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|Sertraline Concentrate

Sertraline Concentrate

Sertraline Concentrate is used for:

Treating depression, obsessive-compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD; a severe form of premenstrual syndrome), and social anxiety disorder.

Sertraline Concentrate is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of certain natural substances in the brain, which help to elevate moods.

Do NOT use Sertraline Concentrate if:

• you are allergic to any ingredient in Sertraline Concentrate
• you are taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
• you are taking anorexiants (eg, phentermine), anticholinergics (eg, oxybutynin, scopolamine), astemizole, cyproheptadine, dextromethorphan, disulfiram, fenfluramine and its derivatives, l-tryptophan, pimozide, selegiline, sibutramine, St. John"s wort, terfenadine, or tramadol

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

Before using Sertraline Concentrate:

Some medical conditions may interact with Sertraline 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 seizures, thoughts of suicide, have attempted suicide, or have a history of substance abuse
• if you have impaired liver function, a history of digestive system bleeding, are allergic to latex, or consume alcoholic beverages

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

• Carbamazepine, hydantoins (eg, phenytoin), or risperidone because the effectiveness of Sertraline Concentrate may be decreased.
• Anorexiants (eg, phentermine), dextromethorphan, disulfiram, fenfluramine and derivatives, l-tryptophan, MAO inhibitors (eg, phenelzine), selegiline, sibutramine, St. John"s wort, tramadol, buspirone, butyrophenones (eg, haloperidol), cimetidine, linezolid, lithium, macrolides and ketolides (eg, erythromycin), metoclopramide, nefazodone, sumatriptan, or trazodone because side effects such as sedation, confusion, or serotonin syndrome (restlessness, fever, excessive sweating, confusion, twitching, and seizures; which can rarely be life-threatening) may occur
• Anticholinergics (eg, oxybutynin, scopolamine), astemizole, dextromethorphan, disulfiram, pimozide, selegiline, St. John"s wort, terfenadine, tramadol, amiodarone, anticoagulants (eg, warfarin), aripiprazole, beta-blockers (eg, metoprolol), butyrophenones (eg, haloperidol), clozapine, galantamine, H₁ antagonists (eg, diphenhydramine), hydantoins (eg, phenytoin), lamotrigine, lithium, nonsteroidal anti-inflammatory agents (NSAIDs) (eg, ibuprofen), phenothiazines (eg, thioridazine), propafenone, risperidone, sumatriptan, trazodone, or tricyclic antidepressants (eg, amitriptyline) because the side effects of these medicines may be increased by Sertraline Concentrate
• Thyroid hormones (eg, levothyroxine) because the effectiveness of that medicine may be decreased
• Hydantoins (eg, phenytoin) may have their actions and side effects increased by Sertraline Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sertraline 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 Sertraline Concentrate:

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

• Sertraline Concentrate comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Sertraline Concentrate refilled.
• Sertraline Concentrate may be taken on an empty stomach or with food.
• This medication should be taken once daily.
• Before taking Sertraline Concentrate, use the dropper provided to measure the prescribed amount of medicine and mix it with 4 ounces (one-half cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice. Do not mix the concentrate with any other kind of liquid.
• This mixture may become slightly cloudy. This is normal.
• Drink the dose immediately after mixing. Do not mix and store the medicine.
• Take Sertraline Concentrate at the same time each day.
• Do not eat grapefruit or drink grapefruit juice while on Sertraline Concentrate.
• Several weeks may pass before Sertraline Concentrate reaches its full effect.
• If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed, contact your doctor or pharmacist.

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

Important safety information:

• Sertraline Concentrate may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sertraline Concentrate. Using Sertraline Concentrate alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Sertraline Concentrate will add to the drowsiness effects of other medicines. Check all labels of your medicines for drowsiness causing ingredients. Ask your pharmacist if you are unsure which products may cause drowsiness. Do NOT start any new medicines without checking with your doctor or pharmacist.
• 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.
• The dropper dispenser contains natural dry rubber. Notify your health care provider if you are allergic to latex.
• Additional monitoring of your condition is recommended at the start of treatment with Sertraline Concentrate and whenever a change in dose is made.
• If you will be stopping Sertraline Concentrate and starting nefazodone, a period of time should pass before beginning this new medicine. Discuss this situation with your doctor.
• LAB TESTS, including liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and laboratory appointments while taking Sertraline Concentrate.
• Caution is advised when using Sertraline Concentrate in the ELDERLY since they may be more sensitive to the effects of Sertraline Concentrate, including a decrease in sodium levels in the blood. This is especially important if they are also taking "water pills" or diuretics.
• Caution is advised when using Sertraline Concentrate in CHILDREN because they may be more sensitive to the effects of Sertraline Concentrate. It is important to monitor weight and growth in CHILDREN who are taking Sertraline Concentrate.
• In the unlikely event you experience a painful and prolonged erection, seek medical attention immediately or permanent problems could occur.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Sertraline Concentrate during pregnancy, especially during the third trimester. It is unknown if Sertraline Concentrate is excreted in breast milk. If you are or will be breast-feeding while you are using Sertraline Concentrate, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Sertraline 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:

Abnormal skin sensation; agitation; anxiety; changes in vision; constipation; decreased sex drive; decreased sexual ability; diarrhea/loose stools; dizziness; drowsiness; dry mouth; failure to ejaculate; gas; headache; hot flushes; increased sweating; indigestion; loss of appetite; nausea; nervousness; pain; rash; sleeplessness; sore throat; stomach pain; tiredness; tremor; vomiting; weight loss.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; chest pain; muscle disorder; pounding in the chest; seizures; thought of hurting yourself; unusual or rapid weight gain; unusual or severe mental or mood changes; worsening of depression.

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 increased heartbeat; prolonged vomiting; severe dizziness; severe drowsiness; tremor.

Store at controlled room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Keep Sertraline Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Sertraline Concentrate, please talk with your doctor, pharmacist, or other healthcare provider.
• Sertraline 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 summary only. It does not contain all information about Sertraline Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other healthcare provider.