5, 10, 15, 20, 25, 30 and 40 micrograms / hour transdermal patches
buprenorphine
1. What Buprefarm is and what it is used for
Buprefarm 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.
Buprefarm should not be used to relieve acute pain.
Buprenorphine contained in Buprefarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Buprefarm
Do not use Buprefarm
- 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 or narcotics
- if you are taking a type of medicine called an MAOI (eg tranylcypromine, phenelzine, isocarboxazid, 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. Buprefarm should not be used to treat symptoms when you stop taking medicine.
Warnings and cautions
Talk to your doctor or pharmacist before using Buprefarm:
- 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 your bloodstream than normal body temperature
- if you have depression or other conditions treated with antidepressants. If these medicines are used together with Buprefarm, this can lead to the serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Buprefarm”).
If you have had any recent surgery, tell your doctor before using these patches.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age.
Other medicines and Buprefarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Buprefarm must not be taken in combination with so-called MAOIs (eg tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid), or if you have taken this type of medicine in the last two weeks.
- If you are taking medicines such as phenobarbital or phenytoin (medicines commonly used to treat cramps, spastic seizures, or convulsions), carbamazepine (a medicine used to treat convulsions, spastic seizures or convulsions, and certain pain conditions) or rifampicin (a medicine used to treat tuberculosis ), the effects of Buprefarm may be reduced.
- Buprefarm can 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 certain medicines for the treatment of pain, depression, anxiety, mental or mental disorders, sleeping pills, medicines for high blood pressure such as clonidine, other opioids (which can be found in painkillers or certain cough medicines, such as morphine, dextropropoxyphene, codeine, dextromethorphan or noscapine), antihistamines that make you sleepy or narcotics like halothane.
- Concomitant use of Buprefarm and sedatives or medicines for sleep disorders such as benzodiazepines (medicines used to treat anxiety or as a sleeping pill) or similar medicines increase the risk of drowsiness, difficulty breathing ( breathing 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 Buprefarm at the same time as sedatives, the dose should be one and the treatment time is limited by the 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.
Some medicines can aggravate the side effects of Buprefarm and in some cases can cause very serious reactions. Do not take other medicines while taking Buprefarm without first talking to a doctor, especially:
- Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines can affect or be affected by Buprefarm 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.
Buprefarm with alcohol
Alcohol can aggravate some of the side effects and you may feel unwell if you drink alcohol while taking Buprefarm. Drinking alcohol while using Buprefarm 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 Buprefarm if you are pregnant or if you could become pregnant during treatment.
Breast-feeding
Buprenorphine, the active substance in the patch, may inhibit milk production and pass into breast milk. Therefore, you should not use Buprefarm if you are breast-feeding.
Driving and using machines
Buprefarm 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 as a sleeping pill
- 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 Buprefarm, 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 sharpened attention. 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 Buprefarm
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 Buprefarm are available. Your doctor will decide which strength of Buprefarm is best for you.
During treatment, your doctor may change the patch you use to a smaller or larger one if needed. Do not cut or split 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 Buprefarm is too weak or too strong, talk to your doctor or pharmacist.
Adult and elderly patients
Unless your doctor has told you otherwise, apply a Buprefarm patch (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 instructed you to take other painkillers in combination with the patch, follow your doctor’s instructions carefully, otherwise you will not get the full benefit of Buprefarm treatment. 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 Buprefarm may be affected and your doctor will therefore follow you more closely.
Patients under 18 years of age
Buprefarm should not be given to patients under 18 years of age.
How to use Buprefarm
Buprefarm transdermal patch is intended for use on the skin.
Buprefarm acts through the skin. After application, buprenorphine passes through the skin into the bloodstream.
Before applying the transdermal patch
- The buprefarm patch 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 transdermal patch
Step 1: Each transdermal patch is sealed in a sachet. Just before use, cut the sachet along the sealed edge. Remove the transdermal patch. Do not use the patch unless the sachet is intact.
Step 2: The sticky side of the transdermal patch has a clear protective film. Carefully pull off one part of the film. Avoid touching the sticky side of the transdermal patch.
