Patient Medication Information: uses, side effects, how to take - Ciprofloxacin (Sivem Pharmaceuticals, 250 mg, 500 mg, 750 mg)
Serious warnings and precautions box
Fluoroquinolone antibiotics, like CIPROFLOXACIN, are related to disabling and possibly long lasting serious side effects including but not limited to :
Fluoroquinolone antibiotics can also cause serious side effects such as:
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See the Serious side effects and what to do about them table, below for information on these and other serious side effects. |
What CIPROFLOXACIN is used for:
CIPROFLOXACIN are antibiotics used to treat infections caused by bacteria in adults. These include infections of the:
- respiratory tract
- urinary tract (bladder, kidneys)
- prostate
- skin and soft tissues
- bone and joint
It is also used in adults to treat the following conditions:
- carriers of the bacteria Neisseria meningitidis that causes meningitis. It is not used to treat meningitis infections.
- diarrhea caused by bacterial infections
- Typhoid fever
- gonorrhea (an infection caused by the bacteria Neisseria gonorrhea)
Antibacterial drugs like CIPROFLOXACIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, CIPROFLOXACIN should be used exactly as directed. Misuse or overuse of CIPROFLOXACIN could lead to the growth of bacteria that will not be killed by CIPROFLOXACIN (resistance). This means that CIPROFLOXACIN may not work for you in the future. Do not share your medicine.
How CIPROFLOXACIN work:
CIPROFLOXACIN are antibiotics that kill the bacteria causing the infection.
The ingredients in CIPROFLOXACIN are:
Medicinal ingredient: ciprofloxacin as ciprofloxacin hydrochloride.
Non-medicinal ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethyelene glycol, povidone, silica colloidal anhydrous, sodium starch glycolate, stearic acid, talc, titanium oxide.
CIPROFLOXACIN comes in the following dosage forms:
CIPROFLOXACIN 250 mg tablet: White round film-coated tablet with breaking notch on one side. Embossed "cip" on top and "250" on the bottom of the breaking notch. Bottles of 100.
CIPROFLOXACIN 500 mg tablet: White oblong film-coated tablet with breaking notch on both sides. Embossed "cip" on one side of breaking notch and "500" on the other side, on one side of the tablet only. Bottles of 100.
CIPROFLOXACIN 750 mg tablet: White oblong film-coated tablet with breaking notch on both sides. Embossed "cip" on one side of breaking notch and "750" on the other side, on one side of the tablet only. Bottles of 50.
Do not use CIPROFLOXACIN if:
- you are allergic to ciprofloxacin, other quinolone antibiotics or any of the non-medicinal ingredients in these products (see “The ingredients in CIPROFLOXACIN are:”).
- you are taking tizanidine, a medication that relaxes muscles.
- you are currently taking agomelatine (currently not marketed in Canada), used to treat depression.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CIPROFLOXACIN. Talk about any health conditions or problems you may have, including if you:
- have a history of seizures or epilepsy or are taking medicines that could cause seizures.
- have kidney problems
have risk factors for an aortic aneurysm (an abnormal bulge in a large blood vessel called the aorta) or aortic dissection (a tear in the wall of the aorta):
- o have had an aortic aneurysm or aortic dissection
- o have, or if anyone in your family has, a condition called aneurysm disease which is an abnormal bulge in any large blood vessel in the body.
- o have any of the following conditions: Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis or Behcet’s disease.
- o are 65 years of age or older
- o have high blood pressure.
- o have atherosclerosis, which is a hardening of your blood vessels.
- o are taking corticosteroids, medicines used to treat inflammation and suppress the immune system
- have a history of depression
- have vision problems
- have diabetes or are taking antidiabetic medication
are pregnant or are planning to become pregnant
are breastfeeding or planning to breastfeed. Ciprofloxacin passes into breast milk.
Talk to your healthcare professional about ways to feed your baby while you are taking CIPROFLOXACIN.
Other warnings you should know about:
Aortic aneurysm and aortic dissection: Quinolone antibiotics, including ciprofloxacin, have been associated with aneurysms (an enlargement or “bulge” of the aorta or other large blood vessel) and aortic dissection (a tear in the wall of the aorta). Stop taking CIPROFLOXACIN and get immediate medical help if you experience sudden, severe pain in your abdomen, chest or back, a pulsating sensation in your abdomen, dizziness or loss of consciousness.
Blood sugar changes: Medicines like CIPROFLOXACIN can cause blood sugar levels to rise and drop in patients with diabetes. Serious cases of hypoglycemia (low blood sugar levels) that caused coma or death have been seen with medicines like CIPROFLOXACIN. If you have diabetes, check your blood sugar levels often while taking CIPROFLOXACIN. Blood sugar changes have also been seen in patients without diabetes.
