Patient Medication Information: uses, side effects, how to take - Teva-5 ASA
Serious Warnings and Precautions
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What is Teva-5 ASA used for?
- To treat symptoms related to ulcerative colitis when the condition of the disease is mild to moderate. Ulcerative colitis is where the large bowel (colon) and back passage (rectum) becomes red and swollen (inflamed).
- To help prevent a moderate to mild condition of ulcerative colitis from returning.
How does Teva-5 ASA work?
Teva-5 ASA is an anti-inflammatory drug for the bowel. Teva-5 ASA is believed to stop the production of certain substances in your body that cause swelling (inflammation). Teva-5 ASA tablets are designed to prevent the medicine from being released early.
What are the ingredients in Teva-5 ASA?
Medicinal ingredients: Mesalazine or 5-aminosalicylic acid (5-ASA)
Non-medicinal ingredients: Each tablet contains the following inactive ingredients:
ethyl acrylate, hypromellose, iron oxide black, iron oxide red, magnesium stearate, mannitol, methacrylic acid copolymer (Type C), potassium sorbate, povidone, propylene glycol, purified water, and sodium citrate, sodium starch glycolate, talc, triethyl citrate, titanium dioxide and xanthan gum.
Teva-5 ASA comes in the following dosage form:
TEVA-5 ASA (5-aminosalicylic acid) is available as brown-red capsule shaped enteric-coated tablets each containing 400 mg of 5-aminosalicylic acid coated with an acrylic based resin supplied in bottles of 100 and 500.
Do not use Teva-5 ASA if:
- You are allergic to mesalamine (5-ASA) or any of the ingredients in Teva-5 ASA.
- You have a history of sensitivity to salicylates, for example acetylsalicylic acid (i.e. Aspirin®).
- You have severe liver problems.
- You have severe kidney problems.
- You have an ulcer in the stomach or intestines.
- You have a blocked urinary tract.
- You are unable to swallow the whole tablet.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Teva-5 ASA. Talk about any health conditions or problems you may have, including if you:
- have higher than normal blood urea nitrogen (BUN) levels (renal function test)
- have a history of kidney problems
- are taking other ulcerative colitis drugs that contain Mesalamine. Speak to your doctor before switching your treatment to Teva-5 ASA.
- had an allergic reaction to sulfasalazine. Stop taking Teva-5 ASA and speak to your doctor if you experience a rash or a fever.
- have pyloric stenosis. Pyloric Stenosis is a condition in where the passage from the stomach to the small intestine is narrow or blocked. Pyloric stenosis may keep the Teva-5 ASA tablet from reaching the colon as quickly as it normally would.
Other warnings you should know about:
Treatment with Teva-5 ASA can increase your risk of certain side effects, including:
- Liver problems: You may develop liver function problems, including liver failure.
Kidney Stones: You may develop kidney stones when using Teva-5 ASA. Be sure to drink enough liquids while you are taking Teva-5 ASA. Speak to your doctor about how much water or other liquids you should be drinking. Symptoms of kidney stones may include:
o blood in urine
o urinating more often
o pain in back, side, stomach and groin
Acute Intolerance Syndrome: Mesalamine, the medicinal ingredient in Teva-5 ASA, can cause acute intolerance syndrome. Your doctor may monitor your kidney function if you have kidney disease while on treatment. Speak to your doctor immediately if you experience any of the following symptoms:
o cramping
o sudden abdominal pain
o bloody diarrhea
o fever
o headache
o rash
Colitis (inflamed colon): Teva-5 ASA can cause the symptoms of colitis to worsen. Speak to your doctor immediately if you suddenly experience any of the following symptoms:
o abdominal pain
o bloody diarrhea
o fever
o headache
o rash or itchy skin
o eye infection
Pregnancy and breastfeeding:
If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your doctor.
- Tell your doctor right away if you become pregnant or think you are pregnant during treatment with Teva-5 ASA.
Taking mesalamine during pregnancy have been reported to cause:
o early Labor
o stillbirth (death of baby)
o low birth weight of baby
- If you breastfeed your baby while taking Teva-5 ASA, your baby could develop / start to have diarrhea. It is important to monitor your baby’s stool and contact your doctor right away if they have diarrhea. Your doctor may advise you to stop breastfeeding your baby.
