5 micrograms / hour, 10 micrograms / hour, 20 micrograms / hour depot patch
buprenorphine
What Buprenorphine Glenmark is and what it is used for
Buprenorphine Glenmark contains the active substance buprenorphine which belongs to a group of medicines called strong analgesics or “painkillers”.
Your doctor has prescribed this to relieve moderate, prolonged pain that requires the use of a strong painkiller.
Buprenorphine Glenmark should not be used to relieve acute pain.
Buprenorphine Glenmark transdermal patches work through the skin. After application, buprenorphine passes through the skin into the bloodstream. Each transdermal patch works for seven days.
The buprenorphine contained in Buprenorphine Glenmark 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 Glenmark
Do not use Buprenorphine Glenmark
- 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 have myasthenia gravis (a condition with a specific type of severe muscle weakness)
- if you have previously had withdrawal symptoms such as worry, anxiety, tremors, or sweating when you quit alcohol.
Buprenorphine Glenmark should not be used to treat symptoms when you stop taking medicine.
Warnings and cautions
Talk to your doctor or pharmacist before using Buprenorphine Glenmark:
- if you have seizures, spastic seizures, or convulsions
- if you have 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 normal body temperature.
- if you have depression or other conditions treated with antidepressants. If these medicines are used in combination with Buprenorphine Glenmark, this can lead to the serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Buprenorphine Glenmark”).
If you have recently had surgery, talk to 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 Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- 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 Buprenorphine Glenmark 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.
- Buprenorphine Glenmark must not be taken with 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 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 tuberculosis ) the effects of Buprenorphine Glenmark may be reduced.
- Buprenorphine Glenmark may make some people feel drowsy, nauseous, or weak or make them breathe slower or weaker. These side effects may get worse if you take other medicines that cause the same side effects 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 are (against eg allergy) that makes you drowsy or narcotics like halothane.
- Buprenorphine Glenmark must be used with caution if you are also taking benzodiazepines (medicines used to treat anxiety or as a sleeping pill). This combination can cause severe breathing problems.
Concomitant use of Buprenorphine Glenmark with sedatives or sleeping pills such as benzodiazepines or similar medicines increases 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.
However, if your doctor prescribes Buprenorphine Glenmark together with sedative (sedative) medicine, the dose should be one and the duration of treatment for concomitant treatment should be limited by your doctor.
Tell your doctor if you are taking any sedatives, and follow your doctor’s dosing recommendation carefully. It may be a good idea to inform friends or relatives that they should be aware of the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Buprenorphine Glenmark with alcohol
Alcohol can aggravate some of the side effects and you may feel unwell if you drink alcohol while taking Buprenorphine Glenmark. Drinking alcohol while using Buprenorphine Glenmark 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 Buprenorphine Glenmark if you are pregnant or if you could become pregnant during treatment.
Breast-feeding
Buprenorphine, the active substance in the transdermal patch, can inhibit milk production and pass into breast milk. Therefore, you should not use Buprenorphine Glenmark if you are breast-feeding.
Driving and using machines
Buprenorphine Glenmark 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 Buprenorphine Glenmark 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.
How to use Buprenorphine Glenmark
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Buprenorphine Glenmark is available in different strengths. Your doctor will decide which strength of Buprenorphine Glenmark is best for you.
When patients start using Buprenorphine Glenmark, 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 Glenmark 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 necessary. 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 Glenmark 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 Glenmark patch(according to the detailed description below) and replace it every seven days, preferably at the same time of day. The 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 other painkillers in combination with the patch, follow your doctor’s instructions carefully, otherwise you will not get the full benefit of the treatment with Buprenorphine Glenmark. The patch should be worn for 3 full days before dose one is increased, this is when the given dose one reaches full effect.
Patients with kidney disease/dialysis patients
No specific dose change is necessary for patients with kidney disease.
Patients with liver disease
In patients with liver disease, the effects and duration of action of Buprenorphine Glenmark may be affected and your doctor will therefore follow you more closely.
Patients under 18 years of age
Buprenorphine Glenmark should not be used in patients under 18 years of age.
How to use Buprenorphine Glenmark
Buprenorphine Glenmark is intended for use on the skin.
Buprenorphine Glenmark acts through the skin. After applying (applying) the patch, buprenorphine passes through the skin into the bloodstream.
Before applying the transdermal patch
- Buprenorphine Glenmark should be placed on a relatively hairless or almost completely hairless skin surface. 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, e.g. 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.
Apply the transdermal patch
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 start to drop, 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 Glenmark (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 the transdermal patch” below).
Replacing the transdermal patch
- Remove the old transdermal patch.
- 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 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.
Duration of treatment
Your doctor will tell you how long to take Buprenorphine Glenmark. Do not stop treatment without consulting your doctor, as your pain may return and you may feel unwell (see also “If you stop using Buprenorphine Glenmark” 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 Buprenorphine Glenmark
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 a doctor.
Do not apply extra patches to compensate for forgetting to apply one.
If you stop using Buprenorphine Glenmark
If you stop using Buprenorphine Glenmark 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 side effects when you stop taking Buprenorphine Glenmark 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 Glenmark 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 Glenmark 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 a doctor immediately if you experience wheezing, wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching – especially if they are spread all over the body.
There is a risk that you may become addicted to Buprenorphine Glenmark.
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 ( tremor )
- respiratory distress
- abdominal pain or discomfort, diarrhea, indigestion, dry mouth
- sweating, rash
- fatigue, the feeling of abnormal weakness, muscle weakness, swelling of hands, ankles, or feet.
Uncommon (may affect up to 1 in 100 people):
- mood swings, restlessness, anxiety, elation, hallucinations, nightmares, decreased sex drive
- an altered taste sensation, speech difficulties, decreased sensitivity to pain or touch, tingling or numbness
- memory loss, migraine, fainting, concentration or coordination problems
- dry eyes, blurred vision
- ringing or rumbling sound in the ears, dizziness or tingling sensation
- 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
- spasm, aches, and pains
- difficulty starting to urinate
- inability to empty the bladder completely
- fever
- increase in the number of accidents (eg fall accidents)
- withdrawal symptoms such as agitation, anxiety, sweating, or shaking when you stop using Buprenorphine Glenmark.
If you need to take blood samples, tell your doctor that you are using Buprenorphine Glenmark. This is important because Buprenorphine Glenmark 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 (chest pain associated with heart disease)
- psychological disorder
- balance difficulties
- swelling of the eyelids or the face, contraction of the pupil are
- difficulty breathing, worsening of asthma, hyperventilation
- fainting, especially when getting up
- difficulty swallowing
- local allergic reaction with clear signs of swelling (in which case treatment should be discontinued)
- 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
- earache
- 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.
- abdominal pain or discomfort due to colic
- personality change
- withdrawal symptoms in newborns whose mothers have received Buprenorphine Glenmark 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 Glenmark
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 expiration date is the last day of the specified month.
Buprenorphine Glenmark 5 micrograms/hour and Buprenorphine Glenmark 10 micrograms/hour:
Do not store above 25 ° C.
Buprenorphine Glenmark 20 micrograms/hour:
No special storage instructions.
Do not use the patch if the seal on the sachet 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 the 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.
Buprenorphine Glenmark 5 micrograms/hour:
A transdermal patch contains 5 mg buprenorphine in a 6.25 cm 2 large patches, and emits 5 micrograms of buprenorphine per hour (over a period of 7 days).
Buprenorphine Glenmark 10 micrograms/hour:
A transdermal patch containing 10 mg buprenorphine in a 12.5 cm 2 large patches, and releases 10 micrograms of buprenorphine per hour (over a period of 7 days).
Buprenorphine Glenmark 20 micrograms/hour:
A transdermal patch containing 20 mg buprenorphine in a 25 cm 2 large patches, and releases 20 micrograms of buprenorphine per hour (over a period of 7 days).
- Other ingredients are:
An adhesive layer (containing buprenorphine):
povidone K90, levulinic acid, oleyl oleate, acrylic acid ‑ butyl acrylate ‑ (2 ‑ Ethylhexyl) acrylate ‑ vinyl acetate copolymer (5: 15: 75: 5)
Adhesive layer (without buprenorphine): (2 ‑ ethylhexyl) acrylate ‑ glycidyl methacrylate ‑ (2 ‑ hydroxyethyl) acrylate-vinyl acetate copolymer (68: 0.15: 5: 27)
Separating foil between the adhesive layers with and without buprenorphine:
Poly (ethylene terephthalate) film
Back layer:
polyester
Protective layer:
Poly (ethylene terephthalate) film, siliconized
Blue ink
What the medicine looks like and the contents of the pack
Depot patches
Available in three sizes.
Buprenorphine Glenmark 5 micrograms/hour:
A beige-colored transdermal patch with rounded corners and marked with “Buprenorphine” and “5 µg / h”.
Buprenorphine Glenmark 10 micrograms/hour:
A beige transdermal patch with rounded corners and marked with “Buprenorphine” and “10 μg / h”
Buprenorphine Glenmark 20 micrograms / hour:
A beige transdermal patch with rounded corners and marked with “Buprenorphine” and “20 μg / h”
A transdermal patch is sealed in a child- resistant sachet. The patches are available in cartons containing 2, 4, 5, 8, or 12 transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany
Manufacturer
Tesa Labtec GmbH
Heykenaukamp 10
21147 Hamburg
Germany
This medicinal product is authorized under the European Economic Area under the names:
| Denmark | Buprenorphine Glenmark 5 micrograms / hour; 10 micrograms / hour; 20 micrograms / hour transdermal patches |
| Finland | Buprenorphine Glenmark 5 microg / tunti; 10 micrograms / tunti; 20 microg / tunti depot loader |
| Germany | Buprenorphine Glenmark 7 days 5 micrograms / hour; 10 micrograms / hour; 20 micrograms / hour transdermal patch |
| Netherlands | Buprenorphine Glenmark 5 micrograms / hour; 10 micrograms / hour; 20 micrograms / hour 7 days transdermal patch |
| Norway | Buprenorphine Glenmark 5 micrograms / hour; 10 micrograms / hour; 20 micrograms / hour transdermal patch |
| UK | Bunov 5 micrograms / h; 10 micrograms / h; 20 micrograms / h transdermal patch |