Norspan 5 micrograms / hour transdermal patch, Norspan 10 micrograms / hour transdermal patch, Norspan 15 micrograms / hour transdermal patch, Norspan 20 micrograms / hour transdermal patch, Norspan 25 micrograms / hour transdermal patch, Norspan 30 micrograms / hour transdermal patch, Norspan transdermal patch / Norspan
What Norspan is and what it is used for
Norspan transdermal locks contain 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.
Norspan should not be used to relieve acute pain.
Norspan transdermal patches act through the skin. After application, buprenorphine passes through the skin into the bloodstream. Each patch works for seven days.
Buprenorphine found in Norspan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Norspan
Do not use Norspan
- 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 worry, anxiety, tremors or sweating when you quit alcohol.
Norspan 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 Norspan:
- if you are being treated with antidepressants. If these medicines are used together with Norspan, this can lead to serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Norspan”).
- if you suffer from seizures, spastic seizures or convulsions
- if you suffer from breathing problems while sleeping ( sleep apnea )
- 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 or anyone in your family has ever abused or been addicted to alcohol, prescription drugs or illegal drugs (“abuse”)
- if you smoke
- if you have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for another mental illness
- if you have a fever, as this may lead to higher levels of the active substance being absorbed into your bloodstream than normal body temperature
- if you suffer from constipation.
Sleep-related breathing problems
Norse sleep can cause sleep-related breathing problems such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxia (low oxygen content in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty staying asleep or excessive fatigue during the day. Contact your doctor if you or any other person observes these symptoms. Your doctor may consider reducing dose one.
This drug can cause skin reactions at the application site which usually manifests as mild or moderate skin inflammation and the appearance usually includes redness, swelling, itching, rash, small blisters, and painful / burning sensation at the application site. The cause is usually skin irritation and these reactions stop after the Norspan patch has been removed. More serious allergic reactions may occur, such as runny blisters, which may spread outside the application site and not disappear quickly after Norspan removal. Chronic allergic reactions can lead to open sores, bleeding, sores, discoloration of the skin, and infection. Contact your doctor if you notice any of the above skin reactions.
This medicine may increase your pain sensitivity, especially in high doses. Tell your doctor if this happens. It may be necessary to reduce your dose or change your medicine.
If you have had any recent surgery, tell your doctor before using these patches.
Like other opioids, Norspan can affect your body’s normal production of hormones, such as cortisol or sex hormones, especially if you have been taking high doses for a long time.
Children and young people
Do not give this medicine to patients under 18 years of age.
Other medicines and Norspan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can aggravate the side effects of Norspan and in some cases can cause very serious reactions. Do not take other medicines while taking Norspan without talking to a doctor first, especially:
- Antidepressants such as moclobemide, tranylcypromine, citalopram , escitalopram, fluoxetine , fluvoxamine, paroxetine , sertraline , duloxetine, venlafaxine , amitriptyline, doxepine or trimipramine. These medicines can affect or be affected by Norspan 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, enhanced reflexes, tense muscles and body temperature above 38 ° C. Contact your doctor if you experience such symptoms.
- Norspan should not be taken 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 seizures, spastic seizures or convulsions), carbamazepine (medicines used to treat seizures, spastic seizures or convulsions) or rifampicin (medicines used to treat tuberculosis ) , the effects of Norspan may decrease.
- Norse span 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 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), antihistamines that make you sleepy or narcotics like halothane.
- Concomitant use of Norspan transdermal patches and sedatives such as benzodiazepines or similar 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 other treatment options are not possible. If your doctor prescribes Norspan transdermal patches at the same time as sedatives, dose themone 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.
Norspan with food, drink and alcohol
Alcohol can aggravate some of the side effects and you may feel unwell if you drink alcohol while wearing Norspan. Drinking alcohol while wearing Norspan can also affect your ability to react.
Pregnancy, breastfeeding and fertility
Do not use Norspan if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby unless your doctor tells you to. The doctor must have carefully considered the benefits and risks for both the mother and the child.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Norspan 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 are given an increased dose .
