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Introduction About TAPENAX ER 50 TABLET
TAPENAX ER 50 TABLET contains Tapentadol which belongs to the group of medicines called Opioids. It is used in adults for the management of severe chronic pain which can only be managed by a strong (opioid) painkiller.
TAPENAX ER 50 TABLET is not recommended for use in patients having severe kidney or liver problems, asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia), paralysis of the gut (muscles of the gastrointestinal tract).
TAPENAX ER 50 TABLET should be used with caution in patients who have slow or shallow breathing, increased pressure in the brain, disturbed consciousness up to coma, head injury or brain tumour, pancreatic or biliary tract disease (pancreatitis), increased tendency towards epilepsy, have tendency to abuse medicines (habituating), moderate liver problems, kidney disease and intolerance to certain sugars (such as lactose).
TAPENAX ER 50 TABLET is not recommended for use in pregnant women unless recommended by the doctor and it is not recommended for use in breast-feeding women. TAPENAX ER 50 TABLET is not recommended for use in children and adolescents (below 18 years of age) and it should be used with caution in elderly patients (aged 65 years of age).
The most common side effects of taking TAPENAX ER 50 TABLET are nausea, constipation, dizziness, drowsiness, headache, decreased appetite, indigestion and flushing. Consult your doctor if any of the side effects worsen.
Uses Of TAPENAX ER 50 TABLET
- manages severe chronic pain in adults
How TAPENAX ER 50 TABLET Works
TAPENAX ER 50 TABLET acts directly on the central nervous system and reduces the feeling of pain by interrupting the way in which pain is signalled between brain and the body. TAPENAX ER 50 TABLET binds with certain receptors called µ-opioid receptors and also increases the release of a nerve chemical called norepinephrine which causes inhibition of certain receptors leading to pain relief.
How to use TAPENAX ER 50 TABLET
Take TAPENAX ER 50 TABLET as advised by your doctor. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Side Effects Of TAPENAX ER 50 TABLET
Common
- nausea, vomiting
- constipation, diarrhoea, indigestion
- dizziness, drowsiness, headache
- decreased appetite
- anxiety, depressed mood
- sleep problem
- nervousness, restlessness
- disturbance in attention
- trembling, muscle twitches
- flushing
- shortness of breath
- itching, rash
- increased sweating
- feeling of weakness, fatigue
- feeling of body temperature change
- mucosal dryness
- accumulation of water in the tissue
Uncommon
- allergic reaction including swelling beneath the skin, hives, and in severe cases difficulty breathing, collapse or shock, a fall in blood pressure
- weight loss
- disorientation, confusion
- excitability (agitation)
- perception disturbances
- abnormal dreams
- euphoric mood (extreme happiness and excitement)
- depressed level of consciousness
- memory or mental impairment
- fainting
- sedation (excessive sleepiness)
- balance disorder
- difficulty in speaking
- numbness, abnormal sensations of the skin such as tingling, prickling
- abnormal vision
- faster or slower heart rate, palpitations, decreased blood pressure
- abdominal discomfort
- hives
- delay in passing urine or frequent urination
- sexual dysfunction
- drug withdrawal syndrome
- feeling abnormal, irritability
Rare
- drug dependence
- thinking abnormal
- epileptic fits
- near fainting
- abnormal coordination
- dangerously slow or shallow breathing (respiratory depression)
- impaired gastric emptying
- feeling drunk
- feeling of relaxation
Stop taking TAPENAX ER 50 TABLET and inform your doctor immediately if you experience any of the following side effects:
- signs of an allergic reaction (such as difficulties in breathing, wheezing, swelling of the eyelids, face or lips, rash or itching (covering your whole body)
- breathing more slowly or weakly than normal
How To Manage Side Effects
Nausea or vomiting:
Stick to simple meals while taking this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly (such as daily walk). Consult your doctor if the symptom does not improve.
