Sertraline capsules

What are sertraline capsules?

Sertraline HCl Capsules are a prescription medicine used to treat:

• A certain type of depression called Major Depressive Disorder (MDD) in adults.
• Obsessive Compulsive Disorder (OCD) in adults and children 6 years and older.
• It is not known if Sertraline HCl Capsules are safe and effective for use in children under 6 years of age with OCD or children with other behavioral health conditions.

What is the most important information I should know about sertraline capsules?

Sertraline HCl Capsules may cause serious side effects, including:

• Increased risk of suicidal thoughts or actions.
• Sertraline HCl Capsules 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.
  
  How can I watch for and try to prevent suicidal thoughts and actions?
  • Depression or other mental illnesses are the most important causes of suicidal thoughts or actions.
  • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you or your child develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you or your child develop suicidal thoughts or actions.
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
    
    Call your healthcare provider or get emergency help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you:
    
  • attempts to commit suicide
  • acting aggressive or violent
  • new or worse depression
  • feeling agitated, restless, angry, or irritable
  • an increase in activity and talking more than what is normal for you
  • acting on dangerous impulses
  • thoughts about suicide or dying
  • new or worse anxiety or panic attacks
  • trouble sleeping
  • other unusual changes in behavior or mood

Who should not take sertraline capsules?

Do not take Sertraline HCl Capsules if you or your child:

• are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (MAOI).
• are being treated with the antibiotic linezolid or intravenous methylene blue.
• are taking the antipsychotic medicine pimozide because this can cause serious problems.
• are allergic to sertraline or any of the ingredients in Sertraline HCl Capsules. See the end of this Medication Guide for a complete list of ingredients in Sertraline HCl Capsules.

Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with Sertraline HCl Capsules.

What should I tell my healthcare provider before taking sertraline capsules?

Before taking Sertraline HCl Capsules, tell your healthcare provider about all medical conditions, including if you or your child:

• have or have had bleeding problems
• have, or have a family history of, bipolar disorder, mania, or hypomania
• have or have had seizures or convulsions
• have high pressure in the eye (glaucoma)
• have low sodium levels in your blood
• have heart problems
• have kidney or liver problems
• have an allergy or sensitivity to FD&C Yellow No. 5 (Tartrazine)
• are pregnant or plan to become pregnant. Sertraline HCl Capsules may harm the unborn baby. Taking Sertraline HCl Capsules during the third trimester of pregnancy may cause the baby to have withdrawal symptoms after birth or may cause the baby to be at an increased risk for a serious lung problem at birth. Talk to your healthcare provider about the risk to the mother and the unborn baby if Sertraline HCl Capsules are taken during pregnancy.
  • Tell your healthcare provider right away if you or your child becomes pregnant during treatment with Sertraline HCl Capsules.
  • There is a pregnancy registry for females who are exposed to Sertraline HCl Capsules during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Sertraline HCl Capsules and their baby. If you or your child become pregnant during treatment with Sertraline HCl Capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.
• are breastfeeding or plan to breastfeed. Sertraline HCl Capsules may pass into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Sertraline HCl Capsules.

Tell your healthcare provider about all the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sertraline HCl Capsules and some medicines may interact with each other causing serious side effects. Sertraline HCl Capsules may affect the way other medicines work and other medicines may affect the way Sertraline HCl Capsules works. Sometimes the doses of other medicines will need to be changed during treatment with Sertraline HCl Capsules. Your healthcare provider will decide whether Sertraline HCl Capsules can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

• medicines used to treat migraine headaches called triptans
• tricyclic antidepressants
• fentanyl
• lithium
• tramadol
• tryptophan
• buspirone
• amphetamines
• phenytoin
• St. John’s Wort
• medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet medicines, warfarin, and other anticoagulants
• diuretics

Ask your healthcare provider if you are not sure if you or your child take any of these medicines. Your healthcare provider or pharmacist can tell you if it is safe to take Sertraline HCl Capsules with other medicines.

Do not start or stop any other medicines during treatment with Sertraline HCl Capsules without talking to your healthcare provider first. Stopping Sertraline HCl Capsules suddenly may cause you or your child to have serious side effects. See, “What are the possible side effects of Sertraline HCl Capsules?”

Know the medicines you or your child take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take sertraline capsules?

