Patient Medication Information: uses, side effects, how to take - Teva-Moclobemide
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-MOCLOBEMIDE is a prescription medication used to treat the symptoms of depression in adults more than18 years of age.
What it does:
TEVA-MOCLOBEMIDE is a short-acting antidepressant and belongs to the family of drugs called Reversible Inhibitor of Monoamine Oxidase-type A (RIMA). TEVA-MOCLOBEMIDE inhibits the imbalance of certain chemicals in the brain by increasing their concentrations.
This action accounts for the antidepressant activity of
TEVA-MOCLOBEMIDE.
When it should not be used:
Do not take TEVA-MOCLOBEMIDE if:
- You have known allergy to moclobemide or to any of the other ingredients TEVA-MOCLOBEMIDE contains.
- You suffer from a mental problem that makes you confused, lose contact with reality or unable to think and judge clearly
- You are currently taking a medication to treat depression (a tricyclic/tetracyclic antidepressant, a selective serotonin reuptake inhibitor (SSRI), a serotonin-norepinephrine reuptake inhibitor (SNRI) or a conventional monoamine oxydase inhibitor (MAO-I)).
- You are currently taking selegiline
- You are currently taking the pain medications meperidine or tramadol
- You are currently taking thioridazine
- You are currently taking a migraine medication such as rizatriptan, sumatriptan or other triptans
- You are currently taking bupropion (WELLBUTRIN or ZYBAN).
- You are currently taking dextromethorphan
- You have a pheochromocytoma (a tumor of the adrenal gland)
What the medicinal ingredient is:
Moclobemide
What the nonmedicinal ingredients are:
Lactose, povidone, sodium starch glycolate, talc, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, triethyl citrate.
100 mg and 150mg Tablets: corn starch, triacetin, synthetic yellow iron oxide, synthetic red iron oxide,
300 mg Tablets: sodium lauryl sulfate, hydroxypropyl cellulose,
What dosage forms it comes in:
TEVA-MOCLOBEMIDE is available in 100 mg (orange), 150 mg (pale yellow) and 300 mg (white) single scored, oval, film- coated tablets.
WARNINGS AND PRECAUTIONS
TEVA-MOCLOBEMIDE is not for use in children under 18 years of age.
New or Worsened Emotional or Behavioral Problems:
Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.
TEVA-MOCLOBEMIDE may take from a few days to several weeks to be really effective, so patience is needed to give the drug a chance to work.
Do not drive a vehicle or perform hazardous tasks until you know how TEVA-MOCLOBEMIDE affects you.
Effects on Pregnancy and Newborns:
If you are already taking/using TEVA-MOCLOBEMIDE 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.
Angle-Closure Glaucoma:
TEVA-MOCLOBEMIDE can cause an acute attack of glaucoma. Seek immediate medical attention if you experience eye pain, changes in vision, swelling or redness in or around the eye.
BEFORE you use TEVA-MOCLOBEMIDE talk to your doctor or pharmacist if:
- you have ever had a bad reaction to TEVA-MOCLOBEMIDE or any of the inactive ingredients.
- you are allergic to other medicines, food and dyes.
- you are taking ANY other medicines (prescription or nonprescription) particularly cimetidine, meperidine, selegiline, thioridazine, buspirone, clomipramine, anesthetics, other antidepressants, blood pressure medications, or medications used to treat certain mental illnesses other than depression.
- you are planning to take cough and cold medications containing dextromethorphan or allergy medications.
- you experience psychotic symptoms or are taking antipsychotic medication
- you will be undergoing anesthesia or are taking/will be taking opioid pain medications
- you have any other illnesses/diseases, including a history of liver or kidney disease, thyroid disorders, heart problems, or high blood pressure.
- you are pregnant, plan on becoming pregnant, or are breastfeeding.
- you have a habit of excessive alcohol consumption or street drug use.
This information will help your doctor decide whether you should use TEVA-MOCLOBEMIDE and what extra care may need to be taken while you are on the medication. You should always consult your doctor or pharmacist before using other medications while on TEVA-MOCLOBEMIDE.
