Patient Medication Information: uses, side effects, how to take - Pylera
What is Pylera used for?
- Pylera is used with omeprazole to treat ulcers that are infected by the bacterium Helicobacter pylori (H. pylori).
- Antibacterial drugs like Pylera treat only bacterial infections. They do not treat viral infections.
How does Pylera work?
Pylera contains 3 different active ingredients:
- Tetracycline and metronidazole are antibiotics that kill bacteria and reduce infections.
- Bismuth subcitrate helps the antibiotics treat the infection.
Pylera should be taken with a medicine called omeprazole. Omeprazole reduces the amount of acid that your stomach produces. Pylera taken with omeprazole works together to treat the infection and reduce inflammation of the stomach lining.
What are the ingredients in Pylera?
Medicinal ingredients: bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride Non-medicinal ingredients: D&C Yellow # 10, FD&C Blue # 1, FD&C Red # 40, gelatin, lactose, magnesium stearate, talc, titanium dioxide and white ink.
Pylera comes in the following dosage forms:
Capsules containing 140 mg of bismuth subcitrate potassium (equivalent to 40 mg of bismuth oxide), 125 mg of metronidazole and 125 mg of tetracycline hydrochloride.
Do not use Pylera if you:
are pregnant or breast-feeding.
- suffer from kidney problems.
- suffer from liver problems.
- are allergic to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, tetracycline or any of the other ingredients in Pylera.
- have an active neurological disorder.
- have a history of abnormal blood cells (blood dyscrasia), underactive thyroid (hypothyroidism) or underactive adrenal glands (hypoadrenalism).
- have a condition called Cockayne syndrome. Severe liver damage that may be fatal has happened when people with Cockayne syndrome have taken metronidazole.
Do not give Pylera to children under 18 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Pylera. Talk about any health conditions or problems you may have, including if you:
- Are taking other bismuth products
- Have inherited condition of lactose intolerance such as Lapp lactose deficiency or glucose-galactose malabsorption. Pylera contains lactose.
- Have reduced kidney function or are on a controlled potassium diet; Pylera contains approximately 96 mg of potassium per dose (3 capsules containing 32 mg of potassium each).
- Have any problems with your heart rhythm such as an arrhythmia. Pylera can change your heart rhythm, especially when taken with other medicines that also change heart rhythm.
Other warnings you should know about:
- Pylera may cause a harmless and temporary darkening of the tongue and/or black stool.
- Avoid exposure to the sun or sun lamps while taking Pylera. You may be more likely to sunburn while taking Pylera.
- Avoid drinking alcohol while taking Pylera.
- Pylera may make oral birth control (“the pill”) less effective. Use another type of birth control while taking Pylera. Talk to your doctor if you think that you have become pregnant while taking Pylera.
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 Pylera:
- Medicines used to thin the blood or which prevent clotting (e.g. warfarin).
- Antacids which contain aluminum, calcium or magnesium.
- Supplements containing iron, zinc or sodium bicarbonate.
- Other antibiotics.
- Methoxyflurane (an anaesthetic).
- Oral contraceptives (birth control).
- Other drugs that contain bismuth.
- Drugs that decrease liver activity (e.g. cimetidine).
- Lithium used to treat some mental illness.
- Digoxin used to treat heart conditions.
- Insulin used to treat diabetes.
- Disulfiram used to treat alcoholism.
- Milk or dairy products.
Medicines that change your heart rhythm such as:
- Amiodarone (used to treat heart rate abnormalities);
- Ondansetron (used to treat nausea and vomiting);
- Methadone (used as substitution therapy in opioid dependence);
- Domperidone (used to treat nausea and vomiting).
How to take Pylera:
- Take Pylera exactly as your healthcare professional has told you to.
- Swallow capsules whole with a full glass (250 mL) of water. Do not open the capsules.
Take Pylera after meals and with a snack at bedtime.
- Be sure to swallow capsules while you are standing or sitting upright. This is to reduce irritation of your throat.
- You must not lie down right after taking Pylera.
- Pylera should be taken with another medicine called omeprazole.
- Although you may feel better early in treatment, Pylera should be used exactly as directed.
- Misuse or overuse of Pylera could lead to the growth of bacteria that will not be killed by Pylera (resistance). This means that Pylera may not work for you in the future.
- Do not share your medicine.
- Talk to your healthcare professional if you are not sure how to take Pylera.
Usual dose:
Take 3 capsules four times per day (after meals and at bedtime). Pylera should be taken for 10 days. Omeprazole should be taken with the morning and evening doses.
Overdose:
| If you think you, or a person you are caring for, have taken too much Pylera, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you forget to take Pylera, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you miss more than 4 consecutive doses of Pylera (1 day), contact your doctor.
What are possible side effects from using Pylera?
The most common side effects are:
- Abnormal stool
- Diarrhea
- Indigestion
- Abdominal Pain
- Nausea
- Headache
- Flu syndrome
- Bad or metallic taste
These are not all the possible side effects you may have when taking Pylera. If you experience any side effects not listed here, tell your healthcare professional.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
Allergic reaction: Swelling of face, lips, tongue or throat or itchy lumpy rash | √ | ||
| Neurological deterioration: uncoordinated muscle movement and confusion | √ | ||
| UNKNOWN | |||
| Aseptic meningitis (inflammation of the brain): fever, chills, headache, neck stiffness, sensitivity to light, loss of appetite, nausea, vomiting, fatigue. | √ | ||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (serious skin reaction that may affect more than one or more organs): fever, severe rash, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinate less often, less urine. | √ | ||
| Encephalopathy (damage / disease of the brain): confusion, memory loss, sleepiness, hallucinations, personality changes, involuntary muscle movements, seizures, loss of consciousness. | √ | ||
Liver problems including acute liver failure: stomach pain or discomfort on your right side below the ribs, loss of appetite, swollen belly, nausea, vomiting, fever, fatigue, feeling unwell, disorientation or confusion, yellowing of the skin | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| or eyes, dark urine, pale stools, itching, sleepiness. | |||
| Peripheral neuropathy (nerve damage): numbness, tingling, pain or a feeling of weakness in the arms or legs, muscle weakness, sensitivity to touch. | √ | ||
| Pseudomembranous colitis (bowel inflammation): severe or persistent diarrhea, abdominal pain, nausea, vomiting, fever. | √ | ||
| Stevens-Johnson syndrome: (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands. | √ | ||
| Toxic Epidermal Necrolysis (TEN) (severe skin reaction): redness, blistering and/or peeling of large areas of the skin. | √ | ||
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.
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. |
Storage:
Store Pylera between 15-30°C and protect from light.
Keep out of reach and sight of children.
If you want more information about Pylera:
- 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 calling 1-866-571-5118.
Distributor: Confab Laboratories, Inc., 4355 Boul. Sir Wilfrid Laurier, St-Hubert, QC J3Y 3X3