POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/03/270/002, EU/1/03/270/001, EU/1/03/270/003.
Kentera oxybutynin transdermal patch
PACKAGE LEAFLET: INFORMATION FOR THE USER
Kentera 3.9 mg / 24 hours transdermal patch
Read all of this leaflet carefully before you start using Kentera.
In this leaflet:
1. What Kentera is and what it is used for
2. Before you use Kentera
3. How to use Kentera
4. Possible side effects
5. How to store Kentera
6. Further Information
1. WHAT KENTERA IS AND WHAT IT IS USED FOR
Kentera is used in adults to control the symptoms of urge incontinence and/or increased urinary frequency and urgency.
Kentera works by allowing the bladder to expand and accommodate more urine.
2. BEFORE YOU USE KENTERA
Do not use Kentera:
Take special care with Kentera:
If you have any of the following:
Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever and heat stroke if you are exposed to high environmental temperatures.
Kentera is not recommended for use in children or adolescents.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Applying the Kentera patch at the same time as taking other medicines that have similar side effects such as dry mouth, constipation and drowsiness, may increase how often and how severe these side effects are experienced.
Oxybutynin may slow the digestive tract and thereby influence the adsorption of other oral medicines, or the use of this medicine together with other medicines may increase the effect of oxybutynin. Especially:
Using Kentera with food and drink
Oxybutynin may cause drowsiness or blurred vision. Drowsiness may be increased by consumption of alcohol.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Kentera should not be used during pregnancy unless clearly necessary.
When oxybutynin is used during breast-feeding, a small amount is excreted in the mother’s milk. Use of oxybutynin while breast-feeding is therefore not recommended.
Driving and using machines
Because Kentera may produce drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving or using machinery.
3. HOW TO USE KENTERA
Always use Kentera exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.
Apply a new Kentera patch twice weekly (every 3 to 4 days) according to the instructions for use. Change the patch on the same two days every week, for example, every Sunday and Wednesday or Monday and Thursday. Printed on the inside flap of your Kentera package, you will find a Kentera calendar checklist that will help you to remember your dosing schedule. Mark the schedule you plan to follow and remember always to change your patch on the same two days of the week you have chosen on your calendar. Make sure to wear only one patch at a time and wear your patch continuously, until it is time to apply a new one.
Where to apply
Apply the patch to a clean, dry, smooth area of skin on your abdomen, hips or buttocks. Avoid placing the patch in the waistline area to prevent tight clothing from rubbing against the patch. Do not expose the patch to the sun. Place the patch underneath your clothing. Rotate application sites with each new application. Do not apply a patch to the same place on your body for at least 1 week.
How to apply
Each patch is individually sealed in a protective sachet. Please read all the information below before you begin to apply Kentera.
To apply Kentera:
Step 1: Choose a spot for the patch that is:
Step 2: Open the sachet that contains the patch.
Step 3: Apply one half of the patch to your skin.
Step 4: Apply the second half of the patch to your skin.
Bathing, showering, swimming and exercise:
You should wear each patch all the time until you apply a new one. Baths, showers, swimming and exercise should not affect the patch as long as you don’t rub the patch as you wash. Avoid soaking in a hot bath for a long period of time, which can make the patch come off.
If the patch comes off:
If the patch starts to lift off your skin, apply a little bit of pressure using your fingertips. The patch is designed to re-stick. Very rarely will the patch come off completely. If it does, try putting the same patch back on the same spot. If it sticks firmly all over, leave it on. If not, take it off and put a new patch on a new spot. No matter what day this happens, continue with the twice-a-week schedule that you have marked on your patch box.
If you forget to change the patch after 3-4 days:
As soon as you remember, remove the old patch and apply a new one to a new spot on your abdomen, hips or buttocks. No matter what day this happens, continue with the same twice-a-week schedule for your next patch, even if it means changing the new patch before 3 to 4 days have elapsed.
How to remove
When changing the patch, remove the old patch slowly. Fold it in half (sticky sides together) and throw it away to keep out of the reach of children and pets. Mild redness may be present at the application site. This redness should disappear within several hours after removal of the patch. If irritation persists, please contact your doctor.
Gently washing the application site with warm water and a mild soap should remove any adhesive that remains on your skin after removal of the patch. A small amount of baby oil may also be used to remove any excess residue. Rings of adhesive that become soiled may require a medical adhesive removal pad that should be available from your pharmacist. Alcohol or other strong solvents may cause skin irritation and should not be used.
After use the patch still contains substantial quantities of active ingredients. Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment. Hence, after removal, the used patch should be folded in half, adhesive side inwards so that the release membrane is not exposed, placed in the original sachet and then discarded safely out of reach of children. Any used or unused patches should be discarded according to local requirements or returned to the pharmacy. Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
If you use more Kentera than you should
The patient should not apply more than one patch at a time.
If you forget to use Kentera
Apply a Kentera patch as soon as you realise your patch is missing, or you have missed a scheduled day of application.
If you stop using Kentera
Your urge incontinence may return and you may have increased urinary frequency if you decide to stop using the patch. Continue to use Kentera as long as your doctor tells you to.
Talk to your doctor or pharmacist if you have any questions on the use of this medical product.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Kentera can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
Very common side effect:
Common side effects:
Uncommon side effects:
If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor.
5. STORING KENTERA
Keep out of the reach and sight of children.
Do not use Kentera after the date shown on the sachet and the carton.
Do not refrigerate or freeze.
The used patches should be folded in half, adhesive side inwards so that the release membrane is not exposed, placed in the original sachet and then discarded safely out of the reach of children. Any used or unused patches should be discarded according to local requirements or returned to the pharmacy. Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
6. FURTHER INFORMATION
What Kentera contains
The active substance is oxybutynin. Each transdermal patch releases 3.9 mg of oxybutynin per 24 hours.
Each patch of 39 cm2 contains 36 mg of oxybutynin.
The other ingredients are: Each patch contains triacetin, and acrylic adhesive solution. The oxybutynin, triacetin and acrylic adhesive are coated on clear PET/EVA backing film and covered with a siliconised polyester release liner.
What Kentera looks like and contents of the pack
Kentera is a transdermal patch and it is packaged in cartons containing 2, 8, and 24 patches. Each patch consists of a clear backing film that has the pharmaceutical ingredients coated on the side containing the protective backing film. The backing film is to be removed prior to patch application.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was approved in July 2014
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
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