Diarrhoea:
Drink lot of fluids, such as water to keep yourself hydrated. Avoid eating high-fat or spicy foods. Try to avoid taking any medicine on your own to manage diarrhea and consult your doctor if the symptom gets worse.
Stomach pain:
Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the symptom does not improve, consult your doctor.
Headache:
Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.
Warning & Precautions
Pregnancy
TAPENAX ER 50 TABLET is not recommended for use in pregnant women unless recommended by the doctor as it can cause withdrawal symptoms in the new-born baby when used for prolonged period of time, which might be life threatening and could also possibly lead to dangerously slow or shallow breathing in the newborn. Consult with your doctor before taking TAPENAX ER 50 TABLET.
Breastfeeding
TAPENAX ER 50 TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking TAPENAX ER 50 TABLET.
Driving and Using Machines
Do not drive or use any machinery while taking TAPENAX ER 50 TABLET if you experience drowsiness, dizziness, blurred vision or impairment of reactions.
Alcohol
Avoid consumption of alcohol while taking TAPENAX ER 50 TABLET as it may increase the effect of drowsiness.
Kidney
TAPENAX ER 50 TABLET is not recommended for use in patients with severe kidney problems. It should be used with caution in patients suffering from kidney disease. Consult your doctor before taking TAPENAX ER 50 TABLET.
Liver
TAPENAX ER 50 TABLET is not recommended for use in patients with severe liver problems. TAPENAX ER 50 TABLET should be used with caution in patients with moderate liver problems and your doctor may adjust the dose. Consult your doctor before taking TAPENAX ER 50 TABLET.
Allergy
Do not take TAPENAX ER 50 TABLET if you are allergic to Tapentadol or any other ingredients of this medicine.
Lungs
TAPENAX ER 50 TABLET is not recommended for use in patients having lung diseases such as asthma or dangerously slow and shallow breathing (hypercapnia, respiratory depression). It should be used with caution in patients having other breathing issues (slow or shallow breathing). Consult your doctor before taking TAPENAX ER 50 TABLET.
Others
TAPENAX ER 50 TABLET is not recommended for use if you:
- have paralysis of the gut (muscles of the gastrointestinal tract)
- have acute poisoning of alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions)
Before taking TAPENAX ER 50 TABLET inform your doctor if you:
- have increased pressure in the brain or disturbed consciousness up to coma
- had a head injury or brain tumour
- have a disease affecting the pancreas (such as pancreatitis) or biliary tract
- have tendency towards fits
- have tendency to abuse medicines (getting habitual of it)
- have lactose intolerance
Use in paediatrics:
TAPENAX ER 50 TABLET is not recommended for use in children and adolescents (below 18 years of age). Consult your child’s doctor for advice.
Use in geriatrics:
TAPENAX ER 50 TABLET should be used with caution in elderly patients (aged 65 years and above) due to delayed excretion of this medicine in this age group and your doctor may adjust the dose. Consult your doctor before taking TAPENAX ER 50 TABLET.
Interactions
A. Drug–Drug Interactions:
Before taking TAPENAX ER 50 TABLET inform your doctor if you are taking any of the following medicines:
- sedatives such as zolpidem, barbiturates (Ex. amobarbital, pentobarbital) antidepressants such as paroxetine, sertraline and anti-psychotics such as loxapine, clozapine, monoamine oxidase inhibitors (MAOIs) such as isocarboxazid (used to manage depression, anxiety, mood disorders, sleep disturbances)
- opioids such as codeine, oxymorphone, mixed mu-opioid agonist/antagonists such as pentazocine, nalbuphine, partial mu-opioid agonists such as buprenorphine (used to manage severe pain)
- antihistamines such as cetirizine, loratadine (used to manage allergy)
- rifampicin (used to manage tuberculosis)
- St. john’s wort (herbal medicine used to manage depression)
Overdosage:
If you or anyone else accidentally takes too much of TAPENAX ER 50 TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of TAPENAX ER 50 TABLET are pin-point pupils, vomiting, fast heartbeat, drop in blood pressure, collapse, disturbed consciousness or coma (deep unconsciousness), epileptic fits (convulsions), dangerously slow or shallow breathing or stopping breathing may occur.
