PRENOTRIX 52.5 MICROGRAMS / H TRANSDERMAL PATCH - patient leaflet, side effects, dosage

Prenotrix

Buprenorphine

Important things you need to know about Prenotrix Transdermal Patches

• These patches contain a strong pain killer
• Ensure that old patches are removed before applying a new one
• Patches must not be cut
• Do not expose the patches to a heat source (such as a hot water bottle)
• Do not soak in a hot bath or take a hot shower whilst wearing a patch.
• If you develop a fever tell your doctor immediately
• Follow the dosage instructions carefully and only change your patch at the same time of day 72 hours (3 days) later
• If your breathing becomes shallow and weak take the patch off and seek medical help

Read all of this leaflet carefully before you start using this medicine because it contains important 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 foryou 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 of the side effects, talk to your doctor of pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. WHAT PRENOTRIX IS AND WHAT IT IS USED

FOR

• 2. WHATYOU NEED TO KNOWBEFOREYOU USE PRENOTRIX

• 3. HOWTO USE PRENOTRIX

• 4. POSSIBLE SIDE EFFECTS

• 5. HOWTO STORE PRENOTRIX

• 6. CONTENTS OFTHEPACKAND OTHER INFORMATION

D what prenotrix is and what it

IS USED FOR

Prenotrix is an analgesic (a pain-relieving medicine) intended to relieve moderate to severe cancer pain and severe pain that has not responded to other types of painkillers.

Prenotrix acts through the skin. When the transdermal patch is applied to the skin, the active substance buprenorphine passes through the skin into the blood.

Buprenorphine is an opioid (strong pain reliever), which reduces pain by acting on the central nervous system (specific nerve cells in the spinal cord and in the brain). The effect of the transdermal patch lasts for up to three days.

Prenotrix is not suitable for the treatment of acute (short-lasting) pain.

B

what you need to know before

YOU USE PRENOTRIX

Do not use Prenotrix

• if you are allergic to buprenorphine, soy, peanut or any of the other ingredients of this medicine (listed in section 6);
• if you are dependent on strong pain relievers (opioids);
• if you suffer from a disease in which you have or may have great difficulty breathing;
• if you are taking monoamine oxidase (MAO) inhibitors (certain medicines used to treat depression) or you have taken this type of medicine in the last twoweeks (see „Other medicines and Prenotrix“);
• if you suffer from myasthenia gravis (a certain type of severe muscle weakness);
• If you suffer from delirium tremens (confusion and trembling caused by abstinence from alcohol following habitual excessivedrinking or occurring during an episode of heavy alcohol consumption);
• If you are pregnant.

Prenotrix must not be used to treat withdrawal symptoms in drug-dependent persons.

Warnings and precautions

Talk to your doctor or pharmacist before using Prenotrix

• if you have recently drunk a lot of alcohol;
• if you suffer from seizures or convulsions (fits);
• if your consciousness is disturbed (feeling light-headed or faint) for an unknown reason;
• if you are in a state of shock (cold sweat might be a sign of it);
• if the pressure in your skull is increased (for instance after head injury or in brain disease), and artificial respiration is not possible;
• if you have difficulty breathing or are taking other medicines that may make you breathe more slowly or weakly (see „Other medicines and Prenotrix“);
• if your liver does not work properly;
• if you are inclined to abuse medicines or drugs
• If you have depression or other conditions that are treated with antidepressants. The use of these medicines together with Prenotrix can lead to serotonin syndrome, a potentially life-threatening condition (see „Other medicines and Prenotrix“).

Also, please be aware of the following precautions:

• Some people may become dependent on strong pain relievers such as Prenotrix when they use them over a long period of time. They may havewithdrawal effects when they stop using them (see „If you stop using Prenotrix“).
• Fever and external heat may lead to larger quantities of buprenorphine in the blood than normal. Also, external heat may prevent the transdermal patch from sticking properly. Therefore, do not expose yourself to external heat (e.g. sauna, infra-red lamps, electric blankets, hotwater bottles) and consultyour doctor ifyou have fever.

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

Children and adolescents

• Prenotrixshould not be used in persons below the age of 18 years, because no experience has so far been gained in this age group.

Other medicines and Prenotrix

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may increase the side effects of Prenotrix and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Prenotrix without first talking to your doctor, especially:

• anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, ortrimipramine. These medicines may interact with Prenotrix and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contactyour doctorwhen experiencing such symptoms.
• Prenotrix must not be used together with monoamine oxidase (MAO) inhibitors (certain medicines used to treat depression), or if you have taken this type of medicine for the last 2 weeks.
• Prenotrix may make some people feel drowsy, sick, or faint or make them breathe more slowly or weakly. These side effects may be intensified if other medicines that may produce the same effects are taken at the same time.
• These other medicines include other strong pain relievers (opioids), certain sleeping pills, anaesthetics, and medicines used to treat certain psychological diseases such as tranquillizers, anti-depressants, and neuroleptics.
• If Prenotrix is used together with some medicines, the effects of the transdermal patch may be increased. These medicines include e.g. certain anti-infectives/anti-fungals (e.g. containing erythromycin or ketoconazole) or
• HIV medicines (e.g. containing ritonavir).
• If Prenotrix is used together with other medicines, the effects of the transdermal patch may be reduced. These medicines include certain products, e.g. dexamethasone; medicines to treat epilepsy (e.g. containing carbamazepine, or phenytoin) or medicines for tuberculosis (e.g. rifampicin).

Prenotrix with food, drink and alcohol

You should not drink alcohol while using Prenotrix. Alcohol may intensify certain side effects of the transdermal patch and you may feel unwell. Drinking grapefruit juice may intensify the effects of Prenotrix.

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 taking this medicine.

There is not sufficient experience regarding the use of Prenotrix in pregnant women. Therefore do not use Prenotrix if you are pregnant.

Buprenorphine, the active substance contained in the transdermal patch, inhibits milk formation and passes into the breast milk. Therefore, do not use Prenotrix if you are breast-feeding.

Driving and using machines

Prenotrix may make you feel dizzy or drowsy or experience blurred or double vision and 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,
• when your dosage is changed,
• when you switch to Prenotrix from another pain reliever,
• if you also use other medicines that act on the brain,
• if you drink alcohol.

If you are affected, you should not drive or operate machinery whilst using Prenotrix. This applies also at the end of treatment with Prenotrix. Do not drive or operate machinery for at least 24 hours after the patch has been removed.

• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• Prenotrix has been prescribed to treat a medical or dental problem and;
• you have taken it according to the instructions given by the prescriber or in the information provided with the medicine and;
• it was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Prenotrix contains soya oil

If you are allergic to peanut or soya, do not use this medicinal product.

3

HOW TO USE PRENOTRIX

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Prenotrix is available in three strengths: Prenotrix 35 micrograms/h transdermal patch, Prenotrix 52.5 micrograms/h transdermal patch and Prenotrix 70 micrograms/h transdermal patch.

The choice of which strength of Prenotrix will suit you best will be made by your doctor. During treatment your doctor may change which transdermal patch you use to a smaller or larger one if necessary.

The recommended dose is:

Adults

Unless your doctor has told you differently, attach one Prenotrix transdermal patch (as described in detail below) and change it after 3 days at the latest. To help you remember when to change your transdermal patch, you should make a note on the outer packaging. If your doctor has advised you to take other pain relievers in addition to the transdermal patch, strictly follow the doctor's instruc­tions, otherwise you will not fully benefit from treatment with Prenotrix.

Use in children and adolescents.

Prenotrix should not be used in persons below the age of 18years, because no experience has so far been gained in this age group.

Elderly patients

No dosage adjustment is needed for elderly patients.

Patients with kidney disease/dialysis patients In patients with kidney disease and in dialysis patients, no dosage adjustment is necessary.

Patients with liver disease

In patients with liver disease, the intensity and duration of action of Prenotrix may be affected. If this applies to you, your doctor will check on you more closely.

Method of administration

Before applying the transdermal patch

• Choose an area of skin which is flat, clean and hairless on your upper body, preferably on the chest below the collar-bone or on the upper part of the back. Call assistance if you cannot apply the transdermal patch yourself
• If the chosen area has hairs, cut them 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 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 transdermal patch from sticking properly.

Applying the transdermal patch:

Step 1. Each transdermal patch is sealed in a sachet. Just before use, open the sachet by slicing at the marked side. Take out thetransdermal pat­ch.

Step 2. Start with peel off the loose separation foil.

Step 3. The sticky side of the transdermal patch is covered with a protective foil. Carefully peel off half of the foil. Try not to touch the sticky part of the transdermal patch.

Step 4. Stick the transdermal patch onto the area of skin you have chosen and remove the remaining foil.

Step 5. Press the transdermal patch against your skin with the palm of your hand for about 30 seconds. Make sure that the whole transdermal patch is in contact with your skin, especially at the edges.

Wearing the transdermal patch

You may wear the transdermal patch for up to 3 days. Provided that you have applied the transdermal patch correctly, there is little risk of it coming off. You may shower, bathe or swim while wearing it. However, do not expose the transdermal patch to extreme heat (e.g. sauna baths, infra-red lamps, electric blankets, hot water bottles).

In the unlikely event that your transdermal patch falls off before it needs changing, do not use the same transdermal 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 sides inwards.
• Throw it away carefully, out of the sight and reach of children.
• Stick a new transdermal patch on a different skin site (as described above). Wait at least one week before using the same site again.
• The following table shows you when to change your patch:

POSSIBLE SIDE EFFECTS

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

Side effects are classified as follows:

Duration of treatment

Your doctor will tell you how long you may use Prenotrix. Do not stop using Prenotrix on your own account, because pain may return and you may feel unwell (see also „If you stop using Prenotrix“ below).

If you have the impression that the effect of the Prenotrix transdermal patch is too weak or too strong, tell your doctor or pharmacist.

If you use more Prenotrix than you should

If this happens there may be signs of an overdose of the substance buprenorphine. An overdose may intensify the side effects of buprenorphine such as drowsiness, nausea and vomiting. You may get pin-point pupils and breathing may become slow and weak. You may also get cardiovascular collapse.

As soon as you discover that you have used more transdermal patches than you should, remove the excess transdermal patches and talk to a doctor or pharmacist.

If you forget to use Prenotrix

If you forget an application, stick a new transdermal patch on as soon as you remember. If you are very late changing your transdermal patch, pain may return. In this case please contact your doctor.

Never apply twice the number of transdermal patches to make up for the forgotten application!

If you stop using Prenotrix

If you interrupt or finish using Prenotrix too soon, pain may return.

If you wish to stop use on account of unpleasant side effects, please consult your doctor. He/she will tell you what can be done and whether you can be treated with other medicines.

Some people may experience withdrawal-effects when they have used strong pain relievers for a long time and stop using them. The risk of having effects after you stop using Prenotrix is very low.

However, if you feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty sleeping or digestion problems, tell your doctor.

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

The following side effects have been reported:

Immune system disorders

Very rare: erious allergic reactions (see

below)

Metabolism and nutrition disorders

Rare: loss of appetite

Psychiatric disorders

Uncommon: confusion, sleep disorder, restlessness

Rare: illusions such as hallucinations,

anxietyand nightmares, reduced sex drive

Very rare: dependence, mood swings

Nervous system disorders

Common: dizziness, headache

Uncommon: various degrees of sedation

(calmness), ranging from tiredness to muzziness

Rare: difficulty concentrating, speech

disorder, muzziness, disturbed balance, abnormal skin sensations(num­bness, prickling or burning sensations)

Very rare: muscle twitching, taste

disorders

Eye disorders

Rare: visual disturbance, blurred

vision, swollen eyelids

Very rare: pin-point pupils

Ear disorders

Veryrare: earpain

Muscle and bone disorders

Common: jointpain

Heart and blood circulation disorders

Uncommon: circulatory disorders (such as low blood pressure or, rarely, even circulatory collapse)

Rare: hotflushes

Chest and lung disorders

Common: shortness of breath

Rare: difficulty breathing (respiratory

depression)

Very rare: abnormally rapid breathing,

hiccups

Digestive system disorders

Very common: nausea (feeling sick)

Common: vomiting, constipation

Uncommon: dry mouth

Rare: heartburn

Very rare: retching

Skin disorders (generally at the site of application)

Verycommon: redness, itching

Common: skin changes (exanthema,

generallyon repeated use), sweating

Uncommon: rash

Rare: hives

Very rare: pustules, small blisters

Urinary system disorders

Uncommon: difficulty in passing water, urine retention (less urine than normal)

Reproductive system disorders

Rare: erection difficulties

General disorders

Common: oedema (e.g. swelling of the

legs), tiredness

Uncommon: weariness

Rare: withdrawal symptoms (see

below), administration site reactions

Very rare: chest pain

If you notice any of the side effects listed above, tell your doctor as soon as possible. In some cases delayed allergic reactions occurred with marked signs of infammation. In such a case you should stop using Prenotrix after you have talked to your doctor.

If you experience swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, hives, fainting, yellowing of the skin and eyes (also called jaundice), remove the transdermal patch and call your doctor immediately or seek help at the casualty department of the nearest hospital. These can be symptoms of a very rare serious allergic reaction.

Some people may have withdrawal symptoms when they have used strong pain relievers for a long time and stop using them. The risk of having withdrawal effects when you stop using Prenotrix is low. However, if you feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty sleeping or digestion problems, tell your doctor.

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 any side effects directly via Yellow Card Scheme [] or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE PRENOTRIX

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 on the sachet after „Expiry date (month/year)“. The expiry date refers to the last day of that month.

Storage conditions: Do not store above 25°C.

Do not freeze.

Do not throw away 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.

E

CONTENTS OF THE PACK AND OTHER INFORMATION

What Prenotrix contains

The active substance is: Buprenorphine Prenotrix35 micrograms/htran­sdermal patch: Each transdermal patch contains 20 mg buprenorphine and releases about 35 micrograms of buprenorphine per hour. The area of the transdermal patch containing the active substance is 25 cm2.

Prenotrix 52.5 micrograms/h transdermal patch: Each transdermal patch contains 30 mg buprenorphine and releases about 52.5 micrograms per hour. The area of the transdermal patch containing the active substance is 37.5 cm2.

Prenotrix 70 micrograms/h transdermal patch:

Each transdermal patch contains 40 mg buprenorphine releases about 70 micrograms per hour. The area of the transdermal patch containing the active substance is 50 cm2.

The other ingredients are:

Drug containing adhesive matrix: styrene-butadiene-styrene (SBS) and styrene-butadiene block co-polymers, colophonium resin, antioxidants (2,4-Bis(1,1-Dimethylethyl)phe­nyl phosphite (3:1);

Tris(2,4-Di-Tert-Butylphenyl)phos­phate), aloe vera leaf extract oil (also contains refined soya-bean oil and alpha tocopherol acetate).

Backing foil: pigmented polyethylene, thermoplastic resin and aluminium vapour coated polyester, blue printing colour. Release liner with pull of aid: polyester film, one side siliconised (to be removed prior application).

What Prenotrix looks like and contents of the pack

Prenotrix transdermal patches are tan coloured, rectangular with four rounded edges and topped off corners and are imprinted.

Prenotrix 35 micrograms/h: Buprenorphine 35 p g/h.

Prenotrix 52.5 micrograms/h: Buprenorphine 52.5 pg/h.

Prenotrix 70 micrograms/h: Buprenorphine 70 p g/h.

Prenotrix 35 micrograms/h is available in single sealed sachets of 4, 5, 8, 10, 16, 20, 24 (6 × 4) transdermal patches.

Prenotrix 52.5 micrograms/h is available in single sealed sachets of 4, 5, 8, 10, 16, 20, 24 (6 × 4) transdermal patches.

Prenotrix 70 micrograms/h is available in single sealed sachets of 4, 5, 8, 10, 16, 20, 24 (6 × 4) transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Activase Pharmaceuticals Ltd,

11 Boumpoulinas,3rdfo­or,

P.C. 1060 Nicosia, Cyprus

Manufacturer:

Luye Pharma AG,

Am Windfeld 35,

83714 Miesbach, Germany

This leafletwas last revised in 11/2021

A0130–0131–0132/0/PIL/A7