Bupremyl 5 micrograms / hour transdermal patch, Bupremyl 10 micrograms / hour transdermal patch, Bupremyl 20 micrograms / hour transdermal patch
buprenorphine
1. What Bupremyl is and what it is used for
Bupremyl transdermal patch contains the active substance buprenorphine which belongs to a group of medicines called strong painkillers. It has been prescribed for you by your doctor to relieve moderate, prolonged pain that requires a strong painkiller.
Bupremyl should not be used to relieve acute pain.
The buprenorphine contained in Bupremyl may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you use Bupremyl
Do not use Bupremyl
- 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 a drug addict
- if you are taking a type of medicine called an MAOI (eg 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 special type of severe muscle weakness)
- if you have previously suffered from withdrawal symptoms such as anxiety, tremors or sweating when you quit alcohol.
Bupremyl should not be used to treat symptoms when you stop taking a medicine.
Warnings and cautions
Talk to your doctor, pharmacist or nurse before using Bupremyl:
- if you suffer from seizures, spastic seizures or convulsions
- if you suffer from severe headaches or feel unwell after a head injury or increased pressure in the head (eg due to a brain injury). The patches can aggravate or hide the extent of a head injury.
- if you feel dizzy or weak
- if you have severe liver problems
- if you have abused drugs or alcohol
- if you have a fever, as it may lead to greater amounts of the active substance being absorbed into the bloodstream than at normal body temperature.
- if you have depression or other conditions treated with antidepressants. If these medicines are used together with Bupremyl, this can lead to serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Bupremyl”).
If you have had any recent surgery, tell your doctor before using these patches .
Athletes should be aware that this drug may have a positive effect on doping controls.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age.
Other medicines and Bupremyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Bupremyl must not be taken in combination with so-called MAOIs (eg tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid), or if you have been taking this type of medicine in the last two weeks.
- Bupremyl may in some cases cause very severe reactions when taken with antidepressants such as citalopram , escitalopram, fluoxetine , fluvoxamine, paroxetine , sertraline , duloxetine, venlafaxine , amitriptyline, doxepine or trimipramine. These medicines can affect or be affected by Bupremyl and you may experience symptoms such as involuntary rhythmic muscle twitching, even in the muscles that control eye movements, agitation, hallucinations, coma , heavy sweating, tremors, intensified reflexes, tense muscles and body temperature above 38 ° C. Contact your doctor if you experience such symptoms.
- If you are taking medicines such as phenobarbital or phenytoin (medicines commonly used to treat cramps, spastic seizures or convulsions), carbamazepine (medicines used to treat seizures, spastic seizures, convulsions or certain pain conditions) or rifampicin (medicines used to treat treat tuberculosis ), the effects of Bupremyl may be reduced.
- Bupremyl may make some people feel sleepy, nauseous or weak or make them breathe slower or weaker. These side effects may get worse if other medicines that cause the same side effect are taken at the same time. These include medicines to treat pain, depression, anxiety, mental or mental disorders, sleeping pills, medicines for high blood pressure such as clonidine , other opioids (which may be found in painkillers or certain cough medicines, such as morphine, dextroproproxifene, codeine , dextromethorphan or noskapin), antihistaminesthat make you sleepy or narcotics like halothane.
- Concomitant use of Bupremyl and sedatives for sleep disorders such as benzodiazepines or similar drugs increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.If your doctor prescribes Bupremyl at the same time as sedatives, your dose and treatment time should be limited by your doctor. Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Bupremyl with alcohol
Alcohol can aggravate some of the side effects and you may feel unwell if you drink alcohol while taking Bupremyl. Drinking alcohol while you are taking Bupremyl may also affect your ability to react.
Pregnancy, breastfeeding 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.
Pregnancy
There is insufficient experience with the use of buprenorphine in pregnant women. Therefore, you should not use Bupremyl if you are pregnant or if you could become pregnant during treatment.
Breast-feeding
Buprenorphine, the active substance in the patch, can inhibit milk production and pass into breast milk. Therefore, you should not use Bupremyl if you are breast-feeding.
Driving and using machines
Bupremyl can affect your ability to react so much that you do not react correctly or quickly enough in the event of unexpected or sudden events. This is especially true:
- at the beginning of treatment
- if you are taking medicines for anxiety or sleeping pills
- if you receive an increased dose .
If you are affected (eg feeling dizzy, drowsy or have blurred vision). you should not drive or use machines while using Bupremyl, or for 24 hours after removing the patch.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Bupremyl
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Different strengths of Bupremyl are available. Your doctor will decide which strength of Bupremyl is best for you.
During treatment, your doctor may change the patch you use to a smaller or larger one if needed. Do not divide the patch and do not use a higher dose than recommended. You should not use more than two patches at a time.
If you have the impression that the effect of Bupremyl is too weak or too strong, talk to your doctor or pharmacist.
