Zoloft

What is ZOLOFT?

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 (5-hydroxytryptamine).

What does ZOLOFT do?

ZOLOFT has been prescribed to you by your doctor to relieve your symptoms of the following conditions:

• Depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)
• Obsessive-compulsive disorder
• Panic disorder (repeated, unexpected panic attacks)

What are the ingredients in ZOLOFT?

Sertraline hydrochloride is the active ingredient.

Nonmedicinal ingredients include: cornstarch; lactose (anhydrous), magnesium stearate; sodium lauryl sulfate.

Capsule shells contain: Gelatin, titanium dioxide and dye D & C Yellow #10. 25 and 50 mg capsules also contain dye FD & C Yellow #6 and capsules 100 mg also contain dye FD& C #40. The capsules do not contain tartrazine or gluten.

How do I store ZOLOFT?

• Store at room temperature (15°C-30°C) in a dry place
• Keep the container tightly closed
• Keep all medicines out of the reach and sight of children
• If your doctor decides to stop ZOLOFT treatment, please return any leftover medicine to your pharmacist

Learn More: Taking this medication >

How do I take ZOLOFT?

It is very important for you to take ZOLOFT exactly as your doctor has instructed.

Never increase or decrease the amount of ZOLOFT you, or those in your care if you are a caregiver or guardian, are taking unless your doctor tells you to and do not stop taking this medication without consulting your doctor.

As with all antidepressants, improvement with ZOLOFT is gradual. You should continue to take your medicine even if you do not feel better, as it may take several weeks for your medicine to work.

ZOLOFT should be taken with food – either in the morning or evening. You should swallow the capsule whole; do not divide, crush or chew it.

This medicine has been prescribed only for you. Do not give it to anybody else. If you have further questions, please ask your doctor or pharmacist.

What if I miss a dose?

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

What should I do in case of an overdose?

In case of overdose, contact your doctor, the regional Poison Control Centre or the nearest hospital emergency department, even though you may not feel sick. Take your medicine with you.

Is there anything I should know before taking ZOLOFT?

Before taking ZOLOFT, tell your doctor or pharmacist:

• All your medical conditions
• If you have a history of:
  • seizures
  • liver disease
  • kidney disease
  • high cholesterol
  • heart disease
  • heart rhythm problems
  • slow heart beat
  • are taking medications for your heart
  • manic episodes
• If in your family there is a history of:
  • people younger than 50 years of age having a heart attack
• If the 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
• If you have had a stroke
• If you are known to have heart problems (or predispositions) related to a genetic expression (or modification, variant)
• If you have had a head injury
• If you have diabetes
• If you have a bleeding disorder or have been told that you have low platelets
• If you have blood pressure problems
• Any medications (prescription or nonprescription) which you are taking or have recently taken (within the last 14 days), especially monoamine oxidase (MAO) inhibitors (e.g., phenelzine sulfate, tranylcypromine sulfate or moclobemide) or any other antidepressants, pimozide (an antipsychotic drug), drugs used to treat diabetes, drugs used to thin the blood (anticoagulants), the antibiotic linezolid, methylthioninium chloride (methylene blue) or drugs that affect serotonin (including but not limited to fentanyl, fenfluramine and tryptophan)
• If you are pregnant or thinking about becoming pregnant, or if you are breastfeeding
• If you have a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
• Your habits of alcohol and/or street drug consumption
• Any natural or herbal products you are taking (e.g., St. John’s Wort)
• If you drive a vehicle or perform hazardous tasks during your work
• If you have ever had any allergic reaction to medications, food, etc.

Can I take ZOLOFT with other medications?

Do not use ZOLOFT if you are taking or have recently taken monoamine oxidase inhibitors.

You should avoid taking St. John’s Wort if you are taking ZOLOFT.

You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural/herbal), especially:

• Other antidepressants, such as SSRIs and certain tricyclics
• Other drugs that affect serotonin, such as amphetamines, lithium, linezolid, tramadol, tryptophan, triptans used to treat migraines
• Certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine
• Certain medicines used to treat cough, such as dextromethorphan
• Certain medicines used to treat schizophrenia
• Certain medicines used to treat bipolar depression, such as lithium
• Metoprolol or other medications used to treat high blood pressure and angina
• Certain medicines which may affect blood clotting and increase bleeding, such as oral anti-coagulants (e.g., warfarin, dabigatran), acetylsalicylic acid (e.g., Aspirin) and other non-steroidal anti-inflammatory drugs (e.g., ibuprofen)
• Certain medicines used to treat epilepsy
• Cimetidine

In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking ZOLOFT.

