Zoloft

Are there any serious warnings or precautions that I should know about?

Other warnings you should know about:

Pregnancy: Only take ZOLOFT during pregnancy if you and your healthcare professional have discussed the risks and have decided that you should. If you take ZOLOFT near the end of your pregnancy, you may be at a higher risk of heavy vaginal bleeding shortly after birth. If you become pregnant while taking ZOLOFT, tell your healthcare professional right away.

Effects on newborns: In some cases, babies born to a mother taking ZOLOFT during pregnancy may require hospitalization, breathing support and tube feeding. Be ready to seek medical help for your newborn if they have trouble breathing or feeding, muscle stiffness or floppiness, seizures, jitteriness, or constant crying.

During early pregnancy, there may be a slight increase in the risk of heart defects in the newborn. In late pregnancy, there is a risk of Persistent Pulmonary Hypertension of the Newborn (PPHN), which causes breathing problems.

Falls and fractures: ZOLOFT can cause you to feel sleepy or dizzy and can affect your balance. This increases your risk of falling, which can cause fractures or other fall related-injuries, especially if you take sedatives, consume alcohol, are elderly, or have a condition causing weakness or frailty.

Serotonin toxicity (also known as Serotonin Syndrome): ZOLOFT can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take ZOLOFT with certain anti-depressants or migraine medications. Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma

Driving and using machines: ZOLOFT may make you feel sleepy. Give yourself time after taking ZOLOFT to see how you feel before driving a vehicle or using machinery. ZOLOFT can cause serious side effects including:

• Angle-closure glaucoma (sudden eye pain or change in vision)
• Heart rhythm problems
• Sexual dysfunction

What is ZOLOFT?

ZOLOFT is used in adults to relieve your symptoms of:

• Depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)
• Obsessive-compulsive disorder (recurrent and intrusive thoughts, feelings, ideas, or sensations; recurrent pattern of behaviour, or unwanted thoughts or actions)
• Panic disorder (repeated, unexpected panic attacks)

What does ZOLOFT do?

ZOLOFT belongs to a group of medicines known as antidepressants, more specifically to the family of medicines called SSRIs (Selective Serotonin Reuptake Inhibitors).
ZOLOFT is thought to work by increasing the levels of a chemical in the brain called serotonin. This helps to relieve your symptoms of depression, obsessive-compulsive disorder and/or panic disorder.

What are the ingredients in ZOLOFT?

Sertraline hydrochloride is the active ingredient.

Nonmedicinal ingredients are: Cornstarch; lactose (anhydrous); magnesium stearate; sodium lauryl sulfate.
Capsule shells contain gelatin, titanium dioxide and dye D & C Yellow #10. The 25 mg and 50 mg capsules also contain dye FD & C Yellow #6 and the 100 mg capsules also contain dye FD & C #40.

Is there anything I should know before taking ZOLOFT?

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Do not use ZOLOFT if:

• you are allergic to sertraline hydrochloride or to any of the non-medicinal ingredients in ZOLOFT (see What are the ingredients in ZOLOFT).
• you are currently taking or have recently taken any monoamine oxidase inhibitors (MAOIs), such as phenelzine sulphate, tranylcypromine sulphate, moclobemide. If you are unsure, ask your healthcare professional.
• you are currently taking pimozide

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZOLOFT. Talk about any health conditions or problems you may have, including if you:

• have any diseases or conditions that affect your metabolism or heart function
• have or have a history of:
• seizures
• liver disease
• high cholesterol
• heart disease
• heart rhythm problems
• slow heartbeat
• taking medications for your heart
• manic episodes
• have a family history of people younger than 50 years of age having a heart attack
• have levels of electrolytes in your body are either too high or too low or you have a condition (such as an eating disorder) that can affect your electrolyte levels
• have had a stroke
• are known to have heart problems or have been told you are at risk for heart problems
• have diabetes
• have or have a history of a bleeding disorder or have been told that you have low platelets
• have blood pressure problems;
• are pregnant or thinking about becoming pregnant, or if you are breast feeding
• had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
• drink alcohol and/or use street drugs
• have ever had any allergic reaction to medications, food, etc.

Can I take ZOLOFT with other medications?

