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Tamol tablet

Generic Name(s): Tramadol

Why it's used

Tamol tablet is used for the management of moderate to severe pain in adults. This medicine works by changing the way of chemicals in the brain which generates pain signals in the body.
Opioid Agonist
Tamol is a prescription medicine that belongs to a class of medicines called Opioid Agonist. Opioid agonists are medicines used for the treatment of addiction to opioid drugs such as heroin, fentanyl, oxycodone, hydromorphone, and percocet. These medications work to prevent withdrawal and decrease cravings for opioid drugs.

How to use

Follow directions on the product label, information guide, and provided by your doctor before using Tamol. Use this medicine as per your doctor's instructions.
Tamol is used with or without food. Swallow the whole tablet with liquid. Tamol tablets should not be cut, broken, crushed, chewed and dissolved before use otherwise it can cause overdose or fatal.
The typical adult dose of Tamol is 50-100 mg twice daily if pain does not relieve increase dose up to 150-200 mg twice daily. The maximum dose for adults of Tamol is 300 mg per day per day. Tamol is typically used at the same time every day. Take your prescribed dose once a day at the same time every day. Do not take more than your prescribed dose. 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.
Tamol is to be used for longer periods of time. Tamol is used for the treatment of severe pain.
Tell your doctor if you develop new symptoms. Talk to your doctor if sleepiness, difficulty falling asleep or staying asleep, headache, nervousness, uncontrollable shaking of a part of the body, muscle tightness, changes in mood, heartburn or indigestion, and dry mouth. If you have any kidney disease, in such patients the dosage interval should be prolonged as per the patient requirement. If you have issues with the health of your liver, in such patients the dosage interval should be prolonged as per the patient requirement. Consult with your doctor before stopping the use of Tamol tablet.
To see the impact of Tamol tablet on the body, your doctor may recommend a lower initial dose. Please follow your doctor's instructions carefully. Taking a high dose of this medicine is known to increase the chances of side-effects. A lower dose of Tamol tablet may be recommended to reduce the risk of side-effects. Older patients may see an increase in the risk of side-effects. Hence, a lower dose may be recommended.
When stopping this medicine, it is possible that you may experience withdrawal symptoms such as extreme emotional disturbance (agitation), nervousness, insomnia, excessive abnormal movements (hyperkinesia), tremor, gastrointestinal symptoms, panic attacks, hallucinations, abnormal sensations in the body, tinnitus, unusual CNS symptoms (confusion, delusions, depersonalization, derealization, paranoia), restlessness, shedding tears (lacrimation), mucus discharge from nose (rhinorrhea), yawning, sweating, chills, muscle pain, dilation of the pupil of the eye, irritability, backache, joint pain, weakness, abdominal cramps, nausea, loss of hunger (anorexia), vomiting, diarrhea, increased blood pressure, increased breathing, and increased heart rate. You may need to gradually decrease the dose of this medicine before stopping. This medicine may not be as effective if it is used for extended periods of time.
The safety and effectiveness of using this medicine in children has not been established. This medicine may increase the risk of slow and ineffective breathing and fatal in the children.
If using the orally-disintegrating form of this medicine, make sure you do not consume any food or fluid 5 minutes before or after taking this medicine. Before taking the medicine out of the package, wash your hands thoroughly. Place the medicine on the tongue. Make sure you do not chew or swallow the medicine. You do not need to drink water after consuming the medicine. In certain cases, the medicine can taste slightly bitter. Also, ensure that you do not break or split the medicine.
If using the delayed-release form of this medicine, do not crush or chew the medicine, unless indicated on the package. Crushing or chewing of the medicine can result in unpleasant taste resulting in patients not following the medicine schedule. Crushing or chewing can also release all of the medicine at once, resulting in a decrease of effectiveness and a possible increase in side-effects.
To decrease the possibility of side-effects, you might be recommended to use the extended-release form of this medicine by your doctor. The extended-release medicine helps in maintaining a steady level of the medicine in your body for a longer period of time. Do not crush or chew the medicine, unless indicated on the package or by your doctor.
The Tamol parenteral injection can be intended to use intramuscularly (into the muscle), intravenously (into the blood veins) and slow infusion.
Avoid drinking alcohol with Tamol.
Medicines may be given for uses other than those listed in the medicine guide. Do not use Tamol tablet for symptoms for which it was not prescribed. Do not give Tamol tablet to others who may have similar symptoms as you. Self-medication can cause harm.
Store Tamol tablet at 15°C to 30°C (59°F to 86°F) for tablet and, and away from moisture. Keep this medicine away from children and pets.

