PALEXIA retard 100 mg. 30 tablets
What is PALEXIA retard and what is it used?
Tapentadol - the active substance in PALEXIA retard - is highly analgesic drug which belongs to the group of opioids.
PALEXIA retard is used to treat severe chronic pain in the elderly, which can be adequately controlled with opioid analgesics.
2. BEFORE YOU TAKE PALEXIA retard
Do not take PALEXIA retard
• if you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6)
• If you have asthma or your breathing is dangerously slow or shallow (respiratory depression, hypercapnia)
• if you have paralysis of the gut
• if you have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic drugs (medicines that affect mood and emotions) (see. "Other medicines and PALEXIA retard").
Warnings and Precautions
Talk to your doctor or pharmacist before taking PALEXIA retard if:
• have slow or shallow breathing
• suffer from increased pressure in the brain or impaired consciousness to coma
• you have had a head injury or brain tumor
• you have had an epileptic fit or are at increased risk of having seizures
• suffer from liver or renal disease (see. "How to take PALEXIA retard * ')
• suffer from a disease of the pancreas or bile ducts, including pancreatitis
• using medicines labeled as mixed opioid agonist / antagonist (eg pentazocine, nalbuphine) or partial mu-opioid agonists (eg buprenorphine).
PALEXIA retard may lead to physical and psychological dependence. If you are prone to drug abuse or drug addiction you must take these tablets only for short periods and under strict medical supervision.
Other medicines and PALEXIA retard
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your breathing can become dangerously slow or shallow (respiratory depression), if you use certain hypnotics or tranquilizers (eg. Barbiturates, benzodiazepines) or painkillers such as morphine and codeine (used as a medicine for cough) in combination with PALEXIA retard. If this happens, tell your doctor.
If you are taking medications that suppress the central nervous system (eg. Benzodiazepines, antipsychotics, H1 -antihistamini, opioids, alcohol) in combination with PALEXIA retard, your mind may fail, may occur sleepiness or feeling faint. If this happens, tell your doctor.
Serotonin syndrome is a rare, life-threatening condition has been reported in some patients who received tapentadol in combination with t. Pomegranate. Serotonergic drugs (eg. Some medicines used to treat depression). Signs of serotonin syndrome may be for example, confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable muscle spasms, myoclonus and diarrhea. In this case, you may consult your doctor.
Concomitant use of PALEXIA retard with other types of medicines called mixed mu-opioid agonists / antagonists (eg. Pentazocine, nalbuphine) or partial mu-opioid agonists (eg. Buprenorphine) has not been studied. Possible effects of PALEKSIYA retard is not so good when used together with one of these products. Tell your doctor if you are currently being treated with any of them.
Concomitant use of PALEXIA retard with strong inhibitors or inducers (eg. Rifampicin, phenobarbital, St. John's Wort) of certain enzymes needed for the release of tapentadol from your body can affect the action of tapentadol or cause side effects, especially when starting or stopping of the other drug. Tell your doctor about all the medicines you are taking.
PALEXIA retard should not be taken with MAO inhibitors (a medication to treat depression). Tell your doctor if you are taking or have taken MAO inhibitors prez14 recent days.
PALEKSIYA retard with food, drinks and alcohol
Do not use alcohol while taking PALEKSIYA retard, as you may experience increased side effects such as drowsiness. The effect of this medicine is not affected by food.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. Do not take tablets:
• if you are pregnant, unless your doctor has prescribed this,
• during birth, as it can cause dangerously slow or shallow breathing (respiratory depression) in the newborn,
• breast-feeding, as it can be excreted in human milk.
Driving and using machines
PALEXIA retard can cause drowsiness, dizziness and blurred vision and may impair your reactions. This can happen especially at the start of treatment with PALEXIA retard when your doctor changes your dose or when drinking alcohol or tranquilizers. Ask your doctor whether it is allowed to drive or operate machinery.
PALEXIA retard contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take PALEXIA retard?
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Your doctor will adjust the dose according to the severity of your pain and your individual pain sensitivity. In principle should be taken lowest anesthetic dose.
Adults
The normal dose is 1 tablet every 12 hours. Not recommended daily doses PALEKSIYA retard than 500 mg tapentadol. Your doctor may prescribe a different and more appropriate dose or dosing interval if it is necessary for you. If you feel that the effect of the tablets is too strong or too weak, tell your doctor or pharmacist.
