger than 18 years, the period of risk may extend beyond start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms: anxiety, panic attacks, difficulty sleeping, irritability, hostility, impulsivity, severe restlessness, and mania (mental and/ or physical hyperactivity). These symptoms may be associated with the development of worsening symptoms of depression and/ or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with Remeron. Do not stop taking Remeron.
• Do not take Remeron if you are currently taking, or have taken within the last 14 days, a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).
• Before taking Remeron, tell your doctor if you
  • have liver disease;
  • have kidney disease;
  • have a manic-depressive disorder;
  • have blood problems;
  • have high or low blood pressure or heart disease;
  • have had a heart attack in the last 6 weeks; or
  • have epilepsy or seizures.
• You may not be able to take Remeron, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• The rapidly-disintegrating formulation of Remeron tablets (Remeron SolTab) contains phenylalanine. People with the disease phenylketonuria (PKU) need to monitor their intake of this additive.
• Remeron is in the FDA pregnancy category C. This means that it is not known whether Remeron will harm an unborn baby. Do not take Remeron without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether Remeron passes into breast milk. Do not take Remeron without first talking to your doctor if you are breast-feeding a baby.
• If you are over 60 years of age, you may be more likely to experience side effects such as drowsiness, dizziness, unsteadiness, feeling uncoordinated, and low blood pressure. You may require a lower dose of this medication.

How should I take Remeron?

• Take Remeron exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Remeron is available in a regular tablet formulation (Remeron) that should be swallowed with water. Remeron is also available in a rapidly-disintegrating formulation (Remeron SolTab) that will disintegrate rapidly when placed on the tongue and can be swallowed with or without water.
• If you are taking the Remeron rapidly-disintegrating tablets (Remeron SolTab), open the blister pack with dry hands and use the tablet immediately after removal from the blister pack. Do not attempt to split the rapidly-disintegrating tablets.
• Remeron is usually taken once a day, preferably at bedtime. Follow your doctor's instructions.
• It may be several weeks before you start to feel better. Even when you start to feel better, do not stop taking Remeron without first talking to your doctor.
• Store Remeron at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Remeron overdose include confusion, drowsiness, poor memory, and a fast heartbeat.

What should I avoid while taking Remeron?

• Use caution when driving, operating machinery, or performing other hazardous activities. Remeron may cause drowsiness and dizziness. If you experience drowsiness or dizziness, avoid these activities.
• Dizziness is likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
• Avoid the use of alcohol while taking Remeron. Alcohol may increase drowsiness and dizziness.

What are the possible side effects of Remeron?

• If you experience any of the following serious side effects, stop taking Remeron and call your doctor immediately or seek emergency medical treatment:
  • an allergic reaction (swelling of the lips, face, or tongue; difficulty breathing);
  • seizures;
  • a fast or irregular heartbeat; or
  • fever, chills, a sore throat, flu-like symptoms, or sores in your mouth or nose.
• Other, less serious side effects may be more likely to occur. Continue to take Remeron and talk to your doctor if you experience
  • drowsiness;
  • nausea;
  • increase in weight or appetite;
  • dizziness;
  • dry mouth;
  • constipation; or
  • mild tremor.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Remeron?

• Do not take Remeron if you are currently taking, or have taken within the last 14 days, a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).
• Remeron may increase the effects of other drugs that cause drowsiness, including other antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.
• Drugs other than those listed here may also interact with Remeron. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.