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

• While you are taking Sinequan 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 Sinequan. 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 Sinequan. Do not stop taking Sinequan.
• Use caution when driving, operating machinery, or performing other hazardous activities. Sinequan may cause drowsiness or 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.
• Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Sinequan.

What is Sinequan?

• Sinequan is in a class of drugs called tricyclic antidepressants. Sinequan affects chemicals in the brain that may become unbalanced and cause depression.
• Sinequan is used to relieve symptoms of depression and anxiety 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.
• Sinequan may also be used for purposes other than those listed in this medication guide.

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

• Do not take Sinequan if you have taken a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) within the last 14 days.
• Before taking Sinequan, tell your doctor if you have
  • liver disease,
  • kidney disease,
  • asthma,
  • thyroid disease,
  • diabetes,
  • stomach or intestinal problems,
  • high blood pressure or heart disease,
  • had a heart attack in the last 6 weeks,
  • an enlarged prostate or difficulty urinating, or
  • glaucoma.
• You may not be able to take Sinequan, or you may require a dosage adjustment or special monitoring during therapy if you have any of the conditions listed above.
• While you are taking Sinequan 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 Sinequan. 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 Sinequan. Do not stop taking Sinequan.
• It is not known whether Sinequan will be harmful to an unborn baby. Do not take Sinequan without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• Sinequan passes into breast milk and may affect a nursing baby. Do not take Sinequan 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. Your doctor may prescribe a lower dose of this medication.

How should I take Sinequan?

• Take Sinequan exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass (8 oz) of water.
• Sinequan may be taken several times a day or in one daily dose (usually at bedtime). Follow your doctor's instructions.
• It may be several weeks before you start to feel better, but do not stop taking Sinequan without first talking to your doctor.
• Store Sinequan at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. If it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. 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 an Sinequan overdose include seizures, confusion, drowsiness, agitation, hallucinations, and low blood pressure (dizziness, fatigue, fainting).

What should I avoid while taking Sinequan?

• Use caution when driving, operating machinery, or performing other hazardous activities. Sinequan may cause drowsiness or 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.
• Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Sinequan.
• Do not stop taking Sinequan suddenly. This could cause symptoms such as nausea, headache, and malaise.

What are the possible side effects of Sinequan?

• If you experience any of the following serious side effects, stop taking Sinequan and contact your doctor immediately or seek emergency medical treatment:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, face, or tongue; or hives);
  • seizures;
  • a fast or irregular heartbeat;
  • a heart attack;
  • high blood pressure (blurred vision, severe headache);
  • difficulty urinating; or
  • fever with increased sweating, muscle stiffness, or severe muscle weakness.
• Other, less serious side effects may be more likely to occur. Continue to take Sinequan and talk to your doctor if you experience
  • drowsiness or dizziness;
  • dry mouth and eyes;
  • constipation;
  • mild tremor;
  • sweating;
  • mild agitation, weakness, or headache;
  • ringing in the ears;
  • nausea; or
  • loss of weight or appetite.
• 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 Sinequan?

• Do not take Sinequan if you have taken a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) within the last 14 days.
• Sinequan 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 other prescription or over-the-counter medicines without first talking to your doctor.
• Drugs other than those listed here may also interact with Sinequan. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.