Buprenorphine 52.5 mcg. 5 patch

What is Buprenorphine Actavis is and what it is used
Buprenorphine Actavis has analgesic (pain medicine), intended to relieve moderate to severe cancer pain and severe pain which does not comply with treatment with other painkillers. Buprenorphine is an opioid (strong painkiller) which reduces pain by acting on the central nervous system (specific nerve cells in the spinal cord and brain). Buprenorphine Actavis is not suitable for the treatment of acute (short-term) pain.

2. What you should know before using Buprenorphine Actavis
Do not use Buprenorphine Actavis:
if you are allergic to buprenorphine, soybean, peanut or any of the other ingredients of this medicine (listed in section 6);
if you are dependent on strong painkillers (opioids);
If you suffer from a disease in which you have or may have severe breathing difficulties;
if you are taking monoamine oxidase (MAO)-inhibitors (certain medicines used to treat depression) or if you have taken this type of medicine in the last two weeks (see "Other medicines and Buprenorphine Actavis");
if you suffer from myasthenia gravis (a certain type of severe muscle weakness);
If you suffer from delirium tremens (confusion and tremors caused by alcohol dependence after habitual excessive drinking or heavy binge).
Buprenorphine Actavis should not be used to treat symptoms of dependence addicts.

Warnings and Precautions
Talk to your doctor or pharmacist before using Buprenorphine Actavis:
if you drink large amounts of alcohol;
if you suffer from seizures or convulsions;
if your mind is disturbed (feeling light-headed or fainting) for an unknown reason;
if you are in a state of shock (cold sweat may be a sign of it);
if you intracranial pressure is increasing (for example after head injury or brain disease), and it is not possible to conduct artificial respiration;
if you have difficulty breathing or are taking other drugs that can slow or weaken your breathing (see "Other medicines");
if your liver is not working properly;
if you are inclined to abuse medicines or drugs.
Please consult your doctor if any of these apply to you or were applicable to you in the past.

Also, you must know and observe the following precautions:
Some people may become dependent on strong pain killers like Buprenorphine Actavis when using them continuously. They can cause withdrawal effects when you stop using them (see "If you stop using Buprenorphine Actavis");
High temperatures and exposure to external heat can lead to release of greater amounts of buprenorphine in the blood than normal. Also, exposure to external heat can interfere with the adhesion of the transdermal patch. Therefore, do not expose yourself to external heat (eg sauna, infrared lamps, electric blankets, hot water bottles), and consult your doctor if you have fever;
The use of the drug can lead to positive results when conducting doping test.
Children and adolescents
Buprenorphine Actavis is not recommended for use in people aged under 18 years, since the product has not been studied in this age group.
Other medicines and Buprenorphine Actavis
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Buprenorphine Actavis should not be used concurrently with monoamine oxidase (MAO) inhibitors (certain medicines used to treat depression and Parkinson's disease) or if you have taken this type of medicine in the last two weeks;
Buprenorphine Actavis may make some people feel drowsy, sick or weak, or delay or weaken breathing. These side effects may be intensified if other drugs with the same effects are taken at the same time. These drugs are other strong painkillers (opioids), some sleeping pills, anesthetics, and drugs used to treat certain psychiatric disorders such as tranquilizers, antidepressants and neuroleptics. Some of these combinations at higher doses can cause serious problems with the regulatory center of respiration in the brain, which can be life-threatening;
The effects of transdermal patch may increase when Buprenorphine Actavis is used simultaneously with certain drugs, such as some anti-infective / anti-fungal (eg. Containing erythromycin or ketoconazole) or medicines to treat HIV infection (eg. Containing ritonavir);
The effects of transdermal patch can be reduced when Buprenorphine Actavis is used together with other medicines, such as the following products: dexamethasone; drugs for the treatment of epilepsy (eg. containing carbamazepine or phenytoin) or drugs for treatment of tuberculosis (eg. rifampicin).
Buprenorphine Actavis with alcohol
You should not drink alcohol while using Buprenorphine Actavis. Alcohol may intensify certain side effects of the transdermal patch and you may feel unwell.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to have a baby, ask your doctor or pharmacist before using this medicine.

pregnancy
There is no experience on the use of buprenorphine in pregnant women. Therefore, you should not use Buprenorphine Actavis if you are pregnant or may become pregnant during treatment.

breastfeeding
Buprenorphine, the active substance contained in the transdermal patch, inhibits the formation of breast milk and passes into breast milk. Therefore, you should not use Buprenorphine Actavis if you are breastfeeding.

