Leaflet: information for the user

Kentera 3.9 mg / 24 hours, transdermal patch

oxibutinina

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What isKenteraand what it is used for

2.What you need to know before starting to useKentera

3.How to useKentera

4.Possible side effects

5.Storage ofKentera

6.Contents of the pack and additional information

Kentera is used in adults to control symptoms of urgency incontinence and/or increased frequency and urgency of urination.

Kentera works by allowing the bladder to expand and hold more urine.

Do not useKentera

• If you are allergic to oxybutynin or any of the other components of this medication (listed in section 6).
• If you have a rare disease called myasthenia gravis that makes the muscles of the body weak and tire easily.
• If your bladder does not empty completely when you urinate, the use of oxybutynin may worsen the problem. You should discuss this with your doctor before using Kentera.
• If you have digestive problems due to reduced stomach emptying after meals, you should consult your doctor before using Kentera.
• If you suffer from glaucoma or have a family history of glaucoma, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Kentera, if you suffer from any of the following.

• Liver problems
• Kidney problems
• Difficulty urinating
• Intestinal obstruction
• Blood in the stool
• Generalized muscle weakness
• Difficulty swallowing

As treatment with oxybutynin may reduce sweating, the risk of fever and heatstroke is higher when the ambient temperature is higher.

Children and adolescents

The use of Kentera is not recommended in children or adolescents.

Other medications and Kentera

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medications.

Using the Kentera patch at the same time as taking other medications that have similar side effects, such as dry mouth, constipation, and drowsiness, may increase the frequency or severity of these side effects.

Oxybutynin may slow down the functioning of the digestive tract and affect the absorption of other oral medications; on the other hand, the use of this medication with other medications 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 illnesses).
• Tricyclic antidepressants (used to treat depression).
• Dipyridamole (used to treat blood clotting problems).
• Atropine and other anticholinergics (used to treat stomach disorders such as irritable bowel syndrome).

Use of Kentera with alcohol

Oxybutynin may cause drowsiness and blurred vision. Drinking alcohol may increase drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Kentera should not be used during pregnancy unless clearly necessary.

When oxybutynin is used during breastfeeding, a small amount is excreted in the mother's milk. Therefore, the use of oxybutynin during breastfeeding is not recommended.

Driving and operating machinery

Since Kentera may cause drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving and operating machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Apply a new Kentera patch two times a week (every 3 or 4 days) in the manner indicated. Change the patch always on the same two days, for example, Sundays and Wednesdays, or Mondays and Thursdays.

Inside the Kentera packaging, you will find a calendar that will help you remember when it's time for your dose. Mark the days when you decide to apply the medication and do not forget to change the patch always on the same two days of the week that you have chosen. Make sure you only have one patch on your body at a time, and keep it applied permanently until it's time to change it for a new one.

Where to apply

Apply the patch to a clean, dry, and smooth area of the skin on your abdomen, buttocks, or thighs. Do not apply the patch in the waist area, as there is a risk of friction against tight clothing. Do not expose to the sun. Place the patch under clothing. Alternate the application sites with each new application. Do not apply another patch to the same site for at least one week.

How to apply

Each patch is individually wrapped in a protective cover. Read the following instructions before applying Kentera for the first time.

To apply Kentera

Step 1: Choose an appropriate place to apply the patch.

• Recently washed skin, but dry and fresh (wait a few minutes after a hot bath or shower).
• Where you have not applied talcum powder, lotions, or body oils.
• Where you do not have cuts, rashes, or other skin irritations.

Step 2: Open the package containing the patch.

• Break the seal on the right side of the package, as indicated in the diagram.
• Do not use scissors to cut the package: it may damage the patch.

-Remove the patch from the package.

-Do not cut or divide the patch. Do not use damaged patches.

-Apply it immediately to the skin; do not store the patch outside the airtight package.

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

• Doubles the patch carefully and removes one half of the protective covering that covers the adhesive surface of the patch.
• Without touching the adhesive surface, apply the adhesive side to the skin at the selected location on the abdomen, buttocks, or thighs and press.

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

• Doubles the patch over itself, pressing on the covering.
• Takes the covering off by pulling on it slightly.
• Grabs the edge by one corner and removes the second half of the covering. Try not to touch the adhesive surface of the patch.
• Presses with fingers on the entire patch for at least 10 seconds to secure it well. Make sure the entire patch adheres to the skin, including the edges.
• Disposes of the protective coverings.

