"The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
Aurobindo Pharma Ltd., Dr. Reddy's La"...
This leaflet is part III of a three-part “Product Monograph” published when REMERON® was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about REMERON®. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
REMERON® belongs to a group of medicines known as anti-depressants.
REMERON® has been prescribed to you to relieve your symptoms of depression. Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.
What it does:
The way REMERON® works to treat depression is unknown. REMERON® is thought to have an effect in the brain on chemicals called serotonin and norepinephrine.
When it should not be used:
Do not use REMERON® if you are:
- allergic to it or any of the components (see section What the important nonmedicinal ingredients are);
- currently taking or have recently taken monoamine oxidase (MAO) inhibitors (including some types of anti-depressants and anti-Parkinson treatments) (see section INTERACTIONS WITH THIS MEDICATION).
What the medicinal ingredient is:
What the important nonmedicinal ingredients are:
Colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, titanium dioxide, yellow and red iron oxides.
What dosage forms it comes in:
Tablets: 30 mg – The tablet can be divided into equal halves, resulting in two tablets of 15 mg.
WARNINGS AND PRECAUTIONS
During treatment with these types of medications, it is important that you and your doctor have good ongoing communication about how you are feeling.
REMERON® 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 REMERON®. 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 REMERON® 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 REMERON® on your own.
BEFORE you use REMERON®, talk to your doctor or pharmacist:
- if you have ever had an allergic reaction to any medication;
- if you have QT/QTc prolongation or a family history of QT/QTc prolongation;
- if you have heart disease;
- about all your medical conditions, including a history of seizures, liver or kidney disease, heart problems, such as certain kinds of heart conditions that may change your heart rhythm, a recent heart attack, heart failure, or take certain medicines that may affect the heart's rhythm, diabetes, low blood pressure, glaucoma (increased intra-ocular pressure), high cholesterol and/or high triglycerides (fats in the blood), difficulties in urinating as a result of an enlarged prostate, psychiatric diseases such as schizophrenia and bipolar disorder (alternating periods of elation/overactivity and depressed mood);
- about any medications (prescription or nonprescription) you are taking (refer to the next section for specific interactions with REMERON®);
- about any natural or herbal products you are taking (e.g., St. John's Wort);
- if you are pregnant or thinking of becoming pregnant, or if you are breastfeeding;
- about your habits of alcohol consumption;
- if you have hereditary galactose intolerance or glucose-galactose malabsorption.
REMERON® is not for use in children under 18 years of age.
Refrain from potentially hazardous tasks, such as driving a car or operating dangerous machines, until you are certain that this medication does not affect your mental alertness or physical coordination.
Contact your physician before stopping or reducing your dosage of REMERON®. 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 REMERON®. 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 REMERON® to alleviate these symptoms.
Effects on Pregnancy and Newborns
If you are already taking/using REMERON® 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.
Possible complications at birth (from taking any newer antidepressant, including REMERON®):
Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti-depressants, such as REMERON®, 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 newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti-depressant 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.
If you are pregnant, or nursing, and taking an SSRI or other newer anti-depressants, such as REMERON®, 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. See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM section.
INTERACTIONS WITH THIS MEDICATION
Serious Drug Interactions
Do not use REMERON if you are taking or have recently taken:
- Monoamine oxidase inhibitor (e.g., phenelzine, tranylcypromine, moclobemide, selegiline, linezolid, methylene blue)
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, venlafaxine and certain tricyclics
- other drugs that affect serotonin such as tryptophan, triptans, lithium, tramadol, methylene blue (used to treat high levels of methemoglobin in the blood), St. John's Wort
- ketoconazole(medicine for treating fungal infections)
- cimetidine (used to treat reflux and stomach ulcers)
- erythromycin [used to treat bacterial infections (antibiotic)]
- drugs used to treat Human Immunodeficiency Virus (HIV), such as a combination of fosamprenavir and ritonavir
- nefazodone (used to treat depression)
- certain drugs used to treat epilepsy, such as carbamazepine and phenytoin
- rifampicin (used to treat tuberculosis)
- warfarin (used to prevent blood clotting)
- benzodiazepines (e.g midazolam, oxazepam and diazepam) – as REMERON® may add to the sedative effects of these agents.
- medicines that may affect the heart's rhythm such as certain antibiotics and some anti-psychotics.
Avoid alcoholic drinks while taking REMERON®.
PROPER USE OF THIS MEDICATION
Usual adult dose:
It is very important that you take REMERON® exactly as your doctor has instructed. Generally, most people take between 15 mg and 45 mg per day. There is only one tablet strength available - 30 mg - and that tablet shows a score line. This means that in order to get the 15 mg and 45 mg doses, the 30 mg tablet must be divided into two 15 mg tablets, by breaking it along the score line.
15 mg dose: Take one half of a 30 mg tablet
30 mg dose: Take one 30 mg tablet
45 mg dose: Take one 30 mg tablet + one half of a 30 mg tablet
How to take REMERON®:
- Never increase or decrease the amount of REMERON® 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 (see WARNINGS AND PRECAUTIONS when taking REMERON®).
- Some symptoms may begin to improve within about two weeks, but significant improvement can take several weeks. Continue to follow the doctor's instructions.