Driving and using machines
Buprenorphine Actavis may make you feel dizzy and affect your reactions to such an extent that you can not react adequately or quickly enough in the event of unexpected or sudden events. This is especially:
at the beginning of treatment;
when another anesthetic go to treatment with Buprenorphine Actavis;
if you use other drugs that act on the brain;
if you drink alcohol.
During treatment with Buprenorphine Actavis and at least 24 hours after treatment should not drive or operate machinery.

Buprenorphine Actavis contains soya oil
If you are allergic to peanuts or soya, do not use this product.

3. How to use Buprenorphine Actavis
Always take this medicine exactly as your doctor has told you. If you're not sure, check with your doctor or pharmacist.
Buprenorphine Actavis is available in three strengths: Buprenorphine Actavis 35 microgram / hour transdermal patch Buprenorphine Actavis 52.5 micrograms / hour transdermal patch and buprenorphine Actavis 70 microgram / hour transdermal patch.
Choosing the most appropriate for you Buprenorphine concentration Actavis will be made by your doctor. During treatment, if necessary Your doctor may change the concentration of the transdermal patch, using from at lower or higher.

The recommended dose is:
Adults
Unless your doctor tells you something different, stick a transdermal patch Buprenorphine Actavis (as detailed below) and replace it at the latest after three days.
To help you remember when to change the transdermal patch, you need to mark in the calendar of the outer packaging. If your doctor has advised you to take other painkillers in addition to the transdermal patch, strictly follow the doctor's instructions, otherwise the benefit of treatment with Buprenorphine Actavis will not be complete.

Elderly
No need dose adjustment in elderly patients.

Patients with kidney disease / dialysis patients
In patients with kidney disease and dialysis patients, there is no need for dose adjustment.

Patients with liver disease
In patients with liver disease, intensity and duration of action of buprenorphine Actavis may be affected. If this applies to you, your doctor will monitor you more closely.

Use in children and adolescents
Buprenorphine Actavis should not be used in people under the age of 18 years, because until now there is no experience of use in this age group.

Route of administration
This patch for transdermal administration (application to the skin). Buprenorphine Actavis operates through the skin. When the transdermal patch applied to the skin, the active substance buprenorphine passes through the skin into the bloodstream.

Method of administration
Prior to application of the transdermal patch
Select a skin surface which is smooth, clean and depilated in the upper part of the body, preferably on the chest below the clavicle or on the upper part of the back. If we can not apply the transdermal patch, get help;
If the chosen area has hairs, trim them with scissors. Do not shave !;
Avoid skin that is red, irritated or has any other blemishes, for instance large scars;
The section of skin that you choose must be dry and clean. If necessary, wash it with cold or lukewarm water. Do not use soap or other detergents. After a hot bath or shower, wait until your skin is completely dry and become cool. Do not use lotion, cream or ointment to the chosen area. This can prevent proper adhesion of the transdermal patch.
Instructions for opening the sachet protected children
Please do not open the sachet before actually intend to use the transdermal patch.
1. Cut up to the mark / tip arrows on each side.
2. Tear heat-sealed bag along side scored two locations.
3. Open the bag and place the patch.

Application of the transdermal patch
1. Each transdermal patch is sealed in a sachet.
2. Begin by separating the protective film.
3. Peel off one half of the peelable film coating transdermal patch and try not to touch the sticky side.
4. Stick the transdermal patch to the area of skin that you have chosen and remove the remaining half of the film.
5. Press the transdermal patch to the skin with the palm of your hand for 30 to 60 seconds. Ensure that the whole transdermal patch is in contact with the skin, especially on the edges.
6. Wash hands after use of the transdermal patch. Do not use cleaning products.
Wear the transdermal patch
You can wear the transdermal patch to 3 days. Provided that you have seated the transdermal patch, the risk of it comes off is small. You can bathe in the tub to take a shower or swim while wearing it. However, do not expose the transdermal patch to extreme heat (eg sauna, infrared lamps, electric blankets, hot water bottles).
Unlikely Your transdermal patch to fall before you need to replace it, do not use the same transdermal patch again. Immediately stick the new one (see "Replacing the transdermal patch" below).

Replacing a transdermal patch
Take the old transdermal patch;
Fold in half with the sticky side inwards;
Dispose of it carefully;
Place the new transdermal patch at a different skin site (as described above). Wait at least a week before using the same skin area.
Duration of treatment
Your doctor will tell you how long you can use Buprenorphine Actavis. You should not stop using Buprenorphine Actavis in its decision because pain may return and become unwell (see also "If you stop using Buprenorphine Actavis" below).
If you have the impression that the effect of Buprenorphine Actavis transdermal patch is too weak or too strong, please tell your doctor or pharmacist.

If you use more than the amount of Buprenorphine Actavis
If this happens can be signs of an overdose of the substance buprenorphine. In overdose may intensify the side effects of buprenorphine such as drowsiness, nausea and vomiting. Pupils you can become pin-point and your breathing become slow and weakened. You also get cardiovascular collapse.
As soon as you find that you use more transdermal patches than you should, remove the excess transdermal patch and talk to a doctor or pharmacist.

If you forget to use Buprenorphine Actavis
If you forgot to stick the patch, install a new transdermal patch as soon as you remember. If you are very late changing the transdermal patch, the pain can be restored. In this case, please contact your doctor.
Never put two pieces of transdermal patches to make up for the missed application!

If you stop using Buprenorphine Actavis
If you are interrupted or completed using Buprenorphine Actavis too early, the pain can be restored.
If you wish to stop treatment because of the occurrence of unpleasant side effects, please consult your doctor. He / she will tell you what can be done and whether it can be treated with other drugs.
Some people may experience withdrawal symptoms if used continuously strong painkillers when they cease to use them. The risk of effects after you stop using Buprenorphine Actavis is very low. However, if you feel agitated, anxious, nervous or instability if you are hyperactive, have difficulty sleeping or digestive problems, tell your doctor.

If you have further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the hands, feet, ankles, face, lips, mouth or throat become swollen and have difficulty in swallowing and breathing, hives, fainting, yellowing of the skin and eyes (jaundice), remove the transdermal patch and call immediately to your doctor or seek care in the emergency department of the nearest hospital. These may be symptoms of a very rare serious allergic reactions.

Reported the following adverse reactions:
Very common (may affect more than 1 in 10 people):
Nausea (feeling sick), flushing, itching.

Common (may affect up to 1 in 10 people):
Dizziness, headache, shortness of breath, vomiting, constipation, skin changes (rash and fever, usually after repeated use), sweating, edema (eg swelling of the feet), fatigue.

Uncommon (may affect up to 1 in 100 people):
Confusion, sleep disturbances, restlessness, varying degrees of sedation (calming), ranging from fatigue to confusion and reduced consciousness, circulatory disorders (such as low blood pressure or in rare cases even circulatory collapse), dry mouth, rash, difficulty urination, urinary retention (less urine than normal), fatigue.

Rare (may affect up to 1 in 1000 people):
Loss of appetite, illusions such as hallucinations, anxiety and nightmares, decreased sex drive, difficulty concentrating, speech disorder, confusion and blurred consciousness, balance disorder, abnormal sensation of the skin (numbness, tingling or burning), visual disturbances, blurred vision, swollen eyelids, hot flashes, difficulty breathing (respiratory depression), heartburn, hives, difficulty erection withdrawal symptoms (see below), reactions at the injection site.

Very rare (may affect up to 1 in 10,000 people):
Severe allergic reactions, dependence, mood changes, muscle twitching, taste disturbances, pinpoint pupils, ear pain, unusual shortness of breath, hiccups, nausea, pustules (pustules), small blisters, pain in the chest.

If you notice any of the side effects listed above, tell your doctor as soon as possible.

In some cases, monitored delayed in time allergic reactions, together with pronounced signs of inflammation. In such cases, you should stop using Buprenorphine Actavis after talking to your doctor.
Some people may experience withdrawal symptoms when used continuously strong painkillers and stop using them. The risk of effects after you stop using Buprenorphine Actavis is very low. However, if you feel agitated, anxious, nervous or instability if you are hyperactive, have difficulty sleeping or digestive problems, tell your doctor.

If you get any side effects, contact your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Buprenorphine Actavis
Keep out of reach of children.
Do not use Buprenorphine Actavis after the expiry date stated on the carton and sachet. The expiry date refers to the last day of that month.
Storage conditions: Do not store above 25 ° C. Do not freeze.
Disposal of used or unused transdermal patch