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Introduction About ULTRACET TABLET
ULTRACET TABLET is a combination of Paracetamol and Tramadol which belongs to the group of medicines called Analgesics and Opioid analgesics respectively. ULTRACET TABLET is used in the management of moderate to severe pain.
Pain is a complex and unpleasant sensation consisting of a physiological and a psychological response to a noxious stimulus. Pain is a warning mechanism that protects us by influencing it to withdraw from harmful stimuli, which is primarily associated with injury.
Before taking ULTRACET TABLET, inform your doctor if you have respiratory disorders, gastrointestinal obstruction, including paralytic ileus, fits or seizures, have recently suffered from a head injury, depression, intolerance to some sugars, kidney or liver problems.
ULTRACET TABLET is not recommended for use in pregnant women and during breast-feeding more than once as it may pass through breast milk.
ULTRACET TABLET is not recommended for use in children (under 12 years of age) and should be used with caution in elderly patients (aged 65 years and above).
The common side effects of taking ULTRACET TABLET are nausea, dizziness, drowsiness, vomiting, gastrointestinal problems (such as constipation, flatulence, diarrhoea), stomach pain and dry mouth. Consult your physician if any of the side effects worsen.
Uses Of ULTRACET TABLET
- Manage moderate to severe pain
How ULTRACET TABLET Works
ULTRACET TABLET contains Tramadol and Paracetamol. Tramadol acts on pain receptors present in the central nervous system. It blocks the nerve signals responsible for pain. Paracetamol acts as an analgesic by inhibiting the release of certain chemical mediators that produce pain. Tramadol and paracetamol, in combination, have a faster action and provide quick relief from pain.
How to use ULTRACET TABLET
Take ULTRACET TABLET as advised by your physician.
For tablet:
Swallow the medicine with a glass of water. Do not crush or chew the medicine.
For effervescent tablet:
Take ULTRACET TABLET by dissolving in a glass of drinking water.
Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Side Effects Of ULTRACET TABLET
Common
- nausea
- dizziness, drowsiness
- vomiting
- digestion problems (constipation, flatulence, diarrhoea)
- stomach pain
- dry mouth
- itching, sweating
- headache, shaking
- confusion, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits)
Uncommon
- increase in pulse or blood pressure increase in pulse or blood pressure, heart rate or heart rhythm disorders
- difficulty or pain on passing water/protein in the urine
- skin reactions (such as rashes, hives)
- tingling or numbness sensation in hands or feet, ringing in the ears, involuntary muscle twitching
- depression, nightmares, memory lapses
- difficulty swallowing, blood in the stools
- shivering, hot flushes, pain in the chest
Rare
- uncoordinated movements
- addiction
- blurred vision
Stop taking ULTRACET TABLET and contact your doctor immediately if you experience any of the following side effects:
- allergic rection (signs include skin rashes, sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting)
- hallucinations (hearing, seeing or sensing things that are not really there)
- breathing difficulty
- fits
- transient loss of consciousness (syncope)
How To Manage Side Effects
Nausea or vomiting:
Try to take ULTRACET TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich, fried or spicy foods. Consult your doctor if the symptom does not improve.
Diarrhoea:
Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for managing diarrhea. Consult your doctor if the symptom does not improve.
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom does not improve.
Dry mouth:
Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.
Warning & Precautions
Pregnancy
ULTRACET TABLET is generally not recommended for use in pregnant women. Consult your doctor before taking it.
Breastfeeding
ULTRACET TABLET is not recommended for use during breast-feeding more than once as it may pass through breast milk. Consult your doctor before taking it.
Driving and Using Machines
Do not drive or operate any machines if you feel drowsy after taking ULTRACET TABLET.
Alcohol
Avoid consumption of alcohol while taking ULTRACET TABLET because it might make you feel drowsy and it is not recommended for use in patients with acute alcohol poisoning.
Kidney
ULTRACET TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking ULTRACET TABLET.
Liver
ULTRACET TABLET is not recommended for use in patients with severe liver disorder and should be used with caution in patients with liver problems or jaundice. Consult your doctor before taking ULTRACET TABLET.
Allergy
Do not take ULTRACET TABLET if you are allergic to Paracetamol, Tramadol or any other ingredients of this medicine.