Step 3: Attach the transdermal patch to the selected area and remove the remaining protective film.
Step 4: Press the transdermal patch against the skin with the palm of your hand for 30 seconds. Make sure that the entire transdermal patch is in close contact with the skin, especially around the edges.
To wear the transdermal 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. The heat from the outside can also prevent the patch from sticking properly. If you have a fever, it may affect the effects of Buprefarm (see section “Warnings and precautions” above).
If the patch should come off before you need to change it, do not use the same patch again. Immediately install a new one (see “Replacing transdermal patches” below).
Replacement of transdermal patches
- Remove the old transdermal patch.
- Fold it in half with the sticky sides inwards.
- Open and take out a new patch. Use the empty sachet to dispose of the old patch. Now dispose of the sachet safely.
- Apply a new transdermal patch to another area of skin (see description above). A new patch should 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 you should be treated with Buprefarm. Do not stop treatment without consulting a doctor, as your pain may return and you may feel unwell (see also “If you stop using Buprefarm” below).
As soon as you discover that you have used more patches than you should, remove all patches. 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 use Buprefarm
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 Buprefarm
If you stop using Buprefarm too soon 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 effects when you stop taking Buprefarm 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 Buprefarm 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.
Serious side effects when using Buprefarm are reminiscent of those observed for other strong painkillers, e.g. difficulty breathing and low blood pressure.
This medicine may cause allergic reactions, however, severe allergic reactions are rare. Remove the patch and contact your doctor immediately if you experience wheezing, wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching – especially if it is spread all over the body.
There is a risk that you will become addicted to Buprefarm.
In patients treated with buprenorphine, the following other adverse reactions have been reported:
Very common (may affect more than 1 user in 10):
- Headache, dizziness, drowsiness
- Constipation, nausea, or vomiting
- Skin itching
- 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, insomnia, nervousness, tremors
- Respiratory distress
- Stomach pain or discomfort, diarrhea, indigestion, dry mouth
- Sweating, rash
- Fatigue, the feeling of abnormal weakness, muscle weakness, swollen hands, ankles, or feet
Uncommon (may affect up to 1 in 100 people):
- Mood swings, restlessness, anxiety, elation, hallucinations, nightmares, decreased sex drive, aggression
- An altered taste sensation, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness
- Memory loss, migraine, fainting, problems with concentration or coordination
- Dry eyes, blurred vision
- Ringing or rumbling sound in the ears, feeling of dizziness or dizziness
- High or low blood pressure, chest pain, fast or irregular heartbeat
- Coughing, hiccups, hissing (rustling, wheezing) breathing sounds
- Gases in the stomach
- Weight loss
- Dry skin
- Spasm you, pains
- Difficulty starting to urinate
- Difficulty emptying the bladder completely
- Urinary incontinence
- Fever
- Increase in accidents (eg fall accidents)
- Withdrawal symptoms such as agitation, anxiety, sweating, or trembling when you stop using Buprefarm
If you need to take a blood sample, remind your doctor that you are using Buprefarm. This is important because Buprefarm can affect the way the liver works and this in turn can affect the results of certain blood tests.
Rare (may affect up to 1 in 1,000 people):
- Angina pectoris (severe chest pain that occurs with heart problems)
- Psychological disorder
- Balance disorders
- Facial or eyelid swelling, the contraction of the pupil are
- Difficulty breathing, worsening of asthma, hyperventilation
- Fainting sensation, especially when getting up
- Difficulty swallowing
- Local allergic reaction with clear signs of swelling (in which case treatment should be stopped)
- Swelling and irritation of the nose
- Decreased erection, impaired sexual function
- Flu-like illness
- Reddening of the skin
- Dehydration
Very rare (may affect up to 1 in 10,000 people):
- Muscle twitching
- Ear pain
- Blisters
Has been reported (occurs in an unknown number of users):
- Seizures, spastic seizures, or convulsions
- Inflammation of the intestinal wall. Symptoms may include fever, vomiting and abdominal pain or discomfort
- Stomach pain or discomfort due to colic
- Personality change.
- Withdrawal symptoms in newborns whose mothers have received buprenorphine during pregnancy. Symptoms may include screaming, irritability and restlessness, tremors, difficulty eating, sweating, and not gaining weight.
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 Buprefarm
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. date. The expiration date is the last day of the specified month.
Buprefarm 5 micrograms/hour, Buprefarm 10 micrograms/hour, and Buprefarm 15 micrograms/hour: Do not store above 25 ° C.
Buprefarm 20 micrograms / hour, Buprefarm 25 micrograms / hour, Buprefarm 30 micrograms / hour, Buprefarm 40 micrograms / hour: This medicine does not require any special storage instructions.
Do not use the patch if the dose bag seal is broken.
Used patches should be folded with the sticky side inwards and stored in a safe way so that children do not have access to the patch. Return used patch to a pharmacy, preferably in the original packaging.
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.
Buprefarm 5 micrograms / hour:1 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).
Buprefarm 10 micrograms / hour:1 transdermal patch contains 10 mg buprenorphine in a patch size of 12.5 cm 2and releases 10 micrograms buprenorphine per hour (over a period of 7 days).
Buprefarm 15 micrograms / hour:1 transdermal patch contains 15 mg of buprenorphine in a patch size of 18.75 cm 2 and delivers 15 micrograms of buprenorphine per hour (over a period of 7 days).
Buprefarm 20 micrograms / hour:1 transdermal patch contains 20 mg buprenorphine in a patch size of 25 cm 2 and releases 20 micrograms buprenorphine per hour (over a period of 7 days).
Buprefarm 25 micrograms / hour:1 transdermal patch contains 25 mg buprenorphine in a patch size of 31.25 cm 2and delivers 25 micrograms buprenorphine per hour (over a period of 7 days).
Buprefarm 30 micrograms / hour:1 transdermal patch contains 30 mg of buprenorphine in a patch size of 37.5 cm 2and emits 30 micrograms of buprenorphine per hour (for a period of 7 days).
Buprefarm 40 micrograms / hour:1 transdermal patch contains 40 mg buprenorphine in a patch size of 50 cm 2 and emits 40 micrograms buprenorphine per hour (for a period of 7 days). - Other ingredients are Adhesive layer (containing buprenorphine): povidone, levulinic acid, oleyl oleate, acrylic acid-butyl acrylate (2-Ethylhexyl) acrylate-vinyl acetate copolymer.
Adhesive layer (without buprenorphine): (2-ethylhexyl) acrylate-glycidyl methacrylate- (2-hydroxyethyl) acrylate-vinyl acetate copolymer.
Separating film between adhesive layers with and without buprenorphine: Polyethylene terephthalate film.
Backing: polyester.
Protective layer: Polyethylene terephthalate film (siliconized)
Blue ink.
What the medicine looks like and the contents of the pack
Depot patches.
Seven sizes are available.
Buprefarm 5 micrograms/hour: Each transdermal patch is beige with rounded corners and marked “Buprenorphine” and “5 μg / h”.
Buprefarm 10 micrograms/hour: Each transdermal patch is beige with rounded corners and marked “Buprenorphine” and “10 μg / h”.
Buprefarm 15 micrograms/hour: Each transdermal patch is beige with rounded corners and marked “Buprenorphine” and “15 μg / h”.
Buprefarm 20 micrograms/hour: Each transdermal patch is beige with rounded corners and marked “Buprenorphine” and “20 μg / h”.
Buprefarm 25 micrograms/hour: Each transdermal patch is beige with rounded corners and marked “Buprenorphine” and “25 μg / h”.
Buprefarm 30 micrograms/hour: Each transdermal patch is beige with rounded corners and marked “Buprenorphine” and “30 μg / h”.
Buprefarm 40 micrograms/hour: Each transdermal patch is beige with rounded corners and marked “Buprenorphine” and “40 μg / h”.
A sealed, child-protective sachet contains a transdermal patch. The patches are available in cartons containing 1, 2, 3, 4, 5, 8, 10, or 12 transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com