5 micrograms / hour, 10 micrograms / hour, 15 micrograms / hour, 20 micrograms / hour depot
buprenorphine
1. What Buprenorphine Sandoz is and what it is used for
Buprenorphine Sandoz transdermal patch contains the active substance buprenorphine which belongs to a group of medicines called strong painkillers.
Buprenorphine Sandoz is used in adults to relieve moderate, prolonged pain that requires a strong painkiller.
Buprenorphine Sandoz should not be used to relieve acute pain.
The buprenorphine contained in Buprenorphine Sandoz 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 you use Buprenorphine Sandoz
Do not use Buprenorphine Sandoz
- 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 monoamine oxidase inhibitor ( 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.
Buprenorphine Sandoz should not be used to treat symptoms when you stop taking a medicine.
Warnings and cautions
Talk to your doctor or pharmacist before using Buprenorphine Sandoz if you:
- recently drank a lot of alcohol
- suffers from seizures, spastic seizures or convulsions
- suffers from severe headache or feels 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.
- feeling dizzy or weak
- have severe liver problems
- have abused drugs, drugs or alcohol
- have a fever, as it can lead to greater amounts of the active substance being absorbed by the blood than at normal body temperature.
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 Buprenorphine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Buprenorphine Sandoz must not be used in combination with so-called MAOIs (eg tranylcypromine, phenelzine, isocarboxazide, 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 (medicines used to treat convulsions, spastic seizures or convulsions and certain pain conditions) or rifampicin (medicines used to treat treat tuberculosis ), the effects of Buprenorphine Sandoz may be reduced.
- Buprenorphine Sandoz 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, dextropropoxyphene , codeine , dextromethorphan or noskapin), antihistaminesthat make you sleepy or narcotics like halothane.
- Concomitant use of Buprenorphine Sandoz with sedatives or antiepileptic drugs such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when no other treatment options are possible. If your doctor prescribes Buprenorphine Sandoz at the same time as sedatives, you should take a doseone 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.
Buprenorphine Sandoz with alcohol
Alcohol can aggravate some of the side effects and you may feel unwell if you drink alcohol while using Buprenorphine Sandoz. Drinking alcohol while using Buprenorphine Sandoz may also affect your ability to react.
Pregnancy and breastfeeding
Do not use Buprenorphine Sandoz if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
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.
Driving and using machines
Buprenorphine Sandoz 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 Buprenorphine Sandoz, 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 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 Buprenorphine Sandoz
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 Buprenorphine Sandoz are available. Your doctor will decide which strength of Buprenorphine Sandoz is best for you.
When patients start using Buprenorphine Sandoz, they often experience some nausea and vomiting (see section 4). This usually resolves after the first week of treatment. It is a good idea to book a follow-up appointment with your doctor a week or two after you start using Buprenorphine Sandoz patches to make sure you are taking the right dose and to deal with any side effects .
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 up to a maximum total dose of 40 micrograms / hour.
If you have the impression that the effect of Buprenorphine Sandoz is too weak or too strong, talk to your doctor or pharmacist.
Adult and elderly patients
Unless your doctor tells you otherwise, attach a Buprenorphine Sandoz transdermal patch (as described in detail 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 your treatment with Buprenorphine Sandoz. 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 liver disease
In patients with liver disease, the effects and duration of action of Buprenorphine Sandoz may be affected and your doctor will therefore follow you more closely.
Use for children and adolescents
Buprenorphine Sandoz transdermal patches should not be given to patients under 18 years of age.
Method of administration
Buprenorphine Sandoz is intended for use on the skin.
Buprenorphine Sandoz acts through the skin. After applying (applying) the patch, buprenorphine passes through the skin into the bloodstream.
Before applying Buprenorphine Sandoz transdermal patches
- Choose a skin area that is not irritated or damaged on the outside of the upper arm, the upper part of the chest, the upper part of the back or on the side of the chest (see the pictures below). Ask for help if you can not attach the patch yourself.
- Buprenorphine Sandoz transdermal patches 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
Step 1. Each patch is sealed in a protective bag. Just before use, open the protective bag by tearing along the marked line. Remove the patch. Do not use the patch unless the protective bag is intact.
Step 2. The sticky side of the patch has a clear protective film. Carefully pull off one part of the protective film. Avoid touching the sticky side of the patch.
Step 3. Apply the patch to the selected area of skin and remove the remaining protective film.
Step 4. Press the patch against the skin with the palm of your hand for 30 seconds. Make sure that the entire patch is in close contact with the skin, especially around the edges.
To wear the patch
You must wear the transdermal 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 Buprenorphine Sandoz (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 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.
- Even using patches containing active substances that may harm children or animals, so make sure to use patches stored out of the reach and sight of them.
