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|Sinequan Concentrate

Sinequan Concentrate

Sinequan Concentrate is used for:

Treating depression or anxiety in certain patients. It may also be used for other conditions as determined by your doctor.

Sinequan Concentrate is a tricyclic antidepressant. It is not known exactly how it works. It may increase the activity of certain chemicals in the brain, which help elevate mood.

Do NOT use Sinequan Concentrate if:

• you are allergic to any ingredient in Sinequan Concentrate or to other tricyclic antidepressants
• you have certain prostate problems (eg, asymptomatic prostatic hypertrophy), glaucoma, or trouble urinating
• you are taking cisapride, clonidine, dofetilide, H₁ antagonists (eg, astemizole, terfenadine), or ibutilide, or you have taken a monoamine oxidase (MAO) inhibitor (eg, furazolidone, phenelzine, isocarboxazid) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sinequan Concentrate:

Some medical conditions may interact with Sinequan Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems, seizures (eg, epilepsy), overactive thyroid, prostate problems (eg, benign prostatic hypertrophy [BPH]), blood problems (eg, porphyria), other mental or mood problems, suicidal thoughts or attempts, or alcohol abuse

Some MEDICINES MAY INTERACT with Sinequan Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, quinidine, propafenone, flecainide), antifungal medicines (eg, fluconazole, terbinafine), carbamazepine, cimetidine, mibefradil, phenothiazines (eg, chlorpromazine, thioridazine), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, sertraline) because side effects of Sinequan Concentrate may be increased
• Anticoagulants (eg, warfarin), cisapride, dofetilide, H₁ antagonists (eg, astemizole, terfenadine), ibutilide, sulfonylureas (eg, tolazamide, glipizide), sympathomimetics (eg, phenylephrine, pseudoephedrine), or tramadol because side effects may be increased by Sinequan Concentrate
• Clonidine, guanadrel, guanethidine, or guanfacine because the effectiveness of these medicines may be decreased
• MAO inhibitors (eg, furazolidone, phenelzine, isocarboxazid) because severe toxic effects may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sinequan Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sinequan Concentrate:

Use Sinequan Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sinequan Concentrate may be taken with or without food.
• Sinequan Concentrate must be diluted before taking. Dilute Sinequan Concentrate in 4 ounces of water, milk, or fruit juice.
• Taking Sinequan Concentrate at bedtime may help reduce side effects (eg, daytime drowsiness). Discuss this possibility with your doctor.
• If you miss a dose of Sinequan Concentrate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you take 1 dose daily at bedtime, do not take the missed dose the next morning.

Ask your health care provider any questions you may have about how to use Sinequan Concentrate.

Important safety information:

• Sinequan Concentrate may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sinequan Concentrate. Using Sinequan Concentrate alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Sinequan Concentrate will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Sinequan Concentrate may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Antidepressants can increase suicidal thoughts and actions in some children and teenagers. This risk may be higher in individuals with bipolar illness (also called manic-depressive illness), a family history of bipolar illness, or a history of attempting suicide. Pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood.
• Limit your alcohol consumption while taking this medicine.
• Sinequan Concentrate may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Sinequan Concentrate. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Sinequan Concentrate.
• After you start taking Sinequan Concentrate, several weeks may pass before you feel the full benefit.
• Taking Sinequan Concentrate at bedtime may help reduce side effects (eg, daytime drowsiness). Discuss this possibility with your doctor.
• LAB TESTS may be required to monitor your therapy or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sinequan Concentrate with caution in the ELDERLY because they may be more sensitive to its effects.
• Sinequan Concentrate is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Sinequan Concentrate during pregnancy. Sinequan Concentrate is excreted in breast milk. Do not breast-feed while taking Sinequan Concentrate.

Possible side effects of Sinequan Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; constipation; diarrhea; dizziness; drowsiness; dry mouth; excess sweating; headache; heartburn; increased appetite; indigestion; nausea; unpleasant taste; urinary retention; vomiting; weakness; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal movements; aggressive or bizarre behavior; agitation; anxiety; blurred vision or other vision changes; chest pain; constipation; difficulty speaking and swallowing; disorientation; eye pain; fainting; fast, slow, or irregular heartbeat; hair loss; hallucinations; hostility; irritability; loss of balance; mood swings; nervousness or restlessness; panic attacks; ringing in the ears; seizures; shakiness; sore throat or fever; trouble sleeping; twitching of the face or tongue; unusual bleeding or bruising; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include agitation; confusion; drowsiness; dry mouth; enlarged pupils; fast or irregular heartbeat; flushing; loss of consciousness; seizures.

Store Sinequan Concentrate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sinequan Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Sinequan Concentrate, please talk with your doctor, pharmacist, or other health care provider.
• Sinequan Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sinequan Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.