Remeron Soltab

Name: Remeron Soltab

Canadian Brand Name

  1. Remeron RD

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Manufacturer

  • Organon Usa, Inc.

Remeron SolTab Precautions

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

1.  Suicidal thoughts or actions:
  • 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 Remeron SolTab 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. Remeron SolTab may be associated with these serious side effects:

  • trouble breathing, swelling of the face, tongue, eyes or mouth
2.  Manic episodes:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
3.  Decreased White Blood Cells called neutrophils, which are needed to fight infections. Tell your doctor if you have any indication of infection such as fever, chills, sore throat, or mouth or nose sores, especially symptoms which are flu-like. 4.  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
5.  Seizures 6.  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
7.  Sleepiness. It is best to take Remeron SolTab close to bedtime. 8.  Severe skin reactions: Call your doctor right away if you have any or all of the following symptoms:
  • severe rash with skin swelling (including on the palms of the hands and soles of the feet)
  • painful reddening of the skin and/or blisters/ulcers on the body or in the mouth
9.  Severe allergic reactions:
  • rash, itchy welts (hives) or blisters, alone or with fever or joint pain
10. Increases in appetite or weight. Children and adolescents should have height and weight monitored during treatment. 11. Increased cholesterol and triglyceride levels in your blood

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

  • dizziness
  • abnormal dreams
  • agitation
  • anxiety
  • fatigue
  • confusion
  • headache
  • shaking
  • tingling sensation
  • nausea, vomiting
  • sweating

Do not take Remeron SolTab if you:

  • are allergic to Remeron SolTab or any of the ingredients in it. 
  • take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. It is recommended that Remeron SolTab not be used in combination with an MAOI within 14 days of initiating or discontinuing therapy with an MAOI. People who take Remeron SolTab 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)

Remeron SolTab and Pregnancy

Tell your healthcare provider 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.

Remeron SolTab falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Remeron SolTab FDA 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 Remeron SolTab 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. Remeron SolTab is not approved for use in pediatric patients.

Commonly used brand name(s)

In the U.S.

  • Remeron
  • Remeron Soltab

In Canada

  • Remeron RD

Available Dosage Forms:

  • Tablet, Disintegrating
  • Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tetracyclic

Remeron Soltab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Decreased or increased movement
  • mood or mental changes, including abnormal thinking, agitation, anxiety, confusion, and feelings of not caring
  • shortness of breath
  • skin rash
  • swelling
Rare
  • Change in menstrual cycle (periods)
  • convulsions (seizures)
  • decreased sexual ability
  • menstrual pain
  • mood or mental changes, including anger, feelings of being outside the body, hallucinations (seeing, hearing, or feeling things that are not there), mood swings, and unusual excitement
  • mouth sores
  • sore throat, chills, or fever

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • dizziness
  • drowsiness
  • dry mouth
  • increased appetite
  • weight gain
Less common
  • Abdominal or stomach pain
  • abnormal dreams
  • back pain
  • dizziness or fainting when getting up suddenly from a lying or sitting position
  • increased need to urinate
  • increased sensitivity to touch
  • increased thirst
  • low blood pressure
  • muscle pain
  • nausea
  • sense of constant movement of self or surroundings
  • trembling or shaking
  • vomiting
  • weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Uses of Remeron SolTab

  • It is used to treat low mood (depression).
  • It may be given to you for other reasons. Talk with the doctor.

How is this medicine (Remeron SolTab) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take at bedtime if it causes sleepiness.
  • Take with or without food. Take with food if it causes an upset stomach.
  • Keep taking Remeron SolTab as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it melt. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
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