Consumer Information for: DOM-METOPROLOL-L

What the medication is used for

Dom-METOPROLOL-L is used alone or in combination with another medicine for the following conditions:

to treat high blood pressure.
to treat angina (chest pain triggered by exercise).
to help to protect the heart after a heart attack (myocardial infarction)

What it does

Dom-METOPROLOL-L is a beta-blocker. It helps to control high blood pressure or other heart-related problems.

When it should not be used

You should not be treated with Dom-METOPROLOL-L if you:

are allergic to metoprolol, to any of the other ingredients in Dom-METOPROLOL-L or to another beta-blocker
have breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of a heart disorder).
have a slow or irregular heartbeat.
have sudden and oppressive chest pain (sign of heart attack).
have very poor blood circulation in your limbs (for example, very cold, pale hands or feet, or pain in your leg muscles when you walk).
have low blood pressure.
have non-treated tumor of the medulla of the adrenal glands (pheochromocytoma)
have asthma or had history of difficulty breathing with wheezing or coughing.
have severe skin problems
suffer from severe drop in blood pressure, dizziness, fast heartbeat, rapid and shallow breathing, cold clammy skin (signs of a heart disorder named cardiogenic shock).

What the medicinal ingredient is

Metoprolol Tartrate.

What the non-medicinal ingredients are

Colloidal silicon dioxide, D&C Red No. 30 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polysorbate 80, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide, triethyl citrate.

What dosage form it comes in

Tablets: 25 mg, 50 mg and 100 mg

Warnings and precautions

BEFORE you use pms-METOPROLOL-L talk to your doctor or pharmacist if you :

have heart , liver or kidney disease
have high or low levels of sugar in the blood (diabetes)
are at risk for serious allergic reactions
have chest pain when you are at rest.
have poor blood circulation in your limbs (for example, very cold, pale hands or feet, or pain in your leg muscles when you walk).
have a tumor of the medulla or of the adrenal glands (pheochromocytoma), you would require an additional treatment to Dom-METOPROLOLL
have allergy to or an intolerance to lactose.
have an overactive thyroid gland.
have respiratory disease such as asthma, or sometimes get breathlessness and wheezing.
have a severe syndrome named oculomucocutaneous syndrome whose signs include severe conjunctivitis (red, irritated and watery eye), skin rash and ear infection
are pregnant, or intend to become pregnant. Dom-METOPROLOL-L should not be used during pregnancy. Your doctor will discuss with you the potential risks of taking Dom- METOPROLOL-L during pregnancy.
are breast feeding. If your doctor decides that you must continue to take Dom-METOPROLOL-L you should stop breast- feeding as Dom- METOPROLOL-L passes into breast milk.
are under 18 years old

If you need to undergo an operation where an anesthetic is used, tell your anesthetic professional that you are taking Dom-METOPROLOL-L

Driving and using machines: If you experience dizziness, tiredness or blurred vision during your treatment with Dom-METOPROLOL-L do not drive, use machinery, or perform other tasks that need full attention until you know how you respond to Dom- METOPROLOL-L. Drinking alcohol may increase tiredness.

Interactions with this medication

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal and non- prescription medicines. Some other medicines may interact with Dom-METOPROLOL-L. These include:

medicines used to treat high blood pressure
medicines used to treat chest pain (angina) (e.g. nitroglycerin),
medicines used to treat irregular heartbeat (e.g. amiodarone, propafenone, quinidine, disopyramidetocainide, procainamide, ajmalineamiodarone, flecainide, digitalis glycosides such as digoxin, lidocaine),
anaesthetics, medicines used during surgical operations,
adrenaline or similar substances (sympathomimetics), which are found in some eye and nose drops, and in some cough medicines or remedies for the common cold (e.g. noradrenaline, isoprenaline, ephedrine, phenylephrine, phenylpropanolamine, and xanthine derivatives),
insulin, or medicines used to treat high levels of sugar in the blood (diabetes),
medicines used to relieve pain or inflammation (non- steroidal anti-inflammatory drugs such as COX-2 inhibitors),
antibiotics (e.g. rifampicin),
antivirals (e.g. ritonavir),
antihistamines used to treat hay fever (e.g. diphenhydramine),
medicines used to treat malaria (e.g. hydroxychloroquineor quinine),
antipsychotic medicines (e.g. thioridazine, , chlorpromazine, fluphenazine, haloperidol),
antidepressants (e.g. fluoxetine, paroxetine, fluvoxamine, sertraline, clomipramine, desipramine or bupropion),
MOA Inhibitors and adrenergic neuron blockers (e.g. reserpine or guanethidine),
antifungals (e.g. terbinafine),
ergot alkaloids, used in the prevention and treatment of migraine headaches,
dipyridamole, used to reduce the risk of blood clots,
alcohol
fingolimod, a medicine used to treat multiple sclerosis

Proper use of this medication

Usual Dose

Follow your doctor’s instructions carefully. Do not exceed the recommended dosage.

Your doctor will tell you exactly how many tablets of Dom- METOPROLOL-L to take based on your individual requirements.

High Blood Pressure: the usual maintenance dose is 100- 200 mg daily.

Angina: the usual maintenance dose is 200 mg daily.

To Protect the Heart After a Heart Attack: the usual maintenance dose is 100 mg twice daily.

In general, the daily dosage is in the following range: 100 to 200 mg daily, either once daily (in the morning), or divided into two separate doses (one in the morning and one in the evening).

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

Dom-METOPROLOL-L tablets should be administered preferably with or following a meal.

Do not change the dose or stop the treatment without talking to your doctor. If you stop taking Dom-METOPROLOL-L suddenly, your condition may become worse. Your doctor may want you to reduce the dose gradually before stopping treatment altogether.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

Some of the effects of an overdose of metoprolol tartrate are: an abnormally slow heartbeat or an irregular heartbeat, very low blood pressure, breathlessness, difficulty breathing when lying down, swelling of the feet, loss of consciousness, blue discoloration of the lips, tongue, skin, seizures, nausea and vomiting, sudden and oppressive chest pain and death.

Missed Dose

If you forget to take a dose of Dom-METOPROLOL-L, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose.

Side effects and what to do about them

Like other medication, Dom-METOPROLOL-L may cause some side effects. These side effects may be minor and temporary. However, some may be serious and need medical attention.

Side effects may include: sleep disturbance, fatigue and tiredness especially with activity, headache, dry mouth, nausea and vomiting, diarrhea or constipation and abdominal pain, numbness, a tingling sensation in the extremities, signs of paresthesia, increased sensitivity of the skin to sun, sweating, hair loss, increased weight, and lower back pain.

Based on your health history, your doctor should take blood tests for as long as you are being treated with Dom-METOPROLOL-L.
They may monitor:

blood sugar
heart, liver, kidney, and thyroid function
how Dom-METOPROLOL-L is affecting other medications that you are taking

Serious side effects, how often they happen and what to do about them
Symptom / effect	Talk with your doctor or pharmacist only if severe	Talk with your doctor or pharmacist in all cases	Stop taking drug and seek immediate emergency medical attention
Common
Low Blood Pressure: feeling of lightheadedness or fainting especially when getting up from a lying or sitting position		✔
Chest Pain		✔
Bronchospasm: difficulty breathing with wheezing or coughing		✔
Heart Failure: shortness of breath, leg swelling and tiredness especially with activity			✔
Uncommon
Edema: ankle swelling	✔
Slow or irregular heartbeat (palpitations)		✔
New or Worsening Psoriasis: skin rash (in the form of itchy rash, thickened patches of red/silver skin)	✔
Allergic Reaction: rash, hives, swelling of the face, throat, lips, difficulty swallowing or breathing			✔
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite		✔
Sexuality: Abnormal curvature of the penis. Change in sex drive Change in ability to achieve or maintain an erection	✔ ✔ ✔
Hallucinations: see or hear things that are not there		✔
Depression: feel sad, loss of interest in usual activities changes in sleep and eating patterns		✔
Change in personality and confusion		✔
Visual Disturbance: Blurred vision, dry or irritated eyes	✔
Hearing Disturbance: noises, reduced or loss of hearing	✔
Parasthesia: Colder than usual hands or feet	✔
Gangrene; toes or fingers cold to the touch, discoloured and painful			✔
Kidney Disorder: change in frequency of urination, swelling of extremities, fatigue, skin rash, itching, nausea, vomiting	✔
High Blood Pressure: headaches, vision disorders, nausea and vomiting		✔
Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations.			✔
Decreased Platelets: bruising, bleeding, fatigue and weakness		✔
Retroperitoneal fibrosis: lower back pain, kidney failure (low or no urine produced), high blood pressure, blood clot in the legs (See Blood Clots above)			✔
Arthritis: stiff sore joints		✔
Oculomucocutaneous Syndrome: red, irritated and watery eyes, skin rash and ear infection			✔

This is not a complete list of side effects. For any unexpected effects while taking Dom-METOPROLOL-L contact your doctor or pharmacist.

How to store

Store between 15oC and 30oC. Protect from light and humidity.

Keep all medicines out of the reach and sight of children.

This medicine is prescribed for your specific medical problem and for your own use only. Do not give to other people.

Do not use outdated medicines. Discard them safely out of the reach of children or take them to your pharmacist who will dispose of them for you.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
  Canada Vigilance Program
  Health Canada
  Postal Locator 0701E
  Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. 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 Dominion Pharmacal at 1-888-550-6060.

This leaflet was prepared by
Dominion Pharmacal
Montreal, Canada
H4P 2T4

Last revised: September 27, 2016

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