If you are affected (eg feeling dizzy, drowsy, or have blurred vision), do not drive or use machines while using Norspan, 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 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.
How to use Norspan
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Various forces at Norspan are available. Your doctor will decide which strength of Norspan is best for you.
When patients start using Norspan, 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 Norspan 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, or tell you to use a combination of up to two patches. 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 up to a maximum total dose of 40 micrograms/hour.
Adult and elderly patients
Unless your doctor has told you otherwise, attach a Norspan (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 told 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 Norspan 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 under 18 years of age
Norspan should not be given to patients under 18 years of age.
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 Norspan may be affected and your doctor will therefore follow you more closely.
Before you apply Norspan
- 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.
- Norspan should be attached 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 skin area. 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, cut the protective bag with scissors along the dotted line. Be careful not to damage the transdermal patches with scissors. Remove the patch. Do not use the patch unless the protective bag is intact.
Step 2. The sticky side of the patch has a protective film. Carefully pull off one part of the protective film. Avoid touching the sticky side of the patch.
Step 3. Attach the patch to the selected area 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 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 down with suitable skin tape. You can swim, 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 Norspan (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.
- Used patches also contain active substances that can harm children or animals, so make sure that used patches are kept out of sight and reach 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.
Duration of treatment
Your doctor will tell you how long you should be treated with Norspan. Do not stop treatment without consulting a doctor, as your pain may return and you may feel unwell (see also “If you stop using Norspan” below).
If you have the impression that the effect of Norspan is too weak or too strong, talk to your doctor or pharmacist.
If you have used too much Norspan
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
As soon as you discover that you have used more patches than you should, remove all patches. People who have had an overdose can 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 Norspan
Put on a band-aid 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 Norspan
If you stop using Norspan 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 effects when you stop taking Norspan are very small. However, tell your doctor if you feel upset, anxious, nervous, or shaky, if you become overactive, have difficulty sleeping, or have indigestion.
The analgesic effect from Norspan remains for some time after the patch has been removed. Do not start taking another opioid (strong painkiller) until 24 hours after removing the patch.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects when using Norspan are reminiscent of those observed for other strong painkillers, e.g. difficulty breathing and low blood pressure.
This medicine can 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.
Like all strong painkillers, there is a risk that you will become addicted to Norspan.
In patients treated with Norspan, 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
- 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, tremors
- Respiratory distress
- Stomach pain or discomfort, diarrhea, indigestion, dry mouth
- Sweating, rash
- Fatigue, feeling of abnormal weakness, muscle weakness, swollen hands, ankles or feet
Uncommon (may affect up to 1 in 100 people)
- Restlessness, agitation , elation, hallucinations, nightmares, decreased sex drive, aggression.
- Taste distortion, speech difficulties, decreased sensitivity to pain or touch, tingling or numbness, memory loss, migraine , fainting, problems with concentration and 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
- Cough, hiccup, hissing (rustling, wheezing) breathing sounds
- Gases in the stomach
- Weight loss
- Dry skin
- Spasm you, pains
- Urination disorders, difficulty starting to urinate and completely emptying the bladder
- Fever
- Increase in accidents (eg fall accidents)
- Withdrawal symptoms such as agitation, anxiety, sweating or trembling when you stop using Norspan
If you need to take a blood sample, remind your doctor that you are using Norspan. This is important because Norspan can affect how 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)
- Psychotic disorder
- Balance disorders
- Facial or eyelid swelling, contraction of the pupils
- Breathing difficulties, worsening of asthma , hyperventilation
- A feeling of dullness, especially standing
- Difficulty swallowing
- Local allergic reactions with clear signs of inflammation (in which case treatment should be discontinued)
- Swelling and irritation of the nose
- Decreased erection , impaired sexual function
- Reddening of the skin
- Dehydration
Very rare (may affect up to 1 in 10,000 people)
- Small muscle twitches
- Mood swings
- Ear pain
- Blister-filled blisters
Has been reported ( occurs in an unknown number of users)
- Breathing problems during sleep ( sleep apnea ), see section 2 “Warnings and precautions”
- Seizures, spastic seizures or convulsions
- Inflammation of the intestinal wall. Symptoms may include fever, vomiting and abdominal pain or discomfort
- Increased sensitivity to pain
- Stomach pain or discomfort due to colic
- Personality change
- Withdrawal symptoms in newborns whose mothers have received Norspan during pregnancy. Symptoms may include screaming, irritability and restlessness, tremors, difficulty eating, sweating and not gaining weight.
- Contact dermatitis (skin rash with inflammation that can give a burning sensation), discoloration of the skin.
- A need to take increasing doses of this drug to achieve the same level of pain relief (tolerance).
How to store Norspan
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. The expiration date is the last day of the specified month. Leave unused patches at the pharmacy after the expiry date.
Do not store above 25 ° C.
Do not use the patch if the seal is broken.
The used patch should be folded with the sticky side inwards and discarded safely 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.
Contents of the pack and other information
Content declaration
The active substance is buprenorphine.
Norspan 5 micrograms/hour transdermal patch:
Each transdermal patch contains 5 mg of buprenorphine in a patch size of 6.25 cm 2 and releases approximately 5 micrograms of buprenorphine per hour (over 7 days).
Norspan 10 micrograms/hour transdermal patch:
Each transdermal patch contains 10 mg of buprenorphine in a patch size of 12.5 cm 2 and releases approximately 10 micrograms of buprenorphine per hour (over 7 days).
Norspan 15 micrograms/hour transdermal patch:
Each transdermal patch contains 15 mg of buprenorphine in a patch size of 18.75 cm 2 and releases approximately 15 micrograms of buprenorphine per hour (over 7 days).
Norspan 20 micrograms/hour transdermal patch:
Each transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm 2 and releases approximately 20 micrograms of buprenorphine per hour (over 7 days).
Norspan 25 micrograms/hour transdermal patch:
Each transdermal patch contains 25 mg of buprenorphine in a patch size of 31.25 cm 2 and releases approximately 25 micrograms of buprenorphine per hour (over 7 days).
Norspan 30 micrograms/hour transdermal patch:
Each transdermal patch contains 30 mg of buprenorphine in a patch size of 37.5 cm 2 and releases approximately 30 micrograms of buprenorphine per hour (over 7 days).
Norspan 40 micrograms/hour transdermal patch:
Each transdermal patch contains 40 mg of buprenorphine in a patch size of 50 cm 2 and releases approximately 40 micrograms of buprenorphine per hour (over 7 days).
Other ingredients are:
- Polyacrylate (Durotak 387-2051 & 387-2054)
- Levulinic acid
- Oleyloleat
- Povidon
- Polyethylene terephthalate
What the medicine looks like and contents of the pack
Depot patches. There are different sizes.
5 micrograms/hour: square, beige-colored patch with rounded corners marked Norspan 5 μg / h
10 micrograms/hour: rectangular, beige-colored patch with rounded corners marked Norspan 10 μg / h
15 micrograms/hour: rectangular, beige-colored patch with rounded corners marked Norspan 15 μg / h
20 micrograms/hour: square, beige-colored patch with rounded corners marked Norspan 20 μg / h
25 micrograms/hour: rectangular, beige-colored patch with rounded corners marked Norspan 25 μg / h
30 micrograms/hour: rectangular, beige-colored patch with rounded corners marked Norspan 30 μg / h
40 micrograms/hour: rectangular, beige-colored patch with rounded corners marked Norspan 40 μg / h
Norspan is available in boxes containing 1, 2, 3, 4, 5, 8, 10, or 12 patches (child-protective individually packaged). Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mundipharma AB
Mölndalsvägen 30B
412 63 Gothenburg
Manufacturer
Mundipharma DC BV
Listening 16
3832 RC Leusden
Netherlands
or
Bard Pharmaceuticals Ltd.
Cambridge Science Park
Milton Road
Cambridge CB4 0GW
UK