Metoprolol-L (Sorres Pharma): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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:

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 METOPROLOL-L if you:

• are allergic to metoprolol, to any of the other ingredients

  in 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 forms 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 METOPROLOL-L
• 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.

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

• are breast feeding. If your doctor decides that you must continue to take METOPROLOL-L you should stop breast- feeding as 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 METOPROLOL-L

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

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-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.

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:

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

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.

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-L.

They may monitor:

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

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

HOW TO STORE IT

Store between 15^oC and 30^oC. 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 SUSPECTED 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 3 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, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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 Sorres Pharma Inc. at 1-888-550-6060.

Sorres Pharma Inc.

Montreal, Canada

H4P 2T4

Last revised: March 5, 2014