Sensitivity to light: Sun sensitivity (photosensitivity) can happen when taking CIPROFLOXACIN after exposure to sunlight or artificial ultraviolet (UV) light (e.g. tanning beds). You should avoid too much sunlight or artificial UV light while you are taking CIPROFLOXACIN. Stop taking CIPROFLOXACIN and talk to your healthcare professional if you have sunburn-like skin reactions when exposed to sunlight or UV light.
Clostridium difficile colitis (bowel inflammation): Ciprofloxacin can cause infections of the colon caused by a bacteria called Clostridium difficile. These infections can vary in severity from mild diarrhea to fatal colitis (inflammation of the colon). If you experience diarrhea or other symptoms of colitis, talk to your healthcare professional. Symptoms of colitis can include stomach pain or cramping, rectal bleeding, urgency or inability to pass stool, fatigue, weight loss and fever.
Driving and using machines: Do not drive or use machinery if you feel dizzy or lightheaded. This is more likely to happen if you drink alcohol while taking CIPROFLOXACIN.
Blood tests and monitoring: CIPROFLOXACIN can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Drug resistance: Using CIPROFLOXACIN for too long or not long enough may cause the bacteria to become resistant, and your infection may not be resolved. Your healthcare professional will tell you exactly how long you should be taking CIPROFLOXACIN for.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions:
Do not take CIPROFLOXACIN if are you taking the drugs listed below. Serious drug interactions with CIPROFLOXACIN include:
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The following may also interact with CIPROFLOXACIN:
- antidiabetic medicines, such as glyburide, glibenclamide, glimepiride, insulin • Nonsteroidal Anti-Inflammatory Drugs (NSAIDS), used to treat pain and inflammation
- caffeine
- xanthine derivatives, used to treat lung and breathing problems, such as pentoxifylline
- certain heart medications known as antiarrhythmics, used to treat irregular heartbeat, such as quinidine, procainamide, amiodarone, sotalol
- oral anticoagulants, used to prevent blood clots, such as warfarin, acenocoumarol
- phenytoin, used to prevent seizures
- duloxetine, used to treat depression
- clozapine, used to treat mental health problems such as schizophrenia
- ropinirole, used to treat Parkinson’s disease
- lidocaine, a topical pain reliever
- sildenafil, used to treat erectile dysfunction
- probenecid, used to treat gout
- methotrexate, used to treat cancer and inflammatory conditions such as arthritis and psoriasis
- cyclosporine, used to suppress the immune system in patients who have had organ transplants
- zolpidem, used to treat insomnia
CIPROFLOXACIN should be taken at least 2 hours before or 6 hours after the following:
- o antacids, used to treat heartburn and indigestion
- o multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc
- o calcium-fortified products including food and dairy products
- o medicines used to treat patients with kidney disease on dialysis, such as sevelamer, lanthanum carbonate
- o sucralfate, used to treat and prevent ulcers
- o didanosine chewable/buffered tablets and powder, used to treat HIV infection and AIDS
How to take CIPROFLOXACIN:
- Take CIPROFLOXACIN exactly as prescribed by your healthcare professional. Do not stop taking it or change your dose even if you feel better. Stopping too soon may cause your symptoms to return.
Take CIPROFLOXACIN at about the same times each day. CIPROFLOXACIN can be taken with food or on an empty stomach.
- Do not take CIPROFLOXACIN with dairy products (like milk or yogurt) or calcium-fortified juices alone. However, you may take CIPROFLOXACIN with a meal that contains these products.
- Do not take CIPROFLOXACIN with antacids that contain magnesium or aluminum.
- You should avoid excessive caffeine consumption while taking CIPROFLOXACIN.
- You should drink lots of water while taking CIPROFLOXACIN.
- Swallow the CIPROFLOXACIN tablets whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.
- After treatment has been completed, any remaining CIPROFLOXACIN should not be reused.
Usual dose:
Your healthcare professional will decide on the dose that is right for you, and the length of time you should take CIPROFLOXACIN, based on your age, weight and the condition being treated.
Overdose:
| If you think you, or a person you are caring for, have taken too much CIPROFLOXACIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
If you forget to take CIPROFLOXACIN and it is:
- 6 hours or more until your next scheduled dose, take your missed dose right away. Then take the next dose at your regular time.
- Less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose at your regular time.
Do not take a double dose to make up for a forgotten dose. If you are unsure about what to do, talk to your healthcare professional.
