Ran-Sertraline: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RAN-SERTRALINE 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 it does:

RAN-SERTRALINE belongs to a group of medicines known as antidepressants, more specifically to the family of medicines called SSRIs (Selective Serotonin Reuptake Inhibitors).

RAN-SERTRALINE is thought to work by increasing the levels of a chemical in the brain called serotonin

(5-hydroxytryptamine).

When it should not be used:

• Do not use RAN-SERTRALINE if you are allergic to it or to

  any of the components of its formulation (see list of components at the end of this section). Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.

• Do not use RAN-SERTRALINE if you are currently taking

  or have recently taken monoamine oxidase inhibitors, antidepressants (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide)

• Do not use RAN-SERTRALINE at the same time as

  pimozide

What the medicinal ingredient is:

Sertraline hydrochloride

What the non-medicinal ingredients are:

Cornstarch, Lactose, Magnesium Stearate and Sodium Lauryl Sulfate. In addition, the capsule shells contain the following additional ingredients:

The 25 mg capsules: D&C Yellow #10, FD&C Yellow #6, Gelatin, Titanium Dioxide.

The 50 mg capsules: D&C Yellow #10, FD&C Yellow #6, Gelatin, Titanium Dioxide.

The 100 mg capsules: D&C Yellow #10, FD&C Red #40, Gelatin, Titanium Dioxide.

What dosage forms it comes in:

Capsules: 25 mg, 50 mg, 100 mg

WARNINGS AND PRECAUTIONS

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

RAN-SERTRALINE is not for use in children under 18 years of age.

Changes in Feelings and Behaviour

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 RAN-SERTRALINE. 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 RAN-SERTRALINE 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 RAN-SERTRALINE on your own.

Taking RAN-SERTRALINE 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.

BEFORE taking RAN-SERTRALINE 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 non-prescription) which you

  are taking or have recently taken (within last 14 days), especially monoamine oxidase (MAO) inhibitors (e.g., phenelzine sulfate, tranylcypromine sulfate, moclobemide) or any other antidepressants, pimozide (an antipsychotic drug), drugs used to treat diabetes, drugs used to thin the blood (anticoagulant), 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.

Effects on Pregnancy and Newborns:

If you are already taking RAN-SERTRALINE 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 RAN-SERTRALINE, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms included

feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.

In most cases, the SSRI or other 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 RAN-SERTRALINE may increase the risk of a serious lung condition in babies, called persistent pulmonary 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

RAN-SERTRALINE can cause an acute attack of glaucoma. Having your eyes examined before you take RAN-SERTRALINE 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

INTERACTIONS WITH THIS MEDICATION

Do not use RAN-SERTRALINE if you are taking or have recently taken monoamine oxidase inhibitors.

You should avoid taking St. John’s Wort if you are taking RAN-SERTRALINE.

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 paint), 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., acetylsalicylic acid) and other nonsteroidal 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 RAN-SERTRALINE.

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take RAN-SERTRALINE exactly

  as your doctor has instructed.

• Never increase or decrease the amount of RAN-

  SERTRALINE you, or those in your care if you are a caregiver or guardian, are taking unless your doctor tells you to.

• Do not stop taking this medication without consulting your

  doctor.

• As with all antidepressants improvement with RAN-

  SERTRALINE is gradual. You should continue to take RAN-SERTRALINE even if you do not feel better, as it may take several weeks for your medication to work. Improvement may be gradual.

• RAN-SERTRALINE should be taken with food either in the

  morning or the evening. You should swallow the capsule whole, do not divide, crush or chew the capsules.

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

Overdose:

If you think you have taken too much RAN-SERTRALINE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you happen to 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 forgotten dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, RAN-SERTRALINE 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. However, some may be serious. 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.

If you experience an allergic reaction (including red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.

Some side effects of RAN-SERTRALINE are:

• headache
• nausea
• dry mouth
• diarrhea
• loss of appetite
• sleepiness
• dizziness
• insomnia
• sexual problems including decreased libido, erectile dysfunction and ejaculation failure
• nervousness
• tremor

RAN-SERTRALINE 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 level have been reported in patients receiving SSRIs including RAN-SERTRALINE, 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.

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

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of RAN-SERTRALINE. 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 RAN-SERTRALINE. 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 RAN-SERTRALINE to alleviate the symptoms.

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

HOW TO STORE IT

• Store between 15^oC and 30^oC.
• Keep container tightly closed.
• Keep all medicines out of the reach and sight of children.

• If your doctor tells you to stop taking RAN-SERTRALINE,

  please return any leftover medicine to your pharmacist.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to

Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Ranbaxy Pharmaceuticals Canada Inc. at 1-866-840-1340.

Ranbaxy Pharmaceuticals Canada Inc.

Last revised: June 13, 2018