Do not take ZOLOFT if you:

• are taking or have recently taken (in the last 14 days) any MAOIs such as phenelzine, tranylcypromine, linezolid, methylene blue as you may have serious side effects
• are taking pimozide, an antipsychotic medicine (used to manage psychosis)

The following may also interact with ZOLOFT:

• other antidepressants, such as SSRIs and certain tricyclics
• other drugs that affect serotonin such as, amphetamines, opioids, tryptophan, fenfluramine
• certain medicines called “triptans” which are used to treat migraines, such as almotriptan, sumatriptan, rizatriptan, naratriptan, zolmitriptan
• certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine
• metamizole, used to treat fever or pain
• certain medicines used to treat cough, such as dextromethorphan
• certain medicines used to treat bipolar depression, such as lithium
• drugs that affect your electrolyte levels such as diuretics (“water pills”), laxatives and enemas, amphotericin B, high dose corticosteroids (drugs that reduce inflammation)
• drugs that can affect how your blood clots such as warfarin, dabigatran, acetylsalicylic acid (Aspirin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• certain medicines used to treat seizures such as phenytoin
• cimetidine, a medicine used to treat heartburn
• insulin or oral medicines used to treat diabetes
• an herbal medicine called St. John’s Wort
• alcohol, it is recommended to avoid drinking alcohol while taking ZOLOFT

Learn More: Taking this medication >

How do I take ZOLOFT?

• It is very important that you take ZOLOFT exactly as your healthcare professional has instructed
• Keep taking ZOLOFT unless your healthcare professional tells you to stop
• Continue to take ZOLOFT even if you do not feel better, as it may take several weeks for your medicine to start working
• Take with food either in the morning or the evening
• Swallow the capsules whole, do not divide, crush or chew them

This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may serious.

What should I do in case of an overdose?

If you think you, or a person you are caring for, have taken too much ZOLOFT, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

What if I miss a dose?

If you miss a dose, do not take the missed dose. Just take your next dose at the right time. Do not take a double dose to make up for a missed dose.

Learn More: Safety information >

What are possible side effects from using ZOLOFT?

These are not all the possible side effects you may have when taking ZOLOFT. If you experience any side effects not listed here, tell your healthcare professional.

Common serious side effect is sexual dysfunction including low sex drive, not being able to ejaculate, delayed ejaculation, erectile dysfunction.

Uncommon serious side effects include:
Akathisia (a type of movement disorder): feeling restless and unable to sit or stand still;
Allergic reactions: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up;
Bruising or unusual bleeding from the skin or other areas;
Heart rhythm problems: dizziness, increased heart rate, fainting or seizures;
Liver Disorder: yellowing of the skin or eyes, dark urine and pale stools, abdominal pain, nausea, vomiting, loss of appetite;
Low blood sugar: dizziness, lack of energy, drowsiness;
Low sodium level in the blood: tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles;
Mania: elevated or irritable mood, decreased need for sleep, racing thoughts;
Uncontrollable movements of the body or face.

Rare serious side effects include:
Angle-closure glaucoma (sudden eye pain): increased pressure in your eyes, eye and head pain, swelling or redness in or around the eye, hazy or blurred vision, sudden loss of sight;
Eosinophilic pneumonia: fatigue, muscle pain, lung chest pain, shortness of breath, respiratory symptoms;
Gastrointestinal bleeding (bleeding in the stomach or bowels): vomiting blood, black/tarry stool, blood in the stool;
Seizures (fits): uncontrollable shaking with or without loss of consciousness; Serotonin toxicity: a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (> 38°C), or rigid muscles.

Other serious side effects:
Changes in feelings or behavior (anger, anxiety, suicidal or violent thoughts);
Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue, weakness.

If you experience any of these or other side effects, contact your healthcare professional.

Discontinuation symptoms

Do NOT stop taking ZOLOFT without talking to your healthcare professional first, as it may cause unwanted side effects such as headache, insomnia, numbness, tingling, burning, or prickling, nervousness, anxiety, nausea, sweating, dizziness, jitteriness and weakness.

This is not a complete list of side effects. For any unexpected effects while taking ZOLOFT, contact your health care professional.

How do I store ZOLOFT?

• Store ZOLOFT at room temperature (15-30°C).
• Keep container tightly closed.
• If your healthcare professional tells you to stop taking ZOLOFT please return any leftover medicine to your pharmacist.
• Keep out of reach and sight of children.