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How to take Tamol

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

Tamol Dosage

Dosage for moderate to severe pain

Adult (adults and children above the age of 12 years)
  • Initial: 50-100 mg twice daily in the morning and evening, if the pain does not relieve increase the dose up to 150-200 mg twice daily
  • Maximum: 300 mg/day

Minimum Age

12 years

Forms

Tablet, orally disintegrating
Strength: 50 mg
Tablet, film coated
Strength: 50 mg
Tablet, extended release
Strength: 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 300 mg
Tablet, coated
Strength: 50 mg
Tablet
Strength: 50 mg, 100 mg
Capsule
Strength: 150 mg
Capsule, extended release
Strength: 150 mg

Special Instructions

Capsule
Tamol capsule must be swallowed whole, do not be split, chewed, dissolved or crushed and may be taken without regards to the meal.
Tamol parenteral infusion
The infusion should be prepared immediately before use. The Prepared infusion should be used immediately and store under sterilized conditions at 2 to 8°C for not more than 24 hours.

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued. Avoid taking a repeated dose to make up for a missed dose.

Overdose

What to do if you overdose on Tamol?
In case of overdose, keep open the respiratory tract (aspiration). Provide other life supports like oxygen and blood pressure rising agents to manage sudden decrease in the blood flow to the body organs (circulatory shock) and build up of fluid in the lungs. Provide advanced life supports (open airway and adequate ventilation or breathing) in case of loss of heart functions (cardiac arrest) and abnormal heart rate (arrhythmia). Use opioid antagonists medicines like naloxone or nalmefene in the situation of slow and ineffective breathing and physical dependence. To prevent harmful effects of Tamol, immediate stomach emptying should be performed (gastric lavage) or decontamination of the stomach with charcoal is performed within 2 hours after Tamol intake.
Symptoms of an overdose of Tamol
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:
  • abnormal heartbeat
  • build up of fluid in the lungs
  • cold and clammy skin
  • coma
  • fatal
  • low blood pressure
  • narrowing of the pupils
  • noisy breathing during sleep (atypical snoring)
  • partial or complete airway obstruction
  • skeletal muscle weakness
  • slow and ineffective breathing
  • slow heart rate
If you think you have overdosed on Tamol 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 Tamol

Before you use Tamol tablet, discuss with 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. Tell your doctor if you are allergic any of the following substances: opioids.
Before you use Tamol, tell your doctor of your medical and health history including the following: head injury, seizures, liver problems, kidney problems, thyroid problems, urinating problems, pancreas problems, gallbladder problems, abuse of prescription drugs, alcohol addiction, mental health problems (depression), history of currently taking central nervous system active drugs, circulatory shock, slow and ineffective breathing, rise in pressure around the brain (increased intracranial pressure), brain tumors, stomach or intestinal obstruction, head trauma, metabolic disorders, alcohol or drug withdrawal, or central nervous system infection. The patients using Tamol may experience decrease respiratory function which may further increase intracranial pressure. It also increases the risk of drug abuse, addiction, or misuse in patients with the history of substance abuse or mental health problems. Patients with alcohol withdrawal, metabolic disorders, head trauma, drug withdrawal, central nervous system infection or with a history of epilepsy may experience an increased risk of seizure when using Tamol. Using Tamol in patients taking central nervous system active drugs are at increased risk of suicide. Using Tamol in patients with a history of shock may cause vasodilation which may lead to decreased heart function and blood pressure. Before having surgery during the use of Tamol, discuss with your doctor and dentist about the medicinal products you use including prescription/non-prescription/herbal medicines.
The use of this medicine may change blood amylase. Using Tamol may cause an increase in the blood amylase and obstruction in the flow of digestive juice (spasm of the sphincter of Oddi). Patients with stomach and intestinal conditions such as biliary tract disease, acute pancreatitis should be monitored for worsening of symptoms.
The use of Tamol tablet may change intracranial pressure. Patients more prone to intracranial effects of CO2 retention may experience decreased respiratory function which may lead to a further increase in intracranial pressure. Patients should be monitored for the signs of slow and ineffective breathing and sedation when starting Tamol therapy.
The use of this medicine may change blood pressure. Patients using Tamol may experience a decrease in blood pressure and loss of consciousness. Such patients should be monitored for the signs of low blood pressure after starting the therapy or during dosage adjustment of Tamol.
Tamol tablet can make you feel sleepy. Be careful when using any machinery, driving a vehicle, or doing any other activity that needs you to be fully alert. The consumption of alcohol with Tamol tablet can worsen the sleepiness. Tamol tablet may cause rarely seizures in some people. If you perform any activities where a loss of consciousness may cause harm to you (or others), you should discuss with your doctor.
The use of Tamol tablet is known to be not safe for use in pregnant women. If you are planning to become pregnant or are currently pregnant, you should discuss with your doctor the potential impact of this medicine on the baby before you start to using it. There is no sufficient data available for drug-associated risk for miscarriage, birth defects, growth, and for functional maturation of the child. Prolonged use of Tamol during pregnancy may cause fetal harm such as slow and ineffective breathing, physical dependence, opioid withdrawal syndrome, and mental (psycho-physiologic) effects. Neonatal opioid withdrawal syndrome includes vomiting, tremor, irritability, abnormal sleep pattern, hyperactivity, diarrhea, high pitched cry, and failure to gain weight. Tamol should not be used during or before labor when the use of other analgesic medicines is more appropriate. Tamol may prolong the labor which temporarily decreases the duration, frequency, and strength of uterine contractions. During labor, neonates should be monitored for the sign of sedation and slow and ineffective breathing. The use of Tamol tablet is not safe for use in women who are breastfeeding. If you are breastfeeding a baby, discuss with your doctor if you should either discontinue breastfeeding or stop using this medicine while breastfeeding. There is no sufficient and adequate data available for safety in breastfeeding. Tamol may pass into breast milk which may cause serious harmful effects such as sedation, withdrawal symptoms and slow and ineffective breathing in infants. Tamol tablet should be used while conceiving only when required. The long-term use of Tamol may reduce fertility. It is unknown whether these effects are reversible.
Avoid consuming alcohol together with Tamol. Drinking alcohol may cause sedation, slow and ineffective breathing, coma, fatal, seizures, low blood pressure, severe drowsiness, decreased awareness, and breathing problems.
Tamol tablet may cause increased incidence of side-effects in older patients. Elderly patients may see an increased risk of constipation, fatigue, weakness, low blood pressure on quickly standing up, indigestion (dyspepsia), and slow and ineffective breathing.
Tamol may cause an increased risk of side-effects in children. Children using this medicine may see an increased risk of life-threatening slow and ineffective breathing, fatal, neonatal seizures, and neonatal withdrawal syndrome.
Patients using Tamol for longer duration may experience tolerance, physical and psychic dependence. Long-term use of Tamol in pregnant women may cause neonatal withdrawal syndrome.