Possible side effects from using CIPROFLOXACIN:
These are not all the possible side effects you may have when taking CIPROFLOXACIN. If you have any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea, vomiting, diarrhea
- constipation, gas
- abdominal pain, indigestion, heartburn
- loss of appetite
- dry mouth, trouble swallowing
- feeling lightheaded
- insomnia (difficulty sleeping)
- nightmares
- joint pain, swelling and stiffness
- muscle pain, cramps and spasms
- skin rash, itching
- hot flashes
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
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| Only if severe | In all cases | ||
| Uncommon | |||
| Kidney disorder/problems: nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, mental status changes (drowsiness, confusion, coma) | ✓ | ||
| Rare | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | ✓ | ||
| Ear problems: hearing loss, ringing in the ears (These side effects may last more than 30 days) | ✓ | ||
| Edema: unusual swelling of the face, arms, hands, legs, feet and ankles | ✓ | ||
| Eye problems: repetitive, uncontrolled movements of the eyes, redness and swelling, eye pain, irritation, vision problems, double vision (These side effects may last more than 30 days) | ✓ | ||
| Heart problems (including heart attack): fast heartbeat, palpitations, chest pain, difficulty breathing, fainting | ✓ | ||
| Hyperglycemia (high blood sugar): increased thirst, frequent urination, dry skin, headache, hunger, blurred vision, fatigue | ✓ | ||
| Hypoglycemia (low blood sugar): thirst, frequent urination, hunger, nausea and dizziness, headache, blurred vision, fast heartbeat, tingling, shaking, nervousness, sweating, low energy | ✓ | ||
| Increased intracranial pressure (swelling in the brain): headache, blurred or double vision, confusion, shallow breathing, high blood pressure, nausea | ✓ | ||
| Infection: fever, chills, drowsiness, nausea, | ✓ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| vomiting, diarrhea, generally feeling unwell | |||
| Liver damage: jaundice (yellowing of the skin or eyes), dark urine and pale stools, abdominal pain, nausea, vomiting, loss of appetite, tiredness, fever, skin rash, joint pain and inflammation, pain in the upper right abdomen | ✓ | ||
| Mental health problems: hallucinations, paranoia (see, hear, or believe things that are not real), psychosis (loss touch with reality), confusion, disorientation, anxiety, depression, suicidal thoughts or actions, feeling agitated, restless or nervous, inability to think clearly or pay attention, memory loss (These side effects may last more than 30 days) | ✓ | ||
| Neurological problems: abnormally high level of muscle tone, clumsy involuntary movements, facial paralysis, tongue or throat muscle weakness, trouble speaking, confusion, seizures (convulsions or fits) | ✓ | ||
| Photosensitivity (sensitivity to sunlight): itchy, red or blistering of skin when exposed to sunlight | ✓ | ||
| Rhabdomyolysis (breakdown of damaged muscle): muscle tenderness, weakness, red-brown (tea-coloured) urine | ✓ | ||
| Tendinitis (inflamed tendon) or Tendon rupture (partial or complete tear): swelling and tenderness of one or more joints, pain, inflammation, muscle aches (These side effects may last more than 30 days) | ✓ | ||
| Vaginal yeast infection (inflammation of the vagina): itching, burning or discharge from the vagina | ✓ | ||
| Very rare | |||
| Migraine: severe headache, often accompanied by nausea, vomiting and sensitivity to light | ✓ | ||
| Myasthenia gravis: muscle weakness, drooping eyelids, vision changes, difficulty chewing or swallowing, trouble breathing | ✓ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
Pancreatitis (inflammation of the pancreas): upper abdominal pain, tenderness when touching the abdomen, fever, rapid heartbeat, nausea, vomiting | ✓ | ||
| Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (severe skin reactions): redness, blistering and/or peeling of the skin and/or inside of the lips, mouth, nose, eyes and genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | ✓ | ||
| Unknown | |||
| Acute generalized exanthematous pustulosis (AGEP): rash with small pustules, red and swollen skin, fever, itching, burning | ✓ | ||
| Aortic aneurysm (abnormal bulge in the aorta) or Aortic dissection (tear in the wall of the aorta): sudden, severe pain in abdomen, chest or back, pulsating sensation in the abdomen, dizziness, loss of consciousness | ✓ | ||
| Clostridium difficile colitis (bowel inflammation): severe or persistent diarrhea, abdominal or stomach pain, nausea and vomiting, fever | ✓ | ||
| Kounis syndrome: a mixture of symptoms and signs of an allergic reaction and heart attack or unstable angina, with chest pain, shortness of breath, faintness, nausea, vomiting, fainting, itching, hives, sudden, heavy sweating, unusual paleness, palpitations, hypotension, slow heartbeat | ✓ | ||
| Peripheral neuropathy (problems with nerves): pain, burning, tingling, numbness, weakness in your hands and feet | ✓ | ||
| Prolongation of QT interval (a heart rhythm condition): irregular heartbeat, fainting, loss of consciousness, seizures | ✓ | ||
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store between 15 and 30°C.
Keep out of reach and sight of children.
If you want more information about CIPROFLOXACIN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.sivem.ca) or by