Lungs
ULTRACET TABLET should be used with caution in patients who have severe difficulties in breathing like asthma or severe lung problems. Consult your doctor before taking ULTRACET TABLET.
Others
ULTRACET TABLET is not recommended for use if you:
- have epilepsy (which is not adequately controlled by your current medicine)
- known or suspected gastrointestinal obstruction including paralytic ileus
Before taking ULTRACET TABLET, inform your doctor if you:
- have epilepsy or already experienced fits or seizures
- have recently suffered from a head injury, shock or severe headaches associated with vomiting
- have intolerance to certain sugars
- have depression
Use in pediatrics:
ULTRACET TABLET is not recommended for use in children (under 12 years of age). Consult your child’s doctor for advice.
Use in geriatrics:
ULTRACET TABLET should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking it.
Interactions
A. Drug - Drug interactions:
Before taking ULTRACET TABLET, inform your doctor if you are taking any of the following medicines:
- medicines used to manage nausea and vomiting (Ex. metoclopramide, domperidone or ondansetron)
- medicines used against infections (Ex. ketoconazole, flucloxacillin, erythromycin)
- medicine used to reduce cholesterol in the blood (Ex. cholestyramine)
- medicine used in the management of depression or Parkinson’s disease (Ex. monoamine oxidase inhibitors such as phenelzine, isocarboxazid)
- amitriptyline (used to manage depression)
- medicine used to help stop smoking (Ex. bupropion)
- baclofen (used as muscle relaxant)
- warfarin, phenprocoumon (used to manage or manage blood clots)
- medicine used to manage epilepsy (Ex. carbamazepine)
- morphine, buprenorphine, nalbuphine or pentazocine (used to manage severe pain)
Overdosage:
If you or anyone else accidentally take too much of ULTRACET TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of ULTRACET TABLET includes loss of appetite, nausea, vomiting, malaise, pallor, excess sweating, respiratory depression and seizures.
Synopsis
| Drug | : | Paracetamol, Tramadol |
| Pharmacological Category | : | Analgesics, Opioid analgesics |
| Therapeutic Indication | : | Moderate to severe pain |
| Dosage Forms | : | Tablet, Injection |
More Information
- Keep ULTRACET TABLET out of reach of children
- Store at room temperature
FAQs About ULTRACET TABLET
Q: What is Ultracet Tablet used for?
A: Ultracet Tablet is a prescription medicine used to provide relief from moderate to severe pain conditions.
Q: How long does it take for Ultracet Tablet to reduce pain?
A: The onset of action of Ultracet Tablet varies from person to person but is usually within 30 to 60 minutes after ingestion. However, the full pain-relieving effect may take longer to develop.
Q: Is Ultracet Tablet safe for kidneys?
A: Ultracet Tablet should be used with caution in patients with kidney impairment or renal disease. Therefore, consult your doctor for advice.
Q: Can we take Ultracet Tablet 3 times a day?
A: The dosing frequency of Ultracet Tablet should be decided by your doctor based on your age, body weight, severity of pain and the way you respond to the management. It is important not to exceed the maximum daily dosage recommended by your healthcare provider.
Q: Is Ultracet good for the liver?
A: Ultracet Tablet should be used with caution in patients with mild liver problems. It is strictly not recommended for use in patients with severe liver disorders or jaundice. Therefore, before taking this medicine inform your doctor about your liver health as a precaution.
Q: How does Ultracet Tablet work?
A: Ultracet Tablet contains two pain relieving medicines such as tramadol and paracetamol. Tramadol acts as an opioid analgesic, binding to opioid receptors in the brain and spinal cord to alter the perception of pain. Paracetamol works as a pain reliever and fever reducer by inhibiting the production of certain chemicals in the brain.
Q: What are the side effects of taking Ultracet Tablet?
A: The most common side effects of taking Ultracet Tablet may include dizziness, drowsiness, nausea, vomiting, constipation, headache, dry mouth, flatulence and increased sweating. These side effects are usually mild and temporary but should be reported to your doctor if persistent or severe.
Q: Is it safe to use Ultracet Tablet for the long term?
A: Ultracet Tablet should be used for the shortest duration possible and under the supervision of a healthcare professional. Prolonged use may lead to tolerance, dependence, and withdrawal symptoms upon discontinuation. Regular monitoring is recommended for patients using Ultracet for an extended period.
Q: What are the long-term side effects of using Ultracet Tablet?
A: Long-term use of Ultracet Tablet may increase the risk of adverse effects such as tolerance, dependence, addiction, gastrointestinal bleeding, liver damage (due to acetaminophen), and respiratory depression (especially with high doses of tramadol). Therefore, this medicine should be used under careful medical supervision.
Q: Can Ultracet Tablet be used during pregnancy?
A: Ultracet Tablet is not recommended for use in pregnancy owing to the risk of side effects for growing fetus. Therefore, consult your doctor for advice.
Q: Can Ultracet Tablet be used in children?
A: Ultracet Tablet is not recommended for use in children under the age of 12 years. Dosage and safety in pediatric patients should be determined by a healthcare professional based on individual factors.
Q: How to take Ultracet Tablet?
A: Ultracet Tablet is usually taken orally with a full glass of water, with or without food, as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the prescribed duration of use.
Q: Should I take Ultracet Tablet before or after food?
A: Ultracet Tablet can be taken with or without food, depending on individual preference and tolerance. However, taking it with food may help reduce the risk of stomach upset. Follow the instructions provided by your healthcare provider for the best results.
Q: What types of pain is Ultracet Tablet used for?
A: Ultracet Tablet is used to relieve various types of pain, including pain due to injuries, surgeries, dental procedures, arthritis, and other chronic conditions.
Q: Is Ultracet Tablet 15'S addictive?
A: Ultracet Tablet contains tramadol, which has the potential for abuse and dependence, especially with prolonged use or in individuals with a history of substance abuse. It should be used with caution and only as prescribed by a healthcare professional.
Q: Can I drink alcohol while taking Ultracet Tablet 15'S?
A: It is generally not recommended to drink alcohol while taking Ultracet Tablet, as it may increase the risk of liver damage and central nervous system depression. Alcohol may also enhance the sedative effects of tramadol.
References
1. KD. Tripathi. Opioid Analgesics and Antagonists. Essentials of medical pharmacology. seventh edition. 2017. Page – 469.
2. Moron Merchante I, Pergolizzi JV Jr, van de Laar M, Mellinghoff HU, Nalamachu S, O'Brien J, Perrot S, Raffa RB. Tramadol/Paracetamol fixed-dose combination for chronic pain management in family practice: a clinical review. NIH, National Library of Medicine, National center for biotechnology information. April 2013 [Accessed on 18th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4041254/
3. Joseph V Pergolizzi, Jr, Mart van de Laar, Richard Langford, Hans-Ulrich Mellinghoff, Ignacio Moron Merchante, Srinivas Nalamachu, Joanne O’Brien, Serge Perrot, and Robert B Raffa. Tramadol/paracetamol fixed-dose combination in the management of moderate to severe pain. NIH, National Library of Medicine, National center for biotechnology information. August 2012. [Accessed on 18th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3442743/
4. Janssen Pharmaceutica (Pty) Ltd. Tramacet Tablets (Paracetamol Plus Tramadol). [Revised in February 2016] [Accessed on 18th November 2022] https://www.sahpra.org.za/wpcontent/uploads/2020/06/TRAMACET_PI_Janssen-Pharmaceutica_MCC-Format15-February-2016.pdf
5. Ronak Exim Private Limited. Food and Drugs Authority (Ghana FDA) Paracetamol Plus Tramadol. [Revised in December 2019] [Accessed on 18th November 2022] https://fdaghana.gov.gh/img/pils/Tdrona%20Plus%20Tablets%20(Paracetamol%20and%20Tramadol%20Hydrochloride).pdf
6. Accord Healthcare Limited. Health Products Regulatory Authority (HPRA). [Revised in April 2022] [Accessed on 18th November 2022] https://www.hpra.ie/img/uploaded/swedocuments/69c7503f-69b6-4157-bb80-4c4fdbeff3ba.pdf
7. Janssen Ortho LLC. U.S. Food & Drug Administration. [Revised in August 2017] [Accessed on 18th November 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021123s014lbl.pdf
8. Grunenthal Pharma Ltd. Electronic Medicines Compendium (EMC). [Revised in January 2022] [Accessed on 18th November 2022] https://www.medicines.org.uk/emc/files/pil.455.pdf
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