Patient Medication Information: uses, side effects, how to take - Accrufer
What is ACCRUFER used for?
ACCRUFER is used in adults to treat low levels of iron in your body when:
- other oral iron therapies do not work for you; or
- you cannot tolerate other oral iron therapies.
How does ACCRUFER work?
ACCRUFER is used to replenish your body’s iron. Iron is a key part of your red blood cells that carry oxygen throughout your body.
What are the ingredients in ACCRUFER?
Medicinal ingredients: Ferric maltol
Non-medicinal ingredients: Black printing ink, colloidal anhydrous silica, crospovidone (Type A), FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No.6, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate and titanium dioxide.
ACCRUFER comes in the following dosage forms:
Capsules – 30 mg of Iron (231.5 mg of ferric maltol)
Do not use ACCRUFER if:
- you are allergic to ferric maltol or any of the other ingredients of this medicine.
- you have any illness that causes you to store too much iron in your body or if you have a problem with how your body uses iron.
- you have or will receive multiple blood transfusions.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACCRUFER. Talk about any health conditions or problems you may have, including if you:
- are experiencing a “flare” of your inflammatory bowel disease (IBD)
are pregnant or plan to become pregnant. It is not known if ACCRUFER will harm your unborn baby. Your healthcare professional will decide whether you should take ACCRUFER while you are pregnant.
- are breastfeeding or plan to breastfeed. It is not known if ACCRUFER passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ACCRUFER.
Other warnings you should know about:
ACCRUFER contains lactose. If you have a condition that makes you sensitive to lactose, talk to your healthcare professional before taking this medicine.
ACCRUFER contains FD&C Red No. 40 and FD&C Yellow No.6, which may cause allergic reactions.
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 ACCRUFER:
- Intravenous iron
- Other oral iron tablets or health supplements containing iron
- Mycophenolate (used with other medicines to prevent the body rejecting transplanted organs)
- Some antibiotics, such as ciprofloxacin, tetracycline, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, and chloramphenicol
- Ethynyl estradiol
- Doxycycline
- Penicillamine
- Bisphosphonates
- Some medicines used to treat Parkinson’s disease (entacapone, levodopa) and thyroid problems (levothyroxine)
- Methyldopa
- Dimercaprol
How to take ACCRUFER:
- Take ACCRUFER exactly as your doctor tells you to.
Take ACCRUFER 2 times a day with half a glass of water on an empty stomach 1 hour before or 2 hours after meals.
- Swallow the capsules whole. Do not open, break, or chew the capsules.
Usual dose:
Take one 30 mg capsule twice a day.
Overdose:
Iron overdose is dangerous and can be life-threatening in children, infants and toddlers. In case of accidental overdose, call a doctor or poison control center immediately. This product is not approved for use in children.
| If you think you, or a person you are caring for, have taken too much ACCRUFER, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss a dose of ACCRUFER, skip the missed dose and take the next dose as normal. Do not take a double dose to make up for a forgotten capsule.
What are possible side effects from using ACCRUFER?
These are not all the possible side effects you may have when taking ACCRUFER. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects of ACCRUFER are:
- Stomach pain
- Flatulence (wind)
- Constipation
- Discomfort or bloating in the stomach
- Diarrhea
- Nausea (feeling sick)
- Vomiting
- Discoloured stool
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 | ||
| LESS COMMON | |||
| Increased risk of inflammatory bowel disease (IBD) flare | ✓ | ||
| Too much iron stored in your body (iron overload): Diarrhea; fever; nausea; stomach pain; vomiting (may contain blood); blueish colored lips, fingernails and palms of hands; seizures; pale, clammy skin; shallow and rapid breathing; fatigue or weakness; weak and fast heartbeat. | ✓ | ||
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 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 - 30°C).
Keep out of reach and sight of children.
If you want more information about ACCRUFER:
- 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; the manufacturer’s website www.kyepharma.com, or by calling 1-888-822-7126.