What precautions should be taken during Pregnancy and Nursing, and administering Tamol to Children or the Older Adults?

Pregnant Women

Contraindicated or Not Recommended
Warning: There is no sufficient data available for drug-associated risk for miscarriage, birth defects, growth, and for functional maturation of the child. Prolonged use of Tamol during pregnancy may cause fetal harm such as slow and ineffective breathing, physical dependence, opioid withdrawal syndrome, and mental (psycho-physiologic) effects. Neonatal opioid withdrawal syndrome includes vomiting, tremor, irritability, abnormal sleep pattern, hyperactivity, diarrhea, high pitched cry, and failure to gain weight. Tamol should not be used during or before labor when the use of other analgesic medicines is more appropriate. Tamol may prolong the labor which temporarily decreases the duration, frequency, and strength of uterine contractions. During labor, neonates should be monitored for the sign of sedation and slow and ineffective breathing.

Breastfeeding

Contraindicated or Not Recommended
Warning: There is no sufficient and adequate data available for safety in breastfeeding. Tamol may pass into breast milk which may cause serious harmful effects such as sedation, withdrawal symptoms and slow and ineffective breathing in infants.

Younger Adults Population

Contraindicated or Not Recommended
Warning: Tamol may increase the risk of neonatal withdrawal syndrome, psycho-physiologic effect, seizures, fatal and slow and ineffective breathing in children. Tamol should not be used in children aged between 12-18 years especially with postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, obesity, underlying lung problems and combined use of other medicines. It should not be used in children younger than 12 years and children younger than 18 years having a tonsillectomy or adenoidectomy.

Older Adults Population

Precaution
Warning: Elderly patients having abnormal functioning of the kidney are at increased risk of harmful effects. Such patients may experience constipation, life-threatening slow and ineffective breathing, fatigue, weakness, low blood pressure on quickly standing up, and indigestion (dyspepsia). Precaution should be taken in patients over 65 years. Dosage adjustment and monitoring of the central nervous system, slow and ineffective breathing and functioning of the kidney is recommended.

