5 or 10 or 20 micrograms/hour transdermal patch 
buprenorphine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Buprenorphine STADA is and what it is used for 
2. What you need to know before you use Buprenorphine STADA 
3. How to use Buprenorphine STADA 
4. Possible side effects 
5. How to store Buprenorphine STADA 6. Contents of the pack 
and other information 

1. What Buprenorphine STADA is and what it is used for

Buprenorphine Stada 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.

Buprenorphine Stada should not be used to relieve acute pain.

Buprenorphine contained in Buprenorphine Stada 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 using Buprenorphine STADA

Do not use Buprenorphine STADA

  • 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, 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 Stada 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 Stada:

  • 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 Buprenorphine Stada, it can lead to a serotonergic syndrome, a condition that can be life threatening (see “Other medicines and Buprenorphine Stada”)

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 STADA

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 Buprenorphine Stada and in some cases can cause very serious reactions. Do not take other medicines while taking Buprenorphine Stada without first talking to a doctor, 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 Buprenorphine Stada 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, increased reflexes, tense muscles and body temperature above 38 ° C . Contact your doctor if you experience such symptoms.
  • Buprenorphine Stada must 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 cramps, spastic seizures, or convulsions), carbamazepine (medicines used to treat seizures, spastic seizures or convulsions and certain pain conditions), or rifampicin (medicines used to treat tuberculosis ), the effects of Buprenorphine Stada may be reduced.
  • Buprenorphine Stada 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 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 noskapin), antihistamines are (against eg allergy) that make you sleepy or narcotics like halothane.
  • Concomitant use of Buprenorphine Stada with sedatives or medicines for sleep disorders such as benzodiazepines or similar medicines 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 Buprenorphine Stada at the same time as sedatives, the dose should beone 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 STADA with food, drink, and alcohol

Alcohol can aggravate some of the side effects and you may feel unwell if you drink alcohol while taking Buprenorphine Stada. Drinking alcohol while using Buprenorphine Stada 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 Stada 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 Buprenorphine Stada if you are breast-feeding.

Driving and using machines

Buprenorphine Stada 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 Stada, 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 Buprenorphine STADA

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 Stada are available. Your doctor will decide which strength of Buprenorphine Stada 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 Buprenorphine Stada 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 Stada 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 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 Stada. 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

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 Stada may be affected and your doctor will therefore follow you more closely.

Patients under 18 years of age

Buprenorphine Stada should not be given to patients under 18 years of age.

How to use Buprenorphine Stada

Buprenorphine Stada transdermal patches are intended for use on the skin.

Buprenorphine Stada acts through the skin. After application, buprenorphine passes through the skin into the bloodstream.

Before applying the transdermal patch 

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.

Placement of patches

Buprenorphine Stada 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 if the seal on the sachet is broken.

Cut up the sachet

Step 2. The sticky side of the transdermal patch has a clear protective film. Carefully peel off the first part of the film. Avoid touching the sticky side of the transdermal patch.

Peel off the protective film

Step 3. Attach the transdermal patch to the selected area and remove the remaining protective film.

Attach the transdermal patch

Step 4. Press the transdermal patch against the skin with the palm of your hand and slowly count to 30. Make sure that the entire transdermal patch is in close contact with the skin, especially around the edges.

Press the transdermal patch against the skin

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. Heat from the outside can also prevent the patch from sticking properly. If you have a fever, it may affect the effects of Buprenorphine Stada (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 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 to take Buprenorphine Stada. 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 Stada” below).

Use for children and adolescents

Buprenorphine Stada should not be given to patients under 18 years of age.

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 STADA

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 Buprenorphine STADA

If you stop using Buprenorphine Stada 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 Stada 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 Stada 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 Stada 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 Buprenorphine Stada.

In patients treated with buprenorphine, the following other adverse reactions havebeen 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 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
  • 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
  • Fever
  • Increase in accidents (eg fall accidents)
  • Abstinence symptoms such as agitation, anxiety, sweating, or trembling when you stop using Buprenorphine Stada.

If you need to take blood samples, remind your doctor that you are using Buprenorphine Stada. This is important because Buprenorphine Stada 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 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.

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 STADA

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 Stada 5 micrograms / hour and Buprenorphine Stada 10 micrograms / hour:

Do not store above 25 ° C.

Buprenorphine Stada 20 micrograms / hour:

No 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 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 Stada 5 micrograms / hour:

1 transdermal patch contains 5 mg of buprenorphine in a patch size of 6.25 cm 2 and releases 5 micrograms of buprenorphine per hour (over a period of 7 days).

Buprenorphine Stada 10 micrograms / hour:

1 transdermal patch contains 10 mg buprenorphine in a patch size of 12.5 cm 2 and releases 10 micrograms buprenorphine per hour (over a period of 7 days).

Buprenorphine Stada 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).

Other ingredients are:

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 film between adhesive layers with and without buprenorphine : poly (ethylene terephthalate) film.

Backing : polyester.

Protective layer : poly (ethylene terephthalate) film, siliconized.

Blue ink.

What the medicine looks like and contents of the pack

Depot patches

Three sizes are available.

Buprenorphine Stada 5 micrograms / hour:

Rectangular transdermal patch , beige with rounded corners and marked with “Buprenorphine” and “5 μg / h”.

Buprenorphine Stada 10 micrograms / hour:

Rectangular transdermal patch, beige with rounded corners and marked with “Buprenorphine” and “10 μg / h”.

Buprenorphine Stada 20 micrograms / hour:

Rectangular transdermal patch , beige with rounded corners and marked with “Buprenorphine” and “20 μg / h”.

A sealed, child-protective sachet contains a transdermal patch . The patches are available in cartons containing 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 18, 20, or 24 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Tesa Labtec GmbH

Heykenaukamp 10

21147 Hamburg

Germany

Centrafarm Services BV

New Donk 9

4879 AC Etten-Leur

Netherlands

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Clonmel Healthcare Ltd.

Waterford Road

Clonmel Co. Tipperary

Ireland

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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