Consumer Information for: TEVA-MINOCYCLINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

TEVA-MINOCYCLINE is used for the treatment of infections caused by certain bacteria in many different parts of the body.

Antibacterial drugs like TEVA-MINOCYCLINE treat only bacterial infections. They do not treat viral infections.

What it does

TEVA-MINOCYCLINE is an antibiotic that belong to a class of drugs called tetracyclines. TEVA-MINOCYCLINE works by slowing the growth or reproduction of bacteria that causes the infection.

When it should not be used

Do not use TEVA-MINOCYCLINE if you:

  • are allergic to minocycline or to any of the other ingredients in TEVAMINOCYCLINE
  • are allergic to other tetracycline antibiotics
  • are pregnant or planning to become pregnant. TEVA-MINOCYCLINE can cause damage to your unborn babies bones and teeth. If you get pregnant while taking TEVA-MINOCYCLINE contact to your healthcare professional immediately.
  • are breastfeeding or planning to breastfeed. TEVA-MINOCYCLINE passes into human milk and can cause damage to your baby’s bones and teeth. You should not breastfeed while taking TEVA-MINOCYLCINE.
  • have liver or kidney problems
  • have the autoimmune disease myasthenia gravis

TEVA-MINOCYCLINE is not recommended for children under 13 years old.

What the medicinal ingredient is

minocycline hydrochloride

What the non-medicinal ingredients are

colloidal silicone dioxide, magnesium stearate and starch. The 50 mg capsule shell contains the non-medicinal ingredients: FD&C Yellow #6, gelatin and titanium dioxide. The 100 mg capsule shell contains the non-medicinal ingredients: FD&C Blue #1, FD&C Red #3, FD&C Yellow #6, gelatin and titanium dioxide

What dosage form it comes in

TEVA-MINCOCYCLINE comes in the following dosage forms:
Capsules: 50 mg and 100 mg.

Warnings and precautions

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

  • have liver or kidney problems
  • have the autoimmune disease systemic lupus erythematosus
  • suffer from allergies, asthma, hay fever or itchy skin rashes. You may be more likely to experience side effects while taking TEVA-MINOCYCLINE.
  • are also taking a penicillin antibiotic
  • are taking birth control pills. TEVA-MINOCYLCINE may make your birth control pills less effective. Talk to your healthcare professional about using a back-up method of birth control, such as condoms, while you are taking TEVAMINOCYCLINE.

Other warnings you should know about:

Sensitivity to Sunlight
TEVA-MINOCYCLINE can make your skin more sensitive to the sun. While you are taking TEVA-MINOCYCLINE avoid direct sunlight, sunlamps and tanning beds. If you develop any skin redness or discomfort while taking TEVA-MINOCYCLINE, contact your healthcare professional immediately.

Driving and Using Machines
TEVA-MINOCLYCLINE can cause headaches, light-headedness, dizziness, ringing in the ears and vertigo (feeling like you’re spinning). Use caution when driving or using dangerous machinery while taking TEVA-MINOCYCLINE.

Serious Side Effects Serious side effects, in some cases causing death, have been seen in people taking TEVA-MINOCYLCINE. If you have any of the following symptoms stop taking TEVA-MINOCYLCINE and seek immediate medical help.

  • Allergic reaction (hypersensitivity) with skin rashes: rash, skin redness, peeling skin, blisters on your nose, mouth, eyes or genitals, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, fever, swollen lymph nodes combined with any of the following: liver problems (yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite), lung problems (flu-like symptoms, cough, shortness of breath), kidney problems (decreased urination, nausea, vomiting, swelling of extremities, fatigue), heart problems (chest pain, fast or irregular heartbeat, shortness of breath, swelling in the legs, ankles or feet, fatigue)
  • Lupus-like syndrome: joint and muscle pain, fatigue, fever, swollen lymph nodes, inflammation around the lungs or heart that causes pain or discomfort
  • Serum-sickness syndrome: fever, generally feeling unwell, hives, itching, rash, joint pain, swollen lymph nodes

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

Interactions with this medication

The following may interact with TEVA-MINOCYCLINE:

  • penicillin antibiotics, used to treat infections
  • acne medicines known as retinoids
  • quinapril, used to treat heart problems and high blood pressure
  • blood thinners, used to prevent blood clots
  • birth control pills, TEVA-MINOCYCLINE may make your birth control pills less effective.
  • diuretics or “water pills” used to treat high blood pressure
  • medicines used to treat migraines called ergot alkaloids
  • antacids containing aluminum, calcium, magnesium, bismuth or iron containing products
  • magnesium or zinc salts
Proper use of this medication

How to take TEVA-MINOCYCLINE:

  • Although you may feel better early in treatment, TEVA-MINOCYCLINE should be used exactly as directed.
  • Misuse or overuse of TEVA-MINOCYCLINE could lead to the growth of bacteria that will not be killed by TEVA-MINOCYCLINE (resistance).This means that TEVA-MINOCYCLINE may not work for you in the future.
  • Do not share your medicine.

