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Why it's used

Paratramol Tablet is used for the short-term management of moderate to severe pain. It is a prescription medicine. This medicine works by blocking the reuptake of natural chemicals (norepinephrine and serotonin) which produce pain in the body.
Analgesics
Paratramol belongs to a class of medicines called Analgesics. Analgesics or painkillers are a group of drugs used to achieve analgesia that is relief from pain.

How to use

Follow directions on the product label, information guide, and provided by your doctor before using Paratramol. Eat this medicine as per your doctor's instructions.
Paratramol Tablet is used to relieve pain. Pain medicines usually work the best if used at the first sign of pain and may not work well if delayed until the symptoms have worsened.
Paratramol is eaten with food.
The typical adult dose of Paratramol is 75 mg tramadol and 650 mg paracetamol every 4 to 6 hours (not more than tramadol 300 mg and paracetamol 2600 mg per day). The maximum dose for adults of Paratramol is 300 mg tramadol and 2600 mg paracetamol per day. This medicine is commonly used for a period of 5 days for acute pain. It takes less than one hour for this medicine to start its action. Habit forming tendencies may sometimes be seen with this medicine. You may be at higher than normal risk if you have an addiction to alcohol, or to drugs. To reduce your risk of addiction, take this medicine exactly as prescribed.
Tell your doctor if you develop new or worsening symptoms. Talk to your doctor if skin rash, swelling of the face, swelling of the neck, difficulty in breathing, low blood pressure, and fainting. If you have any kidney disease, the dose should be adjusted in patients with creatinine clearance less than 30 ml/min. Consult with your doctor before stopping the use of Paratramol Tablet.
When stopping this medicine, it is possible that you may experience withdrawal symptoms such as nervousness (agitation), insomnia, muscle spasm (hyperkinesia), tremor, stomach and intestinal symptoms, panic attacks, severe anxiety, hallucinations, tinnitus, unusual CNS symptoms, sweating, insomnia, high fever (rigors), pain, nausea, diarrhea, upper respiratory symptoms, involuntary erection (piloerection), severe anxiety, and tingling or prickling sensation. You may need to gradually decrease the dose of this medicine before stopping.
The safety and effectiveness of using this medicine in children has not been established. The safety and effectiveness of Paratramol have not been studied in children below the age 12 years.
Avoid drinking alcohol with Paratramol.
Medicines may be given for uses other than those listed in the medicine guide. Do not use Paratramol Tablet for symptoms for which it was not prescribed. Do not give Paratramol Tablet to others who may have similar symptoms as you. Self-medication can cause harm.
Store Paratramol Tablet 25°C (77°F); excursions permitted to 15 – 30°C (59 - 86°F), and away from moisture. Keep this medicine away from children and pets.

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How to take Paratramol

Your dose and how often you take Paratramol will depend on the following factors:
  • age
  • patient's health
  • the health of the patient's liver
  • response to the medicine

Paratramol Dosage

Dosage for moderate to severe pain

Adult
  • Recommended: 75 mg of tramadol and 650 mg of paracetamol every 4 to 6 hours
  • Maximum: 300 mg of tramadol and 2600 mg of paracetamol in one day
Children (12 years and older)
  • Recommended: 75 mg of tramadol and 650 mg of paracetamol every 6 hours
  • Maximum: 300 mg of tramadol and 2600 mg of paracetamol in one day

Minimum Age

12 years

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Tablet
Strength: 37.5 mg of tramadol and 325 mg of paracetamol
Film Coated Tablet
Strength: 37.5 mg of tramadol and 325 mg of paracetamol

Special Instructions

Patients with creatinine clearance less than 30 mL/min
The recommended dose of Paratramol in these patients should not exceed 75 mg of tramadol and 650 mg of paracetamol every 12 hours. Take necessary precautions while selecting a dose for the elderly as they are more sensitive to side-effects.

Missed Dose

Avoid taking a double dose to make up for the missed dose and continue with your regular schedule.

Overdose

What to do if you overdose on Paratramol?
If this happens, the patient should contact the doctor immediately. At first, proper breathing and blood flow should be ensured. The blood tests should be performed to monitor the liver function every 24 hours. Then, empty the stomach by irritation causing the patient to vomit. Also, naloxone can be given to treat slow and ineffective breathing and diazepam to control seizures. An oral dose of methionine or an injection of N-acetylcysteine (an antidote of paracetamol) should be given in the vein immediately or within 8 hours. The treatment with oral methionine or an injection of N-acetylcysteine is effective in managing the overdose effect if given within 48 hours of overdose.
Symptoms of an overdose of Paratramol
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Paratramol Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Paratramol

Before you use Paratramol, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information.
Before you use Paratramol Tablet, tell your doctor of your medical history including kidney problems, head injury, emotional disturbances, suicidal attempts or ideation, misuse of alcohol, misuse of tranquilizers, misuse of other CNS-active drugs, allergic reactions to codeine and other opioids, seizures, liver problems, or severe lung problems. The use of Paratramol can be fatal in these patients.
The use of Paratramol Tablet may change sugar level. The use of Paratramol may cause a decrease in sugar level.
The use of this medicine may change liver function test. An increase in the liver function test has been reported with the use of Paratramol.
The use of Paratramol Tablet may change creatinine level. The use of Paratramol may cause an increase in the creatinine level.
Paratramol Tablet is not safe for use in women who are pregnant. If you are pregnant or planning to become pregnant, you should discuss the impact on the fetus with your doctor before you start using this medicine. The use of Paratramol during pregnancy may cause loss of a baby during delivery, seizures to the newborn baby, withdrawal syndrome to the newborn baby, and can be possibly fatal to the baby. Paratramol Tablet is not safe for use in women who are breastfeeding. If you are breastfeeding, discuss with your doctor if you should either discontinue breastfeeding, or stop using this medicine during this period. This medicine may pass into breast milk. It is not known if this medicine is safe for use in women who are conceiving. Consult with your doctor before you use Paratramol Tablet. There is no study regarding the effect of Paratramol on fertility has been reported.
Avoid drinking alcohol with Paratramol. Consumption of alcohol may cause central nervous system depression, and slow and ineffective breathing.
Paratramol can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with Paratramol can worsen the sleepiness. Paratramol may cause seizures in some people. Hence, you should discuss with your doctor before performing any activities where a loss of consciousness may cause harm to you or others.
This medicine may cause stomach bleeding. Regular use of tobacco and alcohol may increase your risk. Discuss with your doctor if you smoke and drink alcohol regularly.

Paratramol Side-effects

The following side-effects may commonly occur when using Paratramol Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
Rarely, the use of Paratramol Tablet may cause the following side-effects:
  • a state of dissatisfaction (dysphoria)
  • abnormal thinking
  • aggravated migraine
  • altered mental processes (cognitive dysfunction)
  • black tarry stool (melaena)
  • bleeding gums
  • blood in the stools
  • changes in activity
  • changes in appetite
  • changes in the way you think (perception)
  • chest pain
  • chills
  • collapse
  • constriction of the pupil (miosis)
  • decreased urine production
  • difficulties or pain on passing urine
  • difficulty in erection (impotence)
  • difficulty in swallowing
  • difficulty in urination
  • difficulty while focusing (concentrating)
  • dilation of the pupil
  • disorders of prostate gland (prostatic disorder)
  • drug dependence and abuse
  • emotional lability
  • fainting
  • fatigue
  • feeling unreal (depersonalization)
  • hives
  • hot flush
  • increase in blood clotting time (elevation of prothrombin times)
  • increased muscle tone (hypertonia)
  • insensibility
  • insomnia
  • loss of body movements
  • memory loss (amnesia)
  • migraine
  • muscle weakness (motor weakness)
  • nightmare (paroniria)
  • nosebleeds
  • overresponsive reflexes (hyperreflexia)
  • palpitation
  • presence of albumin in urine (albuminuria)
  • speech disorders
  • spinning sensation (vertigo)
  • state of intense excitement (euphoria)
  • swelling of tongue
  • tingling sensation
  • tinnitus
  • tremor
  • weakness
  • weight decrease
  • withdrawal syndrome
The following severe side-effects may also occur when using Paratramol Tablet:
Your doctor has prescribed Paratramol Tablet because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Paratramol Tablet.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Patients using other paracetamol-containing products

The patients using other paracetamol-containing products together with Paratramol are at increased risk. Such patients may see an increased risk of liver damage. The use of Paratramol with patients using other products containing paracetamol is not recommended.

Ambulatory patients

The patients that perform excessive physical and mental activities are at increased risk while using Paratramol. Paratramol may diminish the mental or physical abilities of the patient required for the execution of tasks such as operating machines or driving a car. Such patients should take caution while consuming Paratramol.