Learn More: Safety information >

Can ZOLOFT cause any side effects?

Like all medications, ZOLOFT can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects as the dose may have to be adjusted. However, some may be serious. If you experience an allergic reaction or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.

Some side effects include: headache, nausea, dry mouth, diarrhea, loss of appetite, sleepiness, dizziness, insomnia, sexual problems, nervousness or tremor.

ZOLOFT does not usually affect people’s normal activities. However, some people feel sleepy while taking it, in which case they should not drive or operate machinery.

Cases of loss of blood sugar level control, including both higher- and lower-than normal sugar levels have been reported in patients receiving SSRIs including ZOLOFT, with and without pre-existing diabetes. Symptoms associated with low blood sugar level in your blood include weakness, hunger, anxiety, sweating, numbness or tingling in your extremities. These are early warning symptoms and should not be ignored. Contact your doctor if you experience these symptoms.

ZOLOFT may raise cholesterol levels in some patients. Blood cholesterol tests may be required by your doctor during treatment with ZOLOFT.

Discontinuation symptoms

Contact your doctor before stopping or reducing your dosage of ZOLOFT. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, headache, tremor, nausea, vomiting, sweating or other symptoms may occur after stopping or reducing the dosage of ZOLOFT. Such symptoms may also occur if a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of ZOLOFT to alleviate the symptoms.

This is not a complete list of side effects. For any unexpected effects while taking ZOLOFT, contact your doctor or pharmacist.

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

Treatment with these types of medication is most safe and effective when you and your doctor have good communication about how you are feeling.

ZOLOFT is not for use in children under 18 years of age.

Changes in Feelings and Behaviour (anger, anxiety, suicidal or violent thoughts):
It is important that you have good communication with your doctor about how you feel. Discussing your feelings and treatment with a friend or relative who can tell you if they think you are getting worse is also useful.

Some patients may feel worse when first starting or changing the dose of drugs such as ZOLOFT. You may feel more anxious or may have thoughts of hurting yourself or others, especially if you have had thoughts of hurting yourself before. These changes in feelings can happen in patients treated with drugs like ZOLOFT for any condition, and at any age, although it may be more likely if you are aged 18 to 24 years old. If this happens, see your doctor immediately. Do not stop taking ZOLOFT on your own.

Taking ZOLOFT may increase your risk of experiencing sexual problems, which may continue after ZOLOFT has been discontinued. Tell your doctor if you experience symptoms such as a decreased libido, erectile dysfunction or ejaculation failure.

Taking ZOLOFT may increase your risk of breaking a bone if you are elderly or have osteoporosis or have other major risk factors for breaking a bone. You should take extra care to avoid falls especially if you get dizzy or have low blood pressure.

Effects on pregnancy and newborns:

If you are already taking ZOLOFT and have just found out that you are pregnant, you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.

Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressants, such as ZOLOFT, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support, and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.

In most cases, the SSRI or newer antidepressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the antidepressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

Persistent Pulmonary Hypertension (PPHN) and newer antidepressants:

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like ZOLOFT may increase the risk of a serious lung condition in babies called Persistent Hypertension of the Newborn (PPHN) that causes breathing difficulties in newborns soon after birth, making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby, you should contact your doctor immediately.

If you are pregnant and taking an SSRI, or other newer antidepressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor.

Angle-closure Glaucoma

ZOLOFT can cause an acute attack of glaucoma. Having your eyes examined before you take ZOLOFT could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

• eye pain
• changes in vision
• swelling or redness in or around the eye

When should ZOLOFT not be used?

Do not use ZOLOFT:

• If you are allergic to it or to any of the components of its formulation. Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
• If you are currently taking or have recently taken monoamine oxidase inhibitors, antidepressants
  (e.g., phenelzine sulphate, tranylcypromine sulphate or moclobemide)
• At the same time as pimozide