Synopsis
| Drug | : |
Tapentadol |
| Pharmacological Category | : |
mu-opioid agonists |
| Therapeutic Indication | : |
Severe chronic pain |
| Dosage Forms | : |
Tablet, Nasal Spray, Capsule |
More Information
- Keep TAPENAX ER 50 TABLET out of reach of children
- Store at room temperature below 25°C
FAQs About TAPENAX ER 50 TABLET
What is TAPENAX ER 50 TABLET and why is it prescribed?
TAPENAX ER 50 TABLET contains Tapentadol which belongs to the group of medicines called Opioids. It is used in the management of severe chronic pain in adults which can only be managed by a strong (opioid) painkiller.
Is TAPENAX ER 50 TABLET a habit-forming medicine?
TAPENAX ER 50 TABLET may cause psychological and physical addiction. If you have a tendency to become habitual to medicines or if you are dependent on medicines, you should only take TAPENAX ER 50 TABLET for short periods. You must consult with your doctor priorly and discuss with them.
Can TAPENAX ER 50 TABLET cause sleep related breathing problems?
TAPENAX ER 50 TABLET contains an active substance that belongs to the group of opioids which can cause sleep related breathing disorders. This includes central sleep apnoea (shallow, pause of breathing during sleep) and sleep-related hypoxemia (lowered levels of oxygen in the blood). The risk of experiencing such problems depends upon the dose of TAPENAX ER 50 TABLET. Hence, you should not exceed the daily recommended dose. Your doctor may consider altering your dosage if you experience any such problems.
Can I stop taking TAPENAX ER 50 TABLET on my own if I start to feel better?
You must not stop taking TAPENAX ER 50 TABLET until and unless your doctor asks you to stop. Stopping suddenly or too soon may cause your pain to return. If you have been taking TAPENAX ER 50 TABLET for quite some time and you stop suddenly, you may experience symptoms such as restlessness, runny nose, yawning, watery eyes, sweating, chills, muscle pain, joint pain, dilated pupils, irritability, anxiety, backache, weakness, abdominal cramps, etc. If you feel any such symptoms or at all you wish to discontinue taking TAPENAX ER 50 TABLET, ask for your doctor’s advice.
Does TAPENAX ER 50 TABLET affect my ability to drive?
Do not drive or use any machinery if you feel drowsy, dizzy, blurring of vision or impairment of concentration after taking TAPENAX ER 50 TABLET. You can resume with your activities once you feel normal again. Consult your doctor for advice.
References
1. KD. Tripathi. Opioid Analgesics and Antagonists. Essentials of medical pharmacology. Eighth edition. 2018. Page – 505.
2. Dewan Roshan Singh, Kusha Nag, Akshaya N. Shetti, N. Krishnaveni. Tapentadol hydrochloride: A novel analgesic. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. September 2013. [Accessed on 17th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3757808/
3. R van der Schrier, K Jonkman, M van Velzen, E Olofsen, A M Drewes, A Dahan, M Niesters. An experimental study comparing the respiratory effects of tapentadol and oxycodone in healthy volunteers. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. December 2017. [Accessed on 17th August 2022] https://pubmed.ncbi.nlm.nih.gov/29029015/
4. Grunenthal GmbH. Electronic Medicines Compendium (EMC). [Revised in October 2021]. [Accessed on 17th August 2022] https://www.medicines.org.uk/emc/files/pil.12641.pdf
5. Grunenthal GmbH. Electronic Medicines Compendium (EMC). [Revised in September 2021]. [Accessed on 17th August 2022] https://www.medicines.org.uk/emc/files/pil.8046.pdf
6. Grunenthal Pharma Ltd GmbH. Electronic Medicines Compendium (EMC). [Revised in September 2021]. [Accessed on 17th August 2022] https://www.medicines.org.uk/emc/files/pil.5158.pdf
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