Adult and elderly patients
Unless your doctor tells you otherwise, attach a Bupremyl (according to the detailed description below) and change it every seven days, preferably at the same time of day. Your doctor may want to adjust the dose one after 3-7 days until the correct level of pain control has been found. If your doctor has advised you to take one or more painkillers in combination with the patch, follow your doctor’s instructions carefully, otherwise you will not get the full benefit of the treatment with Bupremyl. The patch should be worn for three full days before dose one is increased, this is when the given dose one reaches full effect.
Patients with kidney disease / dialysis patients
In patients with kidney disease, the dose does not need to be changed.
Patients with liver disease
In patients with liver disease, the effects and duration of action of Bupremyl may be affected and your doctor will therefore follow you more closely.
Patients under 18 years of age
Bupremyl should not be given to patients under 18 years of age.
Method of administration
Bupremyl is intended to be applied to the skin.
Bupremyl transdermal patches work through the skin. After application, buprenorphine passes through the skin into the bloodstream.
Before applying the transdermal patch
- Bupremyl should be applied to a skin area where there is not much hair. If there are no suitable hairless skin areas, the hair should be cut off with scissors. Do not shave them.
- Avoid skin that is red, irritated or has other damage such as large scars.
- The area of skin you choose must be dry and clean. Wash with cold or lukewarm water if necessary. Do not use soap, alcohol, oil, lotions or other cleaning products. Wait until the skin is completely dry and cool after a hot bath or shower. Do not apply lotion, skin cream or ointment to the selected area of skin. This may prevent the patch from sticking properly.
Application of the patch
To wear the patch
You should wear the patch for seven days. If you have applied the patch correctly, there is a small risk that it will come off. If the edges of the patch begin to come loose, you can tape them with suitable skin tape. You can bathe, shower or swim with the patch.
Do not expose the patch to strong heat (eg heating pads, electric blankets, heat lamps, saunas, hot baths, heated water beds, hot water bottles, etc.) as it may increase the body’s uptake of the active substance into the bloodstream. Heat from the outside can also prevent the patch from sticking properly. If you have a fever, it may affect the effects of Bupremyl (see section “Warnings and precautions” above).
If the patch should come off before you need to change it, do not use the same patchagain. Immediately insert a new one (see “Replacing the patch” below).
Replacing patches
- Remove the old patch.
- Fold it in half with the sticky sides inwards.
- Open and take out a new patch . Use the empty bag to dispose of the old patch. Now throw the bag safely.
- Apply a new patch on another area of skin (see description above). A new patchshould not be applied to the same skin area for 3-4 weeks.
- Remember to always change your patch at the same time of day. It is important that you record the time of day.
Length of treatment
Your doctor will tell you how long to take Bupremyl. Do not stop treatment without consulting a doctor, as your pain may return and you may feel unwell (see also “If you stop using Bupremyl” below).
As soon as you discover that you have used more patches than you should, remove all patches and call a doctor or hospital immediately. People who have had an overdose may feel very sleepy and feel unwell. They may also have difficulty breathing or lose consciousness and may need emergency hospital care. When you seek care, take this leaflet and any remaining patches with you and show them to your doctor.
If you forget to install a Bupremyl
Put on a patch as soon as you remember. Also write down the date, as your regular changeover day may now have changed. If you are very late in changing patches , your pain may return. In this case, contact your doctor.
Do not apply extra patches to compensate for forgetting to apply one.
If you stop using Bupremyl
If you stop using Bupremyl too quickly or if you stop treatment, your pain may return. Ask your doctor if you want to stop treatment. Your doctor can tell you what can be done and if you can be treated with other medicines.
Some people may experience side effects when they have been using strong painkillers for a long time and then stop using them. The risks of having side effectswhen you stop taking Bupremyl are very small. However, tell your doctor if you feel upset, anxious, nervous or shaky, if you become overactive, have difficulty sleeping or indigestion.
The analgesic effect from Bupremyl remains for some time after the patch has been removed. Do not start taking another opioid (strong painkiller) until 24 hours after the patch has been removed.
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.
Like all strong painkillers, there is a risk that you will become addicted to Bupremyl.
Serious side effects when using Bupremyl are similar to those observed with other strong painkillers, e.g. difficulty breathing and low blood pressure .
Remove the patch and contact your doctor immediately if you get any of the following side effects:
Uncommon (may affect up to 1 in 100 people)
- sudden wheezing, difficulty swallowing or breathing, swelling of the face or lips, rash or itching , especially if it is spread all over the body. These may be symptoms of a severe allergic reaction (hypersensitivity, anaphylaxis ).
- inability of the heart to pump blood or lack of circulation (circulatory collapse)
- inability to empty the bladder ( urinary retention ).
Rare (may affect up to 1 in 1,000 people)
- chest pain that occurs with heart problems (angina)
- severe respiratory problems (respiratory failure, impaired respiratory function)
- persistent constipation with swollen stomach and vomiting (intestinal upset).
Other possible side effects:
Very common (may affect more than 1 user in 10)
- headache, dizziness, drowsiness
- constipation, nausea, vomiting
- itchy skin, reddening of the skin
- skin rash, redness , itching , inflammation or swelling at the application site
Common (may affect up to 1 in 10 people)
- loss of appetite
- confusion, depression, anxiety, insomnia, nervousness, tremor ( tremors )
- respiratory distress
- abdominal pain or discomfort, diarrhea, indigestion, dry mouth
- sweating, rash, other skin reactions (exanthema)
- fatigue, feeling of abnormal weakness, muscle weakness, swollen hands, ankles or feet ( edema ).
Uncommon (may affect up to 1 in 100 people)
- difficulty sleeping, restlessness, anxiety, elation, mood swings, hallucinations, nightmares, decreased sex drive, aggression
- taste distortion, speech difficulties, decreased sensitivity to pain or touch, tingling or numbness in the hands and feet
- memory loss, migraine , fainting, concentration and coordination problems
- dry eyes, blurred vision
- ringing or rumbling sound in the ears ( tinnitus ), feeling of dizziness or dizziness ( vertigo )
- high or low blood pressure , chest pain, fast or irregular heartbeat
- cough, hiccup, hissing (rustling, wheezing) breathing sounds
- gas in the stomach
- weight loss
- dry skin
- muscle spasms, aches and pains ( myalgia )
- urination disorders, inability to control urine
- fatigue (exhaustion)
- fever, chills
- local allergic reactions with clear signs of inflammation (in which case treatment should be discontinued)
- reddening of the skin
- increase in accidents (eg fall accidents)
- withdrawal symptoms such as agitation, anxiety, sweating or trembling when you stop using this medicine
- changes in liver function tests (seen in blood tests).
Rare (may affect up to 1 in 1,000 people)
- mental health problems
- balance disorders
- abnormal vision, facial or eyelid swelling, the contraction of the pupil are
- exacerbation of asthma , unusually rapid or deep breathing
- a feeling of dullness, especially standing
- difficulty swallowing
- itchy, runny nose (runny nose)
- decreased erection , impaired sexual function
- flu-like symptoms
- thirst and dark urine (dehydration).
Very rare (may affect up to 1 in 10,000 people)
- drug addiction
- small muscle twitches
- ear pain
- pimples or blisters on the skin
Has been reported (occurs in an unknown number of users)
- seizures, spastic seizures or convulsions
- inflammation of the intestinal wall ( diverticulitis ) whose symptoms may be fever, vomiting and abdominal pain or discomfort
- repeated pains in the upper abdomen (biliary colic)
- personality change
- Withdrawal symptoms in infants of mothers who received buprenorphine during pregnancy may include crying, irritability and restlessness, tremors, difficulty feeding, sweating and lack of weight gain.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information
5. How to store Bupremyl
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 patch envelope after EXP.
The expiration date is the last day of the specified month.
5 micrograms / hour and 10 micrograms / hour: Do not store above 25 ° C.
20 micrograms / hour: No special storage instructions.
Do not use the patch if the seal is broken.
The applied patch should be folded with the sticky side inwards and discarded safely.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is buprenorphine.
Bupremyl 5 micrograms / hour transdermal patch:
Each transdermal patch contains 5 mg of buprenorphine in a patch size of 6.25 cm 2and releases 5 micrograms of buprenorphine per hour (over a period of 7 days).
Bupremyl 10 micrograms / hour transdermal patch:
Each transdermal patch contains 10 mg of buprenorphine in a patch size of 12.5 cm 2and releases 10 micrograms of buprenorphine per hour (over a period of 7 days).
Bupremyl 20 micrograms / hour transdermal patch:
Each transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm 2and releases 20 micrograms of buprenorphine per hour (over a period of 7 days).
Other ingredients are:
- Povidon K90
- Levulinic acid
- Oleyloleat
- Polyacrylate (5: 15: 75: 5 and 68: 0.15: 5: 27)
- Polyethylene terephthalate
- Polyester
- Siliconized polyethylene terephthalate
- Blue ink
What the medicine looks like and contents of the pack
Depot patches . There are three different sizes:
5 micrograms / hour:
rectangular, beige patch with rounded corners marked Buprenorphine 5 μg / h blue
10 micrograms / hour:
rectangular, beige patch with rounded corners marked Buprenorphine 10 μg / h blue
20 micrograms / hour:
rectangular, beige patch with rounded corners marked Buprenorphine 20 μg / h blue
Each transdermal patch is sealed in a protective envelope. Bupremyl is available in cartons containing 2, 4, 8 or 12 patches .
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
info@mylan.se
Manufacturer
tesa Labtec GmbH, Heykenaukamp 10, 21147 Hamburg,
Germany.
McDermott Lab. Ltd. t / a
Gerard Lab. t / a Mylan Dublin,
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13, Ireland