SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated
NCS HealthCare of KY, LLC dba Vangard Labs
----------
Dispense with Medication Guide available at:
https://granulespharma.com/products/sertraline-tab
Medication Guide
SERTRALINE HYDROCHLORIDE TABLETS (ser' tra leen hye'' droe klor' ide) |
What is the most important information I should know about sertraline hydrochloride tablets?
|
What are sertraline hydrochloride tablets?
Sertraline hydrochloride tablets are a prescription medicine used to treat:
It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
|
Who should not take sertraline hydrochloride tablets?
Do not take sertraline hydrochloride tablets if you: • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. • have taken an MAOI within 2 weeks of stopping sertraline hydrochloride tablets unless directed to do so by your healthcare provider. • have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. • take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride). • take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems. • are allergic to sertraline or any of the ingredients in sertraline hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride tablets. • take Antabuse® (disulfiram) (if you are taking the liquid form of sertraline hydrochloride tablets) due to the alcohol content. People who take sertraline hydrochloride tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms: o high fever o rapid changes in heart rate or blood pressure o uncontrolled muscle spasms o confusion o stiff muscles o loss of consciousness (pass out ) |
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. |
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. |
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. |
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. |
How should I store sertraline hydrochloride tablets?
• Store sertraline hydrochloride tablets at room temperature, 20º to 25ºc (68º to 77ºc) • Keep sertraline hydrochloride tablets bottle closed tightly. Keep sertraline hydrochloride tablets and all medicines out of the reach of children. |
General information about the safe and effective use of sertraline hydrochloride tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride tablets for a condition for which it was not prescribed. Do not give sertraline hydrochloride tablets to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about sertraline hydrochloride tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride tablets that is written for healthcare professionals. For more information about sertraline hydrochloride tablets contact Granules Pharmaceuticals Inc., at 1-877-770-3183. |
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). |
This Medication Guide has been approved by the U.S. Food and Drug Administration
Manufactured by:
Granules India Limited
Hyderabad-500 081, India
Manufactured for:
Granules Pharmaceuticals Inc.
Chantilly, VA 20151
M.L.No.: 37/RR/AP/2003/F/R
Rev: 03/2023