M-Clarithromycin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• M-CLARITHROMYCIN should not be used in pregnancy, especially during the first 3 months. If there are no other medicines you can take for your infection, your healthcare professional may give you M-CLARITHROMYCIN. If this happens, they will discuss the risks to your baby with you. Talk to your healthcare professional before taking M-CLARITHROMYCIN if you are pregnant or think you might be pregnant.

• Taking M-CLARITHROMYCIN along with certain other drugs may lead to serious safety issues. Talk to your healthcare professional about all the medicines you take.

What is M-CLARITHROMYCIN used for?

• M-CLARITHROMYCIN is used to treat certain infections like pneumonia, bronchitis and infections of the sinuses, skin, and throat, that are caused by bacteria.
• It is used with other medicines to kill bacteria called Helicobacter pylori (H. pylori). This may prevent duodenal ulcers from coming back. Duodenal ulcers are sores on the upper part of the small intestine.
• It is used to prevent and to treat MAC disease in patients with HIV. MAC is a short word for Mycobacterium avium complex, the bacteria that cause MAC disease.

Antibacterial drugs like M-CLARITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, M-CLARITHROMYCIN should be taken exactly as directed. Misuse or overuse of M-CLARITHROMYCIN could lead to the growth of bacteria that will not be killed by M-CLARITHROMYCIN (resistance). This means that M-CLARITHROMYCIN may not work for you in the future. Do not share your medicine.

How does M-CLARITHROMYCIN work?

M-CLARITHROMYCIN is an antibiotic that kills bacteria in your body.

What are the ingredients in M-CLARITHROMYCIN?

Medicinal ingredient: Clarithromycin.

Non-medicinal ingredients: Croscarmellose sodium, D&C yellow #10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, purified talc, silica colloidal anhydrous; stearic acid and titanium dioxide.

M-CLARITHROMYCIN comes in the following dosage forms:

250 mg and 500 mg tablets.

Do not use M-CLARITHROMYCIN if:

• You are allergic to clarithromycin or any of the other ingredients in M-CLARITHROMYCIN.
• You are allergic to another medicine called erythromycin or any other medicines from a class of antibiotics called macrolides (such as azithromycin or telithromycin).

• You are taking any of the following medications:

  • Ergotamine, dihydroergotamine (for migraine); Lovastatin, simvastatin, lomitapide (for high cholesterol); Ticagrelor (for cardiovascular disease); Saquinavir (treatment for HIV); Oral midazolam (for trouble sleeping or agitation); Pimozide (for schizophrenia); Colchicine (for gout); Domperidone (for gastrointestinal disorders).

  • Pimozide, ergotamine, dihydroergotamine and colchicine can interact with

    M-CLARITHROMYCIN, possibly leading to an irregular heartbeat. Deaths have occurred.

• You had liver problems after taking M-CLARITHROMYCIN, or any other medicine containing clarithromycin, in the past.
• You have severe liver failure in combination with kidney problems.
• You have a history of heart disturbance or irregular heartbeat such as arrhythmias, QT prolongation or torsades de pointes.
• You have low levels of potassium in the blood (hypokalemia) or low levels of magnesium in the blood (hypomagnesaemia).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-CLARITHROMYCIN. Talk about any health conditions or problems you may have, including if you:

• Have now or have had health problems in the past.
• Have or develop severe diarrhea as this may be a sign of a more serious condition.
• Have kidney problems.
• Have liver problems.
• Are taking medicines called digoxin (for heart failure); atorvastatin or pravastatin (for high cholesterol); or midazolam (a sedative).
• Are taking a medicine called quetiapine (for schizophrenia, bipolar depression). Serious and life-threatening side effects have occurred in people taking clarithromycin and quetiapine, including malignant neuroleptic syndrome (fever, rigid muscles, dizziness, fainting, and altered mental state). Your healthcare professional will decide if you should take this medication.
• Are allergic to other medicines, foods, dyes, or preservatives.
• Are pregnant, trying to get pregnant or think you might be pregnant.
• Are breastfeeding or planning to breastfeed. Clarithromycin passes into your breastmilk and can harm your baby.
• Have a condition called myasthenia gravis which is a chronic disease that causes muscle weakness. M-CLARITHROMYCIN may make your myasthenia gravis worse.
• Are taking M-CLARITHROMYCIN and oral medicines for diabetes (such as gliclazide, glyburide) and / or with insulin as this can result in serious low blood sugar levels (hypoglycemia). Discuss with your healthcare professional how you should monitor your blood sugar levels.
• Are taking warfarin, as there is a risk of serious bleeding with M-CLARITHROMYCIN.
• Are taking triazolam, alprazolam or other benzodiazepines (midazolam). These should be used cautiously with M-CLARITHROMYCIN due to the serious risk of effects on your brain and spinal cord.
• Are taking M-CLARITHROMYCIN and medicines used to prevent blood clots such as dabigatran, rivaroxaban and apixaban, particularly if your healthcare professional has told you that you are at high risk of bleeding.

