Patient Medication Information: uses, side effects, how to take - Apprilon
What APPRILON is used for:
- APPRILON is used for the treatment of bumps and pimples caused by rosacea (roh-ZAY-she-ah) in adults.
- 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.
How APPRILON works:
APPRILON has anti-inflammatory properties that reduce the bumps and pimples caused by rosacea.
The ingredients in APPRILON are:
Medicinal ingredient(s): doxycycline (as doxycycline monohydrate)
Non-medicinal ingredients: hypromellose, methacrylic acid copolymer, opadry beige, sugar spheres, talc and triethyl citrate.
APPRILON comes in the following dosage form(s):
Modified-release capsules, 40 mg
Do not use APPRILON if:
- you are allergic to the medicinal ingredient in APPRILON, or allergic to any medicinal ingredients known as tetracyclines, including doxycycline and minocycline.
- you are allergic to any of the ingredients in APPRILON (see non-medicinal ingredients).
you are pregnant or nursing. Low levels of tetracyclines are released in human breast milk.
- In infants and children up to the age of 8 years.
- you have myasthenia gravis (a chronic disease which can cause muscle weakness).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APPRILON. Talk about any health conditions or problems you may have, including if you:
- are pregnant, planning to become pregnant or if you are breastfeeding.
- have difficulty swallowing, or medical conditions such as a narrowing or blockage in your esophagus (passage from your mouth to stomach).
- have liver or kidney problems.
- have or have recently had a yeast or fungus infection in your mouth or vagina.
- are taking other prescription medications or other medications, including medications purchased without a prescription, such as vitamin or mineral supplements.
- have had a gastrectomy or gastric bypass surgery.
- 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.
Other warnings you should know about
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.
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 APPRILON:
- 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)
How to take APPRILON
- Do not used APPRILON to treat infections.
Usual dose:
APPRILON should be taken once daily in the morning, on an empty stomach, at least one hour before, or two hours after a meal.
- 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.
| If you think you, or a person you are caring for, have taken too much APPRILON, 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 missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.
Possible side effects from using APPRILON:
These are not all the possible side effects you may have when taking APPRILON. If you experience any side effects not listed here, tell your healthcare professional.
- diarrhea
- headache
- nausea
- abdominal pain
- soreness in the nose or throat (nasopharyngitis)
- sinus infection
- skin rash that occurs as a recurring reddish or dark spot in the same place after repeated use of doxycycline and may cause itching or burning (fixed drug eruption).
- Flu-like symptoms shortly after starting the medication (known as Jarisch-Herxheimer reaction).
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 | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Common | |||
| Diarrhoea | ✓ | ||
| Hypertension (High blood pressure): shortness of breath, fatigue, chest pain or pressure, racing pulse or heart palpitations | ✓ | ||
| 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 | ✓ | ||
| Unknown | |||
Severe Cutaneous Adverse Reactions (SCARs) (severe skin reactions that may also affect other organs):
| ✓ | ||
| Clostridium difficile colitis (bowel inflammation): severe (watery or bloody) diarrhea, fever, abdominal pain or tenderness | ✓ | ||
| Skin inflammation with peeling (scaling) and/or any severe skin reactions which may cause you to feel very unwell | ✓ | ||
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store APPRILON capsules between 15° and 25°C. Store in the original package. Keep the package away from direct heat and sunlight.
Do not take APPRILON capsules after the expiry date.
Keep out of reach and sight of children.
If you want more information about APPRILON:
- 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 Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); Galderma Canada Inc. website https://www.galderma.com/canada; or by calling 1-800-467-2081.
Distributed by Galderma Canada Inc.
161 Bay Street, Suite 3900,
Toronto, ON, M5J 2S1
APPRILON is a registered trademark of Galderma Holding SA, used under license by Galderma Canada Inc.