Kentera

Package leaflet: Information for the user

Kentera 3.9 mg / 24 hours – Transdermal patch

oxybutynin
Please read all of this leaflet carefully before using this 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 others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, 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 using 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 Kentera is and what it is 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 hold a larger volume of urine.

2. What you need to know before using Kentera

Do not use Kentera

• if you are allergic to oxybutynin or to any of the other ingredients of this medicine (listed in section 6).
• if you have a rare disease called myasthenia gravis, which causes muscle weakness and rapid muscle fatigue.
• if during urination you are unable to completely empty your bladder, the use of oxybutynin may worsen this condition; in such case, discuss it with your doctor before using Kentera.
• if you have gastrointestinal problems caused by delayed stomach emptying after meals, consult your doctor before using Kentera.
• if you have glaucoma or a family history of glaucoma, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before using Kentera if you have any of the following conditions:

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

Since treatment with oxybutynin may reduce sweating, your risk of fever or heatstroke when exposed to high environmental temperatures is increased.
Children and adolescents
The use of Kentera is not recommended in children and adolescents.
Other medicines and Kentera
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Using the Kentera patch together with other medicines that cause similar side effects—such as dry mouth, constipation, and drowsiness—may increase the frequency and severity of these side effects.
Oxybutynin may slow gastrointestinal motility and thereby affect the absorption of other oral medicines. In other cases, using this medicine together with others may increase the effect of oxybutynin, especially:

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

Kentera and alcohol
Oxybutynin may cause drowsiness or blurred vision. Alcohol consumption may worsen drowsiness.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist 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
Since Kentera may cause drowsiness or blurred vision, patients should be advised to exercise caution when driving or operating machinery.

3. How to use Kentera

Use this medicine exactly as instructed by 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 each week, for example, every Sunday and Wednesday, or every Monday and Thursday.
An internal label inside the Kentera packaging contains a calendar to help you remember the dosing 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 to 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 at the waistline to prevent tight clothing from rubbing against it. Do not expose the patch to sunlight. Wear the patch under clothing. Alternate application sites with each new patch. Do not apply a patch to the same spot on the body for at least one week.

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

To apply Kentera
Step 1: Choose a site for patch application that is:

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

Step 2: Open the pouch containing the patch.

• Tear the pouch along the arrows on the right side, as shown in the illustration below.
• Do not cut the pouch 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 store or keep the patch outside its sealed pouch.

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

• Gently fold the patch and remove the first protective liner covering the adhesive surface.
• Without touching the adhesive surface, press the patch firmly with the adhesive side down onto the chosen area of the abdomen, hips, or buttocks.

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

• Fold the patch over itself. Press firmly on the liner.
• Gently push the liner forward to loosen the edge.
• Grasp the loosened edge at any corner and remove the second piece of the protective liner. Try not to touch the adhesive surface of the patch.
• Press the entire patch firmly onto the skin with your fingertips for at least 10 seconds to ensure it stays in place. Make sure the entire patch adheres to the skin, including the edges.
• Discard the protective liners.

Bathing, showering, swimming, and sports
Do not 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, provided you do not rub it while washing. Avoid soaking in a hot bath for prolonged periods to prevent the patch from detaching.

If the patch starts to come off
If the patch begins to peel away from the skin, press gently with your fingertips. The patch is designed to re-adhere. Very rarely, it may detach completely. If this happens, try to reapply it to the same spot where it was originally placed. If it adheres well all over, leave it in place. Otherwise, remove it and apply a new patch to a different area of skin. Regardless of the day this occurs, continue following the twice-weekly schedule 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 a different area of the abdomen, hips, or buttocks. Regardless of when this occurs, continue following the same twice-weekly schedule for the next patch, even if this means changing the new patch sooner than 3–4 days.

How to remove it
When changing the patch, remove it slowly. Fold it in half (adhesive sides together) and dispose of it safely, out of reach of children and pets. The application site may be slightly reddened. This redness should disappear within several hours after patch removal. If irritation persists, consult your doctor.
To remove any adhesive residue left on the skin after removing the patch, gently wash the application site with lukewarm water and a mild soap. A small amount of baby oil may also be used for this purpose. A medicated adhesive remover pad, generally available from pharmacies, may be needed to remove stubborn adhesive marks. Alcohol or other strong solvents may irritate the skin and should not be used.
After use, the patch still contains significant amounts of active substances. The residual active ingredients in the patch may be harmful if released into aquatic environments. Therefore, after removal, fold the patch in half with the adhesive side folded inward so that the release liner is not exposed, place it back into the original pouch, and dispose of it safely out of reach of children. Both used and unused patches must be disposed of in accordance with local regulations or returned to a pharmacy. Used patches must not be flushed down the toilet or disposed of via 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 have not applied one or have missed the scheduled day.

If you stop using Kentera
If you decide to stop using the patch, urge incontinence may return and the frequency of urination may increase. Continue using Kentera for as long as your doctor considers it appropriate.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people)

• itching around the site of application of the patch

Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (may affect up to 1 in 100 people)

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

Rare side effects (may affect up to 1 in 1,000 people)

• panic reaction
• mental confusion
• hallucinations
• disorientation
• memory impairment
• memory loss
• abnormal tiredness
• poor concentration

Reporting of side effects
If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex 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 stated on the pouch and the carton. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Used patches should be folded in half with the adhesive side turned inwards, so that the release liner is not exposed; they should then be placed into their original pouches and 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 a pharmacy. Used patches must not be flushed down the toilet or disposed of via liquid waste disposal systems.

6. Package contents and other information

What Kentera contains

• The active substance is oxybutynin. Each transdermal patch releases 3.9 mg of oxybutynin over 24 hours. Each 39 cm² patch contains 36 mg of oxybutynin.
• The other components are: each patch contains triacetin and an acrylic adhesive solution. The oxybutynin, triacetin, and acrylic adhesive are covered by a transparent backing film made of PET/EVA and protected by a removable silicone-coated polyester liner.

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

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

Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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