Patient Medication Information: uses, side effects, how to take - Beteflam
What is BETEFLAM® used for?
- BETEFLAM® is a patch used in adults, for a maximum of 30 days, to treat mild to moderate psoriasis (patchy red skin with white scales) on the elbows and knees.
How does BETEFLAM® work?
When placed directly on the affected area, BETEFLAM® helps to reduce redness, swelling and irritation of the skin.
What are the ingredients in BETEFLAM®?
Medicinal ingredient: betamethasone valerate.
Non-medicinal ingredients:
Adhesive base: 1,3-butylene glycol, aluminium glycinate, carmellose sodium, disodium edetate, glycerol, hydroxypropylcellulose, methyl parahydroxybenzoate (E218), polyacrylic acid, polyacrylic acid aqueous solution, propyl parahydroxybenzoate (E216), purified water, sodium hyaluronate, sodium polyacrylate and tartaric acid.
Laminated unwoven cloth: unwoven cloth (polypropylene/polyethylene and rayon fibres) laminated with an ethylene methyl methacrylate copolymer film.
Protective film: polyethylene terephthalate film.
BETEFLAM® comes in the following dosage forms:
Topical patch, 2.25 mg
Do not use BETEFLAM® if you:
- are allergic to betamethasone valerate or to any of the other ingredients in BETEFLAM®.
- are allergic to other corticosteroids.
- have bacterial, fungal, parasitic, viral skin infections (e.g., herpes simplex, chicken pox), tuberculosis or syphilis skin infections, or a skin reaction following a recent vaccination.
- are under the age of 18 years.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BETEFLAM®. Talk about any health conditions or problems you may have, including if you:
have a condition for which you were previously or are currently taking other corticosteroid
drugs.
- have other inflammatory skin diseases caused by poor circulation (such as stasis dermatitis or chronic ulcers in the legs).
- are not able to properly fight infections, or if you are taking drugs which lower your body’s ability to fight infections (immunosuppressants).
- notice that the treated area is not healing.
are pregnant or planning to become pregnant.
- are breastfeeding.
- are older than 65 years.
- have problems with your kidney or liver.
Other warnings you should know about:
When you are in the sun or under UV light, use BETEFLAM® with caution or cover the patch with loose clothing.
Tell your healthcare professional that you are using BETEFLAM® if you are getting a test known as the nitroblue tetrazolium test (NBT) to check for bacterial infections. The corticosteroid contained in BETEFLAM® might affect the results of this test.
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 BETEFLAM®:
Some medicines may affect how BETEFLAM® works and make it more likely that you’ll have side effects. Examples of these medicines include:
- Ritonavir (for HIV)
- Itraconazole (for fungal infections)
How to apply BETEFLAM®:
Carefully clean and dry the skin area where the BETEFLAM® patch will be applied.
Open the sachet and, if necessary, cut the patch so that it fits the area to be treated. Peel off the protective film and apply the medicated adhesive side to the area to be treated.
If the edges of the patch start to lift, you can apply a small piece of medical adhesive tape to the peeling part only.
Never cover the BETEFLAM® patch completely with plastic or occlusive medical dressings.
Do not get the patch wet. If it becomes wet, you must remove the entire patch and wait until the next scheduled dose to apply a new patch.
When you are changing the patch, you should wait about 30 minutes between taking off the old patch and putting on a new one. It is recommended to take a bath or shower at this time.
Once removed from the skin, the BETEFLAM® patch must not be reused.
After you are done using the patch, throw it away so that it cannot be accidentally used or ingested by children or pets.
Usual adult dose:
Always use BETEFLAM® exactly as your healthcare professional has told you.
Apply BETEFLAM® to the skin area to be treated once a day.
Do not use more than 5 patches at the same time.
The patch should be worn for 20 to 24 hours a day. Do not wear the patch for more than 24 hours.
Do not use BETEFLAM® for more than 30 days.
Overdose:
If you think you have applied too much BETEFLAM®, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to use BETEFLAM®, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not apply extra BETEFLAM® patches to make up for missed doses.
What are possible side effects from using BETEFLAM®?
These are not all the possible side effects you may feel when using BETEFLAM®. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
Side effects which may occur when using BETEFLAM® are primarily local effects on the skin at or near where you applied the patch.
- Itchy skin
- Redness, rash or hives
- Irritation or pain
- Swelling
- Skin tightness
- Burning sensation
- The appearance of blood vessels under the surface of your skin
- Skin thinning
- Skin peeling
- Ulceration
- Stretch marks
- Increased sensitivity
- Changes to the colour of your skin
- Unusual hair growth
- Inflammation of hair follicles
- Acne
- Infection
- Eczema
- Dermatitis
- Skin wrinkling, dryness and flaking
- Worsening of psoriasis
Using BETEFLAM® improperly, for too long (longer than 30 days) or using too many patches at a time (more than 5) may be associated with Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, which can cause serious health problems.
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 | ||
RARE Allergic reactions: rash, hives, swelling of the skin | ✓ | ||
| Cushing’s syndrome: weight gain, moon face / rounding of the face and obesity | ✓ | ||
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 help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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 at room temperature (15 - 25°C). Keep the BETEFLAM® patch in its original sachet. After opening of the sachet, the patch should be used immediately.
Keep out of reach and sight of children.
If you want more information about BETEFLAM®:
- 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 (www.healthcanada.gc.ca); the manufacturer’s website www.beteflam.net or by calling (905) 477-4553.