Sertraline Hydrochloride Oral solution

What is this medicine?

SERTRALINE (SER tra leen) is used to treat depression. It may also be used to treat obsessive compulsive disorder, panic disorder, post-trauma stress, premenstrual dysphoric disorder (PMDD) or social anxiety.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bipolar disorder or a family history of bipolar disorder
• diabetes
• heart disease
• liver disease
• receiving electroconvulsive therapy
• seizures (convulsions)
• suicidal thoughts, plans, or attempt by you or a family member
• an unusual or allergic reaction to sertraline, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label.

Before taking your dose, you need to dilute the solution in a beverage. Measure your medicine dose using the dropper in the bottle. Next, place the measured dose in at least 4 ounces (one-half cup) of water, ginger-ale, lemon-lime soda, lemonade or orange juice and mix. Do not mix in grapefruit juice or in any other liquids other than those listed.

Drink all of mixed liquid immediately. Do not mix the dose and store it for later. It must be taken right away. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 7 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride
• medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
• pimozide
• procarbazine
• St. John's wort
• thioridazine

This medicine may also interact with the following medications:

• amphetamine or dextroamphetamine
• aspirin and aspirin-like drugs
• certain diet drugs like dexfenfluramine, fenfluramine, phentermine, sibutramine
• certain migraine headache medicines like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• linezolid
• medicines for sleep
• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• medicines to control heart rhythm like flecainide or propafenone
• metoclopramide
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• other medicines for depression, anxiety, or psychotic disturbances
• pentazocine
• ritonavir
• tolbutamide
• tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Continue to take your medicine even if you do not feel better right away. It can take several weeks before you feel the full effect.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine contains a high-percentage of alcohol that may interact with medicines used to treat alcohol abuse, like Antabuse. You should not take these medicines together.

If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or your symptoms may get worse. Ask your doctor or health care professional for advice on slowly stopping this medicine.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• black or bloody stools, blood in the urine or vomit
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• hallucination, loss of contact with reality
• seizures
• suicidal thoughts or other mood changes
• unusual bleeding or bruising
• unusually weak or tired
• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in appetite
• change in sex drive or performance
• diarrhea
• indigestion, nausea
• increased sweating
• tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.