Elderly
In the elderly (over 65 years) is not usually necessary to change the dosage. However, some patients in this group the release of tapentadol may be delayed. If this applies to you, your doctor may recommend a different dosage regimen.
Hepatic and renal disease (failure)
Patients with severe liver problems should not take these tablets. If you have moderate problems, your doctor will recommend a different dosage regimen. In case of mild liver problems do not need dose adjustment.
Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems do not require a change in dose.
Use in children and adolescents
PALEXIA retard is not suitable for use in children and adolescents under 18 years
How and when should you take PALEXIA retard?
PALEXIA retard is intended for oral administration. Always take the tablets whole with sufficient fluid.
Do not chew, crush or crushing - this can cause an overdose because the medicine will be released into your body too quickly. You can take the tablets on an empty stomach or with food.
How long should you take PALEXIA retard?
Do not take the tablets for longer than prescribed by your doctor.
If you take more dose PALEXIA retard
If you take more than the amount you can get:
• narrowed pupils, vomiting, fall in blood pressure, rapid heart beat, collapse impaired consciousness or coma (deep unconsciousness), epileptic seizures, dangerously slow or shallow breathing or respiratory arrest.
If this happens, should be called a doctor!
If you forget to take PALEXIA retard
If you forget to take the tablets, pain may return. Do not take a double dose to make up the missed dose. Just keep taking the tablets as before.
If you stop taking PALEXIA retard
If you interrupt or stop treatment too soon, your pain is likely to reoccur. If you want to stop treatment, tell your doctor before you do. In principle, the discontinuation will have no effect, but in rare cases, patients who have taken the tablets for some time may feel unwell if they abruptly stop use. Symptoms may include:
• restlessness, watery eyes, runny nose, yawning, sweating, fever, muscle pain and dilated pupils,
• irritability, anxiety, back pain, joint pain, fatigue, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, increased blood pressure, rapid breathing or heartbeat.
If you have any of these symptoms after stopping treatment, consult your doctor.
You should not stop suddenly taking this medicine unless your doctor tells you. If your doctor decides to stop taking the tablets, he / she will tell you how to do it, most often this is done by gradual dose reduction.
If you have any further questions on the use of 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.
Important side effects or symptoms to watch out for and what to do if you have them:
This medicine may cause allergic reactions. Symptoms may be wheezing, difficulty breathing, swelling of eyelids, face or lips, rash or itching, especially throughout the body.
Another serious side effect is the state in which you breathe slower and weaker than normal. It occurs most often in the elderly and weak patients.
If you have any of these important side effects, contact your doctor.
Other side effects may occur:
Very common (may affect more than 1 in 10 people): nausea, constipation, dizziness, drowsiness, headache.
Common (may affect up to 1 in 10 people): decreased appetite, anxiety, depressed mood, trouble sleeping, nervousness, anxiety, attention deficit disorder, tremor, muscle twitching, flushing, shortness of breath, vomiting, diarrhea, indigestion, itching, excessive sweating, rashes, feeling of weakness, fatigue, sense of a change in body temperature, mucosal dryness, water retention in the tissue (edema).
Uncommon (may affect up to 1 in 100 people): allergic reaction to drugs (swelling under the skin, urticaria, and in severe cases, difficulty breathing, low blood pressure, collapse or shock), weight loss, disorientation, confusion, agitation (agitation ), impaired perception, abnormal dreams, euphoric mood, depressed level of consciousness, memory impairment, mental disorder, seizures, sedation, impaired balance, difficulty speaking, numbness, abnormal skin sensations (eg. numbness, prickling), abnormal vision , rapid heartbeat, slow heartbeat, palpitations, low blood pressure, stomach discomfort, hives, delay in passing urine, frequent urination, sexual dysfunction, drug withdrawal syndrome (see. "If you stop taking PALEKSIYA retard"), unusual sense irritability.
Rare (may affect up to 1 in 1,000 people): drug dependence, abnormal thinking, epileptic seizure, near fainting, abnormal coordination, dangerously slow or shallow breathing (respiratory depression), impaired gastric emptying, feeling drunk, feeling of relaxation .
Generally likelihood of suicidal thoughts and behavior is greater in patients suffering from chronic pain. In addition, some medicines for treating depression (which have an impact on the neurotransmitter system in the brain) may increase this risk, especially in early treatment. Although tapentadol also affect neurotransmitters data from the use of tapentadol in humans show an increased risk.
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist.
This includes any possible effects not listed in this leaflet. You can also report side effects directly through:
5. How to store PALEXIA retard?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. |