INTERACTIONS WITH THIS MEDICATION
The following list includes some, but not all, of the drugs that may increase the risk of side-effects while receiving TEVA-MOCLOBEMIDE. You should check with your doctor or pharmacist before taking any other medication (prescription, non-prescription or natural/herbal such as St John’s Wort) with TEVA-MOCLOBEMIDE.
- Alcohol,
- anesthetics,
- buspirone,
- cimetidine,
- clomipramine,
- meperidine,
- selegiline,
- thioridazine,
- other antidepressants,
medications used to treat certain mental illnesses other than depression.
- blood pressure medications, cough and cold medications containing dextromethorphan,
- allergy medications or any medication that contains amphetamine and ephedrine like compounds
- There are no dietary restrictions but excessive amounts of some foods should be avoided such as over 200g of strong cheese or 70g of Marmite yeast extract
PROPER USE OF THIS MEDICATION
Usual adult dose:
The recommended starting dose of TEVA-MOCLOBEMIDE is 300 mg/day (150 mg tablet twice a day). Your doctor may recommend to increase the dose to a maximum of 600 mg /day (300 mg tablet twice a day).
TEVA-MOCLOBEMIDE should always be taken after meals.
TEVA-MOCLOBEMIDE should be swallowed whole with water. TEVA-MOCLOBEMIDE tablets should not be split, crushed, chewed or dissolved as this can destroy it or change its effects.
Take TEVA-MOCLOBEMIDE as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
It is very important that you do NOT stop taking TEVA-MOCLOBEMIDE as soon as you start to feel feeling better.
Discuss with your doctor how long drug treatment should continue, especially if you have had more than one episode of depression.
Overdose:
| 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. |
Signs and symptoms of overdose with TEVA-MOCLOBEMIDE include:
Nausea, vomiting, drowsiness, confusion, slurred speech, memory impairment, reduced reflexes, agitation, increased blood pressure, and seizures.
Missed Dose:
If you forget to take a dose of TEVA-MOCLOBEMIDE take it as soon as possible, then just carry on with the regular times you take your medication. If you remember your missed dose close to the time for your next dose, do not take the missed dose.
Like all medications, TEVA-MOCLOBEMIDE can cause some side effects. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TEVA-MOCLOBEMIDE.
Call your doctor immediately if a combination of the following symptoms occurs:
- Severe throbbing headache which starts at the back of the head and radiates forward
- Neck stiffness
- Heart fluttering, fast or slow heart beat
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
| Common | Insomnia, dizziness, nausea, headache | |||
| Rare | Allergic reaction: skin rash or hives, difficulty breathing, swelling of your face, lips, tongue, or throat | |||
| Unknown | Fast, racing, pounding or irregular heartbeat | |||
| slow heartbeat | ||||
neck stiffness, severe throbbing . headache - starting at the back of the head and radiating forward | ||||
| Changes in eyesight (vision) | ||||
| Diarrhoea or constipation | ||||
This is not a complete list of side effects. For any
unexpected effects while taking TEVA-MOCLOBEMIDE, contact your doctor or pharmacist.
Store TEVA-MOCLOBEMIDE at room temperature between 15° to 30°C.
Do not use TEVA-MOCLOBEMIDE tablets after the expiry date. All expired medications should be returned to your pharmacist.
Keep TEVA-MOCLOBEMIDE and all other medications out of the sight and reach of children.
This product plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:
1-800-268-4127 ext. 1255005(English);
1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Last revised: June 01, 2016
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
Not enough sodium in your blood. Signs of this may be ./ feeling sleepy, confused or having fits (seizures). | ||||
Feeling confused and lost (disoriented) | ||||
| New or Worsened Emotional or Behavioral Problems | thoughts or talk of death or suicide; thoughts or talk of self-harm or harm to others; any recent attempts of self-harm | |||
HOW TO STORE IT
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:
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). 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. |