Tamol Side-effects

The following side-effects may commonly occur when using Tamol tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Tamol tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Tamol tablet may cause the following side-effects:
  • abnormal coordination
  • abnormal dreams
  • back pain
  • blood in the urine (hematuria)
  • bruise (contusion)
  • clamminess
  • cold (nasopharyngitis)
  • cough
  • decreased appetite
  • decreased weight
  • deficiency of male sex hormones (androgen deficiency)
  • depersonalization
  • derealisation
  • difficulty in expelling urine from the bladder (micturition)
  • dilatation of blood vessels (vasodilatation)
  • dilation of the pupil of the eye
  • disturbance in attention
  • disturbance of the sensory organs (perception disorders)
  • ear infection
  • excessive constriction of the pupil of the eye (miosis)
  • extreme happiness and feeling of excitement (euphoric mood)
  • fainting
  • feeling hot
  • feeling jittery
  • feeling of discomfort
  • feeling unhappy (dysphoria)
  • fever
  • flatulence
  • goosebumps (piloerection)
  • hives
  • indigestion (dyspepsia)
  • inflammation of the bronchial tubes (bronchitis)
  • inflammation of the gallbladder (cholecystitis)
  • influenza like illness
  • insufficient blood flow to the brain and other organs (heart collapse)
  • intestinal infection (gastroenteritis viral)
  • involuntary muscle contractions
  • irritability
  • irritation of the throat (sore throat)
  • itchy inflammation of the skin (dermatitis)
  • joint pain (arthralgia)
  • joint sprain
  • joint stiffness
  • joint swelling
  • life-threatening drug-induced skin reaction (harmful epidermal necrolysis)
  • life-threatening skin reaction (Stevens-Johnson Syndrome)
  • loss of sensitivity (hypoesthesia)
  • loss of sex drive (libido)
  • lower limb swelling (peripheral swelling)
  • muscle cramps
  • muscle injury
  • muscle pain
  • muscle spasms
  • muscle twitching
  • muscle weakness (motorial weakness)
  • neck pain
  • nervousness
  • night sweats
  • nightmares
  • pain
  • pain in limb
  • painful swelling and inflammation of the joint (osteoarthritis)
  • painful urination
  • palpitations
  • panic attacks
  • paranoia
  • rash
  • restlessness
  • ringing in the ears (tinnitus)
  • runny nose (rhinorrhea)
  • sedation
  • serious mental illness (delusion)
  • severe headache (migraine)
  • shivering
  • sleep disturbance
  • sneezing
  • speech disorders
  • stomach (abdominal) pain
  • stomach and intestinal discomfort (gastrointestinal discomfort)
  • stone in the gallbladder (cholelithiasis)
  • stuffy nose (nasal congestion/sinus congestion)
  • sudden feeling of cold with shivering (rigors)
  • tingling sensation
  • toothache
  • tremor
  • urinary frequency
  • vertigo
  • viral infection
  • weakness
  • yawning
The following severe side-effects may also occur when using Tamol tablet:
  • neonatal opioid withdrawal syndrome (symptoms occur in a newborn due to addictive opiate drugs while in the pregnancy) (fetal death and loss of a baby during or before delivery (stillbirth))
    Symptoms: irritability, hyperactivity, abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, failure to gain weight neonatal seizures
    Observe and manage the signs of neonatal opioid withdrawal syndrome in newborns. Advise should be taken in pregnant women who are receiving long-term opioids therapy for the increased chances of neonatal opioid withdrawal syndrome.
  • insufficient production of adrenal hormones (adrenal insufficiency) (life-threatening condition)
    Symptoms: nausea, vomiting, eating disorder (anorexia), fatigue, weakness, dizziness low blood pressure
    Confirm the diagnosis of adrenal insufficiency by proper diagnostic testing as soon as possible and use physiological replacement doses of corticosteroids until adrenal function recovers.
  • eye disorder
    Symptoms: blurred vision
  • Symptoms: bacterial serious skin inflammation (cellulitis)
  • respiratory disorder (respiratory arrest and possibly fatal)
    Symptoms: life-threatening slow and ineffective breathing, difficulty in breathing (dyspnea), upper respiratory tract infection, inflammation of the lungs (pneumonia) inflammation within the nasal passage (sinusitis)
    Management of slow and ineffective breathing may include supportive measures, close observation, and use of opioid antagonists, depending upon the clinical status of the patient. Closely monitor the patients for slow and ineffective breathing, primarily within the first 24-72 hours of starting therapy.
  • serotonin-inducing symptoms (serotonin syndrome) (life-threatening condition)
    Symptoms: agitation, hallucinations, coma, increased heart rate, changes in the blood pressure, fever, nausea, vomiting, diarrhea, over-responsive reflexes (hyperreflexia), incoordination rigidity
    Treatment with Tamol should be discontinued if serotonin syndrome occurs.
  • immune system disorder such as an allergic reaction (possibly fatal)
    Symptoms: life-threatening allergic reaction, severe itching of the skin, hives, tightening of the lungs' muscles (bronchospasm), swelling of the skin, life-threatening skin reaction (Stevens-Johnson Syndrome), life-threatening drug-induced skin reaction, difficulty in breathing (dyspnea), wheezing swelling of the skin due to an allergic reaction
    Use of Tamol should be discontinued if life-threatening allergic reactions or other allergic reactions occur and patients should get immediate medical attention.
  • stomach and intestinal disorders
    Symptoms: inflammation of the appendix (appendicitis) inflammation in the pancreas (pancreatitis)
    Patients should be monitored for worsening symptoms and inflammation in the pancreas.
  • metabolism and nutrition disorder
    Symptoms: low blood sugar (hypoglycaemia)
Your doctor has prescribed Tamol 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 Tamol 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.

