What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL08553/0566, PL08553/0565, PL08553/0564.


Panitaz 5 micrograms/h, 10 micrograms/h, 20 micrograms/h Transdermal Patches

Package leaflet: Information for the user

Panitaz 5 micrograms/h, 10 micrograms/h, 20 micrograms/h Transdermal Patches

Buprenorphine

Important things you need to know about Panitaz

  • These patches contain a strong pain killer.
  • This medicine contains buprenorphine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
  • 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 on the same day and at the same time 7 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 information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. What Panitaz is and what it is used for

This medicine has been prescribed for you by your doctor to relieve moderate, long-lasting pain that requires the use of a strong painkiller. It contains the active ingredient buprenorphine which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Panitaz patches should not be used to relieve acute pain.

Panitaz patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch lasts for seven days.

2. What you need to know before you use Panitaz

Do not use Panitaz:

  • 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, moclobamide 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.

Panitaz must not be used to treat symptoms associated with drug withdrawal.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Panitaz:

  • 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 are or have ever been addicted to opioids, alcohol, prescription medicines or illegal drugs
  • if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
  • if you feel you need to take more Panitaz to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever
  • if you have a high temperature, as this may lead to larger quantities of the active ingredient being absorbed into the blood than normal.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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

Children and adolescents

Do not give this medicine to children below 18 years.

Other medicines and Panitaz

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

  • Panitaz patches must not be used together with a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobamide 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 Panitaz patches may be reduced.
  • Panitaz patches 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.
  • Concomitant use of Panitaz and sedatives such as benzodiazepines (medicines used to treat anxiety or to help you sleep) or related drugs increase 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 Panitaz 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.

Panitaz with food, drink and alcohol

Alcohol may make some of the side effects worse and you may feel unwell if you drink alcohol whilst wearing Panitaz patches. Drinking alcohol whilst using Panitaz patches may also affect your reaction time.

Pregnancy and breast-feeding

Do not use Panitaz patches if you are pregnant or think you might be pregnant or are planning to have a baby unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Panitaz patches during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not use Panitaz while you are breastfeeding as buprenorphine passes into breast milk and will affect your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Panitaz patches 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 Panitaz patches, or for 24 hours after removing the patch.

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 while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).
  • This defence applies when:
    • 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 and in the information provided with the medicine.Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3. How to use Panitaz

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

Your prescriber should have discussed with you, how long the course of patches will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

Different strengths of Panitaz patches are available. Your doctor will decide which strength of Panitaz patch will suit you best.

When people first start using Panitaz they often experience some nausea and vomiting (see section 4). This usually passes after the first week of treatment. It’s a good idea to book a follow-up appointment with your doctor a week or two after you first start using Panitaz patches to ensure that you are taking the correct does and to manage any side effects.

During treatment, your doctor may change the patch you use to a smaller or larger one if necessary, or tell you to use a combination of up to two patches. 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, up to a maximum total dose of 40 micrograms/hour.

Adults and elderly patients

Unless your doctor has told you differently, attach one Panitaz 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 the Panitaz patch. 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 under 18 years of age

Panitaz patches should not be used in patients below the age of 18 years.

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 Panitaz patch may be affected and your doctor will therefore check on you more closely.

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). Ask for assistance if you cannot apply the patch yourself.
  • The Panitaz 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 out the transdermal patch. Do not use the patch if the sachet seal is broken.

Step 2: The sticky side of the transdermal patch is covered with a 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 Panitaz patches (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 patch

  • Take the old 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.
  • Even used patches contain some active ingredient that may harm children or animals, so make sure your used patches are always kept out of the sight and reach of them.
  • Stick a new 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 Panitaz patch. Do not stop treatment without consulting a doctor, because your pain may return and you may feel unwell (see also “If you stop using Panitaz” below).

If you feel that the effect of the Panitaz patch is too weak or too strong, talk to your doctor or pharmacist.

If you use more Panitaz 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 Panitaz

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 Panitaz

Do not suddenly stop taking this medicine. If you stop using Panitaz patches too soon or you interrupt your treatment your pain may return. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

The pain relieving effect of Panitaz patch 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 product, 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 Panitaz patches 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.

As with all strong painkillers, there is a risk that you may become addicted or reliant on Panitaz patches.

In patients treated with Panitaz patches, 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, aggression
  • changes in taste, 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 heart beat
  • cough, hiccups, wheezing
  • wind
  • weight loss
  • dry skin
  • flushing of the skin
  • spasms, aches and pains
  • difficulty in beginning the flow of urine
  • fever
  • an increase in accidental injuries (e.g. falls)
  • withdrawal symptoms such as agitation, anxiousness, sweating or shaking upon stopping using Panitaz patches

If you need to have blood tests remind your doctor that you are using Panitaz patches. This is important because Panitaz patches 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
  • difficulty in speaking
  • 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
  • withdrawal symptoms in babies born to mothers who have been given Panitaz in pregnancy may include high-pitched crying, irritability and restlessness, shaking (tremor), feeding difficulties, sweating and not putting on weight
  • dependence and addiction (see “How do I know if I am addicted?”)

Drug Withdrawal

When you stop using Panitaz, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst using Panitaz, it could be a sign that you have become addicted

  • you need to take the medicine for longer than advised by your prescriber
  • you feel you need to use more than the recommended dose
  • you are using the medicine for reasons other than prescribed
  • when you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

If you notice any of these signs, it is important to talk to your prescriber.

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 Yellow Card Scheme, at www.mhra.gov.uk/yellowcard 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.

5. How to store Panitaz

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.

Do not store above 25°C.

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 out of sight and reach of children.

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 Panitaz patches contain

The active substance is buprenorphine.

Each 5 micrograms/h transdermal patch contains 5 mg of buprenorphine in a patch size of 6.25 cm2 and releases about 5 micrograms of buprenorphine per hour (over a period of 7 days).

Each 10 micrograms/h transdermal patch contains 10 mg of buprenorphine in a patch size of 12.5 cm2 and releases about 10 micrograms of buprenorphine per hour (over a period of 7 days).

Each 20 micrograms/h transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm2 and releases about 20 micrograms of buprenorphine per hour (over a period of 7 days).

The other ingredients are polyacrylate, povidone K90, levulinic acid, oleyl oleate, PET film, polyester web, blue printing ink.

What Panitaz patches look like and contents of the pack

Transdermal patch.

Three sizes are available.

Each 5 micrograms/h transdermal patch is beige coloured with rounded corners and is imprinted with "Buprenorphin" and "5 μg/h".

Each 10 micrograms/h transdermal patch is beige coloured with rounded corners and is imprinted with "Buprenorphin" and "10 μg/h".

Each 20 micrograms/h 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 4 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dr. Reddy’s Laboratories (UK) Ltd.
6 Riverview Road
Beverley
East Yorkshire
HU17 0LD
United Kindom

Manufacturer

betapharm Arzneimittel GmbH
Kobelweg 95
Augsburg
86156
Germany

This leaflet was last revised in 02/2020

DR408697

16181-90016-03