November 24, 2014
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ratio-Tecnal C

(ASA - caffeine - codeine - butalbital)

DIN (Drug Identification Number)

00608181 RATIO-TECNAL C 1/2 CAPSULE
00608203 RATIO-TECNAL C 1/4 CAPSULE

What side effects are possible with ratio-Tecnal C?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • constipation
  • dizziness
  • drowsiness (mild)
  • dry mouth
  • lightheadedness
  • heartburn
  • nausea
  • vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • confusion
  • false sense of well-being
  • feeling "drunk" or intoxicated
  • feeling faint
  • increased sweating
  • signs of decreased kidney function (e.g., difficulty or pain urinating, frequent urge to urinate, decrease in amount of urine)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of unusual bleeding (e.g., bloody or black, tarry stools, vomiting of blood or material that looks like coffee grounds, unusual bruising or bleeding, nosebleeds)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of breathing problems such as shallow, irregular breathing, or slow or troubled breathing
  • symptoms of overdose of codeine, such as:
    • abnormally slow or weak breathing
    • cold, clammy skin
    • extreme drowsiness
    • severe dizziness, confusion
    • slow heartbeat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for ratio-Tecnal C?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

October 17, 2013

Health Canada has issued new information concerning the use of Fiorinal-C, Pronal-C, ratio-Tecnal C, and Trianal-C (ASA - caffeine - codeine - butalbital). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

A previous advisory on ASA - caffeine - codeine - butalbital was issued on June 6, 2013. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Abdominal conditions: Codeine may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Bleeding disorders: ASA may increase bruising and bleeding from cuts that may take longer to stop. If you have a bleeding disorder or a history of bleeding problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Breathing: Codeine and butalbital can suppress breathing. If you are at risk for breathing difficulties, such as asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Constipation: Codeine can be very constipating. Eating a high-fibre diet and following good bowel habits will help to minimize this effect. If you develop constipation easily, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: This medication contains codeine and butalbital. Physical dependence, psychological dependence, and abuse have occurred with the use of both these medications. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief.

If you suddenly stop taking this medication, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Gout: ASA may cause or worsen attacks of gout. Symptoms of an acute gout attack include sudden pain, swelling, and stiffness in the affected joint, often the big toe. You may also experience a fever. If this is your first attack, seek medical attention as soon as possible. If you have had gout attacks before, follow your doctor's instructions for dealing with the attack.

Head injury: If you have a head injury or increased pressure in the head, you may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Taking ASA - caffeine - codeine - butalbital over a long period of time may increase the risk of developing kidney disease. If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Other medical conditions: If you are about to undergo surgery of the biliary tract, approach taking codeine with caution, as it may worsen your condition. Codeine will worsen the effects of acute alcohol intoxication and delirium tremens.

As well, if you have low thyroid (hypothyroidism), Addison's disease, benign prostatic hypertrophy (enlarged prostate), gallbladder disease, urethral stricture, decreased function of the adrenal glands, or porphyria, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stomach problems: ASA may cause stomach problems such as ulcers or bleeding. If you have a stomach problem, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Call your doctor immediately if you notice signs such as stomach or abdominal pain, black tarry stools, or vomiting blood. Using ASA at the same time as other anti-inflammatory medications increases the risk of stomach ulcers and bleeding.

Surgery: Do not take ASA - caffeine - codeine - butalbital for 5 to 7 days before any surgery, including dental surgery, unless otherwise directed by your doctor or dentist. If you are scheduled for surgery, let your doctor know that you are taking this medication.

Pregnancy: This medication is not recommended for use by pregnant women unless the anticipated benefits outweigh the possible risks.

ASA does not appear to cause birth defects. Regular use of codeine by pregnant women may cause withdrawal symptoms in the newborn.

Breast-feeding: ASA - caffeine - codeine - butalbital passes into breast milk. Some of the codeine dose is converted into morphine by the body, once it has been taken. For some people, this change happens much faster than for others. If this happens to a nursing mother, the baby is a risk of receiving a morphine overdose through the breast milk.

If you are a breast-feeding mother and are taking ASA - caffeine - codeine - butalbital, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

The use of ASA may be associated with the development of Reye's syndrome in children and teenagers who have illnesses accompanied by fever, especially influenza and chickenpox. ASA should not be given to, or used by, children or teenagers who have chickenpox or flu symptoms unless a doctor is consulted.

Children are especially susceptible to an overdose of caffeine and its side effects on the central nervous system. ASA is one of the most frequent causes of accidental poisoning in toddlers and infants. Medications that contain ASA should be kept out of the reach of all children.

Seniors: Seniors may be more susceptible to the harmful effects of the medicines in this product.

What other drugs could interact with ratio-Tecnal C?

There may be an interaction between ASA - caffeine - codeine - butalbital and any of the following:

  • acetazolamide
  • alcohol
  • alendronate
  • anesthetics
  • angiotensin converting enzyme inhibitors (ACEIs; e.g., captopril, ramipril)
  • antidiabetic medications (eg., insulin, glyburide)
  • antihistamines (e.g., cetirizine, dimenhydrinate, diphenhydramine, hydroxyzine)
  • antipsychotics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
  • "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
  • baclofen
  • barbiturates (e.g., butalbital, phenobarbital, secobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • birth control pills bosentan
  • bupropion
  • buspirone
  • butorphanol
  • calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
  • carbamazepine
  • cefamandole
  • cefoperazone
  • cefotetan
  • chloral hydrate
  • chloramphenicol
  • cholestyramine
  • cimetidine
  • corticosteroids (e.g., dexamethasone, prednisone, methylprednisolone)
  • corticotropin (ACTH)
  • cyclosporine
  • dasatanib
  • dexamethasone
  • dextroamphetamine
  • disulfiram
  • divalproex sodium
  • fluoroquinolone antibiotics (e.g., ciprofloxacin, norfloxacin, moxifloxacin)
  • furosemide
  • ginkgo biloba
  • glucosamine
  • griseofulvin
  • heparin
  • imatinib
  • isoniazid
  • ketorolac
  • lamotrigine
  • macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin)
  • methocarbamol
  • methotrexate
  • monoamine oxidase inhibitors (e.g., tranylcypromine, phenelzine, moclobemide)
  • moxalactam
  • naltrexone
  • non-steroidal anti-inflammaotry medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • other narcotic analgesics (e.g., fentanyl, morphine, oxycodone)
  • pentazocine
  • pentoxiphylline
  • phenothiazines (e.g., perphenazine, thioridazine)
  • phenylbutazone
  • phenytoin
  • plicamycin
  • primidone
  • probenecid
  • protease inhibitors (e.g., daraunavir, indinavir, lopinavir, ritonavir, saquinavir)
  • quinidine
  • rifabutin
  • rifampin
  • selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, sertraline)
  • St. John's wort
  • sulfinpyrazone
  • tetracycline antibiotics (e.g., doxycycline, minocycline, tetracycline)
  • thiazide diuretics (e.g., hydrochlorothiazide, indapamide)
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
  • valproic acid
  • vancomycin
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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