Usual Dose

Children 13 years of age and older: Your healthcare professional will tell you how much TEVA-MINOCYCLINE to give your child and how often based on their body weight.

Adults: 100 mg or 200 mg to start followed by 100 mg every 12 hours.

Overdose

If you think you have taken too much TEVA-MINOCYCLINE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

If you forget to take a dose of TEVA-MINOCYCLINE take it as soon as you remember.

Side effects and what to do about them

What are possible side effects from using TEVA-MINOCYCLINE?
These are not all the possible side effects you may feel when taking TEVAMINOCYCLINE. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • light-headedness, dizziness, vertigo (feeling like you’re spinning or losing your balance)
  • headache
  • loss of appetite, constipation
  • nausea, vomiting, diarrhea
  • indigestion
  • trouble swallowing
  • inflammation or sores in the mouth, lips and/or tongue
  • joint swelling, pain and stiffness, aching muscles
  • rash, itching
  • cough
  • sleepiness
  • fever

TEVA-MINOCYCLINE can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
RARE
Fainting   ✔  
Liver problems: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite     ✔
Inflammation or ulcers of the food pipe (esophagus): trouble swallowing, pain when swallowing, sore throat, hoarse voice, heartburn, chest pain that is worse with eating, nausea     ✔
Kidney problems: decreased urination, nausea, vomiting, swelling of extremities, fatigue     ✔
Unusual hair loss or thinning ✔    
Increased sensitivity of the skin to sun   ✔  
Discolouration of the nails, skin, tongue, gums, lips or teeth ✔    
Shortness of breath   ✔  
VERY RARE
Pseudomembranous colitis: watery, bloody diarrhea, mucus in the stool, abdominal cramps and pain, fever     ✔
Angioedema: swelling of the face, eyes, lips, tongue, throat, arms or legs, trouble breathing or swallowing, hoarseness, itching, hives, rash on the hands, arms and feet, fever, abdominal cramps     ✔
Allergic reaction (hypersensitivity) with skin rashes: rash, skin redness, peeling skin, blisters on your nose, mouth, eyes or genitals, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, fever, swollen lymph nodes combined with any of the following: liver problems (yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite), lung problems (flu-like symptoms, cough, shortness of breath), kidney problems (decreased urination, nausea, vomiting, swelling of extremities, fatigue), heart problems (chest pain, fast or irregular heartbeat, shortness of breath, swelling in the legs, ankles or feet, fatigue)     ✔
Thyroid problems: weight changes, fatigue, heart palpitations, constipation, dry skin, joint or muscle pain   ✔  
Yeast infections: Oral: creamy white bumps on the tongue, cheeks, gums or throat that bleed when scraped, pain, trouble swallowing, bad taste in the mouth Genital and Anal: genital (vagina or penis) or anal itching, burning during intercourse or urination, pain, redness, swelling, discharge   ✔  
Bronchospasm: pain, tightness and a feeling of constriction in the chest and back, trouble breathing, wheezing, coughing, dizziness     ✔
NOT KNOWN
Hearing problems: buzzing, ringing or other persistent noise in ear, loss of hearing ✔    
Tingling or numbness of the hands or feet ✔    
Lupus-like syndrome: joint and muscle pain, fatigue, fever, swollen lymph nodes, inflammation around the lungs or heart that causes pain or discomfort     ✔
High blood pressure in the brain: headache, blurred vision, nausea, vomiting, confusion     ✔
Respiratory disorder:
Pneumonitis: flu-like symptoms, cough, shortness of breath, fever, chills, fatigue 		    ✔
Nervous system disorder:
Seizures or fits 		    ✔
Gastrointestinal disorder:
Inflammation of the pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting 		  ✔  
Immune system disorder:
Serum-sickness syndrome: fever, generally feeling unwell, hives, itching, rash, joint pain, swollen lymph nodes 		    ✔
Blood disorder:
Hemolytic anemia: pale skin, yellow skin, eyes and mouth (jaundice), dark-coloured urine, fever, weakness, dizziness, confusion, reduced ability to exercise

Low levels of white blood cells: infection, fatigue, fever, aches, pain, flu-like symptoms

Low levels of blood platelets: bruising, bleeding, fatigue, weakness 		  ✔  

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

How to store

Bottles should be stored between 15-30°C in tight, light-resistant containers. Unit dose boxes should be stored between 15-25°C and protected from light and high humidity.

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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 TEVA-MINOCYCLINE:

  • Talk to your healthcare professional
  • Find the full Prescribing Information that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/indexeng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

This leaflet was prepared by Teva Canada Limited, Toronto, Ontario M1B 2K9

Last Revised: January 24, 2019

Date modified: