PRENOPATCH

Main information

  • Trade name:
  • PRENOPATCH 10 Microgram per hour Transdermal Patch
  • Dosage:
  • 10 Microgram per hour
  • Pharmaceutical form:
  • Transdermal Patch
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRENOPATCH 10 Microgram per hour Transdermal Patch
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Oripavine derivatives

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Transfer Pending
  • Authorization number:
  • PA1178/013/002
  • Authorization date:
  • 14-07-2017
  • Last update:
  • 06-11-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the patient

[<invented name>] 5 microgram/hour transdermal patch

[<invented name>] 10 microgram/hour transdermal patch

[<invented name>] 20 microgram/hour transdermal patch

buprenorphine

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What [<invented name>] is and what it is used for

What you need to know before you use [<invented name>]

How to use [<invented name>]

Possible side effects

How to store [<invented name>]

Contents of the pack and other information

1.

What [<invented name>] is and what it is used for

[<invented name>] contain the active ingredient buprenorphine which belongs to a group of medicines

called strong analgesics or ‘painkillers’. They have been prescribed for you by your doctor to relieve

moderate, long-lasting pain that requires the use of a strong painkiller.

[<invented name>] should not be used to relieve acute pain.

2.

What you need to know before you use [<invented name>]

Do not use [<invented name>]:

if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in

section 6);

if you have breathing problems;

if you are addicted to drugs;

if you are taking a type of medicine known as a monoamine oxidase inhibitor (examples

include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have

taken this type of medicine in the last two weeks;

if you suffer from myasthenia gravis (a condition in which the muscles become weak);

if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking

or sweating upon stopping taking alcohol.

[<invented name>] must not be used to treat symptoms associated with drug withdrawal.

Warnings and precautions

Talk to your doctor or pharmacist before using [<invented name>]:

if you suffer from seizures, fits or convulsions;

if you have a severe headache or feel sick due to a head injury or increased pressure in your

skull (for instance due to brain disease). This is because the patches may make symptoms

worse or hide the extent of a head injury;

if you are feeling light-headed or faint;

if you have severe liver problems;

if you have ever been addicted to drugs or alcohol;

if you have a high temperature, as this may lead to larger quantities of the active ingredient

being absorbed into the blood than normal.

If you have recently had an operation, please speak to your doctor before using these patches.

Athletes should be aware that this medicine may cause a positive reaction to sports doping control

tests.

Children and adolescents

Do not give this medicine to children and adolescents below 18 years.

Other medicines and [<invented name>]

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

[<invented name>] must not be used together with a type of medicine known as a monoamine

oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide

and linezolid), or if you have taken this type of medicine in the last two weeks.

If you take some medicines such as phenobarbital or phenytoin (medicines commonly used to

treat seizures, fits or convulsions), carbamazepine (a medicine to treat seizures, fits or

convulsions and certain pain conditions), or rifampicin (a medicine to treat tuberculosis) the

effects of [<invented name>] may be reduced.

[<invented name>] may make some people feel drowsy, sick or faint or make them breathe

more slowly or weakly. These side effects may be made worse if other medicines that produce

the same effects are taken at the same time. These include certain medicines to treat pain,

depression, anxiety, psychiatric or mental disorders, medicines to help you sleep, medicines to

treat high blood pressure such as clonidine, other opioids (which may be found in painkillers

or certain cough mixtures e.g. morphine, dextropropoxyphene, codeine, dextromethorphan,

noscapine), antihistamines which make you drowsy, or anaesthetics such as halothane.

[<invented name>] must be used with caution if you are also taking benzodiazepines

(medicines used to treat anxiety or to help you sleep). This combination may cause serious

breathing problems.

[<invented name>] with alcohol

Alcohol may make some of the side effects worse and you may feel unwell if you drink alcohol whilst

wearing [<invented name>]. Drinking alcohol whilst using [<invented name>] may also affect your

reaction time.

Pregnancy, breast-feeding and fertility

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.

Pregnancy

There is not sufficient experience regarding the use of buprenorphine in pregnant women. Therefore

you should not use [<invented name>] if you are pregnant or if you could become pregnant during

treatment.

Breast-feeding

Buprenorphine, the active substance contained in the transdermal patch, may inhibit milk formation

and passes into the breast milk. Therefore, you should not use [<invented name>] if you are breast-

feeding.

Driving and using machines

[<invented name>] may affect your reactions to such an extent that you may not react adequately or

quickly enough in the event of unexpected or sudden occurrences. This applies particularly:

at the beginning of treatment;

if you are taking medicines to treat anxiety or help you sleep;

if your dose is increased.

If you are affected (e.g. feel dizzy, drowsy or have blurred vision), you should not drive or operate

machinery whilst using [<invented name>], or for 24 hours after removing the patch.

3.

How to use [<invented name>]

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

Different strengths of [<invented name>] are available. Your doctor will decide which strength of

[<invented name>] will suit you best.

During treatment, your doctor may change the patch you use to a smaller or larger one if necessary.

Do not cut or divide the patch or use a higher dose than recommended. You should not apply more

than two patches at the same time.

If you feel that the effect of the [<invented name>] is too weak or too strong, talk to your doctor or

pharmacist.

Adults and elderly patients

Unless your doctor has told you differently, attach one [<invented name>] patch (as described in

detail below) and change it every seventh day, preferably at the same time of day. Your doctor may

wish to adjust the dose after 3-7 days until the correct level of pain control has been found. If your

doctor has advised you to take other painkillers in addition to the patch, strictly follow the doctor’s

instructions, otherwise you will not fully benefit from treatment with [<invented name>]. The patch

should be worn for 3 full days before increasing the dose, this is when the maximum effect of a given

dose is established.

Patients with kidney disease/dialysis patients

In patients with kidney disease, no change in dose is necessary.

Patients with liver disease

In patients with liver disease, the effects and period of action of the [<invented name>] may be

affected and your doctor will therefore check on you more closely.

Patients under 18 years of age

[<invented name>] should not be used in patients below the age of 18 years.

Method of administration

[<invented name>] transdermal patch is for transdermal use.

[<invented name>] act through the skin. After application, buprenorphine passes through the skin into

the blood.

Before applying the transdermal patch

Choose an area

of non-

irritated, intact

skin on your

upper arm,

outer arm,

upper chest,

upper back or

side of the

chest. (See

illustrations

besides). Ask

for assistance

if you cannot

apply the patch

yourself.

Upper Arm

or

Front

or

Back

or

The [<invented name>] patch should be applied to a relatively hairless or nearly hairless skin

site. If no suitable hair free sites are available the hairs should be cut off with a pair of scissors.

Do not shave them off.

Avoid skin which is red, irritated or has any other blemishes, for instance large scars.

The area of skin you choose must be dry and clean. If necessary, wash it with cold or

lukewarm water. Do not use soap, alcohol, oil, lotions or other detergents. After a hot bath or

shower, wait until your skin is completely dry and cool. Do not apply lotion, cream or

ointment to the chosen area. This might prevent your patch from sticking properly.

Applying the transdermal patch

Step 1: Each transdermal patch is sealed in a sachet.

Just

before

use, cut the sachet along the sealed edge

with scissors. Take

the transdermal patch. Do not

use the patch if the sachet seal is broken.

Step 2: The

sticky

side

transdermal

patch

covered

with

transparent

protective

foil.

Carefully

peel off one part of the foil. Try not to touch the

sticky

part of the transdermal patch.

Step 3: Stick the transdermal patch on to the area of

skin you have chosen

and remove the remaining foil.

Step 4: Press the transdermal patch against your skin

with the palm of your hand and count slowly to 30.

Make sure that the whole transdermal patch is in

contact with your skin, especially at the edges.

Wearing the transdermal patch

You should wear the patch for seven days. Provided that you have applied the patch correctly, there is

little risk of it coming off. If the edges of the patch begin to peel off, they may be taped down with a

suitable skin tape. You may shower, bathe or swim whilst wearing it.

Do not expose the patch to extreme heat (e.g. heating pads, electric blanket, heat lamps, sauna, hot

tubs, heated water beds, hot water bottle, etc) as this may lead to larger quantities of the active

ingredient being absorbed into the blood than normal. External heat may also prevent the patch from

sticking properly. If you have a high temperature this may alter the effects of [<invented name>]

(see

“Warnings and precautions” section above).

In the unlikely event that your patch falls off before it needs changing, do not use the same patch

again. Stick a new one on straight away (see “Changing the transdermal patch” below).

Changing the transdermal patch

Take the old transdermal patch off.

Fold it in half with the sticky side inwards.

Open and take out a new patch. Use the empty sachet to dispose of the old patch. Now discard the

sachet safely.

Stick a new transdermal patch on a different appropriate skin site (as described above). You

should not apply a new patch to the same site for 3-4 weeks.

Remember to change your patch at the same time of day. It is important that you make a note of

the time of day.

Duration of treatment

Your doctor will tell you how long you should be treated with the [<invented name>]. Do not stop

treatment without consulting a doctor, because your pain may return and you may feel unwell (see

also “If you stop using [<invented name>]” below).

If you use more [<invented name>] than you should

As soon as you discover that you have used more patches than you should, remove all patches and call

your doctor or hospital straight away. People who have taken an overdose may feel very sleepy and

sick. They may also have breathing difficulties or lose consciousness and may need emergency

treatment in hospital. When seeking medical attention make sure that you take this leaflet and any

remaining patches with you to show to the doctor.

If you forget to use [<invented name>]

Stick a new patch on as soon as you remember. Also make a note of the date, as your usual day of

changing may now be different. If you are very late changing your patch, your pain may return. In this

case, please contact your doctor.

Do not apply additional patches to make up for the forgotten application.

If you stop using [<invented name>]

If you stop using [<invented name>] too soon or you interrupt your treatment your pain may return. If

you wish to stop treatment please consult your doctor. They will tell you what can be done and

whether you can be treated with other medicines.

Some people may have side effects when they have used strong painkillers for a long time and stop

using them. The risk of having effects after stopping [<invented name>] is very low. However, if you

feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty sleeping or digestive

problems, tell your doctor.

The pain relieving effect of [<invented name>] is maintained for some time after removal of the patch.

You should not start another opioid analgesic (strong painkiller) within 24 hours after removal of the

patch.

If you have any further questions on 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.

Serious side effects that may be associated with [<invented name>] are similar to those seen with

other strong painkillers and include difficulty in breathing and low blood pressure.

This medicine can cause allergic reactions, although serious allergic reactions are rare. Remove the

patch and tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing,

swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

There is a risk that you may become addicted or reliant on [<invented name>].

In patients treated with buprenorphines, the following other side effects have been reported:

Very common

(may affect more than 1 in 10 people):

Headache, dizziness, drowsiness.

Constipation, feeling or actually being sick.

Itchy skin

Rash, redness, itching, inflammation or swelling of the skin at the application site.

Common

(may affect up to 1 in 10 people):

Loss of appetite.

Confusion, depression, anxiety, difficulty in sleeping, nervousness, shaking (tremors).

Shortness of breath.

Abdominal pain or discomfort, diarrhoea, indigestion, dry mouth.

Sweating, rash, skin eruptions.

Tiredness, a feeling of unusual weakness, muscle weakness, swelling of hands, ankles or feet.

Uncommon

(may affect up to 1 in 100 people):

Mood swings, restlessness, agitation, a feeling of extreme happiness, hallucinations, nightmares ,

decreased sexual drive.

Changes in taste, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness.

Loss of memory, migraine, fainting, problems with concentration or co-ordination

Dry eyes, blurred vision.

A ringing or buzzing sound in the ears, a feeling of dizziness or spinning.

High or low blood pressure, chest pain, fast or irregular heartbeat.

Cough, hiccups, wheezing.

Wind.

Weight loss.

Dry skin.

Spasms, aches and pains.

Difficulty in beginning the flow of urine.

Inability to fully empty the bladder.

Fever

An increase in accidental injuries (e.g. falls).

Withdrawal symptoms such as agitation, anxiousness, sweating or shaking upon stopping using

[<invented name>].

If you need to have blood tests remind your doctor that you are using [<invented name>]. This is

important because [<invented name>] may change the way your liver works and this could affect the

results of some blood tests.

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

Angina (chest pain associated with heart disease).

Mental disorder.

Difficulties with balance.

Swelling of the eyelids or face, a reduction in size of the pupils in the eye.

Difficulty in breathing, worsening of asthma, over breathing.

A feeling of faintness, especially on standing up.

Difficulty in swallowing.

Local allergic reaction with marked signs of swelling (in such cases treatment should be stopped).

Swelling and irritation inside the nose.

Decreased erection, sexual dysfunction.

A flu like illness.

Flushing of the skin.

Dehydration.

Very rare (may affect up to 1 in 10,000 people):

Muscle twitching.

Ear pain.

Blisters.

Not known (frequency cannot be estimated from the available data):

Seizures, fits or convulsions.

Inflammation of the bowel wall. Symptoms may include fever, vomiting and stomach pain or

discomfort.

Colicky abdominal pain or discomfort.

Feeling detached from oneself.

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.

5.

How to store [<invented name>]

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 carton and sachet after EXP.

The expiry date refers to the last day of that month.

[5 microgram/h] & [10 microgram/h]:

Do not store above 25°C.

[20 microgram/h]:

This medicine does not require any special storage conditions.

Do not use the patch if the sachet seal is broken.

Used patches must be folded over on themselves with the adhesive layer inwards, and discarded

safely.

Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What [<invented name>] patches contain

The active substance is buprenorphine.

[5 microgram/h:]

Each transdermal patch contains 5 mg of buprenorphine in a patch size of 6.25 cm

and releases 5

micrograms of buprenorphine per hour (over a period of 7 days).

[10 microgram/h:]

Each transdermal patch contains 10 mg of buprenorphine in a patch size of 12.5 cm

and releases 10

micrograms of buprenorphine per hour (over a period of 7 days).

[20 microgram/h:]

Each transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm

and releases 20

micrograms of buprenorphine per hour (over a period of 7 days).

The other ingredients are:

Adhesive matrix (containing buprenorphine): povidone K90, levulinic acid, oleyl oleate,

Poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5)

Adhesive matrix (without buprenorphine): Poly[(2-ethylhexyl)acrylate-co-glycidylmethacrylate-

co-(2-hydroxyethyl)acrylate-co-vinylacetate] (68:0,15:5:27),

Separating foil between adhesive matrices with and without buprenorphine: Polyethylene

terephthalate film,

Backing foil: polyester,

Release liner: Polyethylene terephthalate film, siliconised

Blue printing ink

What [<invented name>] look like and contents of the pack

Transdermal patch

Three sizes are available.

[5 microgram/h:]

Each transdermal patch is beige coloured with rounded corners and is imprinted with “Buprenorphin” and

“5 μg/h”

[10 microgram/h:]

Each transdermal patch is beige coloured with rounded corners and is imprinted with “Buprenorphin”

and “10 μg/h”

[20 microgram/h:]

Each transdermal patch is beige coloured with rounded corners and is imprinted with “Buprenorphin”

and “20 μg/h”

One transdermal patch is sealed in one child-resistant sachet. The patches are available in cartons

containing

[For DE/H/4393,4397,4621/001-003/DC]

1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 18, 20 or 24 transdermal patches.

[For DE/H/4394/001-003/DC]

2, 4, 5, 8 or 12 transdermal patches.

[For DE/H/4395/001-003/DC]

4 transdermal patches.

[For DE/H/4396, 4424/001-003/DC]

1, 2, 3, 4, 5, 8 10 or 12 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[to be completed nationally]

Manufacturer

[to be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following

names:

[DE/H/4394/001-003/DC]

Denmark

Buprenorphine Glenmark 5 mikrog/time; 10 mikrog/time; 20 mikrog/time 7

dag depotplaster

Finland

Buprenorphine Glenmark 5 mikrog/tunti; 10 mikrog/tunti; 20 mikrog/tunti 7

päivä depotlaastari

Germany

Buprenorphin Glenmark 7 Tage 5 Mikrogramm/Stunde; 10

Mikrogramm/Stunde; 20 Mikrogramm/Stunde transdermales Pflaster

Netherlands

Buprenorfine Glenmark 5 microgram/uur; 10 microgram/uur; 20

microgram/uur 7 dag pleister voor transdermaal gebruik

Norway

Carlosafine

Sweden

Buprenorphine Glenmark 5 mikrogram/timme; 10 mikrogram/timme; 20

mikrogram/timme 7 dag depotplåster

United Kingdom

Carlosafine 5 micrograms/h; 10 micrograms/h; 20 micrograms/h 7 Day

Transdermal patch

[DE/H/4395/001-003/DC]

Ireland

Tranzileve 5 microgram/hour; 10 microgram/hour; 20 microgram/hour

Transdermal Patches

Germany

Buprenorphin AET 5 Mikrogamm/Stunde; 10 Mikrogamm/Stunde;

20 Mikrogamm/Stunde Transdermales Pflaster

United Kingdom

Tranzileve 5 microgram/hour; 10 microgram/hour; 20 microgram/hour

Transdermal Patches

[DE/H/4396/001-003/DC]

Germany

Bupelbe 5 Mikrogramm/Stunde; 10 Mikrogramm/Stunde; 20

Mikrogramm/Stunde transdermales Pflaster

Poland

BENIXOL

United Kingdom

Sevodyne 5 micrograms/h; 10 micrograms/h; 20 micrograms/h transdermal

patches

[DE/H/4397/001-003/DC]

Denmark

Buprenorphine STADA

Finland

Buprenorphine STADA 5 mikrog/t; 10 mikrog/t; 20 mikrog/t depotlaastari

Germany

Buprenorphin AL 5 Mikrogramm/Stunde; 10 Mikrogramm/Stunde; 20

Mikrogramm/Stunde transdermales Pflaster

Ireland

Prenopatch 5 micrograms/h; 10 microgram/h; 20 microgram/h transdermal

patch

Netherlands

Buprenorfine CF Teva 5 microgram/uur; 10 microgram/uur; 20

microgram/uur pleister voor transdermaal gebruik

Sweden

Buprenorphine STADA 5 mikrogram/timme; 10 mikrogram/timme; 20

mikrogram/timme depotplåster

United Kingdom

BUPATCH 5 micrograms/h; 10 micrograms/h; 20 micrograms/h

transdermal patches

[DE/H/4424/001-003/DC]

Denmark

Buprefarm

Finland

Buprefarm

Germany

Buprefarm

Norway

Buprefarm

Sweden

Buprefarm

This leaflet was last revised in <{MM/YYYY}>