Sertraline Tablets

SERTRALINE (SER tra leen) treats depression, anxiety, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). It increases the amount of serotonin in the brain, a hormone that helps regulate mood. It belongs to a group of medications called SSRIs.

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Do not take your medication more often than directed. Keep taking this medication unless your care team tells you to stop. Stopping it too quickly can cause serious side effects. It can also make your condition worse.

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 care team about the use of this medication in children. While it may be prescribed for children as young as 7 years for selected conditions, precautions do apply.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, red or dark brown urine, vomiting blood or brown material that looks like coffee grounds, small red or purple spots on skin, unusual bleeding or bruising
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Serotonin syndrome—irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea
• Sudden eye pain or change in vision such as blurred vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood

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

• Change in sex drive or performance
• Diarrhea
• Excessive sweating
• Nausea
• Tremors or shaking
• Upset stomach

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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

• Bleeding disorders
• Bipolar disorder or a family history of bipolar disorder
• Frequently drink alcohol
• Glaucoma
• Heart disease
• High blood pressure
• History of irregular heartbeat
• History of low levels of calcium, magnesium, or potassium in the blood
• Liver disease
• Receiving electroconvulsive therapy
• Seizures
• Suicidal thoughts, plans, or attempt by you or a family member
• Take medications that prevent or treat blood clots
• Thyroid disease
• An unusual or allergic reaction to sertraline, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Linezolid
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Amphetamines
• Aspirin and aspirin-like medications
• Certain medications for fungal infections, such as ketoconazole, fluconazole, posaconazole, itraconazole
• Certain medications for irregular heart beat, such as flecainide, quinidine, propafenone
• Certain medications for mental health conditions
• Certain medications for migraine headaches, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for seizures, such as carbamazepine, valproic acid, phenytoin
• Certain medications for sleep
• Certain medications that prevent or treat blood clots, such as warfarin, enoxaparin, dalteparin
• Cimetidine
• Digoxin
• Diuretics
• Fentanyl
• Isoniazid
• Lithium
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Other medications that cause heart rhythm changes, such as dofetilide
• Rasagiline
• Safinamide
• Supplements, such as St. John's wort, kava kava, valerian
• Tolbutamide
• Tramadol
• Tryptophan

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.

Tell your care team if your symptoms do not get better or if they get worse. Visit your care team for regular checks on your progress. Because it may take several weeks to see the full effects of this medication, it is important to continue your treatment as prescribed by your care team.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden 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 treatment or after a change in dose, call your care team.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit or stand up slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

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