Patients with increased pressure within the skull or head injury

Such patients may experience carbon dioxide retention, increased cerebrospinal fluid pressure, constriction of the pupil of the eye (miosis) and may hide the presence and extent of a skull disease while using Paratramol. Take necessary precautions while using Paratramol in patients with increased intracranial pressure and head injuries by evaluating their mental health conditions.

Patients consuming alcohol and drugs of abuse

Paratramol may cause an additive effect when used in combination with opioids, alcohol or other illegal drugs that cause central nervous system depression. Avoid the use of alcohol and other medicines containing alcohol.

Patients using central nervous system (CNS) depressants

Patients receiving central nervous system depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, or sedative hypnotics are at an increased risk. Such patients may see an increased risk of slow and ineffective breathing. Paratramol should be used with caution and a low dose is recommended in such patients.

Slow and ineffective breathing

The use of Paratramol with anesthetics or alcohol may cause slow and ineffective breathing in the patients. Paratramol should be used with caution in patients who are at risk of slow and ineffective breathing.

A life-threatening condition (also called as serotonin syndrome)

The patients using serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), triptans, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) are at increased risk. Also, the patients using drugs which disturbs the metabolism of serotonin or tramadol (for example, CYP2D6 and CYP3A4 inhibitors) are at increased risk while using Paratramol. The patients are at increased risk of developing serotonin syndrome with symptoms like nervousness (agitation), hallucinations, increased heartbeat, coma, increased body temperature, blood pressure changes, lack of coordination (incoordination), overresponsiveness (hyperreflexia), vomiting, diarrhea, and nausea.

Suicidal risk

The patients with the previous history of emotional distress, suicidal thoughts or attempts or history of using alcohol, tranquilizers, and other central nervous system active drugs are at increased risk. The use of tramadol can be possibly fatal in such patients. Paratramol should not be consumed in patients who are addiction-prone or suicidal. The use of non-narcotic analgesics is recommended in such patients. Use Paratramol with caution in patients taking alcohol, tranquilizers, antidepressants or have emotional distress or depression.

Risk of occurrence of seizures

The patients taking selective serotonin reuptake inhibitors, tricyclic antidepressants, and other tricyclic compounds (for example, cyclobenzaprine and promethazine), other opioids, MAOIs, neuroleptics and other drugs that reduce the seizure threshold are at increased risk. The risk also increases in patients with seizure disorders, a history of seizures or are susceptible to seizures. The patients are at high risk of seizures while using Paratramol. Use this medicine in patients with seizure disorders only when necessary.

Liver damage

The patients with liver disease or who consume alcohol are at increased risk while using this medicine. The incidence of liver damage is high in patients using more than one product containing paracetamol or exceeding a dose of 4000 milligrams of paracetamol per day. Such patients are at increased risk of liver failure and fatal conditions. The patients should not use more than one product that contains paracetamol. One should contact the doctor immediately upon taking a dose exceeding 4000 mg of paracetamol per day.

Misuse, abuse and diversion

The drug abusers and drug addicts are at increased risk while using this medicine. Misuse and abuse of Paratramol may lead to criminal activity, overdose and can be possibly fatal to such patients. The doctor should take necessary precautions while prescribing Paratramol.

Children aged 12 years and older

The children aged 12 years and older are at increased risk while using this medicine. The children are at the risk of overdose if a dose of more than tramadol 300 mg and paracetamol 2600 mg is taken. The recommended dose should not be exceeded in children. They also should not use any other drug containing paracetamol or tramadol.

Withdrawal symptoms

The patients are at increased risk of developing withdrawal symptoms such as insomnia, anxiety, chills with sweating and a high fever (rigors), sweating, nausea, diarrhea, tremors, pain, goosebumps (piloerection), hallucinations, upper respiratory tract symptoms, panic attacks, and tingling sensation when Paratramol is stopped immediately. The withdrawal symptoms can be avoided by prescribing a low dose before stopping Paratramol after prolonged treatment.

Patients under use of local anesthetics

The use of Paratramol during general anesthesia with nitrous oxide and enflurane may enhance recall of events that occurred during surgery. The use of Paratramol during surgical anesthesia is not recommended.

Patients dependent on opioids

The use of Paratramol as a substitute in patients who are dependent on opioids is not recommended.