Side-effects and Allergic Reactions of Tamol by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:

Side-effects in Children

Following are the side-effects of this medicine in young patients:
  • fatal
  • life-threatening slow and ineffective breathing
  • neonatal seizures
  • neonatal withdrawal syndrome

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:
Use of Tamol should be discontinued if the allergic reaction or other allergic reaction occurs. Patients should take immediate medical attention on the occurrence of an allergic reaction.

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
Use of Tamol should be discontinued if the life-threatening allergic reaction or other allergic reaction occurs. Patients should take immediate medical attention the occurrence of an allergic reaction.
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

Use of serotonergic drugs therapy

Patients undergoing serotonergic drugs therapy such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), triptans, serotonin and norepinephrine reuptake inhibitors (SNRIs), 5-HT3 receptor antagonists, MAO inhibitors which are used to treat depression, are at increased risk when using this medicine. Patients using Tamol with serotonergic drugs are at increased risk of seizures and serotonin syndrome. Symptoms of serotonin syndrome may occur within several hours to a few days, which may include incoordination, blood pressure, hallucinations, anxiety, nausea, coma, increased heartbeat, increased body temperature, overresponsive reflexes (hyperreflexia), rigidity, vomiting, and diarrhea. Patients should stop using Tamol if serotonin syndrome occurs.

Using benzodiazepines or other central nervous system depressants with Tamol

Patients using benzodiazepines or other central nervous system depressants (anxiolytics, tranquilizers, muscle relaxants, general anaesthetics, antipsychotics, other opioids, alcohol, non-benzodiazepine sedative/hypnotics) are at increased risk when using this medicine. These patients may experience extreme sedation, slow and ineffective breathing, coma, and possibly fatal when using Tamol with central nervous system depressants. When Tamol is used with benzodiazepine or other CNS depressant, treatment should be started with the lowest effective dose for the shortest duration. Patients should be monitored for the signs of slow or ineffective breathing and sedation. Patients are also advised not to drive or operate heavy machinery when using benzodiazepines or other CNS depressants in combination. Examine the patients for the risk of drug abuse and inform them for risk of overdose and fatality.

Use of CYP3A4 inhibitors and cytochrome P450 3A4 inducers

Patients using CYP3A4 inhibitors such as erythromycin, ritonavir and ketoconazole, which are used to treat bacterial, and fungal infections respectively or cytochrome P450 3A4 inducer such as carbamazepine, rifampin and phenytoin, which are used to treat seizures are at increased risk when using this medicine. When using Tamol with cytochrome P450 3A4 inhibitors or discontinuing cytochrome P450 3A4 inducer may experience an increase in the level of Tamol in the blood which may result in increased serious harmful effects including seizures, serotonin syndrome (serotonin-inducing symptoms), and may cause potentially slow or ineffective breathing. The use of Tamol with cytochrome P450 3A4 inducers or discontinuing cytochrome P450 3A4 inhibitors may decrease the level of Tamol in the blood that results in sign and symptoms of opioid withdrawal. These patients should also be monitored for signs and symptoms of opioid withdrawal.

Use of cytochrome P450 2D6 inhibitors

Patients using Tamol with cytochrome P450 2D6 inhibitors such as amiodarone, quinidine, which are used to treat irregular heartbeat are at increased risk when using this medicine. Patients using Tamol with P450 2D6 inhibitors may result in an increased level of Tamol and decreased metabolite levels in the blood. It may result in an increased risk of serious harmful effects such as seizures, serotonin syndrome, and withdrawal (after stopping or reducing intake of a drug) syndrome in patients who have the physical dependence on Tamol. In the case of discontinuation of the combined use of CYP2D6 inhibitors with Tamol, results in decreased levels of Tamol and increased metabolite levels in the blood which may increase the harmful effect of opioid and fatal slow and ineffective breathing. These patients should also be monitored for seizures, serotonin syndrome, harmful effects of opioids and signs or symptoms of opioid withdrawal.