Other warnings you should know about:

Serious heart problems:

Use of antibiotics like M-CLARITHROMYCIN have resulted in heart problems such as irregular heartbeat, torsades de pointes and QT prolongation sometimes leading to death. Talk to your healthcare professional if you are elderly or have risk factors such as:

• Heart disease, heart problems or slow heartbeat.
• If you are taking other medicines which are known to cause serious disturbances in heart rhythm.
• If you have disturbances in the levels of salts (electrolytes) in your blood, such as low levels of magnesium (hypomagnesemia).

Antibiotic resistance and HIV:

Development of antibiotic resistance (where the medicine no longer works to kill bacteria) has been seen in patients with HIV taking clarithromycin. To avoid this, you should always take your medicine as advised by your healthcare professional.

Driving and using machines:

If you feel dizzy, confused or disorientated while taking M-CLARITHROMYCIN, do not drive or operate machines.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with M-CLARITHROMYCIN:

• Alfentanil (used during surgery).
• Alprazolam, hexobarbital, phenobarbital, midazolam, triazolam (sedative medications).
• Amlodipine, diltiazem, verapamil (calcium channel blockers often used for high blood pressure).
• Aripiprazole, pimozide, quetiapine, risperidone (for schizophrenia, bipolar depression).

• Atazanavir, indinavir, ritonavir, saquinavir, nevirapine, efavirenz, etravirine, zidovudine

  (treatments for HIV).

• Atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin, lomitapide (for high cholesterol).
• Bromocriptine (used for problems with your pituitary gland and Parkinson’s disease).
• Carbamazepine (for seizures, nerve pain or bipolar depression).

• Cilostazol, digoxin, quinidine, disopyramide, warfarin/acenocoumarol, ticagrelor

  (diseases of your blood vessels and heart).

• Colchicine (treatment for gout).
• Cyclosporine (used for psoriasis, rheumatoid arthritis and after organ transplant).
• Domperidone (used for gastrointestinal disorders).
• Ergotamine, dihydroergotamine (often used for migraine headaches).
• Fluconazole, itraconazole (for fungal infections).
• Insulin, nateglinide, pioglitazone, repaglinide, rosiglitazone (for diabetes).
• Lansoprazole, omeprazole (proton pump inhibitors for heart burn and reflux).
• Methylprednisolone (an anti-inflammatory).
• Phenytoin, valproic acid (treatment of seizures and epilepsy).
• Rifabutin, rifampin (treatments for infections).
• Rivaroxaban, apixaban (to prevent blood clots).
• Sildenafil, tadalafil, vardenafil (treatments for erectile dysfunction).
• St. John’s Wort (for depression).
• Tacrolimus (used after organ transplant).
• Theophylline (asthma and other lung problems).
• Tolterodine (treatment for overactive bladder).
• Vinblastine, ibrutinib (cancer treatment).

How to take M-CLARITHROMYCIN:

• Always take it exactly how your healthcare professional has told you.
• Your healthcare professional will tell you how much M-CLARITHROMYCIN to take and when to take it.
• How much you are prescribed will depend on the condition you have.
• You can take M-CLARITHROMYCIN with or without meals.

Usual dose:

For respiratory tract infections (like pneumonia, bronchitis and infections of the sinuses and throat) and skin infections:

The usual dose of M-CLARITHROMYCIN is 250 mg to 500 mg every 12 hours for 7 to 14 days.

For infections with H. pylori and treatment of duodenal ulcers (a sore in your intestine):

The usual dose of M-CLARITHROMYCIN is 500 mg every 12 hours for 10 days. You will take M-CLARITHROMYCIN together with omeprazole (20 mg once a day) and amoxicillin (1 g every 12 hours).

For prevention and treatment of MAC disease in patients with HIV:

The usual dose of M-CLARITHROMYCIN is 500 mg every 12 hours. Your healthcare professional will tell you how long you should continue taking M-CLARITHROMYCIN for.

Overdose:

Symptoms of M-CLARITHROMYCIN overdose are abdominal pain, vomiting, nausea and diarrhea.

If you think you, or a person you are caring for, have taken too much M-CLARITHROMYCIN, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

• If you miss a dose, take it as soon as you remember.
• If it is almost time for your next dose, do not take the missed dose.
• Take your next dose when you would normally take it.
• Never take a double dose to make up for a missed dose.

What are possible side effects from using M-CLARITHROMYCIN?

These are not all the possible side effects you may have when taking M-CLARITHROMYCIN. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• abdominal pain
• abnormal taste
• diarrhea
• ear disorder (trouble hearing and ringing in your ears)
• flatulence
• indigestion
• headache
• nausea
• rash
• vomiting

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Page 69 of 69 M-CLARITHROMYCIN (Clarithromycin tablets), Product Monograph

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.

Storage:

Keep M-CLARITHROMYCIN and all other medicines out of reach and sight of children.

Store between 15° C and 25° C in a tightly closed container. Protect from light. Do not use beyond the expiration date.

If you want more information about M-CLARITHROMYCIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); or by contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.

Mantra Pharma Inc.

9150 Leduc Blvd., Suite 201

Brossard, Quebec

J4Y 0E3

Last revised: DEC 15, 2022