Details for: PMS-NITROFURANTOIN
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02455676 | PMS-NITROFURANTOIN BID | NITROFURANTOIN | 100 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
pms-NITROFURANTOIN BID is used to treat infections of the urinary tract.
Antibacterial drugs like pms-NITROFURANTOIN BID treat only bacterial infections. They do
not treat viral infections.
What it does
pms-NITROFURANTOIN BID is an antibiotic. It is activated when it is broken down by bacteria. After it is activated, pms-NITROFURANTOIN BID kills bacteria and prevents the growth of infections.
When it should not be used
- you are allergic to any ingredient in pms-NITROFURANTOIN BID. Make sure to read “What are the ingredients in pms-NITROFURANTOIN BID?” above.
- you have a severe disease of the kidneys.
- you are in the final stages of pregnancy (in labour or during delivery) as there is a risk that it might affect the baby
Do not give pms-NITROFURANTOIN BID to newborns or infants under one month of age.
What the medicinal ingredient is
nitrofurantoin
What the non-medicinal ingredients are
carbomer 974P, corn starch, D&C Yellow # 10, FD&C Green # 3, FD&C Red # 40, gelatin, lactose, magnesium stearate, povidone, sugar compressible, talc, and titanium dioxide. The imprinting ink contains butyl alcohol, dehydrated alcohol, FD&C Red # 40 aluminium lake, FD&C Yellow # 6 aluminium lake, FD&C Blue # 2 aluminium lake, FD&C Blue # 1 aluminium lake, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.
What dosage form it comes in
pms-NITROFURANTOIN BID is available as a 100 mg capsule.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-NITROFURANTOIN BID. Talk about any health conditions or problems you may have, including if you:
- have disease of the lungs. You may develop lung disease if you need to take pms-NITROFURANTOIN BID for a number of months. Your doctor must regularly check how your lungs are working. Talk to your doctor about benefits and risks of taking pms-NITROFURANTOIN BID for a long term.
- have liver disease. Your doctor may want to regularly check how your liver is working. Your doctor may want to regularly check how your liver is working. If you get liver disease while taking pms-NITROFURANTOIN BID, you should immediately stop taking the medicine and talk to your doctor.
- have kidney disease
- lack an enzyme (body chemical) called G6PD (glucose-6-phosphate dehydrogenase). Your red blood cells are more easily damaged if you do not have this enzyme. This condition is more common in black people and people of Mediterranean or near- Eastern origin. Your doctor will know about this.
- are breast feeding a baby with suspected or known deficiency in an enzyme called G6PD (glucose-6-phosphate dehydrogenase).
- are pregnant or are planning to become pregnant.
Other warnings you should know about
- The following conditions may increase the chance of developing a side effect which causes
damage to the nerves, altered sense of feeling, like pins and needles:
- anaemia (a decrease in red blood cells causing pale skin, weakness and breathlessness);
- diabetes;
- a lack of vitamin B;
- abnormal levels of salts in your blood;
- you are suffering from an illness that makes you very tired.
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:
- medicines for indigestion (Antacids e.g., magnesium trisilicate);
- medicines for gout (e.g., probenecid or sulfinpyrazone).
You should not take pms-NITROFURANTOIN BID along with medicines that affect your kidneys.
Laboratory tests:
- if you are taking pms-NITROFURANTOIN BID, you may get false positive results when you test your urine for sugars (glucose).
Proper use of this medication
- pms-NITROFURANTOIN BID should be taken every 12 hours with food or milk. This will help to avoid upset stomach.
- Although you may feel better early in treatment, pms-NITROFURANTOIN BID should be used exactly as directed.
- Misuse or overuse of pms-NITROFURANTOIN BID could lead to the growth of bacteria that will not be killed by pms-NITROFURANTOIN BID (resistance). This means that pms-NITROFURANTOIN BID may not work for you in the future.
- Do not share your medicine.
Usual Dose
Adults and Children over 12 years:
One pms-NITROFURANTOIN BID 100 mg capsule twice a day for 7 days. Do not take more
than 2 capsules per day.
If you have a urinary tract infection, your doctor will decide how long you should take pms-NITROFURANTOIN BID.
Overdose
If you think you have taken too much pms-NITROFURANTOIN BID, 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 pms-NITROFURANTOIN BID, do not worry. If you remember later on that day, take that day’s dose as usual. If you miss a whole day’s dose take the normal dose on the next day. Do not take a double dose to make up for a forgotten capsule. If you are not sure ask your doctor or pharmacist.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking pms-NITROFURANTOIN BID. If you experience any side effects not listed here, contact your healthcare professional.
Common side effects in people who take pms-NITROFURANTOIN BID include:
- nausea or vomiting
- headache
- flatulence (passing gas)
| 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 |
|---|---|---|---|
| Lung disease (May include fever, chills, cough, chest pain and shortness of breath) | ✔ | ||
| Liver problems (skin and eyes appear yellowish, itchy skin, dark urine color) | ✔ | ||
| Numbness or tingling | ✔ |
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 at controlled room temperature (15°C to 30°C). 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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/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.
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 (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (www.pharmascience.com), or by calling 1-888-550-6060.
This leaflet was prepared by Pharmascience Inc., Montréal, Québec, H4P 2T4
Last revised: August 26, 2020