Prolonged use of Tamol in pregnant women

Infants are at an increased risk when pregnant women use this medicine for long-term. Infants are at increased risk of neonatal opioid withdrawal syndrome (symptoms occur in a newborn due to addictive opiate drugs while in the pregnancy) when pregnant women use this medicine for a long duration which can be life-threatening. The newborn should be observed for the withdrawal syndrome and should be treated as needed. Pregnant women using Tamol for longer duration should be informed about the risk of neonatal opioid withdrawal syndrome, and provide treatment accordingly.

Ultra-rapid metabolizers taking Tamol

Patients who rapidly convert Tamol into O-desmethyltramadol are at increased risk. These patients are at increased risk of fatal and life-threatening slow or ineffective breathing or experience signs of overdose such as confusion, extreme sleepiness, or shallow breathing when using this medicine. Tamol should not be used in such patients.

Breastfeeding mother taking Tamol

Infants who are breastfeeding from mother taking Tamol are at an increased risk. Infants are at an increased risk of slow and ineffective breathing when a mother is using this medicine. Tamol should not be used during breastfeeding.

Children taking Tamol

Children younger than 12 years, children under 18 years with a history of organ removal surgery and children under 12- 18 years with risk factors such as obesity, serious sleep disease (obstructive sleep apnea), neuromuscular disease, severe pulmonary disease, and combined use of other medicines are at increased risk when using this medicine. Such patients are at an increased risk of life-threatening slow or ineffective breathing and it can be possibly fatal. Avoid the use of Tamol in such patients.

Life-threatening slow and ineffective breathing

Patients undergoing Tamol therapy are at increased risk when using this medicine. These patients are at an increased risk of serious, life-threatening, or fatal slow and ineffective breathing during starting or increasing dose of Tamol. It can be possibly fatal in patients when converting from another opioid to Tamol due to overdose with the first dose. Patients should be monitored for slow and ineffective breathing within 24-72 hours of starting or increased dose of Tamol therapy. Proper dosing is recommended to reduce the risk of slow and ineffective breathing. Management of slow and ineffective breathing includes supportive measures (oxygen and vasopressors), close observation and use of opioid antagonists if needed. Patients are advised to swallow the whole tablet of Tamol to avoid patient's exposure to a harmful dose.

History of mental illness or substance abuse

Patients with a history of mental illness or substance abuse are at an increased risk when using this medicine. Such patients are at an increased risk of addiction, misuse or abuse of Tamol, which may lead to overdose and fatal. These patients should be monitored for the risk and development of addiction, misuse or abuse before using Tamol. To reduce these risks, a small dose medicine should be prescribed and patients should be advised to dispose off the remaining unused drug.

Use of tricyclic compounds, monoamine oxidase inhibitors, or neuroleptics which are used to treat neurological disorders

Patients taking tricyclic compounds (cyclobenzaprine, promethazine), monoamine oxidase inhibtors or neuroleptics are at an increased risk when using this medicine. Patients using Tamol with tricyclic compounds, monoamine oxidase inhibtors or neuroleptics are at increased risk of seizures. Tamol should not be used in patients taking MAOIs and within 14 days of stopping the MAOI therapy.

Patients with epilepsy, seizures and conditions which increase the risk of seizures

Patients with epilepsy, seizures or conditions which increase the risk of seizures such as head trauma, metabolic disorders, alcohol, drug withdrawal and central nervous system infections are at increased risk when using this medicine. These patients are at an increased risk of seizures.

Suicidal behaviour or addiction-prone patients

Patients with addiction-prone or suicidal behaviour are at an increased risk when using this medicine. These patients are at increased risk of suicide when using this medicine. Tamol should not be used in such patients. Use of non-narcotic analgesics should be considered in such patients. Patients are advised not to use more than the recommended dose and not to drink excess alcohol.

Patients with a history of misuse or currently taking central nervous system-active drugs, emotional disturbance, excess alcohol, or depression

Patients with a history of misuse, emotional disturbance, excess alcohol use, depression or currently taking central nervous system-active drugs such as antidepressant drugs or tranquilizers are at increased risk. These patients are at an increased risk of suicide when using this medicine. Precaution should be taken when using Tamol in such patients. Patients are advised not to use more than the recommended dose and not to drink excess alcohol.

Patients with stomach and intestine problems

Patients with stomach and intestine problems such as intestinal paralysis (paralytic ileus) should not use this medicine. These patients may experience disturbances in the flow of bile juices and an increase in blood amylase. Patients with biliary tract disease such as inflammation in the pancreas (acute pancreatitis) should be monitored for worsening of symptoms.

