Consumer Information for: TEVA-TRIMEL DS

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-TRIMEL/ TEVA-TRIMEL DS are used to treat

  • Respiratory tract infections like bronchitis.
  • Pneumocystis jiroveci pneumonitis in infants and children.
  • Gastrointestinal infections such as cholera.
  • Urinary tract infections.
  • Brucellosis which is a disease that is spread from animals to humans. TEVA-TRIMEL/ TEVA-TRIMEL DS is used when another treatment did not work to treat brucellosis. It is used along with another medicine, gentamicin or rifampicin.
Antibacterial drugs like Teva-Trimel I Teva-Trimel DS treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Teva-Trimel I TevaTrimel DS should be used exactly as directed. Misuse or overuse of Teva-Trimel I Teva-Trimel DS could lead to the growth of bacteria that will not be killed by Teva-Trimel I Teva-Trimel DS (resistance). This means that Teva-Trimel I Teva-Trimel DS may not work for you in the future. Do not share your medicine.
What it does

TEVA-TRIMEL/ TEVA-TRIMEL DS contains two different antibiotics called sulfamethoxazole and trimethoprim. TEVA-TRIMEL/TEVA-TRIMEL DS works to:

  • Stop growth of bacteria.
  • Kill the bacteria.
  • Reduce the infection in your body.

When it should not be used

  • You are allergic to sulfamethoxazole, trimethoprim or any of the other ingredients in TEVATRIMEL/ TEVA-TRIMEL DS.
  • You are allergic to sulphonamide medicines. Talk to your doctor if you are allergic to a medicine and you are not sure if it is a sulphonamide medicine.
  • You have kidney problems.
  • You have liver problems.
  • You have a blood disorder.
  • You are pregnant.
  • You are breastfeeding.
TEVA-TRIMEL should not be given to infants who are less than two months old.

TEVA-TRIMEL DS should not be given to children who are less than 12 years old.

Teva-Trimel should not be used to treat pharyngitis caused by streptococcal infection.
What the medicinal ingredient is

TEVA-TRIMEL / TEVA-TRIMEL DS tablets:
Medicinal ingredients: sulfamethoxazole and trimethoprim

TEVA-TRIMEL oral suspension :
Medicinal ingredients: sulfamethoxazole and trimethoprim

What the non-medicinal ingredients are

TEVA-TRIMEL / TEVA-TRIMEL DS tablets:
Non-medicinal ingredients: gelatin, glycerin, magnesium stearate, sodium lauryl sulfate and sodium starch glycolate.

TEVA-TRIMEL oral suspension :
Non-medicinal ingredients: cherry flavor, citric acid, FD&C Red #40, sorbitol, sodium chloride, sodium cyclamate, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, polysorbate 80 and tragacanth.

What dosage form it comes in

TEVA-TRIMEL tablets: containing 400 mg sulfamethoxazole and 80mg trimethoprim. Available in bottles of 100, 500 and 1000 tablets and boxes of 100 unit dose strips.

TEVA-TRIMEL DS tablets: containing 800 mg sulfamethoxazole and 160 mg trimethoprim. . Available in bottles of 100, 500 and 1000 tablets and boxes of 100 unit dose strips.

TEVA-TRIMEL oral suspension: containing 200 mg sulfamethoxazole and 40 mg trimethoprim in each 5 mL. In bottles of 100mL and 400mL.

Warnings and precautions

Serious Warnings and Precautions

  • TEVA-TRIMEL/ TEVA-TRIMEL DS can cause severe skin reactions that may be life threatening. These include Steven-Johnson syndrome and toxic epidermal necrolysis. Symptoms include: rash, blisters, peeling skin, fever, body aches. You may also have blisters and sores or ulcers on your mouth, nose and genitals. Your eyes may get red and swollen. If you get any of these symptoms, stop taking TEVA-TRIMEL/ TEVA-TRIMEL DS and get immediate medical help.
  • TEVA-TRIMEL/ TEVA-TRIMEL DS can cause an allergic reaction in your lungs and airways. Breathing may be difficult and this can be life-threatening if you do not get medical help. Symptoms include difficulty breathing, coughing, wheezing, and a feeling of tightness in the chest. If you get any of these symptoms, stop taking TEVA-TRIMEL/ TEVA-TRIMEL DS and get immediate medical help.
  • You should also stop taking this medicine and contact your healthcare professional if you have any of the following after taking it: sore throat, fever, joint pain, cough, paleness or yellowing of the eyes or skin.
  • are human immunodeficiency virus (HIV) positive .
  • have a condition called Acquired Immunodeficiency Syndrome (AIDS).
  • have known of low potassium level.
  • have severe allergies or asthma.
  • are taking a medicine for epilepsy or seizures.
  • do not have enough folic acid (a vitamin) in your body which is called a folate deficiency.
  • have alcoholism.
  • have rheumatoid arthritis.
  • you are underweight or malnourished.
  • have a disease called glucose 6 phosphate dehydrogenase deficiency.
  • you have a rare blood disorder called porphyria, which can affect your skin or nervous system.
  • follow a diet rich in potassium.
  • have a condition called hypoaldosteronism which mean you have – decreased levels of a hormone called aldosterone.

