Details for: APPRILON
Company: GALDERMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02375885 | APPRILON | DOXYCYCLINE (DOXYCYCLINE MONOHYDRATE) | 40 MG | CAPSULE (IMMEDIATE AND DELAYED RELEASE) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APPRILON is used for the treatment of bumps and pimples caused
by rosacea (roh-ZAY-she-ah) in adults. This medication should
not be used for any other reason than that which it is prescribed.
APPRILON contains an antibacterial ingredient called
doxycycline, and it should be used exactly as directed by your
healthcare professional. Misuse or overuse of APPRILON could
lead to the growth of bacteria that will not be killed by
doxycycline. This means that APPRILON or other medicines that
contain doxycycline may not work for you in the future. Do not
share your medicine.
What it does
APPRILON has anti-inflammatory properties that reduce the bumps and pimples caused by rosacea.
When it should not be used
- If you are allergic to the medicinal ingredient in APPRILON, or allergic to any medicinal ingredients known as tetracyclines, including doxycycline and minocycline.
- If you are allergic to any of the ingredients in APPRILON (see What the important nonmedicinal ingredients are:).
- If you are pregnant or nursing. Low levels of tetracyclines are released in human breast milk.
- In infants and children under 8 years of age.
- If you have myasthenia gravis (a chronic disease which can cause muscle weakness).
- APPRILON should not be used to treat infections.
What the medicinal ingredient is
APPRILON capsules contain the active ingredient doxycycline (as doxycycline monohydrate).
What the non-medicinal ingredients are
Each APPRILON capsule is made of gelatin and contains hypromellose, methacrylic acid copolymer, opadry beige (for colour), sugar spheres, talc and triethyl citrate.
What dosage form it comes in
APPRILON is available in modified-release capsules containing 40 mg of doxycycline (as doxycycline monohydrate). Each capsule contains two types of beads; the immediate-release beads contain 30 mg of doxycycline and the delayed-release beads contain 10 mg of doxycycline.
Warnings and precautions
BEFORE you use APPRILON talk to your doctor or pharmacist if:
- You are allergic to any of the ingredients in APPRILON.
- You are pregnant, planning to become pregnant or if you are breastfeeding.
- You have been diagnosed with myasthenia gravis (a chronic disease which can cause muscle weakness).
- You have difficulty swallowing, or medical conditions such as a narrowing or blockage in your esophagus (passage from your mouth to stomach).
- You have liver or kidney problems.
- You have or have recently had a yeast or fungus infection in your mouth or vagina.
- You are taking other prescription medications or other medications, including medications purchased without a prescription, such as vitamin or mineral supplements.
- You have had a gastrectomy or gastric bypass surgery.
- You spend time in sunlight or artificial sunlight (such as a tanning bed). APPRILON may increase the severity of sunburns. Avoid sunlight or exposure to artificial UV light. Use a good sunscreen (SPF 15 or higher) and wear protective clothing, such as a hat or sunglasses.
Tell your doctor or pharmacist right away and stop taking APPRILON:
- If you develop a hypersensitivity (allergic) reaction which may include symptoms such as difficulty in breathing, fast heartbeat, dizziness, itching, rash, and skin blistering.
- At the first sign of oversensitivity of skin to light/sunlight/Ultra Violet light or skin redness.
- If you develop diarrhea during the course of taking APPRILON.
Interactions with this medication
Drugs that may interact with APPRILON include:
- A medication for hypertension, quinipril.
- Blood thinners (oral anticoagulants). Your doctor may need to change your anticoagulant dose.
- Oral retinoids, such as isotretinoin and acitretin.
- Medications that treat infections, such as penicillin and rifampicin.
- Medications that treat seizures, such as barbiturates, carbamazepine and diphenylhydantoin.
- Chronic alcohol abuse may cause APPRILON to break down more quickly and make the medication less effective.
- Proton pump inhibitors (to reduce stomach acidity) such as omeprazole, pantoprazole, rabeprazole.
- Antacids and dairy products (that contain aluminum, zinc, calcium or magnesium), and iron preparations, activated charcoal, chlostyramine, bismuth chelates and subsalicylate may reduce the absorption of the medicinal ingredient in APPRILON.
- Products that contain iron should be taken at a different time than APPRILON.
- The use of APPRILON may reduce the effectiveness of birth control pills (oral contraceptives).
- Some anesthetics/inhalants (e.g. methoxyflurane).
- Some medications for diabetes (e.g. sulfonylureas)
Proper use of this medication
Usual adult dose
APPRILON should be taken once daily in the morning, on an
empty stomach. It is recommended that the capsule be swallowed
with a full glass of water to avoid potential irritation to the
esophagus (passage from mouth to stomach).
Antacids (containing calcium, aluminum, magnesium or zinc), iron
preparations, activated charcoal, cholestyramine, bismuth chelates
and sucralfate, and foods or drinks containing calcium such as
dairy products and calcium containing fruit juices should only be
taken at least 2-3 hours after taking APPRILON.
Overdose
Do not take more capsules than your doctor has told you to. Taking more than the prescribed dose may increase the chance of side effects.
Missed Dose
If you miss a dose of APPRILON, skip that dose and take the next dose at your regular time. Do not double dose.
Side effects and what to do about them
Common side effects include diarrhea, headache, nausea, and
abdominal pain. Some people may experience soreness in the nose
or throat (nasopharyngitis), sinus infection or an increase in blood
pressure (hypertension). These side effects are generally mild and
do not usually cause patients to stop taking APPRILON.
If you experience symptoms such as severe (watery or bloody)
diarrhea, fever, abdominal pain or tenderness, you may have
Clostridium difficile colitis (bowel inflammation). If this happens,
stop taking the drug and call your healthcare professional
immediately.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Diarrhea | ✔ | ||
| Uncommon | |||
| Unusual or severe sunburn. | ✔ | ||
| Allergic reaction (skin rash, swelling, difficulty swallowing or tightness in the throat). | ✔ | ||
| Darkening of skin, scars, teeth or gums. | ✔ | ||
| Severe headache, migraine or dizziness | ✔ | ||
This is not a complete list of side effects. A complete listing of adverse events that have been reported is contained in the Product Monograph supplied to your doctor and pharmacist. For any unexpected effects while taking APPRILON, contact your doctor or pharmacist.
How to store
Store APPRILON capsules between 15° and 25°C. Store in
the original package. Keep the package away from direct
heat and sunlight.
Keep your APPRILON capsules in a safe place where
children cannot reach them.
Do not take APPRILON capsules after the expiry date.
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 (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
- 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.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
www.galderma.ca
or by contacting the sponsor, Galderma Canada Inc. at:
1-800-467-2081
This leaflet was prepared by Galderma Canada Inc.
Last revised: May 31, 2018