What is the most important information I should know about sertraline hydrochloride tablets?
Sertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.
1. Suicidal thoughts or actions:
• Sertraline hydrochloride and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior,actions, thoughts, or feelings, especially if severe.
o Pay particular attention to such changes when sertraline hydrochloride is started or when the dose is changed.
o Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
o attempts to commit suicide
o acting aggressive or violent
o new or worse depression
o feeling agitated, restless, angry or irritable
o an increase in activity or talking more than what is normal for you
o acting on dangerous impulses
o thoughts about suicide or dying
o new or worse anxiety or panic attacks
o trouble sleeping
o other unusual changes in behavior or mood
2. Serotonin Syndrome. This condition can be life-threatening and symptoms may include:
• agitation, hallucinations, coma, or other changes in mental status
• racing heartbeat, high or low blood pressure
• coordination problems or muscle twitching (overactive reflexes)
• nausea, vomiting, or diarrhea
• sweating or fever
• muscle rigidity
3. Increased chance of bleeding : sertraline hydrochloride and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
4.Manic episodes. Symptoms may include:
• greatly increased energy
• racing thoughts
• Unusually grand ideas
• severe trouble sleeping
• reckless behavior
• excessive happiness or irritability
• talking more or faster than usual
5.Seizures or convulsions.
6.Glaucoma (angle-closure glaucoma). Many antidepressant medicines including sertraline hydrochloride may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
7.Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
8.Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
• Headache • confusion, problems concentrating or thinking, memory problems • weakness or feeling unsteady
9. Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including sertraline hydrochloride, may cause sexual problems.
Symptoms in males may include: • Delayed ejaculation or inability to have an ejaculation • Decreased sex drive • Problems getting or keeping an erection
Symptoms in females may include: • Decreased sex drive • Delayed orgasm or inability to have an orgasm
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with sertraline hydrochloride. There may be treatments your healthcare provider can suggest.
Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider. Stopping sertraline hydrochloride tablets too quickly may cause serious symptoms including:
• anxiety, irritability, high or low mood, feeling restless or changes in sleep habits • headache, sweating, nausea, dizziness • electric shock-like sensations, shaking, confusion
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What should I tell my healthcare provider before taking sertraline hydrochloride tablets?
Before starting sertraline hydrochloride tablets, tell your healthcare provider:
• if you have:
o liver problems o heart problems o bipolar disorder or mania o kidney problems o or have had seizures or convulsions o low sodium levels in your blood o a history of a stroke o high blood pressure o or have had bleeding problems
• are pregnant or plan to become pregnant. Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline hydrochloride tablets during pregnancy.
• are breastfeeding or plan to breastfeed. A small amount of sertraline hydrochloride may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride tablets.
Tell your healthcare provider about all the medicines that you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements.
Sertraline hydrochloride tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take sertraline hydrochloride tablets with your other medicines. Do not start or stop any medicine while taking sertraline hydrochloride tablets without talking to your healthcare provider first.
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How should I take sertraline hydrochloride tablets?
• Take sertraline hydrochloride tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride tablets until it is the right dose for you.
• Sertraline hydrochloride tablets may be taken with or without food.
• If you miss a dose of sertraline hydrochloride tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of sertraline hydrochloride tablets at the same time.
If you take too much Sertraline hydrochloride tablets, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.
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What should I avoid while taking Sertraline hydrochloride tablets?
Sertraline hydrochloride tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride tablets affects you. Do not drink alcohol while you take sertraline hydrochloride tablets.
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What are the possible side effects of Sertraline hydrochloride tablets?
Sertraline hydrochloride tablets may cause serious side effects, including:
• See “What is the most important information I should know about Sertraline hydrochloride tablets?”
The most common side effects in adults who take sertraline hydrochloride tablets include
• nausea, loss of appetite, diarrhea, or indigestion • increased sweating • tremor or shaking • agitation • change in sleep habits including increased sleepiness or insomnia • sexual problems including decreased libido and ejaculation failure • feeling tired or fatigued • anxiety
The most common side effects in children and adolescents who take include abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with sertraline hydrochloride tablets.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sertraline hydrochloride tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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What are the ingredients in sertraline hydrochloride tablets?
Active ingredient: sertraline hydrochloride
Inactive ingredients:
Tablets: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow # 10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet).
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