Patient Medication Information: uses, side effects, how to take - Tenoxicam (AA Pharma)
What is TENOXICAM used for?
- TENOXICAM is a nonsteroidal, anti-inflammatory agent. It is used to relieve symptoms such as inflammation, swelling, fever, stiffness and joint pain, often caused by certain types of arthritis.
TENOXICAM is not recommended for use in children less than 16 years of age.
- TENOXICAM has been prescribed to you. It should not be given to other people or used for other problems unless specified by your doctor.
Serious Warnings and Precautions
Non-steroid anti-inflammatory drugs (NSAIDS), including TENOXICAM, can cause severe side effects that can in some cases lead to death, such as:
- Stomach ulcers,
- Gastrointestinal perforation (a hole in the wall of your stomach or bowels), and
- Gastrointestinal bleeding (bleeding anywhere along the GI tract between mouth and anus)
- Stop taking this medicine immediately if you develop a gastrointestinal perforation or gastrointestinal bleeding. Contact your health care professional immediately. These side effects can occur suddenly and at any time during your treatment. The symptoms and signs of these side effects are listed in the “Serious side effects and what to do about them table” box. It is found later in this leaflet.
Pregnancy:
DO NOT take TENOXICAM if you are pregnant and in a later stage of pregnancy (28 weeks or later). If you are pregnant and in an earlier stage of pregnancy (less than 28 weeks) only take TENOXICAM if you are told to do so by your doctor. Medicines like TENOXICAM may cause harm to you and your baby. Your doctor will need to closely monitor your health and that of your baby (including your amniotic fluid levels) if they prescribe TENOXICAM during this time.
How does TENOXICAM work?
- TENOXICAM works by interfering with the production of compounds in the body that cause pain and inflammation.
What are the ingredients in TENOXICAM?
Medicinal ingredients: Tenoxicam
Non-medicinal ingredients: Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide and yellow ferric oxide.
TENOXICAM comes in the following dosage forms:
Tablets: 20 mg
Do not use TENOXICAM if:
- you are allergic to tenoxicam or any of the other ingredients of this medicine
- you have a history of stomach problems
- you have had any unusual or allergic reactions with other nonsteroidal anti-inflammatory agents or ASA (acetylsalicylic acid) related products
- you are an elder and will been given anesthesia or have surgery
- you have a history of kidney disease or at increased risk of bleeding
- you are pregnant and in a later stage of pregnancy (28 weeks or later).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TENOXICAM. Talk about any health conditions or problems you may have, including if you:
- have a history of stomach ulcer or bleeding
- have a history of kidney or liver disease
- are presently taking medications to relieve your symptoms of arthritis.
- have edema (increased water retention in tissues )
- have a heart failure
- have high blood pressure
- have diabetes
- are taking antihypertensive drugs like β-blockers, angiotensin-converting enzyme inhibitors or some diuretics
- have blood related problems
- are pregnant, planning on becoming or become pregnant while taking TENOXICAM.
- are breast-feeding.
- are weak
Other warnings you should know about:
Tell your doctor, dentist or pharmacist that you consult or see, that you are taking this medication.
Breastfeeding: You should not take TENOXICAM if you are breastfeeding. It is not known if TENOXICAM passes into breast milk.
Serious Skin Reactions: In rare cases, serious or life-threatening skin reactions listed below have been reported with some NSAIDs, such as TENOXICAM.
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Stevens-Johnson syndrome (SJS),
- toxic epidermal necrolysis (TEN),
- exfoliative dermatitis and
- erythema multiforme
You may be at a greater risk of experiencing a serious skin reaction usually during the first month of treatment. Stop taking TENOXICAM and contact your doctor right away if you experience any of the following symptoms at any time during treatment with TENOXICAM:
- fever
- severe rash
- blisters or peeling skin
- swelling of the face
- swollen lymph glands
- flu-like feeling
- yellow skin or eyes
- shortness of breath
- swelling of the legs
- dry cough
- chest pain or discomfort
- feeling thirsty
- urinating less often, less urine or dark urine
Infection: TENOXICAM may mask the usual signs of an infection.
Vision: Blurred and/or reduced vision has been reported with some NSAIS including TENOXICAN. Stop taking TENOXICAM if you develop symptoms of blurred or reduced vision and seek medical attention right away.
Allergic Reactions: Allergic reactions have occurred during treatment with TENOXICAN. Stop taking this medicine immediately if you develop the symptoms of allergic reactions including rashes, trouble breathing and wheezing (bronchospasm) and anaphylaxis.
Driving and Using Machines: Give yourself time to see how you feel before driving a vehicle or using machinery. Blurred or reduced vision and being dizzy or drowsy can occur.
Elderly Patients: Elderly patients may be at a greater risk of developing certain side effects.
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 TENOXICAM:
- Acetylsalicylic Acid or Other NSAIDS (used for inflammation, pain, fever)
- Anticoagulants (used to stop blood clotting)
- Oral anti diabetic drugs (sulfonylureas)
- Phenytoin (used to treat fits/epilepsy)
- Sulfonamides (for infections)
- A diuretic (water pills) like hydrochlorothiazide, furosemide for high blood pressure
- β-blockers for high blood pressure
- Digoxin (for heart problems)
- Antacids like aluminum hydroxide, magnesium hydroxide (used to treat conditions such as indigestion, heartburn)
- Cholestyramine (used to treat high cholesterol)
- Lithium (for mental health problems)
- Methotrexate (used to treat skin problems, arthritis or cancer)
How to take TENOXICAM:
- Take TENOXICAM as directed by your doctor. Ask your healthcare professional if you have any questions.
- Do not take more of it, do not take it more often or do not take it for a longer period of time than prescribed by your doctor.
Take this medicine immediately after a meal or with food to lessen the chance of stomach upset. If stomach upset (nausea, vomiting, stomach pain, diarrhea, or indigestion) occurs and persists, check with your doctor.
- You should take your dose at the same time each day.
- Check with your doctor if you are not getting relief or if any problems develop.
Usual dose:
Adults: The usual dose is 1 tablet (20 mg) each day.
Your healthcare professional may reduce your dose.
Overdose:
If you think you, or a person you are caring for, have taken too much TENOXICAM, 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 TENOXICAM, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time to make up for a missed dose.
What are possible side effects from using TENOXICAM?
These are not all the possible side effects you may have when taking TENOXICAM. If you experience any side effects not listed here, tell your healthcare professional. Side effects include:
- nausea/vomiting
- indigestion/heartburn
- abdominal pain
- dry mouth
- constipation
- difficulty passing urine
- dizziness
- drowsiness
- tiredness
- sweating more than usual
- trouble sleeping
TENOXICAM can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug | ||||||
| Only if severe | In all cases | and get immediate | ||||||
| medical help | ||||||||
| COMMON | ||||||||
| Gastrointestinal (GI) bleeding (bleeding anywhere along the GI tract between mouth and anus): (bleeding in esophagus, stomach or first part of small intestines): blood in vomit, black tarry stool, bright red blood in your stool or coming from rectum, rapid pulse, low blood pressure, low urine flow, confusion, weakness, dizziness; (bleeding from large intestine, rectum): bright red blood in your stool or coming from rectum, rapid pulse, low blood pressure, low urine flow, confusion, weakness, dizziness | √ | |||||||
| Nervous system problems: generally feeling unwell, tingling or numbness of the hands or feet, nervousness | √ | |||||||
| UNCOMMON | ||||||||
| Allergic reaction: skin rash, hives, itching, swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing | √ | |||||||
Gastrointestinal perforation (a hole in the wall of your stomach or bowels): severe abdominal pain and tenderness, nausea, vomiting, chills or fever | √ | |||||||
Stomach or duodenum ulcer: pain and discomfort (indigestion) which is felt between the navel and the breastbone, vomiting blood, | √ | |||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug | ||||||
| Only if severe | In all cases | and get immediate | ||||||
| medical help | ||||||||
| bloody or black tarry stools | ||||||||
| Heart problems: fast or irregular heartbeat, high blood pressure | √ | |||||||
| Kidney problems: blood in the urine | √ | |||||||
| UNKNOWN | ||||||||
Mental health problems: confusion | √ | |||||||
| Photosensitivity: increased sensitivity of the skin to sun (such as redness, itching, swelling, blistering) | √ | |||||||
Blood related problems: Decreased number of red blood cells: tiredness, headaches, being short of breath when exercising, dizziness and looking pale; Lack of white blood cells: frequent infections such as fever, severe chills, sore throat or mouth ulcers; Low blood platelet count: bleeding or bruising more easily than normal. | √ | |||||||
Respiratory problems: bronchospasm: shortness of breath, chest tightness, wheezing or coughing | √ | |||||||
Liver problems: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | √ | |||||||
Eyes, Ears, Nose, Throat: Vision abnormal; buzzing, ringing or other persistent noise in the ears; deafness; bleeding | √ | |||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug | ||||||
| Only if severe | In all cases | and get immediate | ||||||
| medical help | ||||||||
| from the nose; | ||||||||
| RARE | ||||||||
| Severe Skin Reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine | √ | |||||||
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: | |
| |
| (https://www.canada.ca/en/health-canada/services/drugs-health- | |
| products/medeffect-canada/adverse-reaction-reporting.html) for information on how | |
| to report online, by mail or by fax; or | |
| |
| 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 at room temperature 15°C to 30°C. Keep out of reach and sight of children.
If you want more information about TENOXICAM:
- 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). Find the Patient Medication Information on the manufacturer’s website (http://www. aapharma.ca/en/), or by calling 1877-998-9097.
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7