Kentera 3.9 mg/24 hours transdermal patch

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Kentera 3.9 mg/24 hours, transdermal patch

oxybutynin

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the 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 incontinence and/or increased urinary frequency and urgency.

Kentera works by allowing the bladder to expand and hold more 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 condition called myasthenia gravis that causes the body's muscles to become weak and tire easily.
• if your bladder does not empty completely when you urinate, using oxybutynin may worsen this problem. You should discuss this with your doctor before using Kentera.
• if you have gastrointestinal problems due to delayed stomach emptying after meals, you should consult your doctor before using Kentera.
• if you have glaucoma or a family history of glaucoma, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Kentera if you have any of the following conditions:

• Liver problems
• Kidney problems
• Difficulty urinating
• Intestinal obstruction
• Presence of blood in the stools
• Generalized muscle weakness
• Pain when swallowing

As treatment with oxybutynin may reduce sweating, the risk of fever and heat stroke is increased when the ambient temperature is high.

Children and adolescents

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

Other medicines and Kentera

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Using the Kentera patch at the same time as other medicines 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 gastrointestinal tract and thereby affect the absorption of other oral medicines. In addition, taking this medicine together with other medicines 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 seasonal allergic rhinitis).
• 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Kentera should not be used during pregnancy unless clearly necessary.

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

Driving and using machines

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

3. How to use Kentera

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Apply a new Kentera patch twice a week (every 3 or 4 days) as directed. 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 to help you remember when your dose is due. Mark the days on which you have decided to apply the medicine and do not forget to change the patch always on the same two days of the week that you have chosen. Make sure that you only have one patch on your body at a time, and keep it applied continuously until it is time to replace it with a new one.

Where to apply

Apply the patch to a clean, dry, and smooth area of skin on the abdomen, hip, or buttock. It is not recommended to apply the patch at the waistline due to the risk of friction from tight clothing. Do not expose the patch to sunlight. Place the patch under clothing. Alternate application sites with each new application. Do not reapply another patch to the same site for at least one week.

How to apply

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

To apply Kentera

Step 1: Choose an appropriate site for patch application.

• Freshly washed, but dry and cool skin (wait a few minutes after a hot bath or shower).
• An area where no talcum powder, lotions, or body oils have been applied.
• An area without cuts, rashes, or other forms of skin irritation.

Step 2: Open the pouch containing the patch.

• Tear the pouch along the arrows located on the right side of the pouch, as shown in the illustration.

• Do not use scissors to cut the pouch: this could damage the patch.

• Remove the patch from the pouch.

• 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 sealed pouch.

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

• Carefully fold the patch and peel off half of the liner covering the adhesive surface of the patch.
• Without touching the adhesive surface, apply the adhesive part to the selected site on the abdomen, hip, or buttock and press down firmly.

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

• Fold the patch over itself, pressing on the backing.
• Gently pull the liner to lift the edge.
• Hold the edge by one corner and remove the second half of the liner. Try not to touch the adhesive part of the patch.
• Press firmly with your fingers over the entire patch for at least 10 seconds to secure it properly. Ensure that the entire patch adheres to the skin, including the edges.
• Discard the liner protectors.

Bathing, showering, swimming, and exercise

You should wear the patch continuously until it is time to apply a new one. Bathing, showering, swimming, and exercise will not affect the patch as long as you do not rub it during washing. Avoid staying in the bathtub for prolonged periods, as this could cause the patch to detach.

If the patch starts to come off

If the patch begins to lift from the skin, apply gentle pressure with your fingers. The patch is designed to re-adhere. In rare cases, the patch may detach completely. In such cases, try to reapply the same patch to the same site. If the entire patch adheres firmly, leave it in place. If not, remove it and apply a new patch to a different site. Regardless of the day this occurs, continue following your regular twice-weekly schedule as marked on the 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 different site on your abdomen, hip, or buttock. Regardless of the day this occurs, continue with your regular twice-weekly schedule for the next patch, even if this means changing it earlier than 3 or 4 days.

How to remove it

To change the patch, slowly remove the used patch. Fold it in half (with the adhesive side inward) and dispose of it safely, out of reach of children and pets. The application site may become slightly red, but redness should disappear within a few hours after removal. Consult your doctor if irritation persists.

Usually, any remaining adhesive from the removed patch can be removed by gently washing the skin with warm water and mild soap. Baby oil may also be used. To remove residue from previous patches, a special adhesive remover wipe (available at pharmacies) may be necessary. Do not use alcohol or other strong solvents, as these may irritate the skin.

After use, the patch still contains significant amounts of active ingredients that may be harmful to aquatic environments. Therefore, after removal, the used patch should be folded in half with the adhesive side inward so that the release membrane is not exposed, placed back into its original pouch, and then safely discarded out of reach of children. All patches, both used and unused, should 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 in liquid waste systems.

If you use more Kentera than you should

Do not apply more than one patch to the body at a time.

If you forget to use Kentera

Apply a Kentera patch as soon as you realize you have not applied one, or if you missed one of the days marked on your calendar.

If you stop using Kentera

Your urge incontinence may return, and you may experience increased urinary frequency if you decide to stop using the patch. Continue using Kentera unless your doctor advises otherwise.

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

4. Possible adverse effects

Like all medicines, this medicine can have side effects, although not everyone will experience them.

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

• itching around the application site

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

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

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

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

Rare adverse 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 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 leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton. The expiry 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 liner is not exposed, placed back into their original pouch, and then safely discarded out of the reach of children. All patches, both used and unused, should be disposed of according to local regulations or returned to a pharmacy. Used patches must not be flushed down the toilet or disposed of in liquid waste systems.

6. Contents of the pack and other information

Composition of Kentera

• The active substance is oxybutynin.

Each transdermal patch releases 3.9 mg of oxybutynin every 24 hours. Each 39 cm² patch contains 36 mg of oxybutynin.

• The other components are: triacetin and acrylic adhesive solution. The oxybutynin, triacetin, and acrylic adhesive are supported by a transparent PET/EVA reinforcing film and backed with a silicone-coated polyester release liner.

Appearance of the product and contents of the pack

Kentera is a transdermal patch available in cartons containing 2, 8 or 24 patches.

Each patch is covered on the side containing the active substances with a protective reinforcing film. This protective film must be removed before applying the patch.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.eu游戏副本europa.eu