KENTERA 3,9 MG/24 H Plaster transdermalny

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1. Kentera 3.9 mg / 24 hours – transdermal patch
   1. What is Kentera and what is it used for
   2. What you need to know before you use Kentera
   3. How to use Kentera
   4. Possible side effects
   5. How to store Kentera
   6. Contents of the pack and other information

Kentera 3.9 mg / 24 hours – transdermal patch

oxybutynin

Read this leaflet carefully before using the medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Kentera is and what it is used for
• 2. What you need to know before you use Kentera
• 3. How to use Kentera
• 4. Possible side effects
• 5. How to store Kentera
• 6. Contents of the pack and other information

1. What is Kentera and what is it used for

Kentera is used in adults to control the symptoms of urge urinary incontinence and/or increased urinary frequency and urgency.
Kentera works by allowing the bladder to expand and accommodate a larger amount of urine.

2. What you need to know before you use Kentera

Do not use Kentera

• if you are allergic to oxybutynin or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from a rare disease called myasthenia gravis, which weakens the muscles making them easily fatigued.
• if you are unable to completely empty your bladder when urinating, the use of oxybutynin may worsen this problem, in which case you should discuss it with your doctor before using Kentera.
• if you have digestive problems caused by reduced emptying of the stomach after meals, you should consult your doctor before using Kentera.
• if you suffer from glaucoma or have a history of glaucoma in the family, inform your doctor.

Warnings and precautions
Consult your doctor or pharmacist before using Kentera if you suffer from any of the following conditions:

• liver problems
• kidney problems
• difficulty urinating
• intestinal blockage
• blood in the stool
• generalized muscle weakness
• painful swallowing.

Because treatment with oxybutynin can reduce sweating, the risk of fever or heatstroke
increases if you are exposed to high ambient temperatures.

Children and adolescents
The use of Kentera is not recommended in children and adolescents.

Other medicines and Kentera
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Applying the Kentera patch at the same time as taking other medicines with similar side effects, such as dry mouth, constipation and drowsiness, may increase the frequency and
intensity of these side effects.
Oxybutynin may slow down the motility of the digestive tract and therefore affect the absorption of other
medicines taken orally; in other cases, the use of this medicine together with others may increase
the effect of oxybutynin, especially:

• ketoconazole, itraconazole or fluconazole (used in the treatment of fungal infections)
• erythromycin, an antibiotic of the macrolide family (used in the treatment of bacterial infections)
• biperiden, levodopa or amantadine (used in the treatment of Parkinson's disease)
• antihistamines (used in the treatment of allergies, such as hay fever)
• phenothiazines or clozapine (used in the treatment of mental illness)
• tricyclic antidepressants (used in the treatment of depression)
• dipyridamole (used in the treatment of blood coagulation problems)
• atropine and other anticholinergic medicines (used in the treatment of gastrointestinal disorders such as irritable bowel syndrome).

Kentera with alcohol
Oxybutynin can cause drowsiness or blurred vision. Drowsiness may be aggravated by
alcohol consumption.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Kentera should not be used during pregnancy unless absolutely necessary.
When oxybutynin is administered during breastfeeding, a small amount passes into breast
milk. Therefore, the use of oxybutynin during breastfeeding is not recommended.

Driving and using machines
Because Kentera can cause drowsiness or blurred vision, patients should be advised to exercise caution
when driving vehicles or using machines.

3. How to use Kentera

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Apply a new Kentera patch twice a week (every 3 - 4 days) following the instructions for
use. Change the patch on the same two days of each week, for example, every Sunday and Wednesday,
or every Monday and Thursday.
Printed on the inner tab of the Kentera packaging there is a calendar that will help you to
remember the dosage schedule. Mark the schedule you intend to follow and remember to change
the patch always on the same two days of the week that you have marked on the calendar. Make sure you
wear only one patch at a time and wear it continuously, until it is time to
apply a new one.
Where to apply it
Apply the patch to a clean, dry and smooth area of skin on the abdomen, hips or buttocks.
Avoid applying the patch to the waistline to avoid clothing rubbing against the
patch. Do not expose the patch to the sun. Apply the patch under clothing. Alternate the application sites at
each new application. Do not apply any patch to the same point on the body for at least 1 week.

How to apply it
Each patch is individually sealed in a protective sachet. Read all the information written
below before starting to apply Kentera.

To apply Kentera
Step 1: Choose a site to apply the patch that is:

• Recently washed, but dry and cool (wait a few minutes after taking a hot bath or shower).
• Free of talc, lotion and oil.
• Free of cuts, rashes or any other type of skin irritation.

Step 2: Open the sachet containing the patch.

• Tear the sachet along the arrows on the right side, as shown in the drawing below.
• Do not cut the sachet with scissors as this may damage the patch inside.
• Remove the patch.
• Do not cut or divide the patch, do not use the patch if it is damaged.
• Apply it immediately to the skin as described in the following steps; do not keep or store the patch outside the sealed sachet.

Step 3: Apply the first half of the patch to the skin.

• Gently fold the patch and remove the first piece of protective film covering its adhesive surface.
• Without touching the adhesive surface, firmly press the patch with the adhesive side down onto the part of the abdomen, hips or buttocks you have chosen for application.

Step 4: Apply the second half of the patch to the skin.

• Fold the patch onto itself. Press firmly on the film.
• Push the latter slightly forward to detach the edge.
• Grasp the detached edge from any angle and remove the second piece of the film. Try not to touch the adhesive surface of the patch.
• Firmly press the entire patch onto the skin with your fingertips. Press for at least 10 seconds to ensure the patch does not move. Make sure the entire patch adheres to the skin, even around the edges.
• Dispose of the protective films.

Bathing, showering, swimming and sports
Never remove the patch until it is time to apply a new one. Bathing, showering,
swimming and sports do not compromise the effectiveness of the patch as long as you do not rub it while washing.
Avoid immersing yourself in a hot bath for a prolonged period of time, to avoid the patch
detaching.

If the patch detaches
If the patch begins to detach from the skin, press lightly with your fingertips. The patch is made
specifically to be reattached. Very rarely will it come off completely. If this happens, try to put it
back in the same place where you applied it at the beginning. If it sticks well everywhere, leave it as is. Otherwise, remove it and apply a new patch to another area of skin. Regardless of the day
this happens, continue to follow the bi-weekly schedule you marked on the patch box.

If you forget to change the patch after 3 - 4 days
As soon as you remember, remove the used patch and apply a new one to another area of the abdomen, hips or
buttocks. Regardless of the day this happens, continue to follow the same
bi-weekly schedule for the next patch, even if this means changing the new patch before

• 3 - 4 days.

How to remove it
When you change the patch, remove it slowly. Fold it in half (joining the adhesive sides) and throw it
away so that it is out of reach of children and pets. The application site may be slightly reddened. This redness should disappear within a few hours
after removing the patch. If the irritation persists, consult your doctor.
To remove any adhesive residue that remains on the skin after removing the patch, gently wash
the application site with lukewarm water and a mild soap. You can also use a small amount of baby oil for this purpose.
To remove any dirty adhesive circles, you may need a medicated adhesive remover pad, generally available in pharmacies.
Alcohol or other strong solvents can irritate the skin and should therefore not be used.
After use, the patch still contains significant amounts of active ingredients. Residual active ingredients from the
patch can have harmful effects if they reach the aquatic environment. Consequently, after
removal, you must fold it in half, with the adhesive side facing inwards so that the release membrane is not exposed, insert it into the original sachet and dispose of it safely away from
reach of children. Both used and new patches must be disposed of in accordance with local laws
or returned to the pharmacy. Used patches should not be flushed down the toilet or disposed of using liquid waste disposal systems.

If you use more Kentera than you should
Do not apply more than one patch at a time.

If you forget to use Kentera
Apply a Kentera patch as soon as you realize you don't have it on or have missed the
scheduled day for application.

If you stop the treatment with Kentera
If you decide to stop using the patch, urge incontinence may return and the frequency of urination may increase. Continue to use Kentera as long as your doctor deems
appropriate.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects very common(may affect more than 1 in 10 people)

• itching around the application site of the patch

Side effects common(may affect up to 1 in 10 people)

• redness or rash at the application site of the patch
• dry mouth
• constipation
• diarrhoea
• stomach upset
• stomach pain
• headache or drowsiness
• urinary tract infections
• blurred vision
• dizziness

Side effects uncommon(may affect up to 1 in 100 people)

• upper respiratory tract infections or fungal infections
• anxiety
• confusion
• nervousness
• agitation
• sleep disorders
• palpitations
• hot flushes
• back pain
• urinary retention
• difficulty urinating
• common cold
• accidental injury

Side effects rare(may affect up to 1 in 1,000 people)

• panic reaction
• mental confusion
• hallucinations
• disorientation
• impaired memory
• memory loss
• abnormal fatigue
• poor concentration

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Kentera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet and the carton. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Used patches must be folded in half, with the adhesive side facing inwards so that the
release membrane is not exposed; placed in the original sachets, they must be disposed of safely, out of the reach of children. Both used and unused patches must be disposed of in
accordance with local legal requirements or returned to the pharmacy. Used patches must not be thrown into the toilet
or disposed of using liquid waste disposal systems.

6. Contents of the pack and other information

What Kentera contains

• The active ingredient is oxybutynin. Each transdermal patch releases 3.9 mg of oxybutynin in 24 hours. Each 39 cm patch 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 with a transparent PET/EVA coating film and protected by a detachable layer of siliconized polyester.

Description of the appearance of Kentera and contents of the pack
Kentera is a transdermal patch and is packaged in boxes containing 2, 8 and 24 patches.
Each patch is covered with a transparent protective coating film on the side that contains the
pharmaceutical ingredients. Before applying the patch, the protective film must be removed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu.