GENTTS 5 MICROGRAMS/HOUR Transdermal patch

Зміст інструкції

1. GenTTS 10 micrograms/hour transdermal patch, 20 micrograms/hour transdermal patch
   1. What is GenTTS and what is it used for
   2. What you need to know before using GenTTS
   3. How to use GenTTS
   4. Possible side effects
   5. How to store GenTTS
   6. Package Contents and Other Information

GenTTS 5 micrograms/hour transdermal patch

GenTTS 10 micrograms/hour transdermal patch, 20 micrograms/hour transdermal patch

Buprenorphine

Read this leaflet carefully before you start to use 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 only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What GenTTS is and what it is used for
• 2. What you need to know before you use GenTTS
• 3. How to use GenTTS
• 4. Possible side effects
• 5. How to store GenTTS
• 6. Contents of the pack and other information

1. What is GenTTS and what is it used for

GenTTS contains the active ingredient buprenorphine which belongs to a group of medicines called
potent analgesics or “painkillers”. It has been prescribed by your doctor to relieve moderate
and long-lasting pain that requires the use of a strong painkiller.
GenTTS should not be used to relieve acute pain.
GenTTS works through the skin. After application, the buprenorphine passes into the blood through the
skin. Each patch lasts for seven days.

2. What you need to know before using GenTTS

Do not use GenTTS:

• 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 drug dependent;
• if you are taking a type of medicine known as a monoamine oxidase inhibitor (e.g. tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid), or if you have taken this type of medicine in the last two weeks;
• if you suffer from myasthenia gravis (a condition in which muscles become weak);
• if you have experienced withdrawal symptoms such as agitation, anxiety, tremor or sweating after stopping alcohol consumption.

GenTTS should not be used to treat symptoms associated with drug withdrawal.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using GenTTS:

• if you are being treated with antidepressants;

The use of these medicines together with GenTTS can lead to serotonin syndrome, a
condition that can be potentially life-threatening (see “Other medicines and GenTTS”);

• if you suffer from seizures, epileptic fits or convulsions;
• if you suffer from sleep-related breathing disorders (sleep apnea);
• if you have a severe headache or feel unwell due to a head injury or increased pressure inside the skull (e.g. due to a brain disease). This is because the patches may worsen symptoms or hide the extent of a head injury;
• if you suffer from dizziness or fainting;
• if you have severe liver problems;
• if you or someone in your family has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction");
• if you are a smoker;
• if you have ever had mood problems (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental illnesses;
• if you have a high fever, as this may result in greater than normal amounts of active ingredient being absorbed into the blood;
• if you suffer from constipation.

Sleep-related breathing disorders
GenTTS can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing
during sleep) and sleep-related hypoxemia (low level of oxygen in the blood). Symptoms
may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath,
difficulty maintaining sleep, or excessive daytime sleepiness. If you or another person
observe these symptoms, contact your doctor. The doctor may consider a
dose reduction.
This medicine can cause reactions at the application site which usually manifest with
mild or moderate skin inflammation and their typical appearance may include redness, swelling,
itching, rash, small blisters and a feeling of pain/burning at the application site.
In most cases the cause is skin irritation and these reactions disappear after the
removal of GenTTS. Severe allergic reactions may occur, such as blisters with discharge, which
may spread outside the application site and may not resolve quickly after the
removal of GenTTS. Chronic allergic reactions can lead to open wounds, bleeding,
ulcers, skin discoloration and infections. If you notice any of the above skin reactions,
contact your doctor.
This medicine can increase sensitivity to pain, especially at high doses. Tell your doctor
if this happens. A dose reduction or a change of medicine may be necessary.
If you have had surgery recently, talk to your doctor before using these patches.
Like other opioids, GenTTS can affect the normal production of hormones
in the body, such as cortisol or sex hormones, especially if you have taken high doses for a
long period of time.

For athletes: the use of the medicine without therapeutic need constitutes doping and may
still result in a positive doping test.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and GenTTS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines can increase the undesirable effects of GenTTS and sometimes can cause
serious reactions. Do not take other medicines during treatment with GenTTS without first talking to
your doctor, in particular:

• Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or

trimipramine. These medicines can interact with GenTTS and you may experience
rhythmic and involuntary muscle contractions, including the muscles that control
eye movement, agitation, hallucinations, coma, excessive sweating, tremor,
exaggerated reflexes, increased muscle tension, body temperature above
38°C. Seek medical attention when these symptoms occur.

• GenTTS must not be used together with a type of medicine known as a monoamine oxidase inhibitor (some examples include tranylcypromide, phenelzine, isocarboxazide, moclobemide and linezolid), or if you have taken this type of medicines in the last two weeks.
• If you are taking certain medicines such as phenobarbital or phenytoin (medicines commonly used to treat seizures, epileptic fits or convulsions), carbamazepine (a medicine to treat seizures, epileptic fits or convulsions and some pain conditions) or rifampicin (a medicine to treat tuberculosis) the effects of GenTTS may be reduced.
• GenTTS can cause drowsiness, feeling unwell or fainting in some people or make them breathe more slowly or weakly. These undesirable effects may be worsened if taken at the same time as other medicines that produce the same effects. These include some medicines for treating pain, depression, anxiety, mental or psychiatric disorders, medicines to help you sleep, medicines for treating high blood pressure such as clonidine, other opioids (which may be present in painkillers or some cough syrups, for example morphine, dextropropoxyphene, codeine, dextromethorphan, noscapine), antihistamines that cause drowsiness or anaesthetics such as halothane.
• The concomitant use of GenTTS and sedative medicines such as benzodiazepines (medicines used to treat anxiety or to help you sleep) or related drugs increases the risk of drowsiness, respiratory depression, coma and can be life-threatening. For this reason, concomitant use should only be considered when other therapeutic alternatives are not possible. However, if your doctor prescribes GenTTS together with sedative medicines, the dose and duration of concomitant treatment must be decided by your doctor. Tell your doctor about all the sedative medicines you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or relatives so that they are aware of the above signs and symptoms. Seek medical attention if these symptoms occur.

Use of GenTTS with food, drinks and alcohol
Alcohol can worsen some undesirable effects and you may not feel well if you drink alcohol while
using GenTTS. Drinking alcohol during the use of GenTTS can also affect reaction time.

Pregnancy, breastfeeding and fertility
You must not use GenTTS patches if you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, unless your doctor has told you otherwise after carefully
considering the benefits and risks to both mother and baby.
Ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
GenTTS can affect your reactions and you may not react properly or quickly enough in unexpected or sudden situations. This is particularly true:

• at the beginning of treatment;
• if you are taking medicines for treating anxiety or to help you sleep;
• if the dose is increased.

If you experience these symptoms (e.g. dizziness, drowsiness or blurred vision), you should not drive or
use machines during treatment with GenTTS or within 24 hours of removing the
patch.

3. How to use GenTTS

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
doubts, consult your doctor or pharmacist.
Several dosages of GenTTS are available. Your doctor will decide which dosage of GenTTS is most suitable
for you.
During treatment, your doctor may change the patch you are using to a smaller or larger one, if
necessary, or may tell you to use a combination of up to two patches. Do not use a higher dose
than recommended. You must not apply more than two patches at the same time, up to
a maximum total dose of 40 micrograms/hour.
If you think that the effect of GenTTS is too weak or too strong, consult your doctor or pharmacist.

Adults and elderly patients
Unless your doctor has told you otherwise, apply one GenTTS patch (as described
in detail below) and change it every seventh day, preferably at the same time. Your doctor may
want to adjust the dose after 3-7 days to achieve optimal pain control. If your doctor has advised you to take other pain relievers in addition to the patch, follow your doctor's instructions carefully, otherwise you will not get the full benefit from treatment with GenTTS. The patch must be
worn for 3 full days before increasing the dose, this is when the maximum effect of a given dose is determined.

Patients under 18 years of age
GenTTS must not be used in patients under 18 years of age.

Patients with kidney disease/patients undergoing dialysis
In patients with kidney disease, no dose adjustment is necessary.

Patients with liver disease
In patients with liver disease, the effects and duration of action of GenTTS may be affected
and your doctor will monitor you more closely.

Method of administration
GenTTS transdermal patch is for transdermal use.
GenTTS works through the skin. After application, buprenorphine passes into the blood through the
skin.
Do not cut or divide the patch.

Before applying the transdermal patch

Choose an area of intact and unirritated skin on the upper arm, outer arm, upper chest, upper back or side of the chest. (See side images). Ask for help if you cannot apply the patch yourself.

Upper arm or or c a m r a F Front l e or d a n Behind a i l or a t I

• The GenTTS patch must be applied to an area of skin that is mostly glabrous or nearly glabrous. If suitable hair-free areas are not available, the hair must be trimmed with scissors. Do not shave it.
• Avoid areas with red, irritated skin or other imperfections, such as large scars.
• The chosen area of skin must be dry and clean. If necessary, wash it with cool or lukewarm water. Do not use soap, alcohol, oil, lotions or other detergents. After a hot bath or shower, wait until the skin is completely dry and cool. Do not apply lotions, creams or ointments to the chosen area. This could prevent the patch from adhering properly.

Applying the patch

• Step 2: the adhesive side of the transdermal patch is covered by a transparent protective film. Carefully peel off part of the film. Avoid touching the adhesive side of the transdermal patch.
• Step 1: each transdermal patch is sealed in a sachet. Immediately before use, cut the sachet with scissors along the sealed edge. Remove the transdermal patch. Do not use the patch if the sachet seal is broken.

• Step 3: apply the transdermal patch to the chosen area of skin and remove the remaining film.

• Step 4: press the transdermal patch against the skin with the palm of your hand and count slowly to 30. Make sure that the entire transdermal patch is in contact with the skin, especially at the edges.

Wearing the transdermal patch
You must wear the patch for seven days. Provided you have applied the patch correctly,
the risk of it detaching is minimal. If the edges of the patch start to come off, you can secure them with
a suitable adhesive tape. You can shower, bathe or swim while wearing the patch.
Do not expose the patch to external heat sources (e.g. heating pads, electric blankets, heating lamps,
saunas, hot tubs, heated waterbeds, hot water bottles, etc.) as
this could cause a greater amount of active ingredient to be absorbed into the blood than
normal. External heat can also prevent the patch from adhering properly. If you have a high fever,
this may alter the effects of GenTTS (see above “Warnings and precautions”).
In the unlikely event that the patch detaches before it needs to be changed, do not reuse
the same patch. Immediately apply a new one (see below “Changing the transdermal
patch”).

Changing the transdermal patch

• Remove the old patch.
• Fold the patch in half with the adhesive side facing inwards.
• Open and remove a new patch. Use the empty sachet to dispose of the old patch.
• Apply a new patch to a different suitable area of skin (as described above). Do not apply a new patch to the same area for 3-4 weeks.
• Remember to change the patch at the same time of day. It is important to note the time of day.

Duration of treatment
Your doctor will tell you how long you will need to be treated with GenTTS. Do not stop treatment
without consulting your doctor, as the pain may return and you may not feel well (see
below “If you stop using GenTTS”).

If you use more GenTTS than you should
As soon as you realize you have used more patches than you should, remove all the patches and call
your doctor or hospital immediately. People who have taken an overdose may
feel very sleepy and unwell. They may also have difficulty breathing or lose
consciousness and may need emergency treatment in hospital. When you contact your
doctor.

If you forget to apply GenTTS
Apply a new patch as soon as you remember. Also, note the date, as the usual day for changing the patch may be different. If you change the patch very late, the pain may
return. In this case, contact your doctor.
Do not apply an extra patch to make up for the forgotten application.

If you stop using GenTTS
If you stop using GenTTS too early or stop treatment, the pain may return. If
you want to stop treatment, consult your doctor. They will tell you what you can do and whether you can take other
medicines.
Some people may experience side effects when they have used potent pain relievers for a long
period and stop using them. The risk of side effects occurring after stopping GenTTS is very
low. However, if you feel restless, anxious, nervous or shaky, if you are hyperactive, have difficulty sleeping
or have digestive problems, tell your doctor.
The pain-relieving effect of GenTTS is maintained for a certain period after the patch is removed.
Do not start another opioid analgesic (strong pain reliever) within 24 hours of removing the
patch.
If you have any questions about using 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 associated with GenTTS are similar to those observed with other strong painkillers
and include difficulty 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 experience sudden wheezing,
difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching,
especially those affecting the whole body.
As with all strong painkillers, there is a risk of developing dependence on GenTTS.
The following other side effects have been reported in patients treated with buprenorphine:

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

• Headache, dizziness, drowsiness.
• Constipation, feeling unwell or even being sick.
• Itching.
• 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, sleep disturbances, nervousness, tremor (shaking).
• Shortness of breath.
• Abdominal pain or discomfort, diarrhoea, indigestion, dry mouth.
• Sweating, skin rashes.
• Fatigue, feeling unusually weak, muscle weakness, swelling of the hands, ankles or feet.

Uncommon(may affect up to 1 in 100 people):

• Restlessness, agitation, feeling of extreme happiness, hallucinations, nightmares, decreased sexual drive, aggression.
• Changes in taste, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness.
• Memory loss, migraine, fainting, problems with concentration or coordination.
• Dry eyes, blurred vision.
• Ringing or buzzing in the ears, a feeling of dizziness or lightheadedness.
• High or low blood pressure, chest pain, fast or irregular heartbeat.
• Coughing, hiccups, wheezing.
• Flatulence.
• Weight loss.
• Dry skin.
• Spasms, discomfort and pain.
• Difficulty starting to urinate.
• Fever.
• Increased accidental injuries (e.g. falls).
• Withdrawal symptoms such as agitation, anxiety, sweating or tremor after stopping treatment with GenTTS.

If you need to have blood tests, remind the doctor that you are using GenTTS. This is
important because GenTTS can change the way the 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 disorders.
• Difficulty with balance.
• Swelling of the eyelids or face, reduced size of the pupils of the eyes.
• Difficulty breathing, worsening of asthma, rapid breathing.
• A feeling of fainting, especially when standing up.
• Difficulty swallowing.
• Local allergic reaction with marked signs of swelling (in these cases treatment must be stopped).
• Swelling and irritation inside the nose.
• Decreased erection, sexual dysfunction.
• A flu-like illness.
• Skin flushing.
• Dehydration.

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

• Muscle contractions.
• Mood swings.
• Ear pain.
• Blisters.

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

• Problems with breathing during sleep (sleep apnea syndrome), see section 2 “Warnings and precautions."
• Convulsions, epileptic seizures and fits.
• Inflammation of the intestinal wall. Symptoms may include fever, vomiting and stomach pain or discomfort.
• An increased sensitivity to pain.
• Abdominal pain or discomfort due to colic.
• Feeling detached from oneself.
• Withdrawal symptoms in children born to mothers who have been given buprenorphine during pregnancy may include high-pitched crying, irritability and restlessness, agitation (tremor), difficulty feeding, sweating and failure to gain weight.
• Need to take increasingly higher doses of this medicine to get the same level of pain relief (tolerance).
• Contact dermatitis (skin rash with inflammation that may include a burning sensation), skin discolouration.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store GenTTS

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 pack or the sachet. The
expiry date refers to the last day of that month. After the expiry date, take the unused patches
to the pharmacy.
This medicine does not require any particular storage conditions.
Do not use the patch if the seal of the sachet is broken.
Used patches must be folded over on themselves with the adhesive layer facing inwards and disposed of safely,
out of the sight and reach of children.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What GenTTS patch contains
The active ingredient is buprenorphine.
GenTTS 5 micrograms/hour:
Each transdermal patch contains 5 mg of buprenorphine in an area of 6.25 cm and releases 5 micrograms
of buprenorphine per hour (for a period of 7 days).
GenTTS 10 micrograms/hour:
Each transdermal patch contains 10 mg of buprenorphine in an area of 12.5 cm and releases 10
micrograms of buprenorphine per hour (for a period of 7 days).
GenTTS 20 micrograms/hour:
Each transdermal patch contains 20 mg of buprenorphine in an area of 25 cm and releases 20 micrograms
of buprenorphine per hour (for a period of 7 days).
The other ingredients are:
Adhesive matrix (containing buprenorphine): povidone, levulinic acid, oleyl oleate, poly [acrylic acid-
co-butyl acrylate-co-(2-ethylhexyl) acrylate-co-vinyl acetate]
Adhesive matrix (without buprenorphine): poly[(2-ethylhexyl) acrylate-co-glycidyl methacrylate-co-(2-
hydroxyethyl) acrylate-co-vinyl acetate]
Release liner between adhesive matrices with and without buprenorphine: polyethylene terephthalate film,
Support film: polyester
Protective film: polyethylene terephthalate film, siliconized
Blue printing ink.

Description of the appearance of GenTTS and contents of the pack
Transdermal patch
Three strengths are available.
GenTTS 5 micrograms/hour:
Each transdermal patch is beige in color with rounded corners and bears the inscription “Buprenorphin” and “5
μg/h”
GenTTS 10 micrograms/hour:
Each transdermal patch is beige in color with rounded corners and bears the inscription “Buprenorphin” and
“10 μg/h”
GenTTS 20 micrograms/hour:
Each transdermal patch is beige in color with rounded corners and bears the inscription “Buprenorphin” and
“20 μg/h”
One transdermal patch is sealed in a child-resistant sachet. The patches are available in cartons
containing 4 transdermal patches.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Istituto Gentili S.r.l.
Via San Giuseppe Cottolengo 15
20143 Milan (MI)

Manufacturer
Labtec GmbH
Heykenaukamp 10
21147 Hamburg
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Germany: GenTTS 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster
GenTTS 7 Tage 10 Mikrogramm/Stunde transdermales Pflaster
GenTTS 7 Tage 20 Mikrogramm/Stunde transdermales Pflaster

Italy:GenTTS 5 micrograms/hour transdermal patch
GenTTS 10 micrograms/hour transdermal patch
GenTTS 20 micrograms/hour transdermal patch