Metoprolol SR (Pro Doc, 100 mg, 200 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

METOPROLOL 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:

METOPROLOL 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 METOPROLOL if you:

• are allergic to metoprolol, to any of the other

  ingredients in METOPROLOL 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 nonmedicinal ingredients are:

METOPROLOL 25 mg, 50 mg, 100 mg: In addition to metoprolol tartrate, each tablet contains the non-medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

METOPROLOL-L 50 mg: In addition to metoprolol tartrate, each tablet contains the following non-medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. It also contains carnauba wax, D & C Red # 30 Aluminum Lake 30%, hydroxypropyl methylcellulose, polyethylene glycol, Sunset Yellow Aluminum Lake 40% and titanium dioxide.

METOPROLOL-L 100 mg: In addition to metoprolol tartrate, each tablet contains the following non-medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. It also contains carnauba wax, hydroxypropyl methylcellulose, Indigotine Aluminum Lake 12-14% (Blue #2), polydextrose, polyethylene glycol and titanium dioxide.

METOPROLOL SR contain: colloidal silicon dioxide, ferric oxide red (100 mg tablet only), ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, polyethylene glycol, stearic acid and titanium dioxide.

What dosage forms it comes in:

METOPROLOL Tablets 25, 50 & 100 mg METOPROLOL-L 50 & 100 mg

METOPROLOL SR 100 & 200 mg

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WARNINGS AND PRECAUTIONS

BEFORE you use METOPROLOL 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 AMETOPROLOL

• have allergy to or an intolerance to lactose. This

  applies only to METOPROLOL (25 mg, 50 mg, 100 mg) and METOPROLOL-L (50 mg, 100 mg)

• 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.

  METOPROLOL should not be used during pregnancy. Your doctor will discuss with you the potential risks of taking METOPROLOL during pregnancy

• are breast feeding. If your doctor decides that

  you must continue to take METOPROLOL you should stop breast- feeding as METOPROLOL 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 METOPROLOL.

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

    hydroxychloroquine or 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
  • Aldesleukin, a medicine used to treat kidney cancer, or other medicines that may cause a decrease in blood pressure

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 METOPROLOL to take based on your individual requirements.

High Blood Pressure: the usual maintenance dose is 100 to 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.

METOPROLOL SR tablets are intended for maintenance dosing. Once your doctor has identified the correct dosage for you using the regular

METOPROLOL tablets, you may be switched to the METOPROLOL SR tablets. METOPROLOL SR tablets are convenient because you only take one pill a day. METOPROLOL SR tablets should be taken in the morning.

METOPROLOL / METOPROLOL-L /

METOPROLOL SR tablets should be swallowed whole without being chewed, preferably with or following a meal.

Do not change the dose or stop the treatment without talking to your doctor. If you stop taking

METOPROLOL suddenly, your condition may become worse. Your doctor may want you to reduce the dose gradually before stopping treatment altogether.

Overdose:

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

Some of the effects of an overdose of METOPROLOL 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 METOPROLOL, 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 medications, METOPROLOL 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 METOPROLOL. They may monitor:

• blood sugar
• heart, liver, kidney and thyroid function
• how METOPROLOL is affecting other medications that you are taking.

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

HOW TO STORE IT

METOPROLOL/ METOPROLOL-L: Store at room temperature (15°C to 30°C) and protect from light.

METOPROLOL SR: Store at room temperature between 15°C to 30°C.

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 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

If you want more information about METOPROLOL / METOPROLOL-L / METOPROLOL SR:

• 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 (https://health-

  products.canada.ca/dpd-bdpp/index-eng.jsp); or by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.

Pro Doc Ltée Laval, Quebec H7L 3W9

Last revised: August 17, 2021