Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kentera

Document Subject

Generated Narrative: MedicinalProductDefinition mpa346fcd48e1745156d4e5145052e15e4

identifier: http://ema.europa.eu/identifier/EU/1/03/270/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kentera 3.9 mg / 24 hours transdermal patch

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a346fcd48e1745156d4e5145052e15e4

identifier: http://ema.europa.eu/identifier/EU/1/03/270/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - kentera

Attesters

What is in 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

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.

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 have a rare condition called myasthenia gravis that makes the muscles in the body become weak and tire easily.
• if you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem. You should discuss this problem with your doctor before using Kentera.
• if you have digestion problems caused by reduced emptying of the stomach after a meal you should consult your doctor before using Kentera.
• if you have glaucoma or a family history of glaucoma, tell your doctor.

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

• Liver problems
• Kidney problems
• Difficulty urinating
• Intestinal blockage
• Bloody stools
• Generalized muscle weakness
• Painful swallowing

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. Children and adolescents Kentera is not recommended for use in children or adolescents.

Other medicines and Kentera Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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:

• Ketoconazole, itraconazole or fluconazole (used for the treatment of fungal infections).
• Erythromycin a macrolide antibiotic (used to treat bacterial infections).
• Biperiden, levodopa, or amantadine (used to treat Parkinson s disease).
• Antihistamines (used in the treatment of 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 problems).
• Atropine and other anticholinergic medicines (used for treatment in stomach disorders such as irritable bowel syndrome).

Kentera with alcohol Oxybutynin may cause drowsiness or blurred vision. Drowsiness may be increased by consumption of alcohol.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this 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.

Always use this medicine exactly as your doctor has told you. 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:

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

Step 2: Open the sachet that contains the patch.

• Tear open along arrows marked on the right side of the sachet as shown in drawing below.
• Do not cut the sachet with scissors, which might damage the patch inside.
• Pull the patch out.
• Do not cut or divide the patch, do not use damaged patches.
• Apply immediately to your skin; do not keep or store the patch outside the sealed sachet.

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

• Gently bend the patch and remove the first piece of protective liner, which covers the sticky surface of the patch.
• Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of the abdomen, hips or buttocks you have selected for application.

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

• Bend the patch back over itself. Press down on the liner firmly.
• Push the liner forward a little to loosen the edge.
• Grab the loose edge at either corner and peel off the second piece of the liner. Try not to touch the sticky surface of the patch.
• Press the entire patch firmly onto the skin with your fingertips. Press for at least 10 seconds to make sure the patch will stay in place. Be sure all of it sticks to your skin, even around the edges.
• Discard the protective liners.

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 Do 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.

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

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

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

• itching around the site of patch application

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

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

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

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

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

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

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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.

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

Teva B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Manufacturer

Merckle GmbH Ludwig-Merckle-Stra e 3 89143 Blaubeuren Germany

Teva Pharmaceuticals Europe B.V. Swensweg 5 2031 GA Haarlem The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

: +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland ratiopharm GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar A.B.E.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Laboratorios Gebro Pharma, S.A. Tel: +34 932058Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
Specifar A.B.E.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Accord Healthcare Ireland Ltd. Ireland Tel: +353 214619This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: