Patient Medication Information: uses, side effects, how to take - Octasa (Tillotts Pharma, 800 mg)
Serious warnings and precautions box
What Octasa is used for:
- Octasa is used to treat a condition called ulcerative colitis. It is used to start remission in adult patients who have moderately active ulcerative colitis.
How Octasa works:
Octasa is an oral medicine against inflammation, acting locally in the colon. Efficacy of treatment would show through the decrease of blood in the stools as well as the number of stools.
The ingredients in Octasa are:
Medicinal ingredient: mesalazine (also known as 5-aminosalicylic acid [5-ASA] or mesalamine).
- Allergy to a sulfasalazine medicine: Before you take Octasa, tell your healthcare professional if you have ever had an allergy to a sulfasalazine medicine such as salazopyrin. Your healthcare professional will closely monitor you while you are taking Octasa. Stop taking Octasa and get immediate medical help if you get any of the following intolerance reaction symptoms: abdominal cramps or pain, fever, a severe headache or a rash.
- Blood problems: Octasa can cause blood problems. Your healthcare professional will check your blood counts before you take Octasa and while you are taking it. Stop taking Octasa and get immediate medical help if you get blood problems.
- Kidney problems: Octasa can cause kidney problems. Before you take Octasa, tell your healthcare professional if you have kidney problems. Your healthcare professional will check your kidney function before you take Octasa and while you are taking it. Stop taking Octasa and get immediate medical help if you get kidney problems.
- Lung problems: Octasa can cause lung problems. Before you take Octasa, tell your healthcare professional if you have any lung problems including asthma. If you have a history of lung problems, your healthcare professional will monitor you for lung problems while you are taking Octasa.
See “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.
Non-medicinal ingredients: acetone, ferric oxide yellow, ferric oxide red, isopropyl alcohol, lactose monohydrate, macrogol 6000, magnesium stearate, methacrylic acid - methyl methacrylate copolymer (1:2), povidone K25, sodium starch glycolate (type A), talc and triethyl citrate.
Octasa comes in the following dosage form:
Tablet (delayed-release): 800 mg
Do not use Octasa if:
- you are allergic to mesalazine / mesalamine or any of the other non-medicinal ingredients in Octasa
- you are allergic to salicylates such as Aspirin®
- you have severe liver problems
- you have severe kidney problems
- you have an ulcer (gastric or duodenal)
- you have a urinary tract blockage or obstruction
- you are unable to swallow the tablet whole
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Octasa. Talk about any health conditions or problems you may have, including if you:
- have liver problems
- have ever had a heart-related allergic reaction such as inflammation of the heart muscle or heart sac
- have ever developed a severe skin rash or skin peeling, blistering or mouth sores after taking mesalazine
Other warnings you should know about:
Testing:
Before and while you are taking Octasa, your healthcare professional may want to monitor your liver, kidneys, blood and lungs to make sure they are all right.
Nervous system problems:
Tell your healthcare professional immediately if you experience strong or recurrent headache, vision problems, or ringing or buzzing in the ears. These could be symptoms of idiopathic intracranial hypertension (increased pressure in the skull).
Pregnancy:
Before you take Octasa, tell your healthcare professional if you are pregnant or planning to become pregnant. You should not use Octasa while you are pregnant unless your healthcare professional advises that you can.
Breastfeeding:
Before you take Octasa, tell your healthcare professional if you are breastfeeding or are planning to breastfeed. Octasa is released in breastmilk and can have an effect on your baby. It is important to monitor your baby’s stool and contact your healthcare professional right away if they have diarrhea. Your healthcare professional may advise you to stop breastfeeding your baby.
Octasa contains milk sugar (lactose):
If you are intolerant to lactose, you should note that Octasa contains a small amount of lactose. If you have intolerance to some sugars, contact your healthcare professional before taking this medicine.
Urine discoloration:
You may notice red-brown urine discoloration after using toilets treated with bleach products. This is because of a chemical reaction between mesalazine and bleach and is harmless.
Children and adolescents:
The safety and effectiveness of Octasa in this age group have not been established.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions:
If you take any drugs that lower the immune system, such as azathioprine, 6-mercaptopurine or thioguanine, your healthcare professional will closely monitor you for signs of infection (like fever) and will also regularly check your blood counts.
The following may also interact with Octasa:
- drugs that prevent the formation of blood clots like warfarin.
How to take Octasa:
- Always take Octasa exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
You can take the tablet with or without food.
- Swallow the tablet whole with a glass of water.
- Do NOT chew, crush or break the tablets before swallowing them.
There have been a few reports of intact tablets in the stool. What look like whole tablets may be the remains of the tablet coating. If you observe tablets or tablet shells in the stool, you should consult your healthcare professional.
Usual dose:
Adults (including the elderly)
To treat acute phases of ulcerative colitis your daily dose is 6 tablets once daily or in divided doses.
Overdose:
If you think you, or a person you are caring for, have taken too much Octasa, 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.
Missed dose:
If you forget to take a dose at the right time, you should take it as soon as possible. However, if it is almost time for your next dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
Possible side effects from using Octasa:
These are not all the possible side effects you may have when taking Octasa. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- ulcerative colitis getting worse
- hemorrhoids
- headache
- heart beating too fast or too slow
- upper abdominal pain
- indigestion
- stomach or gut (gastrointestinal) pain
- fever
- muscle pain
- joint pain
- menstrual disorder
- cough
- rosacea (redness in the nose, cheeks, chin and forehead)
- high blood pressure
- sensation of tingling, pricking and numbness
- weakness and pain, usually in hands and feet
- hives
- itching skin
- dizziness
- diarrhea
- stomach pain
- wind (flatulence)
- nausea
- vomiting
- hair loss
- weight loss
- low sperm count (reversible)
- increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)
- laboratory tests out of normal range
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 | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Rare | |||
| Myocarditis/Pericarditis (inflammation of the heart muscle and lining around the heart): chest pains, palpitations, shortness of breath | √ | ||
| Very rare | |||
| Blood problems (including low blood cells and platelets): unexplained bruising (without injury), bleeding under your skin, anemia (feeling tired, | √ | ||
| weak and looking pale, especially on lips, nails and inside of eyelids), fever (high temperature), sore throat or unusual bleeding (e.g., nose bleeds) | |||
| Liver problems (including hepatitis, inflammation of the liver): yellowing of skin or eyes, dark urine, abdominal pain or swelling, nausea or vomiting, tiredness | √ | ||
| Pancreatitis (inflammation of the pancreas): pain in upper abdomen and back, fever, rapid pulse, nausea, vomiting, tenderness when touching the abdomen | √ | ||
| Allergic reactions: rash or skin eruption, itching | √ | ||
| Lung problems: difficulty in breathing, wheezing, coughing, rapid breathing or fever | √ | ||
| Kidney problems (including inflammation and scarring of the kidney and kidney failure): swollen extremities, foamy urine, fatigue, weight loss and blood in urine | √ | ||
| Drug fever (fever that occurs while taking the medicine and which disappears when medicine is stopped) | √ | ||
| Unknown | |||
| Disorder of the immune system (lupus-like syndrome which can cause inflammation of the heart sac or membranes around the lungs and heart, rash and/or joint pain) | √ | ||
| Intolerance reactions: increase of symptoms of the underlying disease, nausea, bloody diarrhea, abdominal cramps, acute abdominal pain, fever, severe headache and rash | √ | ||
| Serious skin reactions: fever, flu-like symptoms, reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, | √ | ||
| genitals and eyes, widespread rash, fever and enlarged lymph nodes | |||
Idiopathic intracranial hypertension (increased pressure in the skull): strong or recurrent headache, vision problems, or ringing or buzzing in the ears | √ | ||
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:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
Storage:
Do not store above 25°C. Store in the original package.
Keep out of reach and sight of children.
If you want more information about Octasa:
- 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) or by calling 1-866-391-4503.
OCTASA® is a trademark of Tillotts Pharma AG, Rheinfelden, Switzerland.
Importer/Distributor: C.R.I. Burlington, ON, L7L 6C7