Bath, shower, swimming, and exercise

You must wear the patch continuously until a new one is applied. Bathing, showering, swimming, and exercise will not affect the patch as long as you do not rub it when washing. Avoid staying in the bathtub for a long time, as the patch may come off.

If the patch comes off

If the patch starts to separate from the skin, apply gentle pressure with your fingers. The patch has been designed to reattach. In rare cases, the patch may come off completely. In that case, try to put it back in the same place. If the entire patch adheres firmly, leave it on. If not, remove it and put a new patch in a different place. Regardless of the day it happens, follow the same twice-a-week schedule you have marked on the patch packaging.

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 in a different location on your abdomen, buttocks, or thighs. Regardless of the day it happens, follow the same twice-a-week schedule for your next patch, even if you have to change it before 3 or 4 days have passed.

How to remove it

To change it, remove the used patch slowly. Fold it in half (with the adhesive surface inside) and dispose of it so that it is out of reach of children and pets. The application site may be slightly red, but the redness should disappear a few hours after removing the patch. Consult your doctor if the irritation persists.

Normally, the remaining adhesive from the removed patch can be removed by gently washing the skin with warm water and a mild soap. It can also be cleaned with a little baby oil. To remove previous adhesive marks that have remained, it may be necessary to use a special adhesive remover wipe (available at pharmacies). Do not use alcohol or other strong solvents that may irritate the skin.

After using it, the patch still contains significant amounts of active ingredients that can be harmful to aquatic environments. Therefore, after removing it, the used patch must be folded in half, with the adhesive surface facing inward so that the release membrane is not exposed, placed in its original packaging, and then disposed of safely and out of reach of children. All patches, both used and unused, must be disposed of in accordance with local regulations or returned to the pharmacy. Used patches should not be flushed down the toilet or disposed of in liquid waste disposal systems.

If you use more Kentera than you should

You should not apply more than one patch to your body at a time.

If you forget to use Kentera

Apply a Kentera patch as soon as you remember that you are not wearing it, or if you have missed one of the days marked on the calendar.

If you interrupt treatment with Kentera

Your urge incontinence may return, and you may experience an increase in urinary frequency if you decide to stop using the patch. Continue using Kentera until your doctor tells you otherwise.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may have adverse effects, although not everyone may experience them.

Adverse effectsVery Frequent(may affect more than 1 in 10 people)

• Itching around the application site

Adverse effectsFrequent(may affect up to 1 in 10 people)

• Redness or rash at the application site
• Dry mouth
• Constipation
• Diarrhea
• Stomach discomfort
• Abdominal pain
• Headache or drowsiness
• Urinary tract infections
• Blurred vision
• Dizziness

Adverse effectsRarely Frequent(may affect up to 1 in 100 people)

• Fungal or upper respiratory tract infections
• Anxiety
• Confusion
• Nervousness
• Agitation
• Difficulty sleeping
• Palpitations
• Seizures
• Back pain
• Urinary retention
• Difficulty urinating
• Common cold
• Accidental injury

Adverse effectsRare(may affect up to 1 in 1,000 people)

• Panic attack
• Mental confusion
• Hallucinations
• Disorientation
• Memory deterioration
• Memory loss
• Abnormal fatigue
• Poor concentration

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the box. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Used patches should be folded in half, with the adhesive side inwards so that the release membrane is not exposed, placed in the original packaging, and then disposed of safely out of the reach of children. All patches, both used and unused, must be disposed of in accordance with local regulations or returned to the pharmacy. Used patches should not be flushed down the toilet or disposed of in liquid waste disposal systems.

Kentera Composition

• The active ingredient is oxybutynin.

Each transdermal patch releases 3.9mg of oxybutynin every 24hours. Each patch of 39cm2contains 36mg of oxybutynin.

• The other components are: triacetin and acrylic adhesive solution. Oxybutynin, triacetin, and acrylic adhesive have a transparent PET/EVA reinforcement film and are coated with a silicone-coated polyester release coating.

Appearance of the product and contents of the package

Kentera is a transdermal patch presented in boxes of 2, 8 or 24patches.

Each patch is covered with a protective reinforcement film on the side of the patch covered with the active ingredients. The reinforcement film must be removed before applying the patch.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Last review date of this leaflet:

The detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu