Package Insert: Information for the User
Transtec70 micrograms/hour Transdermal Patch
Buprenorphine
Read this package insert carefully before starting to use this medication,because it contains important information for you.
Transtecis an analgesic (a pain-relieving medication) indicated for the relief of moderate to severe oncological pain and severe pain that does not respond to other types of analgesics. Transtecacts through the skin. When the transdermal patch is applied to the skin, the active substance buprenorphine passes through it into the bloodstream. Buprenorphine is an opioid (a medication for intense pain relief) that reduces pain by acting on the central nervous system (on specific nerve cells in the spinal cord and the brain). The effect of the transdermal patch lasts for up to a maximum of four days. Transtec is not ideal for the treatment of acute pain (short duration).
Transtec should not be used to treat withdrawal syndrome in drug-dependent individuals.
Warnings and precautions
Tolerance, dependence, and addiction
This medication contains buprenorphine, an opioid substance. Repeated use of opioids may reduce the effectiveness of the medication (your body becomes accustomed to the medication, which is known as tolerance). Repeated use of Transtec may also cause dependence, abuse, and addiction, which may lead to a potentially fatal overdose. The risk of adverse effects may increase with a higher dose and longer duration of use.
Dependence or addiction may make you feel like you no longer have control over the amount of medication you need to take or how often you need to take it.
The risk of becoming dependent or addicted varies from person to person. You may be at a higher risk of becoming dependent or addicted to Transtec if:
- You or a family member has a history of alcohol abuse, prescription medication abuse, or illicit substance abuse (“addiction”).
- You are a smoker.
- You have had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.
If you notice any of the following signs while taking Transtec, it could be a sign that you have become dependent or addicted:
- You need to take the medication for a longer period than recommended by your doctor.
- You need to take more doses than recommended.
- You are using the medication for reasons other than those prescribed, such as “to calm down” or “to help you sleep”.
- You have made repeated and unsuccessful attempts to stop or control the use of the medication.
- You do not feel well when you stop taking the medication and feel better when you take it again (“withdrawal symptoms”).
If you notice any of these signs, talk to your doctor to address the most suitable treatment strategy for your case, including when it is appropriate to stop taking it and how to do it safely (see section 3 “If you interrupt treatment with Transtec”).
Consult your doctor or pharmacist before starting to use Transtec
The use of these medications with Transtec may cause serotonin syndrome, a potentially fatal condition (see “Use of Transtec with other medications”),
Also, be aware of the following precautions:
Inform athletes that this medication may result in a positive test in doping control tests.
Respiratory disorders related to sleep
Transtec may cause respiratory disorders related to sleep such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. Contact your doctor if you or someone else observes these symptoms. Your doctor may consider reducing the dose.
Children and adolescents
Transtec should not be used in individuals under 18 years old, as there is no experience to date in this age group.
Use of Transtec with other medications
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Inform your doctor or pharmacist if you are taking:
Use of Transtec with food, drinks, and alcohol
Do not drink alcohol while using Transtec. Alcohol may intensify certain adverse effects of the transdermal patch and you may not feel well.
Taking grapefruit juice during treatment may intensify the effects of Transtec.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.
There is no sufficient experience to date with the use of Transtec in pregnant women. Therefore, Transtec should not be used during pregnancy.
Buprenorphine, the active ingredient contained in the transdermal patch, passes into breast milk and inhibits its production. Therefore, Transtec should not be used during breastfeeding.
Driving and operating machinery
Transtec may make you feel dizzy, drowsy, or have double vision or blurred vision and may alter your reflexes so that you do not react quickly or adequately in unexpected situations.
This applies especially:
If you are affected, you should not drive or operate machinery while using Transtec. This also applies at the end of treatment with Transtec. Do not drive or operate machinery for at least 24 hours after removing the patch.
Consult your doctor or pharmacist if in doubt.
Follow exactly the administration instructions of this medication as indicated by your doctor.This medication is only for your use. Do not give it to others.Do not use this medication after the expiration date printed on the package.Do not use this medication if you are allergic to buprenorphine or any other ingredient in this medication.Do not use this medication if you have a history of addiction or substance abuse.Do not use this medication if you have a history of mental health problems, such as depression or anxiety.Do not use this medication if you have a history of liver or kidney disease.Do not use this medication if you are pregnant or breastfeeding.Do not use this medication if you are taking other medications that may interact with buprenorphine.Do not use this medication if you have a history of seizures or convulsions.Do not use this medication if you have a history of respiratory problems, such as asthma or chronic obstructive pulmonary disease (COPD).Do not use this medication if you have a history of heart problems, such as heart failure or coronary artery disease.Do not use this medication if you have a history of high blood pressure.Do not use this medication if you have a history of thyroid problems.Do not use this medication if you have a history of adrenal gland problems.Do not use this medication if you have a history of pancreatitis.Do not use this medication if you have a history of bowel obstruction or ileus.Do not use this medication if you have a history of urinary retention.Do not use this medication if you have a history of prostate problems.Do not use this medication if you have a history of glaucoma.Do not use this medication if you have a history of cataracts.Do not use this medication if you have a history of eye problems, such as retinal detachment or macular degeneration.Do not use this medication if you have a history of skin problems, such as eczema or psoriasis.Do not use this medication if you have a history of allergic reactions, such as hives or itching.Do not use this medication if you have a history of anaphylaxis.Do not use this medication if you have a history of angioedema.Do not use this medication if you have a history of Stevens-Johnson syndrome.Do not use this medication if you have a history of toxic epidermal necrolysis.Do not use this medication if you have a history of erythema multiforme.Do not use this medication if you have a history of drug-induced lupus erythematosus.Do not use this medication if you have a history of systemic lupus erythematosus.Do not use this medication if you have a history of rheumatoid arthritis.Do not use this medication if you have a history of osteoarthritis.Do not use this medication if you have a history of gout.Do not use this medication if you have a history of pseudogout.Do not use this medication if you have a history of kidney stones.Do not use this medication if you have a history of urinary tract infections.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do not use this medication if you have a history of kidney cancer.Do not use this medication if you have a history of liver cancer.Do not use this medication if you have a history of pancreatic cancer.Do not use this medication if you have a history of thyroid cancer.Do not use this medication if you have a history of adrenal gland cancer.Do not use this medication if you have a history of pituitary gland cancer.Do not use this medication if you have a history of brain cancer.Do not use this medication if you have a history of spinal cord cancer.Do not use this medication if you have a history of bone cancer.Do not use this medication if you have a history of soft tissue cancer.Do not use this medication if you have a history of skin cancer.Do not use this medication if you have a history of eye cancer.Do not use this medication if you have a history of ear cancer.Do not use this medication if you have a history of nose cancer.Do not use this medication if you have a history of throat cancer.Do not use this medication if you have a history of lung cancer.Do not use this medication if you have a history of breast cancer.Do not use this medication if you have a history of ovarian cancer.Do not use this medication if you have a history of cervical cancer.Do not use this medication if you have a history of uterine cancer.Do not use this medication if you have a history of vaginal cancer.Do not use this medication if you have a history of vulvar cancer.Do not use this medication if you have a history of testicular cancer.Do not use this medication if you have a history of prostate cancer.Do not use this medication if you have a history of bladder cancer.Do Like all medicines, this medicine can cause side effects, although not everyone will experience them. Side effects are classified as follows: May affect more than 1 in 10 people May affect more than 1 in 100 people May affect less than 1 in 100 people May affect less than 1 in 1,000 people May affect less than 1 in 10,000 people The frequency cannot be estimated from available data The following side effects have been reported: Immune system disorders Very rare:Severe allergic reactions (see below) Metabolism and nutrition disorders Mental disorders Uncommon:Confusion, sleep disorders, restlessness Rare:Illusions and hallucinations, anxiety, nightmares, decreased libido Very rare:Dependence, mood changes Nervous system disorders Common:Dizziness, headache Uncommon:Different degrees of sedation (serenity), ranging from fatigue to confusion Rare:Difficulty concentrating, speech disorders, confusion, balance disorders, abnormal skin sensations (sensation of heat, tingling or numbness) Very rare:Muscle cramps, taste alterations Eye disorders Rare:Visual disturbances, blurred vision, eyelid swelling Very rare:Constricted pupils Ear and labyrinth disorders Very rare:Ear pain Cardiac and vascular disorders Uncommon:Circulatory disorders (such as hypotension or rarely, loss of consciousness due to blood pressure drop) Rare:Seizures Respiratory, thoracic and mediastinal disorders Common:Shortness of breath Rare:Respiratory depression Very rare:Hyperventilation, hiccups Gastrointestinal disorders Very common:Nausea Common:Vomiting, constipation Uncommon:Dry mouth Rare:Acid reflux Very rare:Hiccups Skin and subcutaneous tissue disorders (usually at the application site) Very common:Erythema, pruritus Common:Changes in the skin (exanthema, usually due to repeated use), increased sweating Uncommon:Rashes Rare:Urticarial hives Very rare:Pustules, vesicles Urinary and renal disorders Uncommon:Urinary retention (less urine than normal), altered urination Reproductive system and breast disorders Rare:Erectile dysfunction General disorders Common:Edema (swelling of the legs), fatigue Uncommon:Weakness (languor) Rare:Symptoms of withdrawal, reactions at the application site Very rare:Chest pain If you notice any of the side effects mentioned above, consult your doctor as soon as possible. In some cases, late-onset local allergic reactions with marked signs of inflammation occur. In these cases, treatment with Transtec should be discontinued after consulting your doctor. If you experience inflammation of the hands, feet, knees, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, hives, fainting, yellowing of the skin and eyes (also known as jaundice), remove the transdermal patch and consult your doctor or go to the nearest hospital immediately. These may be symptoms of a very rare severe allergic reaction. Some people may experience withdrawal symptoms after using potent analgesics for a prolonged period and then stopping them. After treatment with Transtec, the risk of experiencing withdrawal symptoms is low. However, if you feel agitation, anxiety, nervousness, hyperactivity, sleep disorders, or digestive problems, consult your doctor. Reporting of side effects If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine. Keep this medication out of sight and reach of children. Do not use this medicationafter the expiration date that appears on the packaging and on the overwrap after CAD.The expiration date is the last day of the month indicated. This medication does not require special conservation conditions. Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment. Transtec70 micrograms/hourtransdermal patch Contains 40 mg of buprenorphine and releases 70 micrograms of buprenorphine per hour. The area of the transdermal patch containing the active ingredient is 50 cm2. Adhesive matrix:oleate of (Z)-9-octadecen-1-yl; povidone K90; 4-oxopentanoic acid; poly[acrylic acid-co-butyraldehyde-co-(2-ethylhexyl)acrylate-co-vinyl acetate] (5:15:75:5), cross-linked (for the area containing buprenorphine) or not cross-linked (for the area without buprenorphine);separator film between the adhesive matrices with and without buprenorphine: poly(ethylene terephthalate) film,coating layer: poly(ethylene terephthalate) fabric. Release liner on the front covering the adhesive matrix containing buprenorphine to remove before applying the transdermal patch: poly(ethylene terephthalate) film, siliconized, coated on one side with aluminum. Appearance of the productand contents of the package Transtecare transdermal patches with a flesh-colored appearance and rounded corners identified as:Transtec 70 μg/hour, buprenorphine 40 mg. Transtecare presented in packages containing 3, 4, 5, 6, 8, 10, 11, 12, 16, 18, 20, or 24 individually sealed transdermal patches in child-resistant pouches. Only some package sizes may be commercially available. Marketing authorization holder and manufacturer responsible Marketing authorization holder Grünenthal Pharma, S.A. Doctor Zamenhof, 36 - 28027 Madrid, Spain Manufacturer responsible Grünenthal GmbH Zieglerstrasse 6 - D - 52078 Aachen, Germany This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names: GermanyTranstecPRO® AustriaTranstec® BelgiumTranstec® SloveniaTranstec® SpainTranstec® IrelandTranstec® ItalyTranstec® LuxembourgTranstec® PortugalTranstec® United Kingdom (Northern Ireland)Transtec® Last review date of this leaflet: November 2024 Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/4. Possible Adverse Effects
Rare:Loss of appetite
5. Conservation of Transtec
6. Contents of the packaging and additional information
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