- Apply a new patch on 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 to take Buprenorphine Sandoz transdermal patches. Do not stop treatment without consulting a doctor, as your pain may return and you may feel unwell (see also “If you stop using Buprenorphine Sandoz” below).
As soon as you discover that you have used more patches than you should, remove all patches and contact 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 Buprenorphine Sandoz
Put on a transdermal 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 Buprenorphine Sandoz
If you stop using Buprenorphine Sandoz 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 side effects when you stop taking Buprenorphine Sandoz 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 of Buprenorphine Sandoz 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 Buprenorphine Sandoz 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, or difficulty breathing. So even if the eyelids, face or lips swell up, and if you get a rash or itching – especially if it is spread all over the body.
There is a risk that you will become addicted to Buprenorphine Sandoz.
In patients treated with Buprenorphine Sandoz, the following other side effects have been reported:
Very common (may affect more than 1 user in 10)
- Headache, dizziness, drowsiness
- Constipation, nausea, or vomiting
- Skin itching, reddening of the skin
- Skin rash, itching , redness , inflammation or swelling 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, eczema , rash
- Fatigue, a feeling of abnormal weakness, muscle weakness, edema (eg 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
- Taste distortion, decreased sensitivity to pain or touch, tingling or numbness
- Memory loss, migraine, fainting, problems with concentration or coordination
- Dry eyes, blurred vision
- Ringing or roaring sound in the ears
- Feeling of dizziness or dizziness
- High or low blood pressure , chest pain, fast heartbeat, feeling the heart beating, redness
- Coughing, hiccups, hissing (rustling, wheezing) breathing sounds
- Gases in the stomach
- Weight loss
- Dry skin
- Spasm you, pains
- Difficulty urinating, urination disorders, involuntary urination
- Fever
- Increase in accidents (eg fall accidents)
- Abstinence symptoms such as agitation, anxiety, sweating or trembling when you stop using Buprenorphine Sandoz
If you need to take a blood sample, remind your doctor that you are using Buprenorphine Sandoz. This is important because Buprenorphine Sandoz can affect the way your 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 (chest pain that occurs in heart disease)
- Psychotic disorder
- Balance disorders
- Facial or eyelid swelling, the contraction of the pupil are
- Difficulty breathing, worsening of asthma, hyperventilation
- A feeling of dullness, especially standing
- Speech difficulties
- Difficulty swallowing, bowel obstruction
- Local allergic reactions 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
- Dehydration
Very rare (may affect up to 1 in 10,000 people)
- Muscle twitching
- Ear pain
- Blister-filled blisters
- Drug addiction
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 received Buprenorphine Sandoz 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 Buprenorphine Sandoz
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 after EXP. or EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Do not use the patch if the closure of the protective bag is broken.
Used patches should be folded with the sticky side inwards and discarded in a safe way so that children do not access the patch.
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.
Buprenorphine Sandoz 5 micrograms / hour transdermal patch:
Each 6.25 cm 2 transdermal patch contains 5 mg of buprenorphine and emits 5 micrograms of buprenorphine per hour.
Buprenorphine Sandoz 10 micrograms / hour transdermal patch:
Each 12.5 cm 2 transdermal patch contains 10 mg buprenorphine and emits 10 micrograms buprenorphine per hour.
Buprenorphine Sandoz 15 micrograms / hour transdermal patch:
Each 18.75 cm 2 transdermal patch contains 15 mg of buprenorphine and emits 15 micrograms of buprenorphine per hour.
Buprenorphine Sandoz 20 micrograms / hour transdermal patch:
Each 25 cm 2 transdermal patch contains 20 mg of buprenorphine and emits 20 micrograms of buprenorphine per hour.
- Other ingredients are:
Protective layer (removed before applying the patch): siliconized poly (ethylene terephthalate) film.
Adhesive layer (containing buprenorphine) : levulinic acid, oleyl oleate, povidone K90, acrylic acid-butyl acrylate 2- (ethylhexyl) acrylate-vinyl acetate copolymer (5: 15: 75: 5).
Separating film (between the adhesive layers with and without buprenorphine): poly (ethylene terephthalate) film.
Adhesive layer (without buprenorphine) : acrylate adhesive.
Backing layer (with printed text): polyurethane film, printing ink.
What the medicine looks like and the contents of the pack
Buprenorphine Sandoz is a pale yellow-brown rectangular transdermal patch with rounded corners marked “Buprenorphinum 5 μg / h”, “Buprenorphinum 10 μg / h”, “Buprenorphinum 15 μg / h” or “Buprenorphinum 20 μg / h”.
Each patch is individually packaged in a child-resistant bag.
Carton containing 1, 2, 3, 4, 5, 8, 10, 12 or 20 transdermal patches .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sandoz A / S, Edvard Thomsens Vej, 14, 2300 Copenhagen S, Denmark
Manufacturer
Hexal AG, Industriestrasse 25, 83607 Holzkirchen, Germany