• Take Sertraline HCl Capsules exactly as prescribed. Your healthcare provider may need to change the dose of Sertraline HCl Capsules until it is the right dose.
• Take Sertraline HCl Capsules with or without food.
• Swallow Sertraline HCl Capsules whole. Do not open, crush, or chew Sertraline HCl Capsules.
• If you miss a dose of Sertraline HCl Capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take 2 doses of Sertraline HCl Capsules at the same time.
• In case of overdose, get medical help or contact a live Poison Control expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.

What are the possible side effects of sertraline capsules?

Sertraline HCl Capsules may cause serious side effects, including:

• See, "What is the most important information I should know about Sertraline HCl Capsules?"
• Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when Sertraline HCl Capsules are taken with certain other medicines. See, “Who should not take Sertraline HCl Capsules?” Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any of the following signs and symptoms of serotonin syndrome:
  • agitation
  • seeing or hearing things that are not real (hallucinations)
  • confusion
  • coma
  • fast heartbeat
  • changes in blood pressure
  • dizziness
  • sweating
  • flushing
  • high body temperature (hyperthermia)
  • shaking (tremors), stiff muscles, or muscle twitching
  • loss of coordination
  • seizures
  • nausea, vomiting, diarrhea
• Increased chance of bleeding. Taking Sertraline HCl Capsules with aspirin, NSAIDs, or blood thinners may add to this risk. Tell your healthcare provider about any unusual bleeding or bruising.
• Manic episodes. Manic episodes may happen in people with bipolar disorder who take Sertraline HCl Capsules. Symptoms may include:
  • greatly increased energy
  • unusually grand ideas
  • reckless behavior
  • talking more or faster than usual
  • racing thoughts
  • severe problems sleeping
  • excessive happiness or irritability
• Discontinuation syndrome. Suddenly stopping Sertraline HCl Capsules may cause you or your child to have serious side effects. Your healthcare provider may want to decrease the Sertraline HCl Capsules dose slowly. Symptoms may include:
  • nausea
  • sweating
  • changes in mood
  • irritability and agitation
  • dizziness
  • electric shock feeling (paresthesia)
  • tremor
  • anxiety
  • confusion
  • headache
  • tiredness
  • problems sleeping
  • hypomania
  • ringing in the ears (tinnitus)
  • seizures
• Seizures or convulsions.
• Eye problems (angle-closure glaucoma). Sertraline HCl Capsules may cause a type of eye problem called angle-closure glaucoma in people with certain eye problems. You or your child may want to undergo an eye examination to see if you or your child are at risk and receive preventative treatment if you are. Call your healthcare provider if you or your child have eye pain, changes in vision, or swelling or redness in or around the eye.
• Low sodium levels in your blood (hyponatremia). Low sodium levels in the blood that may be serious and may cause death, can happen during treatment with Sertraline HCl Capsules. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in the blood. Stop taking Sertraline HCl Capsules and call your healthcare provider or get emergency medical help right away if you have any signs or symptoms of hyponatremia. Signs and symptoms may include:
  • headache
  • difficulty concentrating
  • memory changes
  • confusion
  • weakness and unsteadiness which can lead to falls
    
    In more severe or more sudden cases, signs and symptoms include:
  • seeing or hearing things that are not real (hallucinations)
  • fainting
  • seizures
  • coma
  • stopping breathing (respiratory arrest)
• Changes in the electrical activity of the heart. Changes in the electrical activity of the heart including QTc prolongation and Torsade de Pointes (TdP) have happened in people who take sertraline which is the medicine contained in Sertraline HCl Capsules.
• FD&C Yellow No. 5. Sertraline HCl Capsules contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.
• Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including Sertraline HCl Capsules, 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 HCl Capsules. There may be treatments your healthcare provider can suggest.

The most common side effects of Sertraline HCl Capsules include:

• nausea, diarrhea, or loose stool
• tremor or shaking
• indigestion
• decreased appetite
• increased sweating
• sexual problems including decreased libido and ejaculation problems

These are not all the possible side effects of Sertraline HCl Capsules.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of sertraline capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Sertraline HCl Capsules for a condition for which it was not prescribed. Do not give Sertraline HCl Capsules to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about Sertraline HCl Capsules that is written for healthcare professionals.

How should I store sertraline capsules?

• Store Sertraline HCl Capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Sertraline HCl Capsules bottle tightly closed.

Keep Sertraline HCl Capsules and all medicines out of the reach of children.

What are the ingredients in sertraline capsules?

Active ingredient: sertraline hydrochloride

Inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives.

For more information about Sertraline Hydrochloride Capsules call Almatica Pharma LLC at 1-877-447-7979.