5 micrograms / hour, 10 micrograms / hour, 20 micrograms / hour depot patch 
buprenorphine

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

Buprenorphine Teva 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 Teva should not be used to relieve acute pain.

The buprenorphine contained in Buprenorphine Teva 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.

What you need to know before using Buprenorphine Teva

Do not use Buprenorphine Teva

  • 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 anxiety, tremors, or sweating when you quit alcohol.

Buprenorphine Teva should not be used to treat symptoms when you stop taking a medicine.

Warnings and cautions

Talk to your doctor or pharmacist before taking Buprenorphine Teva

  • 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 the bloodstream than normal body temperature.
  • if you have depression or other conditions treated with antidepressants.If these medicines are used together with Buprenorphine Teva, this can lead to the serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Buprenorphine Teva”).

If you have had any recent 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 Teva

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 Teva and in some cases can cause very serious reactions. Do not take other medicines while taking Buprenorphine Teva 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 Teva 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 Teva 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 Teva may be reduced.
  • Buprenorphine Teva may make some people feel drowsy, 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), antihistaminesthat make you sleepy or narcotics like halothane.

Concomitant use of Buprenorphine Teva and sedatives or medicines for insomnia 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 Teva at the same time as sedatives, your dose and treatment time should be limited by your 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 Teva with alcohol

Alcohol can aggravate some of the side effects and you may feel unwell if you drink alcohol while taking Buprenorphine Teva. Drinking alcohol while using Buprenorphine Teva 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, Buprenorphine Teva should not be used if you are pregnant or if you could become pregnant during treatment.

Breast-feeding

Buprenorphine, the active substance in the transdermal patch, may inhibit milk production and be excreted in human milk. Therefore, you should not use Buprenorphine Teva while breast-feeding.

Driving and using machines

Buprenorphine Teva 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 Teva, 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.

Buprenorphine Teva contains excipients

Buprenorphine Teva 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 Teva, 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 Teva

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist. 

Different strengths of Buprenorphine Teva are available. Your doctor will decide which strength of Buprenorphine Teva 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.

Talk to your doctor or pharmacist if you feel that the effect of Buprenorphine Teva is too weak or too strong.

Adult and elderly patients

Unless your doctor tells you otherwise, attach a Buprenorphine Teva 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 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 Teva. 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 Buprenorphine Teva may be affected and your doctor will therefore follow you more closely.

Patients under 18 years of age

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

Method of administration

Buprenorphine Teva transdermal patch is intended to be applied to the skin. Buprenorphine Teva transdermal patches act through the skin. After application of the patch, buprenorphine passes through the skin into the bloodstream.

Before applying the patch

Choose a skin area thatis not annoyed ordamaged on the outsideof the upper arm,upper part ofchest, upperpart of the backor on the pageof the chest.(See the pictures herenext to.) Ask forhelp if you do notcan attach the patchself.

Buprenorphine Teva 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, cut the protective bag at the sealed end using 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 clear protective film. Carefully pull off one part of the liner. 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 / and slowly count to 30. 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 with suitable skin tape. You can bathe, shower, or swim with the patch.

Do not expose the patch to excessive heat (eg heating pads, electric blankets, heat lamps, saunas, hot baths, heated water beds, hot water bottles, etc.) as this may cause the active substance to be absorbed by the blood. Heat from the outside can also prevent the patch from sticking properly. If you have a fever, it may affect the effects of Buprenorphine Teva (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 insert a new one (see “Replacing the patch” below).

Replacing patches

  • Remove the old patch.
  • Fold it in half with the sticky side inwards.
  • Open a new bag and take out a new patch . Use the empty bag to discard the old patch. Then dispose of the bag safely.
  • Apply the new patch to another area of ​​skin (see description above). A new patchshould 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 Teva. Do not stop treatment without consulting a doctor, as your pain may return and you may feel unwell (see also “If you stop taking Buprenorphine Teva” below).

If you use more Buprenorphine Teva than you should 

If you forget to use Buprenorphine Teva

Put on a new 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 Teva

If you stop using Buprenorphine Teva 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 Teva 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 Teva 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 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 may become addicted to Buprenorphine Teva.

In patients treated with Buprenorphine Teva, the following other side effects havebeen reported:

Very common (may affect more than 1 user in 10)

  • Headache, dizziness, drowsiness
  • Constipation, nausea or vomiting
  • Skin itching, redness
  • Skin rash, local 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, edema (eg swollen hands, ankles, or feet)

Uncommon (may affect up to 1 in 100 people)

  • Hypersensitivity
  • Sleep disturbance, restlessness, agitation, elation, sudden change between different emotions, hallucinations, nightmares, decreased sex drive
  • Taste distortion, speech difficulties, decreased sensitivity to pain or touch, tingling or numbness
  • Abnormally calm
  • 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 , circulatory collapse ( shock ), chest pain, fast or irregular heartbeat
  • Coughing, hiccups, hissing (rustling, wheezing) breathing sounds
  • Gases in the stomach
  • Weight loss
  • Dry skin, hives, contact dermatitis
  • Spasm you, pains
  • Urination disorders, difficulty starting to urinate and completely emptying the bladder
  • Fatigue, edema
  • Fever, chills
  • Local allergic reactions with clear signs of swelling (in which case treatment should be stopped)
  • Reddening of the skin
  • Increase in accidents (eg fall accidents)
  • Abstinence symptoms such as agitation, anxiety, sweating, or trembling when you stop using Buprenorphine Teva

If you need to take a blood sample, remind your doctor that you are using Buprenorphine Teva. This is important because Buprenorphine Teva 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
  • Visual defects, eyelid swelling or facial swelling, contraction of the pupil are
  • Difficulty breathing, worsening of asthma , hyperventilation
  • A feeling of dullness, especially when standing
  • Difficulty swallowing, intestinal upset
  • 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)

  • Mood swings, addiction
  • Involuntary muscle twitching
  • Ear pain
  • Blisters

Has been reported (occurs in an unknown number of users)

  • Seizures, seizures or convulsions
  • Inflammation of the intestinal wall. Symptoms may include fever, vomiting and abdominal pain or discomfort
  • Stomach pain or discomfort due to bile 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 Teva

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 bag after EXP. The expiration date is the last day of the specified month.

Buprenorphine Teva 5 micrograms/hour and Buprenorphine Teva 10 micrograms/hour

Do not store above 25 ° C.

Buprenorphine Teva 20 micrograms / hour

No special storage instructions.

Do not use the patch unless the protective bag is intact.

The applied patch should be folded with the sticky side inwards and discarded safely.

Do not throw any medicines down the drain or with the 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 Teva 5 micrograms / hour transdermal patch

Each 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).

Buprenorphine Teva 10 micrograms / hour transdermal patch

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

Buprenorphine Teva 20 micrograms / hour transdermal patch

Each transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm 2and releases 20 micrograms of 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 matrices with and without buprenorphine: polyethylene terephthalate film.

Backing: polyester

Protective film: polyethylene terephthalate film, siliconized

Blueprinting ink

What the medicine looks like and contents of the pack

Depot patches

Three sizes are available.

  • Buprenorphine Teva 5 micrograms / hour: Rectangular, a beige patch with rounded corners and marked with “Buprenorphine” and “5 µg / h” in blue.
  • Buprenorphine Teva 10 micrograms/hour: Rectangular, the beige patch with rounded corners and marked with “Buprenorphine” and “10 µg / h” in blue.
  • Buprenorphine Teva 20 micrograms/hour: Rectangular, a beige patch with rounded corners and marked with “Buprenorphine” and “20 µg / h” in blue.

A transdermal patch is sealed in a child-resistant bag. 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

Muhammad Nadeem

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