- The tablets should be taken at the same time each day, preferably as a single evening dose (prior to sleep). Do not chew them.
- Keep taking your tablets until the doctor tells you to stop. The doctor may tell you to take your medicine for several months. Continue to follow the doctor's instructions.
- Do not take a double dose to make up for forgotten doses.
- If you forget to take your evening dose, do not take the missed dose the next morning. Continue treatment in the evening (prior to sleep) with your normal dose.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
The most likely signs of an overdose of REMERON® (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate. The symptoms of a possible overdose may include changes to your heart rhythm (fast, irregular heartbeat) and/or fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes.
Do not take a double dose to make up for forgotten doses. If you forget to take your evening dose, do not take the missed dose the next morning. Continue treatment in the evening (prior to sleep) with your normal dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like other medications, REMERON® can cause some side effects. You may not experience any of them. For most patients, 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.
- You may experience some side effects, such as increase in appetite, constipation, swollen ankles or feet, occasional dizziness or faintness (especially when you get up quickly from a lying or sitting position), nausea, headache, localized swelling, swelling throughout the body, speech disorder, increased creatine kinase blood levels, and difficulty in passing urine (urinary retention).
- In rare cases, other effects may include rash, abnormal sensation in the skin (e.g., burning, stinging, tickling or tingly), involuntary trembling of muscles (tremor), dry mouth, tiredness.
- In very rare cases, other effects may include abnormal sensations in the mouth, sensations of numbness in the mouth and swelling in the mouth. Some side effects are temporary. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.
Decrease in White Blood Cells
If you experience signs of infection such as sudden unexplainable high fever, chills, sore throat and mouth or nose sores, tell your doctor right away. In rare cases, REMERON® can cause a decrease in white blood cells, which are needed to fight infection.
New or Worsened Emotional or Behavioural Problems
A small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience new or worsened feelings of agitation, hostility or anxiety, or thoughts about suicide. Your doctor should be informed of such changes immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own. See also the WARNINGS AND PRECAUTIONS section.
Contact your doctor before stopping or reducing your dosage of REMERON®. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, headache, tremor, nausea, vomiting, sweating and other symptoms have been reported after stopping REMERON®. 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 REMERON® to alleviate the symptoms. See WARNINGS AND PRECAUTIONS section for more information.
Effects on Newborns
Some newborns whose mothers took an SSRI or other newer antidepressants during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. If your baby experiences any of these symptoms, contact your doctor as soon as you can. See WARNINGS AND PRECAUTIONS section for more information.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT
TO DO ABOUT THEM
|Symptom/effect||Talk with your doctor or pharmacist||Seek immediate emergency medical assistance|
|Only if severe||In all cases|
|Common||Drowsiness which can lead to impaired concentration, generally occurring during the first few weeks of treatment||√|
|Rare||Bruising and/or unusual bleeding and symptoms of infection such as sudden high fever, sore throat, mouth ulcers, severe digestive system disturbances or other signs of infection (symptoms of blood cell disturbances).||√|
|Convulsions (loss of consciousness with uncontrollable shaking)||√|
|Fainting/loss of consciousness||√|
|Nightmares/vivid dreams, agitation or confusion||√|
|Hallucinations (strange visions or sounds)||√|
|Mania (feeling elated or emotionally ‘high’)||√|
|Akathisia (feeling restless and unable to stand still)||√|
|Uncontrolled, sudden movements||√|
|Restless legs (feeling of unrest during night mainly located in the legs combined with sudden muscle contractions in the legs)||√|
|Pain in the joints or muscles||√|
|Jaundice (yellowing of eyes or skin, dark urine||√|
|Symptoms of depression (anxiety and disturbed sleep)||√|
|Severe skin reactions such as Stevens-Johnson syndrome (fever, rash, swollen lymph nodes, hives, sore mouth, sore eyes or swelling of lips or tongue)||√|
|Low sodium levels in blood (feeling ill with symptoms of weakness, drowsiness, confusion, combined with achy, stiff or uncoordinated muscles)||√|
|Abdominal pain and nausea; this may suggest inflammation of the pancreas (pancreatitis)||√|
|Very Rare||A combination of symptoms such as unexplainable fever, sweating, increased heart rate, diarrhea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness (can be signs of serotonin syndrome)||√|
|See WARNINGS AND PRECAUTIONS||Changes in feelings or behaviour (anger, anxiety, suicidal or violent thoughts)||√|
|Unknown||Abnormal heart rate or rhythm, palpitations, fainting||√|
This is not a complete list of side effects. For any unexpected effects while taking REMERON®, contact your doctor or pharmacist.
HOW TO STORE IT
- Store at controlled room temperature, 15°C - 30°C in the tight, light-resistant container given to you by the pharmacist.
- Keep REMERON® out of the reach and sight of children.
- Do not use REMERON® after the expiry date indicated on the package.
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side
Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program, Health Canada, Postal Locator 0701E Ottawa, ON, K1A 0K9, Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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. »
If you want more information about REMERON®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or Merck Canada web site www.merck.ca or by calling Merck Canada at 1-800-567-2594
To report an adverse event related to REMERON®, please contact 1-800-567-2594.
Last reviewed on RxList: 12/22/2015
This monograph has been modified to include the generic and brand name in many instances.
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