Patient Medication Information: uses, side effects, how to take - Riva-Dapsone

What is RIVA-DAPSONE used for?

RIVA-DAPSONE is used to treat

leprosy
dermatitis herpetiformis (a skin condition)
actinomycotic mycetoma (a fungal disease)

This medication is sometimes prescribed for other uses; ask your doctor for more information.

Antibacterial drugs like RIVA-DAPSONE treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, RIVA-DAPSONE should be used exactly as directed. Misuse or overuse of RIVA-DAPSONE could lead to the growth of bacteria that will not be killed by RIVA-DAPSONE (resistance). This means that RIVA-DAPSONE may not work for you in the future. Do not share your medicine.

How does RIVA-DAPSONE work?

RIVA-DAPSONE works by killing the bacteria or fungi causing your infection.
When used for the treatment of dermatitis herpetiformis (a skin condition), Dapsone reduces the skin blisters and skin itch.

What are the ingredients in RIVA-DAPSONE?

Medicinal ingredient: Dapsone

Non-medicinal ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate, Microcrystalline Cellulose.

RIVA-DAPSONE comes in the following dosage forms:

Tablet 100 mg

Do not use RIVA-DAPSONE if:

you are allergic to RIVA-DAPSONE, to sulfones, or to any ingredient in this formulation. (See What are the ingredients in RIVA-DAPSONE)
you have high amyloid levels or advanced amyloidosis of the kidneys.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RIVA-DAPSONE. Talk about any health conditions or problems you may have, including if you have:

heart problems
lung disease
liver disease
kidney problems
anemia
lack of the enzyme glucose-6-phosphate dehydrogenase in the body, so that red blood cells don’t work properly.

RIVA-DAPSONE may cause blood cell problems such as:

Hemolytic anemia - red blood cells are destroyed so that they do not do their job carrying oxygen in the body
Methemoglobinemia – where a high amount of methemoglobin is made in the blood, and this prevents oxygen release into body tissues
Lack of the enzyme glucose-6-phosphate dehydrogenase can worsen the above blood cell problems.

Your doctor will do routine blood work during RIVA-DAPSONE treatment to watch for blood problems and changes in liver function.

Other warnings you should know about:

Don’t use RIVA-DAPSONE while pregnant unless advised by your doctor. If you become pregnant while taking RIVA-DAPSONE, tell your doctor immediately.

RIVA-DAPSONE is excreted in breast milk. Your doctor will decide with you if you should continue breastfeeding or stop taking RIVA-DAPSONE.

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 RIVA-DAPSONE:

rifampicin
probenecid
chloroquine
primaquine

These medicines may be affected by RIVA-DAPSONE, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your healthcare professional will advise you.

How to take RIVA-DAPSONE:

Take RIVA-DAPSONE at the same time each day. The tablet should be swallowed with a full glass of water, with or after food.

RIVA-DAPSONE should be taken exactly as directed, for as long as your healthcare professional tells you to. Do not stop taking RIVA-DAPSONE even if you begin to feel better, unless advised by your healthcare professional.

Usual dose:

Leprosy:

When used for the treatment of leprosy, RIVA-DAPSONE is usually taken with one or more other drugs, to prevent the development of resistance.

The usual dose of RIVA-DAPSONE in adults is 100 mg daily. RIVA-DAPSONE dosing in children is based on the child’s body weight.

Dermatitis Herpetiformis:

The usual adult dose is 50 mg to 100 mg RIVA-DAPSONE daily, but a dose as little as RIVA-DAPSONE 50 mg once a week may be adequate.

Actinomycotic Mycetoma:

The usual adult dose is 100 mg RIVA-DAPSONE taken twice a day.

Overdose:

If you think you have taken too much RIVA-DAPSONE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately. Do this even if there are no signs of discomfort or poisoning, as symptoms may not develop right away.

Missed Dose:

If you missed a dose of this medication, take it as soon as you remember. This will help to keep a constant amount of medication in your blood. But, if it is almost time for your next dose, skip the missed dose, and continue with your next scheduled dose. Do not take two doses at the same time.

What are possible side effects from using RIVA-DAPSONE?

These are not all the possible side effects you may feel when taking RIVA-DAPSONE. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

RIVA-DAPSONE may cause:

loss of appetite
nausea
vomiting
headache
dizziness
nervousness
difficulty sleeping

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 Anemia symptoms (i.e.: hemolysis, methemoglobinemia) rapid heart rate shortness of breath unusual tiredness or weakness jaundice, or yellowing of the skin and eyes dark coloured urine bluish colouring of the skin		✓
UNCOMMON Low white blood cell symptoms persistent fever chills increased infections (e.g. sore throat, mouth sores, swollen lymph glands) weakness bleeding gums		✓
Mood or other mental changes		✓
Numbness, tingling, pain, burning or weakness in hands and feet		✓
RARE Hypersensitivity reaction fever flu-like symptoms rash			✓
Skin reactions severe skin rash itching, redness, scaling or peeling of skin painful blisters			✓
Kidney problems back pain swollen, puffy skin especially in the face, arms, legs (feet and ankles) and belly area change in appearance of urine painful and frequent urination		✓

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:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for more information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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:

RIVA-DAPSONE tablets should be stored at room temperature and protected from light.

Keep out of reach and sight of children.

If you want more information about RIVA-DAPSONE:

Talk to your healthcare professional
Find the full prescribing information 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.html); the manufacturer’s website www.labriva.com, or by calling 1-800-363-7988.

Laboratoire Riva Inc.

660 Boul. Industriel

Blainville Québec

J7C 3V4

www.labriva.com

Last Prepared: May 24, 2019

Rx or OTC	Prescription (Rx)?
DIN	02489058
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Dapsone 100 MG
Dosage form(s)	Tablet
Route(s) of administration	Oral
Drug class (WHO ATC)	J Antiinfectives for systemic use J04 Antimycobacterials J04B Drugs for treatment of lepra J04BA Drugs for treatment of lepra J04BA02 Dapsone
Company	LABORATOIRE RIVA INC.
Current status	Dormant
Current status date	July 22, 2024

Riva-Dapsone: Uses, Side Effects and Dosage