Interactions with Tamol

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.
Your doctor's guidelines may need to be followed while taking this medicine along with serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), serotonin and norepinephrine reuptake inhibitors (SNRIs), 5-HT3 receptor antagonists (mirtazapine, trazodone, tramadol), triptans, which are used to treat depression. The use of Tamol with serotonergic drugs may cause serotonin syndrome (serotonin-inducing symptoms). If the use of Tamol with serotonergic drugs is necessary, then the patient should be carefully observed while starting treatment and during dose adjustment. Treatment with Tamol should be discontinued if serotonin syndrome occurs.
Tamol tablet interacts with CYP3A4 inducers such as carbamazepine, phenytoin, and rifampin, which are used to treat seizures and bacterial infections. The use of Tamol with CYP3A4 inducers may decrease the level of Tamol in the blood which further results in reduced drug efficacy or withdrawal syndrome in patients who have the physical dependence on Tamol. In case of discontinuation of the combined use of CYP3A4 inducer with Tamol, it may increase the level of Tamol in the blood, which leads to increase the harmful effect of opioid and may cause seizures, serotonin syndrome, and fatal slow or ineffective breathing. The patient taking carbamazepine may decrease the pain-relieving (analgesic) effect of Tamol which leads to increase Tamol metabolism and risk of seizure. If the use of Tamol with the CYP3A4 inducer is necessary, the dose of Tamol should be increased until the stable effects of the drug are achieved. Follow the patients for the signs of opioid withdrawal. If CYP3A4 inducer is discontinued, the dose of Tamol should be reduced. Patients should be monitored for the signs of seizures, serotonin syndrome (serotonin-inducing symptoms), slow or ineffective breathing, and sedation. The use of carbamazepine with Tamol should be avoided if the seizure occurs.
There may be an interaction of Tamol with CYP3A4 inhibitors such as macrolide antibiotics (erythromycin), azole-antifungal agents (ketoconazole), protease inhibitors (ritonavir), which are used to treat bacterial, fungal and viral infections respectively. The use of Tamol with CYP3A4 inhibitors may increase the level of Tamol in the blood which results in increased metabolite levels. Patients should be monitored for serious harmful effects including seizures, serotonin syndrome (serotonin-inducing symptoms), and fatal slow or ineffective breathing, especially when the CYP3A4 inhibitors are added after a stable dose of Tamol is achieved. In the case of discontinuation of the combined use of CYP3A4 inhibitors with Tamol, it may decrease the level of Tamol in the blood which further results in reduced drug efficacy or withdrawal syndrome in patients who have the physical dependence on Tamol. If the use of Tamol with the CYP3A4 inhibitors is necessary, the dose of Tamol should be reduced until the stable effects of the drug are achieved. If CYP3A4 inhibitors are discontinued, the dose of Tamol should be increased. Patients should be monitored for the signs of opioid withdrawal syndrome.
Tamol tablet may interact with CYP2D6 inhibitors such as quinidine, fluoxetine, paroxetine and bupropion, which are used to treat heart disease and depression. The use of Tamol with CYP2D6 inhibitors may result in an increased level of Tamol and decreased metabolite levels in the blood, especially when the CYP2D6 inhibitors are added after a stable dose of Tamol is achieved. It results in decreased the effectiveness of Tamol and may increase the risk of serious harmful effects such as seizures, serotonin syndrome, and withdrawal (after stopping or reducing intake of a drug) syndrome in patients who have the physical dependence on Tamol. In the case of discontinuation of the combined use of CYP2D6 inhibitors with Tamol, it may decrease the level of Tamol and increased metabolite levels in the blood which may increase the harmful effect of opioid and increase the risk of fatal slow and ineffective breathing. If the use of Tamol with the CYP2D6 inhibitors is necessary, patients should be monitored for the signs of seizures, serotonin syndrome and opioid withdrawal. If CYP2D6 inhibitors are discontinued, the dose of Tamol should be reduced until the stable effects of the drug are achieved, and such patients should be monitored for signs of slow or ineffective breathing and sedation.
Special instructions need to be followed while taking this medicine along with central nervous system depressants such as benzodiazepines and other sedatives/hypnotics, antipsychotics, tranquilizers, anxiolytics, general anesthetics, muscle relaxants, other opioids, which are used to treat depression, anxiety and muscle spasms. The use of Tamol with benzodiazepines or other CNS depressants may increase the risk of low blood pressure, slow or ineffective breathing, profound sedation, coma, and possibly fatal. Patients should be monitored for the signs of slow or ineffective breathing or sedation. Limit the dosage or minimize the duration in such patients.
Your doctor's guidelines may need to be followed while taking this medicine along with diuretics, which are used to treat blood pressure. The use of opioids may reduce the effectiveness of diuretics by releasing the antidiuretic hormone. Patients should be monitored for the reduced diuresis (overproduction of urine) effects on blood pressure and the dose of diuretic should be increased as needed.
Tamol tablet interacts with mixed agonist/antagonist and partial agonist opioid analgesics such as butorphanol, nalbuphine, pentazocine, buprenorphine, which are used to treat moderate to severe pain. The use of Tamol with mixed agonist/antagonist and partial agonist opioid analgesics may reduce the pain-relieving (analgesic) effects of Tamol and cause withdrawal symptoms. Patients should avoid the use of both medicines together.
Special instructions need to be followed while taking this medicine along with muscle relaxants, which are used to treat muscle spasms. Tamol may increase the neuromuscular (muscle functioning) blocking effect of muscle relaxants and enhance the risk of slow or ineffective breathing. Patients should be monitored for the signs of slow and ineffective breathing and decrease the dose of Tamol or muscle relaxants as needed.
There may be an interaction of Tamol with monoamine oxidase inhibitors (MAOIs) such as phenelzine, tranylcypromine, linezolid, which are used to treat depression. The use of Tamol with monoamine oxidase inhibitors may cause serotonin syndrome (serotonin-inducing symptoms) and increase the harmful effect of opioid such as coma and slow or ineffective breathing. Tamol should not be used in patients taking MAOIs and within 14 days of stopping the MAOI therapy.
Tamol tablet may interact with warfarin, which is used to treat blood clots. The use of Tamol with warfarin may increase prothrombin time (blood clotting parameter) and ecchymose (bleeding beneath the skin). Patients should take necessary precaution while using Tamol with warfarin. Dosage adjustment of warfarin and regular monitoring of the prothrombin time should be needed in such patients.
Tamol tablet may interact with anticholinergic drugs, which are used to treat asthma, motion sickness, and diarrhea. The use of Tamol with anticholinergic drugs may increase the risk of severe constipation, and inability to empty the bladder, which may cause intestinal paralysis (paralytic ileus). Patients should be monitored for the signs of reduced stomach muscle contractions (reduced gastric motility) and inability to empty the bladder when Tamol is used with anticholinergic drugs.
There may be an interaction of Tamol with digoxin, which is used to treat heart conditions. The use of Tamol with digoxin may increase the harmful effects of digoxin. Patients should be monitored for the signs of harmful effects of digoxin and adjust the dose of digoxin as required.
This page does not contain all the possible interactions of Tamol 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.