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

Interactions with this medication

  • medicines used to remove excess water from the body called diuretics such as furosemide, indapamide and hydrochlorothiazide.
  • phenytoin, a medicine used to treat seizures.
  • pyrimethamine, a medicine used to treat malaria and toxoplasmosis.
  • medicines used for treatment of HIV/AIDS such as abacavir, lamivudine, zidovudine, emtricitabine.
  • medicine used to thin your blood and prevent clots such as warfarin.
  • medicines for treatment of irregular heartbeat such as digoxin.
  • medicines used to control blood sugar such as metformin, gliclazide and insulin
Proper use of this medication

  • Swallow tablets whole with water.
  • The oral suspension should be taken by mouth.
  • Take TEVA-TRIMEL/ TEVA-TRIMEL DS at the same time every day.
  • Drink plenty of fluids while taking TEVA-TRIMEL/ TEVA-TRIMEL DS.
  • Take TEVA-TRIMEL/ TEVA-TRIMEL DS exactly as it has been prescribed to you by your doctor.
  • TEVA-TRIMEL DS should not be given to children who are less than 12 years old.

Usual Dose

  • Your healthcare professional will decide how much TEVA-TRIMEL/ TEVA-TRIMEL DS you should take and for how long you should take it.
  • Take exactly how much your healthcare professional tells you take.

Adults and children over 12 years old:

  • The usual dose of TEVA-TRIMEL is two tablets twice a day.
  • The usual dose of TEVA-TRIMEL DS is one tablet twice a day.
  • Your doctor may give you a different amount depending on the infection you have.

Children under 12 years old:

Children between 6 and 12 years old: One half to one TEVA-TRIMEL tablet or 5 to 10mL pediatric TEVA-TRIMEL oral suspension twice a day.
Children 2 to 5 years old: 2.5 to 5 mL pediatric TEVA-TRIMEL oral suspension twice a day
Children under 2 years old: 2.5 mL pediatric TEVA-TRIMEL oral suspension twice a day

Overdose

If you have taken too much TEVA-TRIMEL/ TEVA-TRIMEL DS you may have the following symptoms:

  • severe dizziness.
  • loss of appetite.
  • severe abdominal pain – colic.
  • nausea.
  • vomiting.
  • headache.
  • drowsiness.
  • loss of consciousness.
If you think you have taken too much TEVA-TRIMEL/ TEVA-TRIMEL DS, contact your 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, skip the missed dose and resume your usual dosing schedule.
  • Never take two doses to make up for a missed dose.
Side effects and what to do about them

These are not all the possible side effects you may feel when taking TEVA-TRIMEL/ TEVA-TRIMEL DS. If you experience any side effects not listed here, contact your healthcare professional.

TEVA-TRIMEL/ TEVA-TRIMEL DS can cause abnormal blood test results. Your doctor 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
VERY COMMON
Nausea   ✔  
Vomiting   ✔  
Diarrhea (having slightly soft to watery stool)   ✔  
Headache   ✔  
Loss of appetite   ✔  
Rash   ✔  
Hives   ✔  
Dizziness (drowsiness, light headedness) ✔    
Constipation (hard to pass stool). ✔    
COMMON
Weakness ✔    
Fatigue (tiredness) ✔    
Insomnia (inability to sleep) ✔    
Vision problems ✔    
Alopecia (hair loss) ✔    
Nose bleed ✔    
Muscle or joint pain     ✔
Thrush (yeast infection of the mouth and throat): redness, burning or soreness, white bumps inside mouth or on tongue   ✔  
Hypoglycaemia (low blood sugar): dizziness or light-headedness, shakiness, nervousness or anxiety, feeling confused, sweating, chills.   ✔  
Abdominal or stomach pain or discomfort.      
Yeast infection of vagina: burning, itching, pain, redness soreness, swelling or irritation of the vagina or vulva, thick, white vaginal discharge with a cottage cheese appearance   ✔  
Dyspepsia (indigestion): discomfort or pain in the upper abdomen. ✔    
Itching of the skin ✔    
RARE
Hallucination   ✔  
Depression   ✔  
Nervousness      
Confusion   ✔  
Shortness of breath   ✔  
Liver problems: persistent nausea, vomiting, pain in the stomach or abdominal area, unusual tiredness, yellowing of the eyes or skin, dark urine)     ✔
Pancreatitis (inflammation of the pancreas): abdominal pain that lasts, pain may spread out towards the back, nausea, vomiting.     ✔
C. difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness.     ✔
Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by infection), sudden headache or stiffness of your neck, with fever, nausea, vomiting, sensitivity to light     ✔
Allergic reactions: difficulty breathing, cough, fever, hives, itching, swelling of your tongue or throat.     ✔
Steven-Johnson syndrome and toxic epidermal necrolysis (severe life-threatening skin reactions): a flat red rash, blisters body aches, fever, red and swollen eyes, sores on mouth, nose and genitals.     ✔

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

Store tablets at 15° to 30°C in a dry place and protect them from light.

Store oral suspension at 15° to 30°C and protect it from light.

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

  • 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 (http://hc-sc.gc.ca/indexeng.php) the manufacturer’s website www.tevacanada.com, or
  • by calling 1-800-268-4127 ext. 3.
  • By e-mail: druginfo@tevacanada.com
  • Fax: 1-416-335-4472

This leaflet was prepared by:

Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada
M1B 2K9
www.tevacanada.com

Last Revised: February 2, 2018

Report a problem or mistake on this page
Please select all that apply:
Date modified: