HAPOCTASIN 52.5 MICROGRAMS / H TRANSDERMAL PATCHES - patient leaflet, side effects, dosage

Patient leaflet - HAPOCTASIN 52.5 MICROGRAMS / H TRANSDERMAL PATCHES

Hapoctasin 35microgram/h, 52.5microgram/h and 70microgram/h transdermal patches

Buprenorphine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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
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

5] what hapoctasin is and what it is used for

2] What you need to know before you use Hapoctasin

51 How to use Hapoctasin

4l Possible side effects

51 How to store Hapoctasin

6l Contents of the pack and other information

51 What Hapoctasin is and what it is used for

Hapoctasin 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.

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

51 what you need to know before you use hapoctasin

Do not use Hapoctasin if you:

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

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

Warnings and precautions

Talk to your doctor or pharmacist before using Hapoctasin

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 Hapoctasin”)
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 Hapoctasin can lead to serotonin syndrome, a potentially life-threatening condition (see ‘Other medicines and Hapoctasin’).

Also, please be aware of the following precautions:

Some people may become dependent on strong pain relievers such as Hapoctasin when they use them over a long period of time. They may have withdrawal effects when they stop using them (see “If you stop using Hapoctasin”).
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, hot water bottles) and consult your doctor if you have a fever.

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

Sleep-related breathing disorders

Buprenorphine can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Children and adolescents

Hapoctasin should 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 Hapoctasin

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 Hapoctasin and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Hapoctasin without first talking to your doctor, especially: Anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Hapoctasin 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. Contact your doctor when experiencing such symptoms.
Hapoctasin 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 in the last 2 weeks.
Hapoctasin 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 tranquillisers, anti-depressants and neuroleptics.
Concomitant use of Hapoctasin and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Hapoctasin together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

If Hapoctasin is used together with some medicines, the effects of the transdermal patch may be increased. These medicines include e.g. certain anti-infectives/antifungals (e.g. containing erythromycin or ketoconazole) or HIV medicines (e.g. containing ritonavir).
If Hapoctasin 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).

Hapoctasin with food, drink and alcohol

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

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.

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

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

Driving and using machines

Hapoctasin 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 Hapoctasin 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 Hapoctasin. This applies also at the end of treatment with Hapoctasin. Do not drive or operate machinery for at least 24 hours after the patch has been removed.

Discuss with your doctor or pharmacist if you are unsure about anything.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you.
It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
– The medicine 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.

Hapoctasin contains soya oil.

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

51 how to use hapoctasin

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

Hapoctasin is available in three strengths:

Hapoctasin 35microgram/h transdermal patch, Hapoctasin 52.5microgram/h transdermal patch and Hapoctasin 70microgram/h transdermal patch.

The choice of which strength of Hapoctasin 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 Hapoctasin 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 Hapoctasin.

Use in children and adolescents

Hapoctasin should not be used in persons below the age of 18 years, 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 Hapoctasin may be affected. If this applies to you, your doctor will check on you more closely.

Instruction for opening of child resistant pouch

1. Incise up to markings / arrowheads at each side
2. Rip at both notches along the heat-sealed joint
3. Open the pouch and take out the patch.

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:

1. Please do not open the sachet before you actually intend to use the transdermal patch. Each transdermal patch is sealed in a sachet.
2. Start with peeling off the loose separation film.
3. Peel off one half of the strip-film of the transdermal patch and try not to touch the sticky part.
4. Stick the transdermal patch onto the area of skin you have chosen and remove the remaining film.
5. Press the transdermal patch against your skin with the palm of your hand for 30 to 60 seconds. Make sure that the whole transdermal patch is in contact with your skin, especially at the edges.
6. Wash your hands after using the transdermal patch. Do not use any cleansing products.

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.

Possible side effects

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

Side effects are classified as follows:

Very common:

may affect more than 1 in 10 people

Common:

may affect up to 1 in 10 people

Uncommon:

may affect up to 1 in 100 people

Rare:

may affect up to 1 in 1,000 people

Very rare:

may affect up to 1 in 10,000 people

Not known:

frequency cannot be estimated from the available data

The following side effects have been reported:

Immune system disorders

Very rare: serious allergic reactions (see below)

Metabolism and nutrition disorders

Rare: loss of appetite

Psychiatric disorders

Uncommon: confusion, sleep disorder, restlessness

Rare: illusions such as hallucinations, anxiety and 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

Very rare: ear pain

Heart and blood circulation disorders

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

circulatory collapse)

Rare: hot flushes

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)

Very common: redness, itching

Common: skin changes (exanthema, generally on repeated use), sweating

Uncommon: rash

Rare: hives

Very rare: pustules, small blisters

Not known: dermatitis contact (skin rash with inflammation which may

include burning sensation), skin discolouration

Musculoskeletal and connective tissue disorders

Common: arthralgia (joint pain)

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 inflammation. In such a case you should stop using Hapoctasin 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 and 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 Hapoctasin 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

T|

How to store Hapoctasin

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”. 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 to protect the environment.

6l

Contents of the pack and other information

What Hapoctasin contains

The active substance is: Buprenorphine.

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

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

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

The other ingredients are:

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 layer: pigmented polyethylene, thermoplastic resin and aluminium vapour coated polyester, blue printing colour.

Release liner with pull off aid: polyester film, one side siliconised (to be removed prior application).

What Hapoctasin looks like and contents of the pack

The patches are tan coloured rectangular with four rounded edges and topped off corners and imprinted with Buprenorphin 35 pg/h.

The patches are tan coloured, rectangular with four rounded edges and topped off corners and imprinted with Buprenorphin 52.5 pg/h.

The patches are tan coloured, rectangular with four rounded edges and topped off corners and imprinted with Buprenorphin 70 pg/h.

Each patch is packed in single sealed sachets.

Hapoctasin 35microgram/h is available in single sealed sachets of 4 transdermal patches.

Hapoctasin 52.5microgram/h is available in single sealed sachets of 4 transdermal patches.

Hapoctasin 70microgram/h is available in single sealed sachets of 4 transdermal patches.

The following strengths of the patches are available:

Hapoctasin 35microgram/h, Hapoctasin 52.5 microgram/h, Hapoctasin 70 microgram/h

Marketing Authorisation Holder

Accord, Barnstaple, EX32 8NS, UK

Manufacturers

Luye Pharma AG Am Windfeld 35 D-83714 Miesbach Germany

This leaflet was last revised in December 2021

If you would like a leaflet with larger text, please contact 01271 385257.

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