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 Teva-5 ASA:
- aminosalicylates. Taking Teva-5 ASA with aminosalicylates may increase your risk of developing a blood clot.
- azathioprine, 6-mercaptopurine. Taking Teva-5 ASA with these drugs may increase your risk of developing a blood disorder.
- medicines that can change the acidity level of the stool, such as lactulose
- medicines to treat ulcers such as cimetidine, famotidine
- nonsteroidal anti-inflammatory drugs (NSAID). Taking Teva-5 ASA with these drugs may increase your risk of side effects to your kidneys.
Treatment with Teva-5 ASA can affect the results of a urine test. Tell your doctor or nurse that you are taking Teva-5 ASA when taking a urine test.
How to take Teva-5 ASA:
- Take Teva-5 ASA exactly as your doctor tells you to take it. Do NOT take more of it than prescribed. Speak to your doctor or pharmacist if you are not sure.
- Take the exact dose your doctor tells you to take during remission. Following your doctor’s instructions can reduce the risk of your symptoms returning.
- Do NOT stop using Teva-5 ASA abruptly.
- Swallow tablets whole. Do NOT crush or chew the tablet.
- The whole tablet or a part of it may occasionally appear in your stool. Speak to your doctor if this occurs frequently.
Usual Adult Dose:
Treatment of moderate to mild ulcerative colitis:
- Take two to eight 400 mg tablets daily in divided doses.
- Your doctor may increase your daily dose to twelve 400 mg tablets if your condition is severe.
Treatment for the maintenance of remission of ulcerative colitis:
Take four 400 mg tablets daily in divided doses.
Overdose:
Missed Dose:
If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take double the dose.
What are possible side effects from using Teva-5 ASA?
These are not all the possible side effects you may feel when taking Teva-5 ASA. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- acne
- aches and muscle cramps
- constipation
- coughing
- chills
- diarrhea
- dizziness
- dry mouth
- feelings of confusion, anxiety or nervousness
- hair loss
- headache or migraine
- increased appetite
- joint and groin pain
- lower back discomfort or back pain
- low energy or feeling unwell
- menstrual (period) pain
- nausea and vomiting
- rash
- runny nose
If you think you, or a person you are caring for, have taken too much Teva-5 ASA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
- sore throat
- stuffy head
- sweating
Your doctor may run tests, including a blood test, to check your liver function and blood cell counts.
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 | ||
| COMMON | |||
| Worsening of your ulcerative colitis symptoms | √ | ||
| UNCOMMON | |||
Kidney stones (hard little pebbles that form in your kidneys) blood in urine, urinating more often, pain in your back, side, belly or groin. | √ | ||
| Eye problems: itchy, red eyes with discharge, pain, swelling and blurred vision | √ | ||
| Ear problems: ear pain | √ | ||
| Pneumonia (infection in the lungs): chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking chills, nausea, vomiting or diarrhea, shortness of breath | √ | ||
| Fast heartbeat: pounding, fluttering, racing, skipping beats, chest discomfort or shortness of breath | √ | ||
| Chest pain | √ | ||
| Stomach pain | √ | ||
| RARE | |||
| Fever (higher than normal body temperature) | √ | ||
Allergic (hypersensitivity) reactions itching; rash, swelling of face or hands, tightness in chest, trouble breathing | √ | ||
| Lung problems (thickening and scaring of lung tissues): Shortness of breath, fast, shallow breathing, dry cough | √ | ||
Kidney problems changes in urine output, cloudy or tea-coloured urine, blood in the urine, weight gain (from retaining fluid), confusion, swelling of the | √ | ||
eyes, hands, legs, and feet Additional less specific symptoms may include: drowsiness, fatigue, nausea, vomiting, rash, persistent itching, and back pain | |||
Liver problems severe abdominal pain or distension, nausea, vomiting, drop in appetite, bloating, together with yellowing of the skin and eyes, and abnormal liver function tests | √ | ||
Acute intolerance syndrome cramping, stomach pain, bloody and excessive stools, fever, headache and rash | √ | ||
| Stevens-Johnson syndrome (SJS) (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 | √ | ||
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.
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:
Teva-5 ASA should be stored at controlled room temperature (15°C - 30°C). Protect from light.
Keep out of reach and sight of children.
If you want more information about Teva-5 ASA:
- Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website
- http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.