Interactions of Tamol by Severity

Severe

The following medicines are usually not to be taken together without consulting with your doctor or pharmacist.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Tamol be not used?

Slow and ineffective breathing

This medicine should not be used in patients with slow and ineffective breathing. These patients are at an increased risk of respiratory arrest and possibly fatal.

Shortness of breath (bronchial asthma)

This medicine should not be used in unmonitored patients with acute or severe bronchial asthma or in absence of resuscitative equipment (a device which provides oxygen to lungs of an unconscious patient).

Stomach or intestinal obstruction

This medicine should not be used in patients known or suspected with stomach or intestinal obstruction such as intestinal paralysis (paralytic ileus). These patients are at an increased risk of obstruction in the flow of digestive juice (spasm of the sphincter of Oddi).

Allergic to Tamol

This medicine should not be used in patients with a history of allergy to Tamol and other opioid drugs. This medicine increase the risk of life-threatening allergic reaction (anaphylaxis) and allergic reactions including severe itching of the skin, hives, tightening of the lungs muscles (bronchospasm), swelling due to fluid accumulation, life-threatening skin reaction (Stevens-Johnson Syndrome), and life-threatening drug-induced skin reaction in patients with a history of allergy to Tamol.

Use of monoamine oxidase inhibitors (MAOIs)

Tamol should not be used in patients taking monoamine oxidase inhibitors (MAOIs) such as phenelzine, tranylcypromine, linezolid in the last 14 days. These patients are at increased risk of slow and ineffective breathing and coma.

Children younger than 12 years

This medicine should not be used in children younger than 12 years. These children are at increased risk of slow and ineffective breathing and coma.

Children younger than 18 years undergone surgery

This medicine should not be used for management after tonsils removal surgery (tonsillectomy) and nasal passage lymphoid tissue removal surgery in the children younger than 18 years. These children are at increased risk of slow and ineffective breathing and coma.

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 Tamol 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 Tamol tablet .
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