Interactions with Paratramol

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
Paratramol Tablet interacts with carbamazepine, which is used to prevent and control seizures. When carbamazepine is used with Paratramol, the pain-reducing effect of Paratramol is reduced, and the breakdown or elimination of Paratramol is increased. Paratramol should not be used in combination with carbamazepine.
There may be an interaction of Paratramol with triptans, which are used to treat migraine. Patients taking triptans in combination with Paratramol may experience increased serotonergic activity in the central nervous system (serotonin syndrome). Take necessary precautions while using Paratramol in combination with triptans.
Paratramol Tablet may interact with monoamine oxidase inhibitors, which are used to treat depression. The use of Paratramol with monoamine oxidase (MAO) inhibitors may cause diarrhea, confusion, increased heartbeat, trembling, excessive sweating, seizures or coma. In patients taking MAO inhibitors, Paratramol should be given after two weeks of MAO inhibitors treatment.
Your doctor's guidelines may need to be followed while taking this medicine along with quinidine, which is used to treat or prevent irregular heartbeat. The use of quinidine with tramadol may increase the level of tramadol and lowers the level of the amount of metabolite of Paratramol.
Special instructions need to be followed while taking this medicine along with alcohol, which is used for sleepiness effect. Alcohol may increase sleepiness effect of Paratramol. Thus, the use of alcohol with Paratramol while using machines and driving vehicles may be dangerous. The use of alcohol or alcohol containing products should be avoided while taking Paratramol.
Your doctor's guidelines may need to be followed while taking this medicine along with serotonergic drugs, used to treat depression. The use of Paratramol with serotonin and norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, antipsychotics may cause seizures and serotonin syndrome in the patients. The use of α2-adrenergic blockers, triptans, St. John’s Wort, lithium or linezolid may cause a life-threatening condition (called as, serotonin syndrome) in the patients. Take necessary precautions while using Paratramol in combination with serotonergic drugs.
Special instructions need to be followed while taking this medicine along with cytochrome 2D6 and cytochrome 3A4 inducers or inhibitors. The use of Paratramol with cytochrome 2D6 (for example, paroxetine, fluoxetine, and amitriptyline) and cytochrome 3A4 inhibitors (for example, erythromycin, ketoconazole) or inducers (for example, St. John’s Wort and rifampin) may affect the breakdown and amount of Paratramol. These patients may suffer from seizures and a life-threatening condition (called as, serotonin syndrome).
Paratramol Tablet interacts with opioid agonists-antagonists, which are used to treat pain. When the Paratramol is used with opioid agonists-antagonists (for example, buprenorphine, nalbuphine, pentazocine), the pain-relieving effect gets reduced and increases the risk of withdrawal symptoms. Paratramol should not be used along with opioid agonists-antagonists.
There may be an interaction of Paratramol with warfarin like compounds, which are used to prevent blood clottimg. The use of Paratramol with warfarin-like compounds may cause an increase in the blood clotting time. Regularly monitoring of the prothrombin time should be done in the patients using Paratramol together with warfarin-like compounds.
Paratramol Tablet may interact with digoxin, which is used to treat heart failure. When Paratramol is used in combination with digoxin, an increase in the level of digoxin may occur.
Special instructions need to be followed while taking this medicine along with other central nervous system depressants, which are used to treat anxiety and insomnia. If the Paratramol is used with other central nervous system depressants, such as other anxiolytics, sedative antidepressants, hypnotics, sedative antihistamines, centrally-acting antihypertensive drugs, neuroleptics, thalidomide and baclofen, the patient may suffer from increased central depression and the impact on alertness can cause driving and use of machines harmful. Take necessary precautions while using Paratramol in such patients.
Paratramol Tablet interacts with mirtazapine, which is used to treat depression. The use of Paratramol with mirtazapine may cause seizures and a life-threatening condition (called as, serotonin syndrome) in the patients. Use this medicine with caution in such patients.
There may be an interaction of Paratramol with seizure threshold-lowering medicines. The use of Paratramol with seizure threshold-lowering medicines (for example, tetrahydrocannabinol, mirtazapine, bupropion) may cause seizures in the patients. Take necessary precautions while using Paratramol in combination with seizure threshold-lowering medicines.
Paratramol Tablet may interact with other opioid derivatives (including antitussive drugs and substitutive treatments), benzodiazepines and barbiturates, which are used to treat anxiety. When the Paratramol is used with other opioid derivative drugs, barbiturates, or benzodiazepines the risk of slow and ineffective breathing increases that can result in the fatality in cases of overdose. Use this medicine with caution in such patients.
This page does not contain all the possible interactions of Paratramol Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Paratramol is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Paratramol Tablet .
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